Commercial production utilizing flow chemistry began June 2018 at Kaneka Singapore

TOKYO, Aug. 14, 2018 /PRNewswire/ — Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Mamoru Kadokura) have installed continuous manufacturing equipment to be applied to pharmaceutical products at Kaneka Singapore Co. (Pte.) Ltd, (Headquarters: Singapore; President: Kazuhiko Yamada) with commercial production under cGMP already underway as of June 2018.

Kaneka officially starts continuous manufacturing under GMP

In the field of small molecule pharmaceutical products, the recent demands have begun to  trend toward an increased number of more diversified and smaller volume targets. With these changes, more efficient production technology is needed to address the broad range of targets now required. Continuous manufacturing, or Flow Chemistry, is a manufacturing technology that allows the introduction  of raw materials with little to no operator exposure and presents an  easy, safe and convenient approach to manufacturing, including reactions that may require tough or dangerous conditions under typical batch reaction conditions. Our equipment is a unique, Kaneka designed reactor that allows diversity of application through the ability to select the relevant parameters of the reaction tubing based on laboratory and scale-up research providing the highest performance of reactions. Kaneka Singapore has been qualified as a manufacturer from the US FDA *1 in 2017, and we expect to apply this  continuous manufacturing infrastructure to various Regulatory Starting Material (RSM), Intermediate, and API projects, including targets requiring GMP *2 production.

Kaneka has capability from process development to commercial production with excellent quality assurance, and we now aim to expand our solution services in the Health Care business field utilizing this new technology. 

 *1 Abbreviated name of Food and Drug Administration. It is an agency within the Department of Health and Human Services in US and  has responsibility for regulating the manufacturing, marketing, and distribution of pharmaceutical products.
 *2 Abbreviated name of Good Manufacturing Practice, the recommended guidelines and minimum requirements to ensure that products are consistently high in quality.

< Kaneka Singapore Co. (Pte.) Ltd. >
Representative: CEO, Kazuhiko Yamada
Paid-in Capital: 16 million Singapore dollars
Headquarter: Singapore
Establishment: 1979
Business field: Sales and manufacturing of pharmaceutical products.

Contact:
Alan Walker
VP Pharma, Kaneka Americas Holding
(212) 705-4392

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SHENZHEN, China, Aug. 8, 2018 /PRNewswire/ — TIENS Group, one of leading corporations in the Healthcare industry, unveiled a new high-tech Customer Experience Store in Shenzhen. Li Jinyuan, founder and chairman of TIENS group, announced the official opening of its first store in the world on August 3 in Luohu District, Shenzhen. The store offers a unique customer experience through a combination of advanced technology and experiential marketing, allowing visitors to explore the world of TIENS Group and learn how the company’s products positively impact the lives of global consumers. The launch date was chosen to coincide with the company’s 23^rd anniversary.

Two young fashion women pass by the Experiencing center

TIENS’ new interactive customer experience is part of the company’s “One Body, Multiple Wings” strategy for global expansion.  As a large multinational corporation, Li and TIENS recognized the need for their business to be more responsive to the market, consumers, and their needs. To meet this challenge, TIENS Group studied the latest trends in technology and consumer behavior. Their findings showed that many consumers prefer to learn about products through interactive experiences which formed the foundation for the TIENS Experience Store.

Visitors to the TIENS Experience Store are immersed in futuristic technology from the moment they enter. Guests can experience TIENS’ specialty health and lifestyle products through interactive methods such as touch-screen computers and live product demonstrations. TIENS Group simultaneously analyzes visitor behavior with facial recognition and big data analysis to develop specialized omnichannel sales and marketing strategies that meet their customers’ needs.

According to Zhang Zhongtao, president of TIENS Group for Greater China, this effort represents a culmination of more than two decades of persistent innovation. Said Zhang, “Under the guidance of our Chairman, Li Jinyuan, and our ‘One Body, Multiple Wings’ strategy, TIENS Group is creating a model for a better life and a better future.”

Peggy Liu (Liu Yu), head of global strategic planning and operations for TIENS Group, echoed Zhang’s sentiments. Said Liu, “Twenty-three years ago, TIENS set out from China on the path of innovation and brought our strategy of ‘One Body, Multiple Wings’ to countries worldwide. Now, we are bringing our philosophy directly to consumers with the creation of the TIENS Experience Store. For thousands of global consumers, the TIENS Experience Store marks the beginning of a new “Fusion Lifestyle Era,” where technology works for the betterment of our lives.” 

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SHANGHAI, Aug. 9, 2018 /PRNewswire/ — In July, 2018, I-Mab Biopharma (I-Mab) announced that it received clinical trial approval from China National Drug Administration (CNDA) for TJ103 (TG103) injection: an innovative, humanized, long-acting recombinant glucagon-like peptide-1 (hGLP-1) fused with a hybrid Fc (hyFc) for type 2 diabetes treatment

Type 2 diabetes is a common chronic disease characterized by high blood glucose. According to Frost & Sullivan’s data for 2017, there are estimated 120 million people with type 2 diabetes in China. However, only 44% of patients are receiving treatment, and many patients have insufficient blood glucose control; therefore, this chronic disorder has reached a pandemic level and unmet medical needs remain substantial.

Many of the anti-diabetic drugs on the markets are liable for hypoglycemia which is a significant safety concern. Thanks to its low risk of hypoglycemia, GLP-1 analog is an important class of anti-diabetic drug. However, currently no long-acting GLP-1 agonists have been approved in China yet, and the short-acting GLP-1 products on the market need to be injected once or twice daily.

TJ103 promotes glucose concentration dependent insulin secretion and inhibits glucagon production in the body without causing the risk of hypoglycemia. It is also designed molecularly with extended half-life to enable once-weekly or bi-weekly subcutaneous administration, which can significantly improve convenience and as a result to improve patient treatment compliance. In preclinical studies, and the on-going Phase I trial conducted in Germany, TJ103 demonstrated a good safety profile.

I-Mab Biopharma plans to conduct clinical trials in China to comprehensively assess the safety and efficacy of TJ103, as well as exploring the treatment compliance, the quality of life and other potentials, in hopes of bringing the innovative drug to patients with type 2 diabetes in China, which can significantly improve the treatment effect and quality of life of the patients.

About I-Mab

Facilitated by a merger between Third Venture Biotech and Tasgen Bio, followed by a Series B financing of US$150 million in 2017, I-Mab has rapidly built a highly experienced team with world-class R&D capabilities. On June 29, 2018, I-Mab announced that it had successfully raised US$220 million in Series C financing with a group of reputable investors led by Hony Capital, one of the largest amounts ever raised in Series C by an innovative biotech company in China.

I-Mab focuses on discovery and development of First-in-Class and Best-in-Class biologics in the areas of immuno-oncology and immuno-inflammation. The company has already initiated a Phase 2 clinical trial and is prepared to submit multiple IND applications for additional trials in China and in the US, including Phase 2 and Phase 3 studies.

www.i-mabbiopharma.com

Contact: IR@i-mabbiopharma.com, PR@i-mabbiopharma.com

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BEIJING, Aug. 9, 2018 /PRNewswire/ — Shineco, Inc. (“Shineco” or the “Company”) (NASDAQ: TYHT), a manufacturer and distributor of Chinese herbal medicines, organic agricultural products, specialized textiles, and other health and well-being focused plant-based products in China, announced today its Apocynum Fiber and Comprehensive Utilization Industry Park Project (the “Project”) has been included in the official 13th Five-Year Plan of Bayingolin Mongol (“Bazhou”) Autonomous Prefecture. The Project is operated by the Company’s joint venture company, Xinjiang Shineco Taihe Agriculture Technology Ltd. (“Xinjiang Taihe”).

The 13th Five Year Plan describes the strategy for Bazhou’s development for 2016-2020 in the Korla National Economic and Technological Development Zone in Xinjiang and includes concrete targets regarding the environment and efficiency. As a key project of the 13th Five-Year Plan for Bazhou, the Company is expected to invest in the industrialization of Apocynum through its wholly owned subsidiary Shineco Beijing Technology Development Co., Ltd. The initial investment in the Project was approximately RMB1.1 billion and the second phase of investment is expected to be more than RMB4 billion. The Project includes the following, an Apocynum fiber comprehensive extraction plant, a hemp blended fiber plant, an apparel manufacturing plant, a biopharmaceutical plant, a health food factory, a research and innovation center as well as an e-commerce center. The Project is designed to optimize the agricultural industrial structure and industrial development in Bazhou and is expected to make great impact on the local society and the local economy.  

Xinjiang is located in the heart of Eurasia and is a core region of the “One Belt and One Road” infrastructure plan. Within Xinjiang, Bazhou has a good industrial foundation in cotton spinning, weaving and dyeing, and pharmaceuticals. Bazhou’s infrastructure is conducive to the expansion of Apocynum blending, biotechnology and other industries. The Project combines the strengths of Apocynum products with the geographic advantages of Xinjiang, to stabilize the supply chain, and establish more effective distribution and marketing channels to promote the development of Xinjiang’s regional economy and drive the rapid development of the local economy.

Mr. Yuying Zhang, Chairman and Chief Executive Officer of Shineco, stated, “After the signing of the cooperation agreement with the Development Zone Management Committee on November 15, 2017, our ‘Apocynum Fiber and Comprehensive Utilization Industrial Park’ project has progressed rapidly. In March 2018, it was approved by the Economic Development Bureau of the Development Zone. In April, the project was listed by the State of Bazhou as a ’13th Five-Year Plan’ development project. We are excited that our project was included in the local ’13th Five Year Plan’ project by the State of Bazhou and was referred to the provincial government for the Xinjiang Autonomous Region’s ’13th Five-Year Plan’ project. This is very rare in non-state-owned investment projects and demonstrates the importance of the Apocynum industry for local economic development.”

Mr. Zhang continued, “With the strong support and cooperation of local governments in Bazhou, we believe that the development of the Project will be swift. Shineco plans to take on the mission and responsibility of societal development and contribute to the ‘One Belt and One Road’ infrastructure plan. Upon the completion of the Project, we estimate the revenue to reach RMB51.4 billion with a projected investment return at as high as 183.6%.”

About Shineco, Inc.

Incorporated in August 1997 and headquartered in Beijing, China, Shineco, Inc. (“Shineco” or the “Company”) is a Delaware holding company that uses its subsidiaries’ and variable interest entities’ vertically- and horizontally-integrated production, distribution and sales channels to provide health and well-being focused plant-based products in China. Utilizing modern engineering technologies and biotechnologies, Shineco produces, among other products, Chinese herbal medicines, organic agricultural produce and specialized textiles. For more information about the Company, please visit  www.tianyiluobuma.com.

Forward-Looking Statements

This press release contains information about Shineco’s view of its future expectations, plans and prospects that constitute forward-looking statements. Actual results may differ materially from historical results or those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets into its portfolio of products and services, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the technical skills and experience necessary to meet the requirements of its clients, and its ability to protect its intellectual property. Shineco encourages you to review other factors that may affect its future results in Shineco’s registration statement and in its other filings with the Securities and Exchange Commission.

For more information, please contact:

Tina Xiao
Ascent Investor Relations LLC
Phone: +1-917-609-0333
Email: tina.xiao@ascent-ir.com

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New NCCN Guidelines for gestational trophoblastic neoplasia created to ensure pregnant women with cancer receive life-saving treatment while preserving fertility.

FORT WASHINGTON, Pennsylvania, Aug. 9, 2018 /PRNewswire/ — The National Comprehensive Cancer Network^® (NCCN^®) has released new treatment guidelines for a group of rare cancers that impact women during pregnancy. Gestational trophoblastic neoplasia (GTN), also known as gestational trophoblastic disease (GTD), can occur when tumors develop in the cells that would normally form the placenta during pregnancy. It happens in approximately one out of every 1,000 pregnancies in the United States, though it is more common in many Asian and African countries. Due to the rare nature of this condition, and the small number of specialists worldwide, providers often are not aware of how to provide the best care for people with GTN.

“These guidelines are sorely needed,” explained David Mutch, MD, Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, who leads the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) Committee for GTN. “By compiling expert consensus, we can standardize the way this uncommon disease is treated. When treated properly, GTN can almost always be cured, but deviating from that standard can have severe consequences. Plus, by providing clear instructions for how best to treat GTN, we can streamline the insurance approval process for more efficient care.”

The NCCN Guidelines^® for GTN details treatments for several variations of the disease. For molar pregnancy (also known as a hydatiform mole, a rare mass that can form inside the womb during early pregnancy, resulting in an abnormal fetus), surgery is the first, and often only treatment required. It is generally performed via suction dilation and curettage. Low-risk GTN is primarily treated with single-agent chemotherapy, although additional chemotherapy or surgery may be required for persistent disease. With high-risk GTN, treatment typically involves multi-agent chemotherapy, with possible radiation therapy for brain metastasis. Surgery can be used for chemotherapy-resistant disease.

Dr. Mutch was joined on the GTN Committee by John Lurain, III, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University and R. Kevin Reynolds, MD, University of Michigan Rogel Cancer Center. The committee is a subset of the larger NCCN Guidelines Panel for Cervical, Uterine, and Vulvar Cancers, of which all three are members.

“We’re fortunate to have several recognized experts in GTN on our panel,” said Wui-Jin Koh, MD, Seattle Cancer Care Alliance, Chair of the NCCN Guidelines Panel for Cervical, Uterine, and Vulvar Cancers, and incoming Chief Medical Officer for NCCN. “These rare, potentially aggressive malignancies are highly curable. That’s why it’s so important to correctly diagnose, treat, and monitor people with GTN. When patients are appropriately managed — as described in these standardized guidelines — not only do they generally achieve excellent long-term outcomes, but fertility can also be preserved for the majority of patients.”

“If someone with a rare type of cancer doesn’t live near one of the world’s experts on that disease, it doesn’t mean their treatment path can’t be based on that expertise,” said Robert W. Carlson, MD, Chief Executive Officer, NCCN. “NCCN Guidelines provide care recommendations for 97 percent of all cancer patients, plus numerous additional recommendations covering screening, prevention, and supportive care. We have plans to add several more new guidelines in the next year, to build out our library of NCCN Harmonized Guidelines for regions with different resource levels, and to publish more translations for non-English speaking clinicians. We know that people with cancer all over the world are relying on NCCN Guidelines to make sure they get the best possible care for their cancer.”

The NCCN Guidelines for GTN bring the total number of NCCN Guidelines to 72. They are available free-of-charge online at NCCN.org or via the Virtual Library of NCCN Guidelines mobile app for smartphones and tablets. NCCN Guidelines are the most frequently-updated medical guidelines in the world, with new versions released at least once a year, and more often as needed. These evidence and expert consensus-based guidelines are downloaded millions of times a year by oncologists and other clinicians worldwide.

About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network^® (NCCN^®), a not-for-profit alliance of 27 leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.

The NCCN Member Institutions are: Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope National Medical Center, Duarte, CA; Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Comprehensive Cancer Center, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children’s Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Rogel Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Wisconsin Carbone Cancer Center, Madison, WI; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.

Clinicians, visit NCCN.org. Patients and caregivers, visit NCCN.org/patients. Media, visit NCCN.org/news. Follow NCCN on Twitter @NCCNnews and Facebook @National.Comprehensive.Cancer.Network.

Media Contact:
Rachel Darwin
267-622-6624
darwin@nccn.org

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First American Company Shipping Veggie-Infused Milk Drinks Into China With ‘Organic’ Clearly Stated On Packaging In Compliance To Chinese Regulations

JUPITER, Florida, Aug. 10, 2018 /PRNewswire/ — Sneakz Organic LLC, makers of the award-winning line of vegetable-infused milkshakes, is proud to announce that is has achieved what many thought was impossible: Obtaining the prized China Organic Certification. Different from the U.S. classification of what makes a product organic, the PRC (People’s Republic of China) lists the ingredients that you can use, as opposed to what you cannot use; so if an ingredient is not included on the list prior, the company must work to adjust its formula or work to get the ingredient approved before they can receive the certification. As such and in just 22 months, Sneakz Organic was able to create a brand new category of product and add two of its ingredients to the approved list in order to receive this esteemed certification.

Sneakz Organic Achieves Organic Certification in China for New Category of Vegetable-Infused Milkshakes

Sneakz Organic Milkshakes are made with a propriety blend of USA-certified organic vegetables and other nutrients such as high protein to help kids get their daily serving of veggies in a “good for you, fun for you” way. The flavorful shakes are shelf-stable and delivered in a convenient on-the-go style packaging so that families can enjoy them anytime, anywhere. Sneakz currently offers three flavors; chocolate, strawberry and vanilla.

“The time has finally come.  It’s been an incredible 22 months to get us to where we are today and being one of few to achieve organic certification in China we’re extremely pleased with the accomplishment.  From day one we had a clear ‘no debate’ mindset entering into this journey, where we were heart set against removing the word ‘organic’ from our packaging for the Chinese market,” says Jim Costa, principal at Sneakz Organic LLC. “Our milkshakes met all the criteria by every definition, whether it was the formulation, ingredients, process, milk supply, manufacturing, warehousing, etc.”

This certification carries much meaning for the Sneakz team. As they continue to expand their presence in the U.S. market and grow the brand offerings, the young company also is hoping to extend its international footprint. While the U.S. continues as Sneakz Organic’s core market, there is significant opportunity in regions with growing nutritional needs, especially for children in Asian markets with extreme milk deficits. Leveraging the enhanced productivity and output of U.S. dairy – specifically the quality and price advantage – Sneakz is hoping to support these struggling countries and bring its veggie-infused milkshake-style beverages to as many kids and families as possible.

In addition to Sneakz Organic Milkshakes, the company currently offers a non-dairy, vegan protein drink mix that also features a half-serving of the organic vegetable blend, high protein content and GanedenBC30 probiotics. Sneakz will introduce a new meal replacement powder mix in the fall of 2018 as well.

“We are very focused on delivering quality products that are healthy, good tasting and put smiles on kids’ faces,” says Jeff Robbins, CEO of Sneakz Organic LLC. “Both Jim and I have been in business a long time, but at the end of the day, our biggest joy is seeing a mom give her little ones a Sneakz Organic Milkshakes and seeing them light up with excitement. Knowing that it not only makes kids happier, but also healthier, makes all the difference. We hope to continue growing the brand and helping to make the world a little better than it was when we first entered it.”

Sneakz Organic LLC will begin shipping its vegetable-infused milkshakes to the Chinese market in September 2018. To learn more about Sneakz Organic LLC, visit www.sneakz.com.

PRESS CONTACT:

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BEIJING, Aug. 10, 2018 /PRNewswire/ — With the expansion of healthcare reform and the increase in consumption, China’s medical health services have guided multi-dimensional innovation and advancement. It is estimated that by 2030, the scale of China’s health service industry will reach 16 trillion. The health & wellness market has called for cross-regional modernization and accelerated expansion of the industry circle.

On June 27, 2018, representatives from more than a dozen well-known health & wellness corporations, medical institutions, hospitals, VC and start-up companies around the world gathered in Shanghai to participate in the 2018 Plug and Play China Summer Summit – Sino-U.S. Health & Wellness Summit. It was hosted jointly by Plug and Play with Deloitte China and Fosun Technology Innovation Center to discuss the frontiers of investment and technological innovation in the healthcare industry. The summit also received support from the Shanghai Biomedicine Technology Industry Promotion Center and Shanghai Pudong International Chamber of Commerce.

A group full of talents

Dozens of “superstars” in the health & wellness industry gathered at the Sino-US Health & Wellness Summit, including:

• Deloitte China
• Fosun Pharma
• Philips Healthcare Innovation Centre
• Johnson & Johnson China
• Medlmmune
• Green Leaf Group
• Pfizer
• Shanghai Second Military Region University
• Changzheng Hospital
• Yueyin Capital
• 3E Bioventures Capital
• SBCVC
• K2VC
• Feifan Capital
• Fudan University
• Xi’an Jiaotong-Liverpool University
• Shanghai Huangpu District Government
• Shanghai Center of Biomedicine Development
• United Nations Industrial Development Organization (Shanghai)
• Shanghai Pudong International Chamber of Commerce.

As seen by many industry leaders, Plug and Play China kicked off the Health & Wellness summit opening ceremony by formally announcing the introduction of original businesses in the health & wellness verticals of China and further expanding upon its innovative eco-environment layout.

Peter Xu, president and managing partner of Plug and Play China, stated, “China’s economic development, aging status, and government’s promotion all provide developmental soil for the healthcare industry. Many companies from overseas want to enter China, and domestic health care companies are actively seeking targets for overseas import, investment, mergers and acquisitions. Plug and Play have been deeply involved in Silicon Valley for so many years that they have a precise understanding of healthcare technology. It is the right time for us to build such a bridge connecting China and the world.”

According to Julia Belaya, Director of Health and Wellness at Plug and Play Silicon Valley, Plug and Play’s global healthcare innovation platform was established in 2016. After only two years of development, it has entered partnerships with more than 20 well-known health & wellness companies worldwide. In 2017, Plug and Play invested in more than 30 health and medical technology innovation projects.  Presently, the Health & Wellness vertical has come to China to help industry-related companies around the world to succeed in China. Rahim Amidi, CEO and founder of PNP, and Dr. Xiaochun Chen, PNP China Co-founder, also attended the summit.

“Deloitte China has been in close collaboration with Plug and Play for a long time. We believe that by combining the experience and insights of both parties, it can help set a new trend for the industry and the direction of innovation development, as well as to build connections amongst large companies and start-ups that contribute to a revolutionary innovative ecosystem.” Yu Chao, the managing partner of Deloitte China Life Sciences and Medical Industry Management Consulting, also attended the event and discussed the “application of artificial intelligence in health & wellness fields.” The keynote speech pointed out that “the development of artificial intelligence is gradually infiltrating into products and services in various industries, but data and application have become the bottleneck of current AI development, and the maturity of the underlying technology still needs huge improvement.”

Shen Yun, Assistant President of Fosun and Executive Director of Fosun Technology Innovation Center, said at the summit, “Fosun is committed to promoting the application of advanced science and technology for the health, happiness and prosperity in families around the world, while providing solutions for the satisfaction of families. In the near future, combining Fosun’s industrial connections and the global science and technology acceleration platform of Plug and Play. Fosun Technology Innovation Center will strategically cooperate with Plug and Play, especially in the field of health.” Xu Zhe, Vice President and General Manager of Strategy Department of Fosun Health Holdings, also attended the event and shared thoughts on the theme of “Fosun Medical Health Investment”.

In the future, Plug and Play China will cooperate with Deloitte China and Fosun Technology Innovation Center to boost the development of China’s health industry.  Plug and Play China continues to connect corporates and startups from different industries as a leading accelerator for unicorns.

Plug and Play China: Embracing Open Innovation

The health & wellness industry is a microcosm of the current state of innovation in China. With the development of digital advancements and the integration of cutting-edge technologies such as artificial intelligence, Internet of Things, big data, blockchain, and traditional industries has broadened significantly. Moreover, the definition of boundaries in the industries are changing; more and more cross-border innovations are taking place. Plug and Play China is committed to accelerating this type of innovation.

Plug and Play puts forward the concept of “Innovation, Entrepreneurship and Venture”. In other words, the “Innovation” of large enterprises, the “Entrepreneurship” of entrepreneurial teams and the “Venture” of capital, which together form a solid “triangle” of a virtuous innovative ecosystem. At Plug and Play, cross-industry and cross-field enterprises are matched based on actual application scenarios and technical needs. The entrepreneurial teams can also directly interact with CEOs and CTOs of corporations in depth and simultaneously explore the possibility of technology landing in the unique Unicorn Accelerator.

Based on this “triangulation law,” Plug and Play is committed to maximizing the value in innovation and promoting the revolution and advancement of the industry. Just like Peter Xu said, “Ecology boosts innovation; innovation beautifies ecology.”

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HSINCHU, Taiwan and WUHAN, China, Aug. 10, 2018 /PRNewswire/ — JHL Biotech has announced it received a positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for its proposed bevacizumab biosimilar, JHL1149 to treat patients with non-small cell lung cancer (NSCLC).

The EMA, like other regulatory authorities such as the U.S. Food and Drug Administration and State Drug Administration of China (SDA), adopts the principle of a step-wise approach and the totality of the evidence from all studies in regulating the development and approval of biosimilars. In its correspondence to JHL, the EMA confirmed it agrees with JHL’s development approach, clinical development proposal, and study design of the global Phase III clinical study for JHL1149 in patients with non-small cell lung cancer (NSCLC). Based on the EMA’s review of these factors, the results of the Phase III clinical study will be acceptable for the submission of a Marketing Authorization Application as a biosimilar product, assuming the Phase III trial is completed successfully.

About JHL Biotech
JHL Biotech, Inc. is a biopharmaceutical company founded by a group of industry veterans with deep experience in biologics development and operations. With a mission to provide the world with affordable medicines of exceptional quality, the company is focused on research and development of new protein-based therapies and biosimilars. JHL Biotech’s experienced leadership team, ongoing global clinical trials for its pipeline of biosimilar candidates and two Asia-based world-class biologics manufacturing facilities built in accordance with United States, European Union, and ICH cGMP regulations and standards uniquely position the company to be a leading global supplier of high quality biologics. JHL Biotech is backed by premier financial firms, including Kleiner Perkins Caufield & Byers, Sequoia Capital, Biomark Capital, Milestone Capital, Fidelity and the China Development Industrial Bank. For more information, please visit www.jhlbiotech.com.

Media Contact
Jill Liu | Email: jliu@jhlbiotech.com | Phone: +86-27-87879208
Amber Chen | Email: achen@jhlbiotech.com | Phone: +886 3-658-3899
Lee Henely | Email: lhenely@jhlbiotech.com | Phone: +886 3-658-3899

Forward-Looking Statement
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. JHL undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond the control of either company. Actual results or outcomes may differ materially from those implied by the forward-looking statements.

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HSINCHU and WUHAN, China, Aug. 10, 2018 /PRNewswire/ — JHL Biotech has announced it received a positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for its proposed trastuzumab biosimilar, JHL1188, to treat breast cancer.

The reference biologic trastuzumab is a humanized monoclonal antibody designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential when it is overexpressed. Given on its own as monotherapy, as well as in combination with or following standard chemotherapy, trastuzumab has been shown to improve overall survival, response rates, and disease-free survival while maintaining quality of life in women with HER2-positive breast cancer. The reference innovator biologic achieved approximately US$7 billion in sales globally in 2017 accordingly to publicly available sources.

The EMA, like other regulatory authorities such as the U.S. Food and Drug Administration and State Drug Administration of China (SDA), adopts the principle of a step-wise approach and the totality of the evidence from all studies in regulating the development and approval of biosimilars. In its correspondence to JHL, the EMA confirmed it agrees with JHL’s development approach, clinical development proposal, and study design of the global Phase III clinical study for JHL1188 in patients with metastatic breast cancer. Based on the EMA’s review of these factors, the results of the Phase III clinical study will be acceptable for the submission of a Marketing Authorization Application as a biosimilar product, assuming the Phase III trial is completed successfully.

About JHL Biotech
JHL Biotech, Inc. is a biopharmaceutical company founded by a group of industry veterans with deep experience in biologics development and operations. With a mission to provide the world with affordable medicines of exceptional quality, the company is focused on research and development of new protein-based therapies and biosimilars. JHL Biotech’s experienced leadership team, ongoing global clinical trials for its pipeline of biosimilar candidates and two Asia-based world-class biologics manufacturing facilities built in accordance with United States, European Union, and ICH cGMP regulations and standards uniquely position the company to be a leading global supplier of high quality biologics. JHL Biotech is backed by premier financial firms, including Kleiner Perkins Caufield & Byers, Sequoia Capital, Biomark Capital, Milestone Capital, Fidelity and the China Development Industrial Bank. For more information, please visit www.jhlbiotech.com.

Media Contact
Jill Liu | Email: jliu@jhlbiotech.com | Phone: +86-27-87879208
Amber Chen | Email: achen@jhlbiotech.com | Phone: +886 3-658-3899
Lee Henely | Email: lhenely@jhlbiotech.com | Phone: +886 3-658-3899

Forward-Looking Statement
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. JHL undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond the control of either company. Actual results or outcomes may differ materially from those implied by the forward-looking statements.

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TOT BIOPHARM’s high-end oncology drug technology platform garners great attention

SUZHOU, China, Aug. 8, 2018 /PRNewswire/ — TOT BIOPHARM Company Limited (“TOT BIOPHARM”), headquartered in Suzhou Industrial Park, China, today announced the completion of a Series B financing round, raising US$102 million in capital. The financing round was supported by China Universal (Cayman) GP Limited and several renowned domestic and foreign investors, as well as investors who had participated in earlier rounds, including Center Laboratories Group, Vivo Capital, Chengwei Capital, Yuanta Financial Holdings Group and Cathay Capital. TOT BIOPHARM focuses on the R&D, manufacturing and marketing of high-end anti-tumor drugs. The company now has over 10 drugs in the R&D stage, including three biologics and three small molecules, which have received investigational new drug application (IND) approvals, as well as one antibody-drug conjugate (ADC), which is expected to receive approval soon. All project pipelines are meeting their milestones and all products on the roadmap are expected to reach the market according to their planned timelines.

TOT BIOPHARM general manager Gloria Huang said, “With the completion of this round, we are very pleased to see that our achievements to date as well as what we foresee for the future have been recognized by several renowned domestic and foreign investors and continue to receive the support of our existing shareholders. The financing will allow us to accelerate development of our key pipelines. TOT BIOPHARM is taking advantage of the high-speed growth opportunities in China’s oncology market. In the future, we will also utilize the existing advantages of our established platforms to expand multi-perspective partnerships and cooperation at different levels, so that the benefits of resource integration will be maximized.”

Vivo Capital, a major shareholder of TOT BIOPHARM, has partnered with the Series B investment team spanning several projects across multiple sectors. Existing shareholders and several renowned investors participated in the Series B round, fully demonstrating that investors have confidence in TOT BIOPHARM’s current achievements and future prospects. As a hi-tech company with the advantage of having built an integrated product R&D, manufacturing and marketing platform in the Chinese anti-tumor drug market, TOT BIOPHARM has been at the forefront of technological innovations and expansion into international markets for many years, and, as a result of having held steadfast to this approach, has achieved solid and steady progress. The firm has entered into strategic partnerships with several top-tier companies in the global anti-tumor sector. The completion of the Series B round will serve to accelerate the R&D of new products as well as the commercialization of existing ones, greatly improving TOT BIOPHARM’s competitive power and value.”

TOT BIOPHARM recently announced results of the Phase I clinical trial (double-blind, head-to-head pharmacokinetics and safety comparisons) of Bevacizumab biosimilar, TAB008, at ASCO 2018, demonstrating that both in pharmacokinetics and safety indicators, TAB008 shows high similarity to Avastin®. TAB008 is now in Phase III clinic trial, and, in terms of progress, TOT BIOPHARM is among the top three firms in China competing to get the drug on market. The financing will further accelerate the progress of TAB008’s Phase III study, as well as other R&D programs. The IND application for TAA013, an ADC, submitted by TOT BIOPHARM, is currently in the review process. With the higher threshold for manufacturing ADCs, the number of companies in China that can produce such drugs is quite limited. However, TOT BIOPHARM has its own manufacturing technologies and capability. The firm is in the process of ramping up production of its third-generation innovative oncolytic virus drug TVP211. Combined with its domestically leading BSL-2 certified virus manufacturing plant, TOT BIOPHARM plans to further accelerate the development program, taking a leadership position in this promising technology sector.

The construction of TOT BIOPHARM’s second-phase project – the monoclonal antibody R&D and manufacturing base was completed and put into operation in May 2018. The base, with a planned cell culture scale of up to 16,000L, was built in full compliance with international standards. Plans call for the establishment of three preparation production lines, responsible for the filling of drugs with different specifications. The facility also plans to successively launch a pre-filled preparation line, a lyophilized preparation line and a Grade OEL-5 plant for the mass production of ADC. The facility also has the flexibility to expand production capacities and adjust the layout of the production areas. Combining the existing 500L pilot plant, the facility is prepared to meet all demands for biologic drugs, from upstream R&D, pilot manufacturing, and clinical trial drugs to commercial production. 

The completion of the financing is a major milestone in TOT BIOPHARM’s efforts to accelerate commercialization of product pipelines. Together with the international standards-compliant monoclonal antibody R&D and manufacturing base, TOT BIOPHARM will open its platforms for collaboration, making it the most distinctive company and the best strategic partner in the high-end oncology field.

About TOT BIOPHARM

Founded in 2010, TOT BIOPHARM COMPANY Ltd. is headquartered in Suzhou Industrial Park in China. It is a bio-pharmaceutical company specializing in developing, manufacturing and commercializing oncology drugs.

TOT BIOPHARM has 3 technology platforms: (1) monoclonal antibodies/ ADCs, (2) oncolytic virus products, and (3) specialty anti-cancer drugs (liposomal drugs). 4 mAbs and 3 small molecules INDs were submitted, and 6 INDs have been approved by CFDA. A Phase III study of a mAb is ongoing.

TOT BIOPHARM established a competitive oncology drugs R&D and manufacturing base in Suzhou Industrial Park. The stage 1 construction includes a 500L-biologic pilot plant, OEL-5 isolator for ADCs, BSL-2 certified viral facility, and small molecule plants (oral and injectable). The Stage 2 construction is a state- of-the-art antibody R&D and manufacturing base with 16,000L capacity to accommodate the high-quality commercial manufacturing.

TOT BIOPHARM upholds its philosophy, “A Balance between Humanity and Technology”, and strives to break through high-tech barriers and develop economical new medication. The company focuses on affordable anti-cancer drugs, and offers patients the most suitable products at a reasonable price. Our ultimate goal as an anti-cancer corporation is to “Help cancer patients achieve mental and physical wellness”. For more information, please visit the company’s website http://www.totbiopharm.cn.

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