• Produced 7 batches at 6,000L/12,000L bioreactor scale for three programs, the largest scale cell culture operations in China at 100% success rate in MFG2, the largest biologics manufacturing facility globally leveraging single-use technology
• Process validation in MFG2 is a key milestone of the innovative “scale-out”, instead of “scale-up” approach for large scale manufacturing 
• Combining multiple single-use bioreactors achieved competitive COGS to traditional stainless steel bioreactor facilities

WUXI, China, July 31, 2018 /PRNewswire/ — WuXi Biologics (2269.HK, WuXi Bio), a leading global open-access biotechnology platform company, offering end-to-end solutions for discovery, development and manufacturing, today announced that a process validation campaign at the 6,000L scale has been initiated to support global product registration and launch for a key partner in the fed-batch facility of MFG2, the 2^nd cGMP manufacturing facility of WuXi Biologics.

The 500,000 sq. ft. state-of-the-art facility, the largest global operation of its kind deploying 14 x 2,000L single-use bioreactors, was completed in the record time of 18 months from the conceptual design to its inaugural cGMP campaign. It implements the pioneering approach of combining multiple 2,000L bioreactor harvests to enable production runs to reach either 6,000L or 12,000L (i.e. “scale-out” instead of “scale-up”), a strategy that was executed under an accelerated construction timeline, at significantly lower CAPEX, and with the elimination of bioreactor scale-up challenges. Since coming online in December 2017, a total of seven batches for three different programs at either the 6,000L or 12,000L scale have been produced. This facility also successfully passed the client’s pre-process validation audit, a critical step in the final stage of product development prior to its BLA filing.

“We are excited to achieve two memorable milestones for WuXi Biologics. The first is to attain definitive affirmation of our innovative approach to large scale commercial manufacturing. With this design concept, we will reach comparable COGS of commercial scale stainless steel bioreactor-based facilities, only much more expeditiously and with less capital investment. By this strategy, we will have approximately 220,000L of bioreactor capacity to provide our global partners with a robust supply chain of premier quality in 2021,” said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. “The 2^nd milestone is that we have successfully run multiple campaigns at both 6,000L and 12,000L scales, the largest scale operations in China. Possessing widely acclaimed technical capabilities and unparalleled capacities, we continue to transform how complex biologics are developed and manufactured globally.”

About WuXi Biologics

WuXi Biologics, a Hong Kong-listed company, is the only open-access biologics technology platform in the world, offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. As of the end of 2017, there were a total of 161 integrated projects, including 90 projects in pre-clinical development stage, 62 projects in early-phase (phase I and II) clinical development, 8 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2021, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.

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SANTA BARBARA, California, July 26, 2018 /PRNewswire/ — Direct Relief today launched a Facebook fundraiser to provide medical care to Rohingya mothers and children in the world’s largest refugee camp.

A Rohingya woman and her child walk towards Hope Field Hospital For Women in Madhuchara camp on January 18, 2018, in Cox’s Bazar, Bangladesh. (Photo by Rajib Dhar for Direct Relief) (PRNewsfoto/Direct Relief)

Mass violence in Myanmar has forced hundreds of thousands of Rohingya people to flee their homes with only what they could carry, seeking refuge over the border in Bangladesh.

More than 600,000 Rohingya people are now living in the Kutupalong-Balukhali refugee camp. While striving to secure shelter and sustenance, their already precarious situation is compounded by extreme weather, including monsoon rains and cyclones that pound Bangladesh every year and have turned the refugee camps into mud fields.

Medical care for the Rohingya is extremely limited, with few places for women and children to receive medical treatment. Parents need health facilities to treat their children when they are sick and soon-to-be mothers need regular care and potential life-saving treatment when giving birth.

That is why Direct Relief is raising support for the Hope Foundation for Women & Children of Bangladesh, a local health organization providing critical care to the Rohingya.

From July 25 through August 10, Direct Relief will match every donation made to Hope Foundation on Facebook, up to a maximum of $100,000. Facebook has waived all processing fees for fundraisers hosted on the platform, meaning Hope Foundation will receive 100 percent of donations made through fundraiser.

The fundraiser page is available at this link: Rally for the Rohingya People

When Rohingya communities began fleeing into Bangladesh, Hope Foundation was already providing free health care at its established maternity hospital on the outskirts of Cox’s Bazar, more than an hour’s drive from the nearest refugee camp. Seeing the urgent medical needs among the newly arrived refugees, Hope Foundation rapidly scaled up its operation, establishing maternal health clinics across the camp and beginning work on a field hospital.

If the Hope Foundation receives the funds needed to complete construction and purchase medical equipment, the field hospital each month will be able to safely deliver more than 100 babies, provide prenatal care to 400 women, and serve more than 6,000 outpatients. The facility will be the first field hospital of its kind, providing critical care, reducing travel time to the nearest medical clinic, and increasing the overall health of refugees in the camp.

Because many patients find it difficult or impossible to travel, Hope also manages six to nine outreach clinics at any given time, making every effort to reach pregnant women and new mothers in the camps who cannot trek to health facilities. Hope also operates four ambulances and a fleet of 20 tomtoms (three-wheeled vehicles) to shuttle patients. As the rains worsen and walking becomes more treacherous, these transport options will become increasingly important.

For more information on the Hope Foundation, please see the following articles:

About Direct Relief

Established in 1948 with a mission to improve the health and lives of people affected by poverty or emergencies, Direct Relief delivers lifesaving medical resources throughout the world—without regard to politics, religion, ethnic identities, or ability to pay. With operations spanning more than 70 countries and all 50 states in the U.S., Direct Relief is the only charitable nonprofit to obtain Verified Accredited Wholesale Distributor (VAWD) accreditation by the National Association of Boards of Pharmacy. Among other distinctions, Direct Relief earns a perfect score of 100 from independent evaluator Charity Navigator, was listed among the world’s most innovative nonprofits by Fast Company, and has received the CECP Directors’ Award, the Drucker Prize for Nonprofit Innovation, and the President’s Award from Esri for excellence in GIS mapping. For more information, please visit https://www.DirectRelief.org.

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SUZHOU, China, July 30, 2018 /PRNewswire/ — CStone Pharmaceuticals (CStone) today announced that its IND application for CS3006, a small-molecule inhibitor of mitogen-activated protein kinase (MEK), has been approved by the China National Drug Administration (CNDA) for clinical trials, just 3 months after the CNDA accepted the IND application.

“It’s a great honor for us that the CNDA has granted a special approval for CS3006, so that the clinical trials of CS3006 can be conducted in China soon,” noted Dr. Frank Jiang, Chief Executive Officer of CStone. “CS3006 is a highly selective MEK 1/2 inhibitor independently developed by CStone. It’s also the second candidate drug for clinical trials both in China and overseas following CS1003. Together, they laid a solid foundation for accelerating the global presence of CStone.”

“In a range of preclinical pharmacodynamic, pharmacokinetic, and toxicological experiments, we have already obtained abundant data about CS3006 to support the proposed clinical trials. In particular, CS3006 has demonstrated good pharmacokinetic properties as well as promising synergistic activity when combined with our anti-PD-1 antibody (CS1003),” said Dr. Jon Wang, Chief Scientific Officer of CStone. “All these data provided solid support for the quick CNDA approval of CS3006 clinical trial application. As next steps, we will accelerate the clinical trial process for CS3006 in China, work diligently to explore combination potentials of CS3006 with other drug candidates in our pipeline to develop novel and more effective therapies to benefit more patients.”

About the MEK pathway

The RAS-RAF-MEK-ERK signal transduction pathway is among the most fundamental intracellular signaling pathways found in the majority of cells and is responsible for regulating key cellular activities such as cell growth, proliferation, survival, and apoptosis. MEK1 and MEK2 are serine/threonine protein kinases that act downstream of RAS and RAF to activate ERK. The inhibition of MEK can affect tumor cell survival, proliferation, and differentiation. Currently, three MEK inhibitors have been approved and marketed globally: Novartis’s MEKINIST® (trametinib), Roche’s COTELLIC® (cobimetinib) and Array’s Mektovi (binimetinib).

About CStone Pharmaceuticals

CStone Pharmaceuticals is a clinical stage biopharmaceutical company devoted to the development of innovative drugs. With a broad pipeline, the company engages in the development of cancer therapeutics with a special focus on immuno-oncology based combination therapies. All members of the management team are seasoned executives from top multinational pharmaceutical companies. CStone has successfully built up its core competency in clinical development and translational medicine. The company is backed by prestigious VC/PE funds via two financing rounds to date, raising $150 million in a Series A round in July 2016, followed by $260 million in a Series B round in May 2018. With an experienced team, a rich pipeline, a robust R&D model, and substantial funding, CStone is well positioned as the partner of choice for multinational pharmaceutical / biotech companies to develop drugs in China and the Asia-Pacific region.

For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com

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Source: Foresee Pharmaceuticals Co., Ltd.

– Lactic acid bacteria, green onion and ginger in kimchi serve as natural antiviral agents, highly effective in preventing influenza.

– Kimchi has the greatest antiviral effect when it is the most delicious (best fermentation periods).

– When the SARS epidemic swept China, some argued that kimchi had safeguarded Koreans against the epidemic.

– A joint research team from the Korea Food Research Institute and the World Institute of Kimchi proved kimchi’s effectiveness against flu for the first time in the world.

SEOUL, South Korea, July 26, 2018 /PRNewswire/ — Kimchi, a well-known traditional fermented Korean food, is highly effective in preventing influenza virus in winter, according to the results of cell·animal experiments.

A joint research team from the Korea Food Research Institute and the World Institute of Kimchi recently announced that lactic acid bacteria and fermentation metabolites in kimchi inhibit the growth of influenza virus — proving kimchi’s effectiveness against flu for the first time in the world, along with the genetic information of strains(metagenome), fermentation metabolites, and bioactive mechanism.

Flu viruses are pathogens that cause acute respiratory conditions in winter. Swine flu (influenza A), which struck the world in 2009, and avian influenza (AI), which recently infected poultry in some countries, are two strains of influenza viruses. Due to mutation of virus, the prevention of flu from these kinds of viruses is so difficult, and infections caused by them are difficult to treat as well.

The research team, which consists of Dr. Kim, In-Ho (Korea Food Research Institute), Dr. Choi, Hak-Jong (World Institute of Kimchi), Korea University College of Medicine, and Dr. Ryu, Byung Hee (Daesang Corp., one of the leading food producers in Korea), collected kimchi samples at each fermentation stage (less-fermented, well-fermented, and over-fermented) and injected them into flu virus-infected cells and animals.

In this study, extracts from the kimchi sample at the ‘well-fermented’ stage (about 3-7 days after kimchi is made, when kimchi tastes best) were administered to cells infected with the influenza virus (H1N1) and the avian influenza virus (H7N9). In all of the cells, plaque formation significantly reduced, which means that the growth of the flu virus had been inhibited.

In the animal experiment where flu virus-infected mice were fed kimchi extracts, the rate of suffering from weight loss due to the flu also declined. In addition, the survival rate of the mice who consumed kimchi extracts was 30% higher than those who did not.

Dr. Kim, In-Ho of Korea Food Research Institute said, “Lactobacillus plantarum, which is produced in large quantities during the fermentation of kimchi, and its sub-ingredients such as green onion and ginger are thought to hinder the growth of influenza virus. We concluded that bioactive compounds from lactic acid bacteria produced by kimchi fermentation serve as antiviral agents by affecting the virus membrane surface or promptly activating immune cells mobilization.” He added, “Our study is the world’s first that scientifically verified kimchi’s effectiveness against influenza viruses such as swine flu and AI viruses. In addition, we succeeded in isolating useful and safe lactic acid bacteria from kimchi, contributing to broadening its industrial applications. In other words, this can be applied not only to fermented foods including kimchi, paste, and liquors but also to animal feeds, and food and drug materials. It can also lay the milestone for the development of fermented foods and strains optimized for the constitution of Koreans, through analysis of microbial genome and metabolites in fermented foods as well as mechanism. As such, we have launched new food products in partnership with Daesang corp, aiming to contribute to safeguarding Koreans against virus threats of modern society and to strengthening Korea’s competitiveness as the birthplace of kimchi.”

In 2003, SARS (Severe Acute Respiratory Syndrome) was pandemic in many parts of the world including Hong Kong and mainland China, except for Korea where very few people were infected with the virus. Regarding this, some argued that kimchi has an antiviral effect. The results of the study (Effects of heat-killed Lactobacillus plantarum against influenza viruses in mice) were published in the February 2018 issue of the Journal of Microbiology.

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SHANGHAI, July 26, 2018 /PRNewswire/ — I-Mab Biopharma (“I-Mab”), a company focusing on innovative biologics in immuno-oncology and immuno-inflammation, and ABL Bio Corporation (“ABL Bio”), a South Korean biotechnology company, today jointly announced that two companies had entered into a strategic partnering agreement for ABL Bio to in-license the global rights excluding Greater China to I-Mab’s bispecific antibodies (BsAb) of undisclosed target with licensing payments of approximately US$100 million in total. The two companies also agreed on a collaboration to co-develop additional BsAbs as part of the partnership.

I-Mab Biopharma and ABL Bio Announce Global Collaboration on Innovative Bispecific Antibodies

Under the terms of the agreement, ABL Bio will pay US$2.5 million in upfront payment. I-Mab will also receive research & development, regulatory and sales-based milestone payments, which could result in aggregate payments of US$100 million from ABL Bio. In addition, ABL Bio will pay tiered royalties on net sales. The partnership also includes three more collaborative bi-specific antibody projects. I-Mab and ABL Bio will share the development cost as well as rights in China, South Korea and rest of the world in different configurations.

I-Mab Biopharma and ABL Bio Announce Global Collaboration on Innovative Bispecific Antibodies

“This partnership with ABL Bio is a latest addition to our growing portfolio of global partnerships spanning from early stage projects to clinical assets. We are very pleased to work with ABL Bio for their cutting-edge discovery and antibody engineering platform for novel therapeutic antibodies,” said Jingwu Zang, the founder and CEO of I-Mab. “Bi-specific antibody truly represents the next wave biologics in cancer immunotherapy for its unique modality to create target synergy,” Zang added.

“We are very excited about our partnership with I-Mab to develop First-in-Class and Best-in-Class BsAbs and our collaboration will accelerate the development of innovative immunotherapy,” said Sang Hoon Lee, the founder and CEO of ABL Bio. Lee also mentioned “We look forward to a productive and successful partnership since I-Mab is a leader in the immunology field. Because of the strong synergies between both companies, we believe this collaboration will provide a great example for our industry.”

I-Mab has successfully completed a string of in-licensing deals with global pharmaceutical companies such as MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and Genexine, Inc. (KOSDAQ: 095700) to enrich its China portfolio. This out-licensing and partnership is the second such transaction for I-Mab and marks the beginning of I-Mab’s ability to out-license or co-develop its own innovative biologics through global partnerships.

About I-Mab:

Facilitated by a merger between Third Venture Biotech and Tasgen Bio, which was followed by a Series B financing of USD 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, representing one of the largest amount 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 clinical trials in China and the US, including Phase 2 and Phase 3 studies. www.i-mabbiopharma.com

Contact:
Raven Lin, Vice President of Corporate Development
raven.lin@i-mabbiopharma.com

About ABL Bio:

ABL Bio is a privately held South Korean biotechnology company developing antibody therapeutics for immuno-oncology and neurodegenerative disease. ABL Bio was founded in 2016 and recently completed series C fund raising of USD 65 million in 2018 after successful series A and B financing in 2016 and 2017. ABL001, a bispecific antibody (BsAb) targeting VEGF and DLL4 is currently in Phase 1 clinical trial for oncology. In the neurodegenerative disorder space, ABL Bio is harnessing its BsAb expertise to develop next-generation BsAbs designed to maximize blood-brain barrier (BBB) penetrance and therapeutic efficacy. The most advanced molecule is ABL301, an α-synuclein -targeting BsAb that penetrates the BBB via a receptor-mediated transcytosis (RMT) and is in development for Parkinson’s disease (PD). ABL Bio is also actively developing immune-oncology therapies and has built strong R&D team to develop First-in-Class and Best-in-Class BsAbs. www.ablbio.com

Contact:
Sang Hoon Lee, CEO & Founder
sang.lee@ablbio.com

Photo – https://photos.prnasia.com/prnh/20180726/2196876-1-a
Photo – https://photos.prnasia.com/prnh/20180726/2196876-1-b

Source: China Biologic Products Holdings, Inc.

SYDNEY, July 26, 2018 /PRNewswire/ — Monash plant scientists have discovered a new molecular mechanism of gene regulation, which could have major implications for the development of treatment strategies for Friedreich’s ataxia — a debilitating genetic disorder that causes damage to the nervous system.

The study – the first plant-based original research paper with an exclusive Australian affiliation to the prestigious journal Cell, was published today.

“Our findings have opened up unprecedented opportunities with immense potential for human genetic diseases,” said study lead Associate Professor Sureshkumar Balasubramanian, from the Monash School of Biological Sciences.

“This research has major implications for our understanding of how the genetic mutation that underlies Friedreich ataxia, leads to damage of the nervous system and thus symptoms of this condition,” said Professor Martin Delatycki, a clinician and researcher from Murdoch Children’s Research Institute who has studied Friedreich ataxia for more than 20 years.

“This may lead to treatments that are desperately needed for this devastating disorder,” he said.

Friedreich’s ataxia is the most commonly inherited genetic ataxia affecting young adults for which there is currently no cure.

The disease occurs due to a type of DNA mutation referred to as ‘triplet repeat expansion’. In individuals affected by Friedreich’s ataxia, the mutation is present in a region (known as intron) of the affected gene, which is removed during the production of mRNA.

However, the presence of the expansion typically leads to a reduction in the levels of the mRNA, which in turn results in reduced protein leading to disease.

“While there have been efforts to increase the mRNA levels as a potential therapeutic strategy, it has been difficult, since it was not clear how the triplet repeat expansion results in the reduced in mRNA levels,” Associate Professor Sureshkumar Balasubramanian said.

The researchers made their discovery using the model plant Arabidopsis thaliana.

“When we found the first and only triplet expansion associated genetic defect outside humans, we asked the fundamental question ‘how do triplet expansions lead to reduced mRNA levels?’,” Associate Professor Sureshkumar Balasubramanian said.

“We show in this paper that triplet repeat expansions lead to accumulation of small RNAs and these small RNAs, target the gene harbouring the repeat expansion via epigenetic gene silencing,” he said.

“We have pointed at least 11 different genes in this process and it is remarkable that if we perturb these genes we can abolish the negative impacts of this mutation – at least in plants,” said Dr Sridevi Sureshkumar, a research fellow who shared the first authorship with Dr Hannes Eimer, a recent PhD graduate from the Balasubramanian group.

World-renowned plant biologist Professor Detlef Weigel Foreign Member of Royal Society from the Max Planck Institute in Germany, described the work as an impressive example of the potential of basic plant research.

“Small RNAs were first discovered in plants, but later found to play important roles in all organisms including humans,” Professor Weigel said.

“Now the Monash group has linked them to a phenomenon with great relevance to human genetic disease.

“This was possible because experiments can be conducted in plants that are simply not possible in humans.”

Other researchers who were part of the Monash-led study include Avilash Singh Yadav, Calvin Kraupner-Taylor, Andrei Seleznev, Tamblyn Thomason, Stephanie Frances Gordon from Balasubramanian group, and collaborator Professor Bernie Carroll and his student Stephen Fletcher from the University of Queensland.

The full paper titled RNA-dependent epigenetic silencing directs transcriptional down regulation caused by intronic repeat expansions can be found here ( https://doi.org/10.1016/j.cell.2018.06.044 ).

Further information:
Silvia Dropulich Marketing, Media and Communications Manager, Science
T: +61 3 9902 4513  M: +61 (0) 0435138743
E: silvia.dropulich@monash.edu

Media interviews:
Associate Professor Sureshkumar Balasubramanian
T:+61 434734536
E: mb.suresh@monash.edu

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