PASADENA, California, Oct. 3, 2018 /PRNewswire/ — iHerb announces the opening of the company’s fifth distribution center in early 2019. iHerb’s fifth and newest distribution center is located in Easton, Pennsylvania and is the company’s fourth distribution center on the East Coast of the U.S. In addition to the Pennsylvania distribution centers, additional locations include California, Kentucky, Illinois and a soon to be opened international center in South Korea.
Herb Announces the Opening of a Fifth Distribution Center
As iHerb continues to grow at a rapid pace, the company required a facility that could meet global customer demand. Easton, Pennsylvania is the ideal location to serve the East Coast of the U.S. as well as international customers serviced by the Air Cargo hub of New York.
“The Lehigh Valley – in particular, Easton – made perfect sense for iHerb’s next distribution and fulfillment location as we continue to expand our customer base rapidly,” said Mark Hoffman, Sr. Vice President of Operations. “This location will allow iHerb to reach a broad portion of the U.S. with fast delivery times and excellent customer experience, further demonstrating the continued importance of the Lehigh Valley area as one of the country’s top logistics hubs.”
The 242,200 square foot Easton facility will be equipped with the latest technology and systems optimized for health products to ensure thorough quality control. The fully automated climate controlled distribution center will immediately hire 130 employees to open, with a potential employee population of over 300 as the business continues to grow.
“The Workforce Board Lehigh Valley and its premier workforce system called PA CareerLink® is pleased to be a strategic partner with iHerb in assisting with their current and ongoing hiring needs for a skilled and qualified talent pipeline. Another company adding flavor to the Lehigh Valley! Welcome, iHerb!” – Nancy Dischinat, Executive Director of the Workforce Board Lehigh Valley.
iHerb has invested extensively in offering the best overall value in the world for over 30,000 quality brand name natural products, shipped directly from state of the art climate controlled facilities. The investment in Easton further demonstrates iHerb’s commitment to quality and customer experience.
About iHerb: iHerb is one of the largest US-based e-commerce retailers offering 30,000 products from 1,200 top brands to millions of customers around the world. iHerb ships directly from GMP certified, state-of-the-art climate controlled warehouses to customers in over 150 countries. Since 1996, iHerb has continued to innovate in bringing the highest quality products, at the best possible value, delivered with the most convenient customer experience. https://www.iherb.com/.
Veloce BioPharma’s VBP-926 (Povidone-Iodine) Demonstrates Statistically Significant and Clinically Significant Results in Phase 2b Study for Chemotherapy-Associated Paronychia
Positive clinical results provide basis for pivotal Phase 3 clinical trials
FORT LAUDERDALE, Fla., Oct. 3, 2018 /PRNewswire/ — Veloce BioPharma, LLC (“Veloce”), a clinical-stage biopharmaceutical company dedicated to developing topical therapeutics for unmet needs in dermatologic and ophthalmic diseases, today announced positive results of its Phase 2b study of dilute povidone-iodine in a novel DMSO solvent system for the topical treatment of chemotherapy-associated paronychia, or painful and inflamed nail units resulting as a side effect of chemotherapy.
The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study was designed to evaluate the safety, tolerability and efficacy of two strengths of VBP-926 (1% PVP-I, 2% PVP-I) vs. vehicle in 102 subjects with chemotherapy-associated paronychia. Results from the study showed that VBP-926 (2%) met the primary efficacy endpoint of grade-improvement on the Paronychia Severity Grading Scale. Consistent with previously reported case series results, VBP-926 was well-tolerated at both doses and provided both morphological resolution and symptomatic relief in affected nails.
“This trial clearly demonstrated the clinical benefit of VBP-926 2% solution,” said Dr. Kara Capriotti, MD, President and Director of Dermatology programs at Veloce. “We are well positioned to move VBP-926 into Phase 3 development and continue advancing a product that targets an indication with no approved therapies. Addressing the pain and discomfort suffered by patients with chemotherapy-associated paronychia is an enormous unmet need and we are encouraged to be getting closer to a topical therapy that can solve this problem.”
Phase 2b results showed that VBP-926 at the higher concentration met the primary efficacy endpoint. The 2% dose reached statistical significance for nail grade improvement from baseline to the end of therapy for change in the Paronychia Severity Grading Scale (p=.0003). No treatment-related serious adverse events were reported. Adverse events were mild in severity and reversible when treatment was discontinued.
Mario Lacouture, MD, Director, Oncodermatology Program at Memorial Sloan Kettering Cancer Center and Lead Investigator of the trial, commented, “Chemotherapy-associated paronychia is a frequent side effect of cancer treatments, and may impair quality of life and administration of anti-cancer treatments. This study is of interest, as it showed a significant reduction in paronychia score at the higher concentration of VBP-926 solution.” Dr. Lacouture’s research was funded by Veloce BioPharma.
About VBP-926
VBP-926 is a broad-spectrum, resistance-free biocidal topical solution that has the ability to eradicate all known microorganisms including bacteria, viruses, yeasts, molds, fungi and protozoa.
About Chemotherapy-Associated Paronychia
Systemic chemotherapy employed for the treatment of a variety of common malignancies can induce painful nail changes associated with mixed polymicrobial infections in a subset of patients. Iatrogenic paronychia has been clearly associated with numerous classes of cancer chemotherapies. Epidermal Growth Factor Receptor Inhibitors, taxanes, MEK inhibitors, mTOR inhibitors, anthracyclines and DNA/RNA synthesis inhibitors are known inciting drugs. Nail changes associated with higher morbidity include periungual erythema, edema, exudate, suppurative onycholysis and periungual or subungual pyogenic granuloma.
About Veloce BioPharma
Veloce BioPharma, LLC is a privately held clinical-stage pharmaceutical company focused on the development of topical therapeutics for unmet needs in dermatology and ophthalmology.
BOSTON, Oct. 2, 2018 /PRNewswire/ — With the successful installation of the 100th Mediso multi-modality preclinical PET system, the Tulane National Primate Research Center(TNPRC), division of the Tulane University, has become the fourth site in North America to install the MultiScan LFER150 PET/CT preclinical imager.
In keeping with the mission of the center, the MultiScan LFER150 PET/CT will help enable researchers to improve human and animal health by using non-invasive in-vivo imaging techniques to find better treatments for major infectious diseases. The MultiScan LFER 150 PET/CT is the only research-focused, large bore integrated PET/CT scanner supporting whole-body imaging of non-human primates (NHPs) and smaller animal models at sub-millimeter PET resolution. The system features the most versatile integrated PET/CT gantry ever built, enabling dynamic studies both in lying and sitting position, required for awake NHP studies. Due to its unique construction, CT and PET systems share the same field-of-view, eliminating the need for moving the subject during acquisition.
The LFER150 PET/CT will support TNPRC’s research program in infectious diseases, particularly in tuberculosis research focused on vaccine development, pathogenesis, and therapeutics.
“We have invested years to make the LFER150 PET/CT a dedicated and effective tool for imaging nonhuman primates for both PET and CT modalities. We are proud to be working with prestigious institutions like the TNPRC”, says Illes Muller, Managing Partner of Mediso USA. Like all preclinical PET/CT systems from Mediso, the LFER150 has been designed for quantitative assessment of PET and CT studies.
About Mediso USA, LLC
Mediso USA distributes the preclinical imaging portfolio of Mediso in the U.S. and Canada and provides the application development and technical support for life science research. The company’s headquarters is located in Boston, Massachusetts. For more information, please visit http://www.medisousa.com.
About Mediso Ltd.
MedisoLtd. specializes in the field of nuclear and molecular imaging focused on the development, manufacturing, sales and servicing of multi-modality in-vivo imaging systems. It offers complete solutions from hardware design to quantification software, both for clinical patient care and high-level life science research. The nanoScan® family is the first-line choice for preclinical imaging including the world’s first integrated preclinical PET/MRI, PET/CT, SPECT/CT and SPECT/MRI combinations.
SEOUL, South Korea, Oct. 2, 2018 /PRNewswire/ — The Korea Ginseng Association announced schedules of local Korean Ginseng festivals that will be held in many cities in Korea in October.
Seoul (Korean Ginseng Festival)
In Korea, 16 festivals celebrating the harvest season of Korean Ginseng are happening across the country, including Seoul, Gyeonggi, Gangwon, Chungcheong, Jeonbuk, and Gyeongbuk regions. The first event on the list is “The 1st Anseong World Organic Ginseng Summit” that is set to start on October 3.
These annual local Ginseng festivals provide an exciting opportunity to try out Korean Ginseng inspired recipes and foods, along with variety of programs and cultural events.
This year’s programs include harvesting Korean Ginseng, ginseng footbath, ginseng curling and many more that will surely entertain all ages and tastes.
During the festival period, locally produced Korean Ginseng will be available for sale at affordable prices as well.
Ginseng festivals has attracted many foreign tourists as well as Koreans, promoted Korean Ginseng by providing festive opportunities to demonstrate and experience the efficacy and superb quality of Korean Ginseng.
The Korea Ginseng Association’s chairman Ban-Sang-Bae said, “Korean Ginseng is already world-famous,” and added “I hope people from all around the world to become more familiar with Korean Ginseng, formerly known for its medicinal use, through tasting and experiencing Korean Ginseng at these festivals.
Detailed information and schedules for Korea’s Korean Ginseng festival can be obtained at the Korea Ginseng Association’s website (http://www.korean-ginseng.org).
New international report also shows almost 120 countries and territories now require graphic picture warnings on cigarette packages
TORONTO, Oct. 1, 2018 /PRNewswire/ — An international report released today by the Canadian Cancer Society (CCS) shows there is tremendous momentum worldwide for tobacco plain packaging. There are now 25 countries and territories moving forward with plain packaging, with 9 having adopted the measure and 16 working on it.
Canadian Cancer Society (National Office)
The number of countries requiring plain packaging is expected to accelerate further because of the World Trade Organization (WTO) decision on June 28, 2018 that Australia’s plain packaging requirements are consistent with WTO’s international trade agreements.
The CCS report, Cigarette Package Health Warnings: International Status Report, documents global progress on plain packaging, ranks 206 countries and territories on the size of their health warnings on cigarette packages and lists countries and territories that require graphic picture warnings.
The report found that 118 countries and territories now require picture health warnings on cigarette packages, an increase from 100 in 2016. This represents 58% of the world’s population. Canada was the first country to require picture health warnings in 2001.
“There is an unstoppable worldwide trend for countries to use graphic pictures on cigarette packages to show the deadly health effects of smoking and to require plain packaging,” says Rob Cunningham, senior policy analyst, Canadian Cancer Society. “Australia was the first country to implement plain packaging in 2012 and now the dominoes are falling.”
Guidelines under the international tobacco treaty, the WHO Framework Convention on Tobacco Control (FCTC), recommend that countries consider implementing plain packaging. Plain packaging includes health warnings on packages and prohibits tobacco company branding such as colours, logos and design elements. It also requires the brand name to be a standard font size, style and location on the package and the brand portion of each package to be the same colour such as an unattractive brown. Finally, the package format is standardized. Plain packaging regulations put an end to packaging being used for product promotion, increases the effectiveness of package warnings, curbs package deception and decreases tobacco use.
Plain packaging has been implemented in Australia (2012), France (2016), the United Kingdom (2016), Norway (2017), Ireland (2017), New Zealand (2018) and Hungary (2018). It will be implemented in Uruguay (2019) and Slovenia (2020) and is in process or under consideration in Canada, Belgium, Thailand, Georgia, Singapore, Nepal, Sri Lanka, South Africa, Romania, Jersey, Guernsey, Taiwan, Chile, Finland, Turkey and Saudi Arabia.
Cigarette package warnings are a highly cost-effective way to increase awareness of the negative health effects of smoking and to reduce tobacco use. Picture-based warnings convey a more powerful message than a text-only warning and the effectiveness of warnings is known to increase with size.
Guidelines under the FCTC recommend that warnings should:
be as large as is achievable;
include a rotated series of graphic pictures;
be at the top of both the front and back of packages.
Picture warnings are especially valuable for low- and middle-income countries where there are higher rates of illiteracy and where governments may have few resources. Health departments determine the content of warnings and the tobacco industry is responsible for printing the warnings on packages. Examples of graphic picture warnings include a diseased lung or mouth, a patient with lung cancer in a hospital bed and a child being exposed to second-hand smoke.
“It is extremely positive for global public health that almost 120 countries and territories have implemented picture health warnings and that so many are moving toward plain packaging,” says Cunningham. “The international momentum poses a threat to tobacco industry sales worldwide and will save lives lost to cancer and other tobacco-related diseases.”
In total 107 countries and territories have required warnings to cover at least 50% of the package front and back (on average), up from 94 in 2016 and 24 in 2008. There are now 55 countries and territories with a size of at least 65% (on average) of the package front and back. The top countries ranked by warning size as an average of the front and back of the package are:
1. 92.5% East Timor (Timor-Leste) (85% of front, 100% of back) 2. 90% Nepal (90%, 90%) 2. 90% Vanuatu (90%, 90%) 4. 87.5% New Zealand (75%, 100%) 5. 85% Hong Kong (S.A.R., China) (85%, 85%) 5. 85% India (85%, 85%) 5. 85% Thailand (85%, 85%) 8. 82.5% Australia (75%, 90%) 9. 80% Sri Lanka (80%, 80%) 9. 80% Uruguay (80%, 80%)
In the 2016 report, Nepal and Vanuatu were top ranked at 90%.
The report was released today in Geneva, Switzerland, at the 8th session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control (FCTC) being held October 1-6. The report supports the implementation of the FCTC. The FCTC has an obligation for parties to require health warnings that “should be 50% or more of the principal display areas but shall be no less than 30% of the display areas” and may be in the form of, or include, picture warnings. There are now 181 countries that are parties to the FCTC.
This is the 6th Canadian Cancer Society international report on cigarette package health warnings. Previous reports were published in 2008, 2010, 2012, 2014 and 2016.
About the Canadian Cancer Society The Canadian Cancer Society is a national community-based organization whose mission is the eradication of cancer and the enhancement of the quality of life of people living with cancer. When you want to know more about cancer, visit our website www.cancer.ca or call our toll-free, bilingual Cancer Information Service at 1 888 939-3333.
For further information: Rob Cunningham, Senior Policy Analyst, Canadian Cancer Society, Phone: +1-613-762-4624, Email: rcunning@cancer.ca; Rosie Hales, Communications Specialist, Canadian Cancer Society, Phone: +1-416-934-5338, Email: rosie.hales@cancer.ca
YONGIN, South Korea, Sept. 30, 2018 /PRNewswire/ — GC Pharma (formerly known as Green Cross) announced today it has received approval from the South Korean Ministry of Food and Drug Safety (MFDS) expanding the indication for GCFLU Quadrivalent™ (Seasonal Influenza Vaccine) to include use in persons 6 months and older. Prior to this, the vaccine was approved for use in persons 3 years of age and older.
GCFLU Quadrivalent
“The flu is a serious diseases with a significant impact on public health, “said Byung-Wha Kim GC Pharma Executive Vice President. “The expanded indication builds upon GC Pharma’s legacy as the first local manufacturer to bring quadrivalent flu vaccines to the South Korean marketplace.”
With this approval, provides are now able to use the GCFLU Quadrivalent™ to vaccinate all eligible persons from 6 months and older.
This expanded indication for the vaccine was based on Phase III clinical studies conducted in children 6 months through 35 months of age.
GCFLU Quadrivalent™ was first approved in 2015 in South Korea for the prevention of influenza disease. It has also received prequalification status from the World Health Organization (WHO).
About Seasonal Influenza
Seasonal influenza may cause three to five million cases of severe illness and up to 500,000 deaths per year worldwide. Vaccination against influenza is considered one of the most effective ways of preventing mortality, complications and hospitalisations.
About GC Pharma
GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in South Korea, GC Pharma is the largest plasma protein product manufacturer in Asia and has been dedicated to quality healthcare solutions for more than half a century. Green Cross Corporation updated its corporate brand to GC Pharma in early 2018. Green Cross Corporation remains the company’s registered, legal name.
This release includes forward-looking statements, which express the current beliefs and expectations of GC Pharma’s management. Such statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
SUZHOU, China, Sept. 30, 2018 /PRNewswire/ — Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops high quality drugs, announced today that the first patient has been dosed in a phase III clinical trial (ORIENT-12) studying sintilimab, a fully human anti-PD-1 monoclonal antibody (IBI-308), as first-line treatment for patients with previously untreated squamous non-small cell lung cancer (NSCLC).
The ORIENT-12 study is a randomized, double-blinded trial conducted in China to evaluate the efficacy and safety of sintilimab or placebo combined with gemcitabine and platinum-based chemotherapy for first-line treatment of advanced or recurrent squamous NSCLC. The phase III study will enroll 348 patients. The study follows on the phase Ib study cohort E that evaluated sintilimab in combination with gemcitabine and cisplatin for first-line treatment of advanced squamous NSCLC. The detailed results of the study will be published in the recent academic conference.
“Advanced squamous non-small cell lung cancer is not suitable for the application of targeted drugs due to the lack of driver genes, and is not suitable for anti-angiogenic drugs. Immunological checkpoint inhibitors bring new hope to patients with squamous NSCLC. Based on the good efficacy and safety of the previous trials, we hope to validate the therapeutic value of the regimen of sintilimab in combination with chemotherapy in the phase III trial of ORIENT-12,” said Professor Caicun Zhou, from the Shanghai Pulmonary Hospital.
“Lung cancer is the most common malignant tumor in China with the highest morbidity and mortality. The development of advanced squamous NSCLC related therapeutic drugs has been stagnant, and there is a huge unmet clinical need. Based on the encouraging efficacy we observed in our phase Ib study of the first-line treatment of advanced squamous NSCLC with sintilimab combined to chemotherapy, we decided to conduct the ORIENT-12 study. The study was the first phase III study in the world to evaluate anti-PD-1 mAb combined with gemcitabine and platinum regimens in the treatment of advanced squamous NSCLC. I hope that the clinical research of sintilimab in this field will be carried out smoothly, so that more cancer patients and families can benefit from the therapy as soon as possible,” said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.
About ORIENT-12 Study
The ORIENT-12 study is a randomized, double-blinded, multicenter, phase III study of a combination of sintilimab or placebo with gemcitabine plus platinum-based chemotherapy for first-line treatment of advanced or recurrent squamous non-small cell lung cancer in China. Patients will be treated with a combination of sintilimab or placebo and gemcitabine plus platinum-based chemotherapy (cisplatin or carboplatin) for 4 cycles, followed by maintenance therapy with either sintilimab or placebo until disease progression. The control group is allowed to crossover to the sintilimab treatment. The participants will be randomized 1:1 to the experimental group or control group. The study will enroll 348 patients.
PFS, the primary end point, will be assessed by an Independent Radiologic Review Commitment (IRRC) based on response evaluation using the RECIST 1.1 criteria.
About Advanced or Recurrent Squamous Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the world’s major malignant tumor with the highest morbidity and mortality. NSCLC accounts for approximately 80% to 85% of all lung cancer cases, and approximately 70% of NSCLC patients at the time of diagnosis are locally advanced or metastatic diseases that are not suitable for surgical resection, and even after undergoing radical surgery for stage I-III patients, about 30-60% of NSCLC patients will experience recurrence or distant metastasis. Among all new cases of NSCLC, squamous cell carcinoma accounts for about 30%. The development of squamous cell carcinoma treatment has been stagnant due to its unique epidemiology, histopathology and molecular characteristics. At present, the first-line regimen for patients with advanced squamous NSCLC is still platinum-based chemotherapy, but the response rate of first-line chemotherapy is about 30%, PFS is about 5.5 months, and OS is about 10.8 months. There are huge unmet medical needs.
About Sintilimab Sintilimab is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-L1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is an anti-PD-1 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, formerly known as CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin’s Lymphoma.
About Innovent Inspired by the spirit of “Start with Integrity, Succeed through Action”, Innovent’s mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Since its establishment from 2011, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities, and a pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune and metabolic diseases. Innovent has built up a pipeline of 17 antibody drug candidates, with four core products in late-stage clinical development in China and one that has a New Drug Application (NDA) accepted by the NMPA with priority review status.
Innovent has a highly talented international team, including many expert returnees with experience in innovative biopharmaceutical drug discovery, development, production and commercialization. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, and other biopharmaceutical companies. Innovent has raised 580 million USD in private financing from numerous world-renowned VC or PE firms, including Eight Roads and F-Prime Capital (which form part of the proprietary investment business of Fidelity), Lilly Asia Ventures, Capital Group, Legend Capital, Temasek, Rock Springs Capital, Cormorant Private Healthcare, Hillhouse Capital, China Life, Ally Bridge, Taikang Insurance Group, and State Development & Investment Corporation.
About the partnership between Innovent Biologics and Eli Lilly and Company Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) in March 2015 announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company. Under the terms of the agreement, Lilly and Innovent shall collaborate to provide support to the development and potential commercialization of at least three cancer treatments over the next decade. In October 2015, they announced an expansion of their drug development collaboration. These collaborations represent that Innovent has struck one of the most comprehensive strategic partnerships of any Chinese company with a multinational partner in terms of the scope and breadth ranging from discovery to commercialization and involving up to six therapeutic antibodies for cancers.
SUZHOU, China, Sept. 30, 2018 /PRNewswire/ — Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops high quality drugs, announced yesterday that its IND application for IBI-188, a fully human anti-CD47 monoclonal antibody (mAb) drug candidate, has been approved by the US Food & Drug Administration (FDA) to initiate clinical trials for patients with advanced malignancies and lymphomas.
IBI-188 is the second Innovent molecule to be approved for clinical trials by the FDA. In January, 2018 the FDA IND for IBI308 (Sintilimab, an anti-PD-1 antibody) was also approved. Innovent is the first Chinese biopharmaceutical company to receive clinical trial approval for a CD47 monoclonal antibody from the FDA.
As one of the key targets in the field of anti-tumor immunotherapy, CD47 monoclonal antibody has become a highly researched therapeutic target across the world. Currently, a few CD47 advanced programs are in phase I and II clinical stage outside China. This IND approval demonstrates the significant progress Innovent has made to bring cancer treatments to global markets.
“Innovent, a China based company, was established with an ambition to serve global patient needs. We have been exploring the most advanced research areas and adhere to international innovative R&D and production standards. The FDA IND approval of anti-CD47 monoclonal antibody is an affirmation of our efforts and allow us to further advance Innovent’s innovative programs. We hope that through our efforts, China’s “smart” biologics will play a role on the international stage,” said Michael Yu, Founder, Chief Executive Officer and Chairman.
About IBI-188
IBI-188 is an anti-CD47 IgG4 monoclonal antibody developed by Innovent with independent intellectual property rights. Both in vitro and in vivo experiments showed that IBI-188 can bind to the CD47 antigen on the surface of tumor cells, block the CD47-SIRPα signaling pathway, inhibit the “Don’t Eat Me” signal, and promote the phagocytosis of tumor cells by macrophages, thereby exerting an anti-tumor effect. It has stronger receptor blocking ability than other investigational drugs against this target. Innovent will launch several clinical trials to assess its safety and efficacy for multiple tumor types, including non-Hodgkin’s lymphoma and ovarian cancer.
About IBI-308 (Sintilimab)
Sintilimab is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-L1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is an anti-PD-1 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, formerly known as CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin’s Lymphoma.
About Innovent
Inspired by the spirit of “Start with Integrity, Succeed through Action”, Innovent’s mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Since its establishment from 2011, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities, and a pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune and metabolic diseases. Innovent has built up a pipeline of 17 antibody drug candidates, with four core products in late-stage clinical development in China and one that has a New Drug Application (NDA) accepted by the NMPA with priority review status.
Innovent has a highly talented international team, including many expert returnees with experience in innovative biopharmaceutical drug discovery, development, production and commercialization. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, and other biopharmaceutical companies. Innovent has raised 580 million USD in private financing from numerous world-renowned VC or PE firms, including Eight Roads and F-Prime Capital (which form part of the proprietary investment business of Fidelity), Lilly Asia Ventures, Capital Group, Legend Capital, Temasek, Rock Springs Capital, Cormorant Private Healthcare, Hillhouse Capital, China Life, Ally Bridge, Taikang Insurance Group, and State Development & Investment Corporation.
More subjects on NeuroAiD™ improved to functional independence compared to placebo among subjects receiving rehabilitation up to 3 months after an acute ischemic stroke.
The larger treatment effect of NeuroAiD™ was sustained over 2 years which supports the hypothesis that NeuroAiD™ and rehabilitation might have additive and sustained benefits on neuro-repair processes after stroke.
The results were consistent at various time points and seen on several indices, i.e. modified Rankin Scale (mRS) and Barthel Index.
SINGAPORE, Sept. 28, 2018 /PRNewswire/ — Moleac is pleased to announce the release of the results of an analysis showing the additional effect on post-stroke recovery of NeuroAiD™ combined to rehabilitation, published online in the journal Cerebrovascular Diseases1. Positive results at 3 months of the combination of NeuroAiD™ and rehabilitation had been communicated by Prof. Christopher Chen (CHIMES-E co-principal investigator) during the European Stroke Organization Conference (ESOC 2018) in Gothenburg, May 16. These new results recently published provide convincing data showing that this additive and sustained effect of NeuroAiD™ is maintained over two years in patients having received persistent rehabilitation up to 3 months. They confirm persisting long-term benefits of NeuroAiD™ on patients’ recovery after an ischemic stroke already demonstrated on 880 patients in the CHIMES-Extension study2.
This analysis conducted in 380 patients having received persistent rehabilitation up to 3 months shows that adding NeuroAiD™ increases significantly the odds of improving functional recovery and independence at 3 months and beyond after an acute ischemic stroke, compared to placebo in double-blind with well-balanced groups at baseline. The odds of recovery were increased by more than twice at 6 months and 1 year, with a success rate maintained over 2 years. This confirms the sustained additive effect of NeuroAiD™ to the one of rehabilitation supporting the brain neuro-repair processes spontaneously initiated after the occurrence of any brain lesion All these results were consistent at various time points and seen on 3 indices, i.e. mRS ordinal, mRS dichotomy 0-1, and Barthel Index.
“Stroke recovery is a multi-layered process and is complex. Hence, it is likely that a multi-modal approach may be more effective in achieving better patient outcomes, by regulating more than one endogenous neurobiological process to address the complexity of the stroke recovery process,”saidProf. Nijasri C Suwanwela, director of Chulalongkorn Comprehensive Stroke Center, Chulalongkorn University and co-investigator of the CHIMES-E study². “In this new analysis, we were able to show that NeuroAiD™ combined with rehabilitation achieved better outcome both on functional recovery and independence in activities of daily living than rehabilitation alone,“she added.“There is a need for more data on the effect of combining rehabilitation programs with post-stroke treatments,” she concluded.
These results confirm the hypothesis raised by the CHIMES-E investigators: NeuroAiD™ combined to rehabilitation have a sustained additive effect compared to rehabilitation alone for improving functional outcomes after stroke1. Since most post-stroke patients have already undergone rehabilitation, combining a medical intervention that facilitates adaptive neuroplasticity with rehabilitation may be a logical and simple strategy for such multi-modal therapy, hence suggesting to extend NeuroAiD™ treatment duration beyond the 3 initial months, while recovery process is still in progress.
About CHIMES Society The CHIMES Society is an international academic industry collaboration with the objective to establish new stroke treatments. It is a Singaporean non-profit society founded by a group of experts in stroke and South-East Asian stroke clinicians interested to implement a research project: the NeuroAiD™ Efficacy on stroke recovery trial (CHIMES trial).
The CHIMES-E Study was supported by the CHIMES society and grants were received by CHLC from the National Medical Research Council in Singapore (NMRC) which supports the implementation of CHIMES trial in Singapore.
About Moleac To address therapeutic gaps, Moleac has pioneered a new drug development approach, looking at sources of innovation from Natural Medicines, hence shortening considerably drug development cycle time and investment to bring medicine to sufferers’ unaddressed needs. Moleac’s neurorestorative compound NeuroAiD™ reaches patients in more than 30 countries.
1.
Suwanwela NC, et al. Effect of Combined Treatment with MLC601 (NeuroAiDTM) and Rehabilitation on Post-Stroke Recovery: The CHIMES and CHIMES-E Studies. Cerebrovasc Dis. 2018;5;46(1-2):82-88. doi: 10.1159/000492625
2.
Venketasubramanian N, et al. CHInese Medicine NeuroAiD Efficacy on Stroke Recovery – Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy. Cerebrovasc Dis. 2015;44 39:309–318. doi: 10.1159/000382082
TAIZHOU, China, Sept. 29, 2018 /PRNewswire/ — China SXT Pharmaceuticals, Inc. (the “Company”), a specialty pharmaceutical company focusing on the research, development, manufacture, marketing and sales of Traditional Chinese Medicine Pieces (“TCMPs”) , today announced that its registration statement on Form F-1, relating to a proposed initial public offering (“IPO”) of its ordinary shares, par value $0.001 per share, for gross proceeds of up to $16,500,000 (including full exercise of the over-subscription option), has been declared effective with the U.S. Securities and Exchange Commission (“SEC”). The Company expects to offer a minimum of 2,500,000 and a maximum of 3,750,000 (or 4,125,000 with full exercise of the over subscription option) shares at a price of $4.00 per share. The Company has applied to list its ordinary shares on The NASDAQ Capital Market under ticker symbol “SXTC”.
The offering will be sold on a best efforts basis. Boustead Securities, LLC will act as the sole underwriter for the IPO.
The offering of these securities will be made only by means of a prospectus, forming a part of the registration statement. A copy of the final prospectus relating to the offering may be obtained by contacting Boustead Securities, LLC, email: offerings@boustead1828.com or by calling +1 (949) 502-4409 or standard mail at Boustead Securities, LLC, Attn: Equity Capital Markets, 6 Venture, Suite 265, Irvine, CA 92618, USA. In addition, a copy of the final prospectus relating to the offering may be obtained via the SEC’s website at www.sec.gov.
This press release shall not constitute an offer to sell, or the solicitation of an offer to buy any of the Company’s securities, nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any sale of such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About China SXT Pharmaceuticals, Inc.
Incorporated in 2005 and headquartered in Taizhou City, Jiangsu Province, China, China SXT Pharmaceuticals, Inc. is an innovative pharmaceutical company focusing on the research, development, manufacture, marketing and sales of traditional Chinese medicine pieces, which is a type of Traditional Chinese Medicine that has been processed to be ready for use. For more information, please visit www.sxtchina.com.
About Boustead Securities, LLC
Boustead Securities, LLC (“Boustead”) is an investment banking firm that executes and advises on IPOs, mergers and acquisitions, capital raises and restructuring assignments in a wide array of industries, geographies and transactions, for a broad client base. Boustead’s core value proposition is the ability to create opportunity through innovative solutions and tenacious execution. With experienced professionals in the United States and around the world, Boustead’s team moves quickly and provides a broad spectrum of sophisticated financial advice and services. For more information, visit www.boustead1828.com.
Safe Harbor Statement
This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may, “will, “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Specifically, the Company’s statements regarding trading on the NASDAQ Capital Market and closing the IPO are forward-looking statements. Forward-looking statements are not guarantee of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the following: the Company’s goals and strategies; the Company’s future business development; product and service demand and acceptance; changes in technology; the growth of the pharmaceutical market, particularly the Traditional Chinese Medicine Pieces (“TCMPs”) market, in China; reputation and brand; the impact of competition and pricing; government regulations; fluctuations in general economic and business conditions in China and the international markets the Company serves and assumptions underlying or related to any of the foregoing and other risks contained in reports filed by the Company with the Securities and Exchange Commission. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward‐looking statements to reflect events or circumstances that arise after the date hereof.
For more information, please contact:
At the Company: Alex Shi, CFO Email: ir@sxtchina.com Phone: +86-139-5110-0456
Boustead Securities, LLC Dan McClory, Managing Director and Head of Equity Capital Markets Email: dan@boustead1828.com Phone: +1-949-502-4408
Investor Relations: Tony Tian, CFA Email: ttian@weitianco.com Phone: +1-732-910-9692
