Weekly Top 5 in China (0224-0302)
Kemin Invests in China to Stay Ahead in Enzyme Production and Expand into Food and Clothing Industries
Kemin Industries, a global leading ingredient manufacturer in blending enzymes for feed since 1980s, announced a new partnership with CRVAB Bio-technology Co., Ltd, a biological fermentation company based in Chifeng, Inner Mongolia, China, which has the most efficient fermentation facilities in China, and further outspread the global reach in enzyme production. This investment will strengthen Kemin fermentation and production capabilities by the expanding resources for innovations in both single and blended enzymes as well as probiotic product pipelines, enabling the company to provide customers with higher quality solutions and greater consistency in enzyme products. This new partnership will allow Kemin to hold the lead in the feed enzyme production and expand into areas like food and textile applications.
About Kemin Industries
Kemin is a privately held, family-owned-and-operated company founded in Iowa, USA, 1961. Kemin is a leader in the ingredient manufacturing industry, providing innovative nutritional ingredient solutions to customers in more than 120 countries. Kemin maintains top-of-the-line manufacturing facilities in which more than 500 specialty ingredients are made for humans and animals in the global feed and food industries, as well as health, nutrition, textiles and commercial horticulture markets.
About CRVAB Bio-technology Co., Ltd
CRVAB Biotech Group is a high-tech corporation specializing in R&D, production, and business of animal nutrition and health products in China. CRVAB has been dealing with R&D, production, technical support and trade business at home and abroad, possessing leading standardized factories and perfect testing equipment, and creating a first-class high-tech premix & feed additive enterprise globally.
BGI Accelerates Phase II Construction of Gene Bank in the Greater Bay Area
On February 18th, China unveiled the latest national strategies for the development of the Guangdong-Hong Kong-Macau Greater Bay Area (the Greater Bay Area, GBA). The “Outline Development Plan for the Guangdong-Hong Kong-Macao Greater Bay Area” emphasized the establishment of the Belt and Road Life Science and Technology Advancement Alliance based on the China National GeneBank (CNGB).
The alliance was first jointly initiated by BGI, The China Center for International Economic Exchanges, and several countries in the 11th China Bio-industry Conference held in May, 2018. It will focus on promoting scientific research cooperation, industry incubation, and regulatory policies. It is expected to promote the international cooperation and industrial development of genetic technology innovation and benefit the belt and road countries.
BGI, as one of the builders and operators of the CNGB and one of the co-sponsors of the alliance, has played a leading role in substantive projects and talent team building and is accelerating the construction of the phase II of the Gene Bank to consolidate the alliance for the development of GBA.
BGI, formed in 1999 to participate in the Human Genome Project, is the world’s largest genetics research center headquartered in Shenzhen, Guangdong, China. It is considered to be world’s leader in gene-sequencing services.
Innovent ‘s New PD-1 Inhibitor Tyvyt® Launch in China
On Feb. 22, 2019, Innovent Biologics hosted the press conference on the launch of Tyvyt® (sintilimab, IBI308), a programmed cell death protein 1 (PD-1) drug, at The Forum for the National Mega Innovation Program in Beijing.
Innovent was granted approval by the National Medical Products Administration (NMPA) to start trials of Tyvyt® in patients with relapsed or refractory classical Hodgkin’s lymphoma. Jointly developed by Innovent and Eli Lilly and Company, Tyvyt® is a fully human anti-PD-1 antibody that binds to PD-1 receptor on T cells, blocking the pathway to restore T-cell response and immune response, thereby destroying tumor cells. Innovent is gearing up for its launch in China, there are currently more than twenty clinical studies, including seven registration studies that are ongoing to evaluate the efficacy on other solid tumors.
The PD-1/PD-L1 Race in China
Bristol-Myers Squibb Co.’s Opdivo (nivolumab), Merck & Co. Inc.’s Keytruda (pembrolizumab), Shanghai Junshi Biosciences’s JS-001 (toripalimab) and Innovent Biologics Inc.’s IBI-308 (sintilimab) are the four anti-PD-1 monoclonal antibody products approved by NMPA.
The approval of the drug is only one step in the milestone of drug clinical development. The expansion of indications in the follow-up research and development pipeline can determine the life cycle and market value of the drug. In China, PD-(L)1 drugs are still in their infancy, however, in the face of favorable government policies, strong financial support, and the participation of overseas talents, the Chinese developers are well equipped to make their way to the market, and will benefit patients enormously across the globe in the foreseeable future.
Established in 2011, Innovent is a Chinese biopharmaceutical company committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of major diseases, such as cancer. Innovent has developed a robust pipeline of 20 innovative assets in the fields of oncology, ophthalmology, autoimmune, and cardiovascular diseases based on a fully-integrated platform, which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities.
Two Cancer Side-Effect Treatments from Solasia of Japan Approved in China
On February 21, 2019, Solasia Pharma officially announced that episil®, a product that treats chemotherapy side effects, has been approved by the National Medical Products Administration (NMPA) in China. episil® is the only pocket-sized lipid-based spray that reduces the severity of oral mucosal inflammation and improve quality of life while undergoing cancer therapy.
episil® was first registered in Europe in 2009 and is now launched in the United States, Europe, Japan and other countries. episil® oral liquid was registered as Class I medical device in Europe, 510(k) medical device in the United States, and approved as Class II medical device in China and Japan.
Sancuso®, another Solasia’s product that treat chemotherapy side effects, is the world’s first and only transdermal patch of the 5-HT3 receptor antagonist, provides chemotherapy patients with a persistently effective new noninvasive drug delivery system for the prevention of nausea and vomiting. Sancuso® was approved for launch last June by the China Nation Drug Administration (CNDA, the former NMPA).
Solasia is an Japan-based pharmaceutical company devoted to developing and marketing, import/export of pharmaceutical products and medical devices, etc. The company is focused on creating a cancer treatment system, by developing innovative cancer drugs, introducing and getting commercial development licenses for great products from leading pharmaceutical and biotech companies in Japan, Europe and U.S.A, and other Asian countries.
China Approves the First Biosimilar HLX01
On February 22nd 2019, National Medical Products Administration (NMPA) approved China’s very first biosimilar, HLX01, an anti-CD20 monoclonal antibody, made by Shanghai Henlius Biotech. Rituximab was the first monoclonal antibody to be used in the treatment of cancer, originally developed by Genentech of Roche and approved by the US FDA in 1997.
In 2000, Rituxan® was imported into China under the trade name MabThera® and the indication was Non-Hodgkin’s Lymphoma (NHL). In March 2014, pre-clinical study results of HLX01 enabled it to become China’s first clinical approved similar biological drugs and obtained approval for clinical trials in the early 2015. The listing of HLX01 will undoubtedly break the monopoly of Roche’s original research drugs in the field of non-Hodgkin’s lymphoma and would help increase biologic drugs’ accessibility and drive down costs.
On average, the annual increase of non-Hodgkin’s lymphoma patients in China is more than 40,000, but since the originator biologics are very expensive, only 20% of patients can access the anti-CD20 targeted therapy. Once Henlius’ HLX01 reached the market, it will benefit more patients in need.
About Shanghai Henlius Biotech
Shanghai Henlius Biotech, Inc. is a joint venture company formed by Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Henlius Biopharmaceuticals Co., Ltd. in February 2010. The company focuses on the development, production and commercialization of mAb biosimilar drugs, bio-betters and novel mAbs using cutting-edge technology.
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