A selection of recent big stories from Chinese pharma, including Novo Nordisk’s updated China strategy, Chinese biotechs’ funding successes, and some significant regulatory approvals.
In Q1 2020, China’s regulator the National Medical Products Administration (NMPA) approved a total of 11 new drugs, 6 imported and 5 domestic
(From www.accestra.com – China Pharmaceutical Regulatory Affairs)
Novo Nordisk China announced on Monday the launch of the China Essentials program — the guidelines to integrate China into Novo Nordisk’s global clinical development program and achieve simultaneous submission for global new drug applications. Following the guidelines, Novo Nordisk will file the Clinical Trial Application of new pipeline products simultaneously in China and globally for the first time. 90 percent of new drug applications are aimed to be submitted simultaneously starting from 2025, as China now holds a very important position when it comes to Novo Nordisk’s global R&D strategy, the company said. It plans to establish strategic partnerships with 20 hospitals nationwide by 2021, expanding their network of clinical trial bases. As a globally recognized leader in clinical trials, Novo Nordisk conducted 14 clinical trials in China from 2015 to 2019 involving 2,971 patients and a total R&D investment of 545 million yuan ($76.9 million).
Ocumension is a China-based company with a mission of being a pioneer in Ophthalmology. It is controlled by 6 Dimensions Capital, a global investment firm with a focus on innovative life science companies in China and the United States. Ocumension develops and provides prescription medicines that meet the evolving needs of patients, healthcare professionals, and caregivers. With its experienced group, Ocumension’s capabilities span from research and development to clinical trial execution to marketing and sales of in-licensed and wholly owned products. Aiming to help more patients, Ocumension is building its portfolio of new medications and technologies through internal research & development and strategic alliance with global partnerships.
Chinese innovative biopharmaceutical firm Mabwell BioScience Co. Ltd. has closed 1.97 billion yuan ($278 million) in a Series A round of financing led by the country’s private equity firm Shenzhen Shiyu Investment Management Co. Ltd. Mabwell is involved in the development of therapeutic monoclonal antibodies (mAb), which can be used to stimulate patients’ immune systems, long-acting recombinant proteins, as well as other macromolecular drugs. A group of Chinese domestic companies participated in the round, including venture capital company Oriental Fortune Capital, Hong Kong-listed Haitong Securities Co. Ltd. private equity unit Haitong Capital, and Loyal Valley Capital (LVC), a private equity firm that invests in middle-market companies, said Mabwell in a WeChat post on Tuesday.
I-Mab, a Chinese drug developer expanding in the U.S., is seeking a partner to jointly develop and sell a cancer drug in the world’s biggest economy, according to people familiar with the matter.The Shanghai-based company is in talks with several large drugmakers over a potential deal that could be worth as much as $2 billion, including an upfront payment in cash and milestone payments based on performance, the people said. I-Mab would also get royalties from future sales of the drug, said the people, asking not to be identified because the matter is private.
CStone announces acceptance of its first New Drug Application in mainland China by the National Medical Products Administration, for the first-in-class precision therapy avapritinib in two gastrointestinal stromal tumor indications
Developed by CStone’s partner Blueprint Medicines, avapritinib is an investigational, orally available, potent and selective inhibitor of KIT and PDGFRA mutant kinases. This is the first time CStone has submitted an NDA to the NMPA and marks another milestone in the Company’s transition toward commercialization. “In just three months after avapritinib was approved by the U.S. FDA, CStone has submitted NDAs for this drug candidate in Taiwan and mainland China, which we hope will soon make this first-in-class precision therapy candidate accessible to patients with advanced GIST in Greater China,” said Dr. Frank Jiang, Chairman and CEO of CStone. “As CStone continues to accelerate its transition toward commercialization, we plan to submit several NDAs in China across multiple indications for our lead assets in the next few months.”
Clover Bio Australia, a division of Sichuan Clover Biopharmaceuticals, announced a $3.5 million investment from CEPI, the Coalition for Epidemic Preparedness, to develop a COVID-19 vaccine. The company will use the money to start an Australian Phase I trial of its COVID-19 S-Trimer vaccine candidate, a vaccine based on Clover Bio’s proprietary Trimer-Tag© platform. The platform, which is usually used to develop cancer candidates, produces the spike proteins of the COVID-19 virus in a native trimeric form.