HONG KONG – Tokyo-headquartered Fujifilm Holdings Corp. will increase production of Avigan on the back of a partnership with India’s Dr. Reddy’s Laboratories Inc. and Dubai-based Global Response Aid.
CAJICA, Colombia, and BEIJING – Last week Sinovac Biotech Ltd., of Beijing, announced the approval by Anvisa, the Brazilian health care surveillance agency, to start phase III trials to test the efficacy and safety of its inactivated COVID-19 vaccine being developed by Sinovac Life Sciences, a subsidiary of the Chinese company, in the Latin American country.
BEIJING – Known for its transgenic mouse platforms to develop antibodies, U.S., China and the Netherlands-based Harbour Biomed Therapeutics Ltd. closed a series C funding round July 9 to raise $102.8 million to advance its late-stage clinical programs and COVID-19 pipeline.
HONG KONG- Boehringer Ingelheim International GmbH and Roche Holding AG have announced new initiatives to seek R&D collaborations in China, increasing both their footprint in China and China’s global biopharma presence. Boehringer Ingelheim announced earlier this month the launch of an External Innovation Hub in Shanghai. Meanwhile, Roche China also launched a collaboration initiative this week to develop therapies for gastrointestinal cancer.
BEIJING – Beijing-based Immunotech Biopharm Ltd. made a strong debut as the first pre-revenue cellular immunotherapy firm to trade on the Hong Kong Stock Exchange (HKEX), raising $142 million via its IPO. Trading under the ticker 6978, the company’s share price closed at HK$15.48 (US$2) on July 10, up 40.7% from its offer price at HK$11.
Although details are yet to come, Equillium Inc.’s chief medical officer, Krishna Polu, told BioWorld that the company will move “urgently and expeditiously” to set up another experiment testing itolizumab in COVID-19 now that Bangalore, India-based partner Biocon Ltd. has unveiled positive phase II results with the CD6-targeting agent. Shares of Equillium (NASDAQ:EQ) closed at $26.50, up $23.31, or 731%, after trading as high as $27.05. “We recognize we have to do a robust study,” said Bruce Steel, CEO of the La Jolla, Calif.-based firm. Talks with the FDA about design come next, but the clinical bid will “very likely include sites outside the U.S.,” where the need is high and where there is “somewhat less competition for patients,” he said.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Asieris, Biogen, Biontech, Diffusion, Eisai, Enzychem Lifesciences, Fujifilm Kyowa Kirin, Immodulon, Merck, Mylan, Novartis, Otsuka, Pfizer, Propeller Health, Senhwa, Sosei.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA, International Coalition of Medicines Regulatory Authorities.
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