Remegen Co. Ltd.’s RC-18 (telitacicept) was granted conditional approval for systemic lupus erythematosus (SLE), marking the first NDA approval for the company that launched the world’s biggest biotech IPO last year. A self-developed dual targeted TACI-Fc fusion protein, telitacicept is the second innovative biologic to treat SLE approved in China.
In the “The World for Asia, Asia for the World” panel discussion at the virtual Wuxi Healthcare Forum, investors and executives took note of the region’s digital capabilities for reducing R&D costs and timelines, while also calling for more harmonization on the regulatory front to empower R&D in Asia.
China’s National Medical Products Administration granted conditional approval two Chinese-developed COVID-19 vaccines in less than 24 hours on Feb. 25. One of the vaccines approved was developed by Tianjin-based Cansino Biologics Inc., and the other by China National Pharmaceutical Group (Sinopharm) through its Wuhan Institute of Biological Products subsidiary.
Liver disease specialist Ascletis Pharma Inc. said its nonalcoholic steatohepatitis (NASH)-focused subsidiary, Gannex Pharma Co. Ltd., will start global development of its oral THR-β agonist, ASC-41, after it obtained an IND approval from the FDA based on positive phase I data generated in China.
NEW DELHI – Significant disruptions to supplies of active pharmaceutical ingredients (APIs) from China caused by the COVID-19 pandemic have led India to fundamentally rethink its supply chains and the structure of its pharmaceutical industry, according to industry executives and consultants.
Chengdu-based Sichuan Clover Biopharmaceuticals Inc., known for its Trimer-Tag technology, raised $230 million in a series C financing round. The proceeds will, most notably, help it advance its COVID-19 vaccine candidate, S-Trimer (SCB-2019), to a global phase II/III trial by June. Following its $43 million series B round in December 2019, Clover said on Tuesday, Feb. 23, that it raised more than $400 million in the last 12 months. The company uses its Trimer-Tag technology platform to produce covalently-trimerized fusion proteins to develop protein-based vaccines and biologic cancer therapies.
HONG KONG – China is steadily greenlighting more COVID-19 vaccines and drugs to go deeper into the clinic, giving the country a growing arsenal against the disease. To date, China’s National Medical Products Administration (NMPA) has approved a handful of drugs and 16 domestically developed COVID-19 vaccine candidates for trials, up from 11 in September 2020.
Chinese cancer and autoimmune specialist Innocare Pharma Ltd. raised HK$3.04 billion ($392 million) in private placements with two Hillhouse Capital subsidiaries and Vivo Opportunity Fund to advance its pipeline, especially its core asset, the BTK inhibitor orelabrutinib.
HONG KONG – Sinovac Biotech Ltd.’s COVID-19 vaccine, Coronavac, received conditional approval for use by the general public from China’s National Medical Productions Administration (NMPA), two days after filing for conditional market authorization.
Shares in Chinese drug developer Jacobio Pharmaceuticals Group Co. Ltd. (HK:1167) rose 3% on their first day of trading in Hong Kong. The company, which develops small-molecule drug candidates to modulate enzymes by binding to their allosteric sites, raised HK$1.35 billion (US$174.1 million) in its IPO, pricing 96 million shares at HK$14. Shares closed at HK$14.42 on Dec. 21 after rising as high as HK$16.50.
