Speaking during the 2021 China Pharmaceutical Innovation 100 Summit, industry insiders called for more regulatory talent and even an organizational revamp to clear innovative products faster and support the global development strategies of Chinese drugmakers.
SHANGHAI – China’s regulatory environment has evolved to encourage drug innovation, but despite remarkable progress, mounting pricing pressure from the government and a weak insurance sector remain as barriers.
Suzhou-China based Cstone Pharmaceuticals Co. Ltd., which in-licensed RET inhibitor pralsetinib from Blueprint Medicines Corp. in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and the country’s first selective RET inhibitor.
Zenas Biopharma LLC launched on March 23 as a U.S. funded cross-border biotech company targeting autoimmune diseases in China. The company, headquartered in Miromar Lakes, Fla., is founded and funded by Tellus Bioventures LLC and Fairmount Funds Management LLC.
The continuing politicization of COVID-19 vaccines is undermining medical science and the international response to the pandemic. “Vaccine nationalism is very troubling,” Jeremy Levin, chair of BIO's executive committee, told BioWorld.
Qihan Biotechology Co. Ltd., a company known for its multiplexable genome editing technology, has yet again extended its series A financing, this time with a $67 million round that will support advancement of its allogeneic cell therapy candidates to IND in China. To date the company has raised more than $100 million.
Like its distinctive name, Dragon Boat Biopharmaceutical Co. Ltd., of Shanghai, raced to victory with the Chinese IND approval for its anti-CSF-1R monoclonal antibody candidate BC-006, marking an important milestone for the company as it embraces a growing focus on innovative medicines.
Chinese eye disease specialist Arctic Vision Biotechnology Co. Ltd. raised more than $100 million in a series B financing round. The clinical-stage company will use the funds to initiate a phase III trial for its core asset, ARVN-001 (triamcinolone acetonide suprachoroidal injectable suspension), for uveitic macular edema in China this year.
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.