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.

Genetron Holdings Ltd. said its blood-based, early screening test for hepatocellular carcinoma (HCC) demonstrated 88% sensitivity and 93% specificity in 1,615 subjects in China vs. 71% sensitivity and 95% specificity with the use of ultrasound plus alpha-fetoprotein (AFP). The primary outcome, unveiled on March 25, came from a multicenter prospective trial that Beijing-based Genetron initiated together with The National Cancer Center China in 2019.

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 the Biotechnology Innovation Organization’s (BIO) executive committee, told BioWorld.

HONG KONG – Bispecific antibody startup Epimab Biotherapeutics Inc. has completed a $120 million series C financing, bringing it closer to a potential IPO next year. The Shanghai-based company said the new funds would help it move EMB-01 into phase II testing this year.

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.

HONG KONG - Bispecific antibody startup Epimab Biotherapeutics Inc. has completed a $120 million series C financing, bringing it closer to a potential IPO next year. The Shanghai-based company said the new funds would help it move its EGFR/cMET-targeted bispecific candidate, EMB-01, into phase II testing this year, as well supporting the advancement of other clinical candidates and an expansion of its pipeline.

HONG KONG – Privately held Wugen Inc. of St. Louis has inked an exclusive deal with Shanghai-based Alpha Biopharma Ltd. to manufacture, develop and commercialize allogeneic cell products in Asia.

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.