China’s National Medical Products Administration (NMPA) gave the green light to Pfizer Inc.’s third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena (lorlatinib), for patients with ALK-positive advanced non-small-cell lung cancer (NSCLC).
Backed by fresh phase III data showing a combination of the IDH1 gene inhibitor Tibsovo (ivosidenib) and azacitidine significantly improved event-free survival and overall survival for adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) vs. azacitidine alone, Cstone Pharmaceuticals Co. Ltd. is working to bring the treatment to Chinese AML patients “as soon as possible,” a spokesperson told BioWorld.
South Korean companies Ubix Therapeutics Inc. and SK Biopharmaceuticals Co. Ltd. are partnering to develop targeted protein degradation cancer therapies.
Bridge Biotherapeutics Inc. inked an exclusive in-license agreement for Shaperon Inc.’s G protein-coupled receptor 19 (GPCR19) agonist, BBT-209, a potential treatment for idiopathic pulmonary fibrosis. Bridge will pay Shaperon ₩2 billion (US$1.63 million) up front. The potential deal value, which includes up-front, milestone, and royalty payments, is ₩30 billion.
Through a $600 million deal, Juniper Biologics Pte. Ltd. has acquired rights from Kolon Life Science Inc. to develop and commercialize TG-C LD (Tissuegene-C low dose) for the treatment of knee osteoarthritis. Singapore-based Juniper will hold the rights for Asia Pacific, the Middle East and Africa and be responsible for developing and commercializing the candidate within those regions.
Elix Inc. has teamed up with Shionogi & Co. Ltd. to validate a retrosynthetic analysis model for drug discovery that will employ chemical reaction data from Shionogi to explore various routes to synthesizing new molecules.
Innovent Biologics Inc. has acquired exclusive rights to commercialize Eli Lilly and Co.’s oncology drugs Cyramza (ramucirumab) and Retsevmo (selpercatinib) in mainland China, where it will be responsible for the pricing, importation, marketing, distribution and sales of the two products.
Zai Lab Ltd. has shared positive top-line data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint.
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax.
Shouyao Holdings Co. Ltd. raised ¥1.48 billion ($233 million) in a listing on the Shanghai STAR Market to support the company’s ongoing clinical programs, led by a second-generation anaplastic lymphoma kinase inhibitor. Company shares (SHA:688197) debuted at ¥39.90, then fell 19.5% to close at ¥32.11 on March 23.