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 (NSCLC) 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. The company expects two more drugs to win approval this year.

Eisai lands new MHLW approvals for lymphoma and carcinoma indications

HONG KONG – Eisai Co. Ltd. has received not one, but two approvals from Japan’s Ministry of Health, Labour and Welfare (MHLW), for its anticancer agent Remitoro (denileukin diftitox) and multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate). Both approvals, each for a rare disease indication, were granted based on the basis of phase II trial results, instead after the usual phase III trials. “Our next step will be to provide information for Remitoro in Japan,” a company spokesman told BioWorld.

Newco news: Eliem Therapeutics Inc. has big plans for big markets

While there is currently a lot of excitement about the roles of non-neuronal cells, especially astrocytes, in various neurological disorders, Eliem Therapeutics Inc. is focusing its attentions on neuronal excitability and its discontents. “We don’t reason in terms of molecular targets, but in terms of neural networks,” co-founder and chief scientific officer Valerie Morisset told BioWorld. Pain signaling, epilepsy, and brain activity in general “in the end… relies on the activity of a neural network, and that is what you need to control to get a therapeutic benefit.” The company, which was founded in 2019, announced funding from RA Capital Management, Access Biotechnology and Intermediate Capital Group.

Newco news: U.S.-China cross-border biopharma launched to target autoimmune diseases

Zenas Biopharma LLC launched on March 23 as a U.S. funded cross-border biotech company targeting autoimmune diseases in China. The company is founded and funded by Tellus Bioventures LLC and Fairmount Funds Management LLC. It is also supported by additional backing by a syndicate of leading global life science investment funds, such as Quan Capital, Wuxi Biologics Healthcare Ventures and Wellington Management. The company’s existence is based on the idea that, despite the Chinese market’s ongoing evolution, there are still drugs that are available elsewhere in the world that are not yet accessible there.

Also in the news

Abbvie, Acerus, Agios, Airway, Ajinomoto, Alvotech, Amplicore, Ascentage, Astellas, Astrazeneca, Biontech, Bright Peak, Brooklyn Immunotherapeutics, Camurus, Design, Diurnal, Dunad, Edgewise, Exagen, Gain, Gilead, Goliver, GSK, Gyroscope, Haima, Idorsia, Ikena Oncology, Intellia, J&J, Mitsubishi, Novadiscovery, Open Orphan, Pfizer, Phoremost, Roche, Servier, Summit, Takeda, Tetra, TFF, Universe, Verastem, Vertex, Vir, Windtree