Weekly Life Sciences Update (No.16): Regulatory Approvals, Clinical Advances, and Strategic Collaborations in Global Biopharma

May 1,Johnson & JohnsonAnnounced that the FDA has approved its antibody therapy Imaavy (nipocalimab) for marketing, intended for the treatment of adult and pediatric patients aged 12 years and older with generalized myasthenia gravis (gMG) who are positive for anti-AChR and anti-MuSK antibodies.

May 1,Hansoh PharmaAnnounced that HS-20089 Injection, a B4-H4 targeted antibody-drug conjugate (ADC) independently developed by the companyGranted NMPA approval for inclusion in the "Breakthrough Therapy Designation," with the proposed indication for treating patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

May 7,AstraZenecaAnnouncement: The combination therapy consisting of Bruton's tyrosine kinase inhibitor, bendamustine, and rituximab has been approved in the European Union (EU) for the treatment of previously untreated mantle cell lymphoma (MCL) adult patients who are not eligible for autologous hematopoietic stem cell transplantation.

May 7,RocheAnnouncement: Gefitumab Injection New Indication Marketing ApplicationApproved by NMPAIn combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS), who are ineligible for autologous hematopoietic stem cell transplantation (ASCT) (2L+DLBCL).

May 8,Roche Pharmaceuticals China New Biopharmaceutical Production BaseThe launch ceremony of the investment project was held at the Zhangjiang Science Hall. The project investment amounts to 2.04 billion RMB, with the first phase of products mainly used for the localized production of treatment drugs for patients with fundus diseases, accelerating the fulfillment of Chinese patients' demand for high-quality medicines.

Recently,PfizerNew Antibacterial Drug Zavicefta^®(Ceftazidime Avibactam Sodium for Injection) has been approved by the NMPA for the treatment of complicated intra-abdominal infections, hospital-acquired pneumonia, and ventilator-associated pneumonia caused by Gram-negative bacteria in children of all age groups (including newborns), as well as infections with limited treatment options.

May 6,BeOne MedicinesThe new indication of Class 1 new drug BGB-45035 developed by BeOne Medicines has received tacit approval for clinical trials, aiming to treat prurigo nodularis.

May 6,Baochuan BioAnnounced that its IND application for the macrophage colony-stimulating factor 1 receptor (CSF-1R) monoclonal antibody has been approved by the NMPA for the treatment of idiopathic pulmonary fibrosis.

May 6,MediLinkYL217 for injection has been approved for clinical use in patients with advanced solid tumors confirmed by pathology, including gastrointestinal, esophageal, gastroesophageal junction, pancreatic or ampullary adenocarcinoma, and neuroendocrine tumors, among others.

May 7,Everest MedicinesAnnouncing Nefukang^®(Budesonide Enteric-Coated Capsules, NEFECON^®）Received full approval from NMPA, lifting the restrictions on proteinuria levels.NEFECON^®For the treatment of adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

May 8,Boehringer IngelheimNamivlumab Tablets (Nerandomilast) Proposed for Priority Review, Indication for Progressive Pulmonary Fibrosis (PPF).

Recently,CardioPulse Medical™Castor^®Custom fenestrated stent graft successfully completes first overseas clinical application in Singapore.

Recently,Yan Yin TechnologyAnnounced the completion of full integration with Alibaba's latest Qwen3 model, which will bring intelligent, efficient, and precise AI experience to biopharmaceutical R&D professionals.

May 9,Jingyin PharmaceuticalsAnnounced the completion of nearly 50 million US dollars in B2 round financing. This round of financing was led by a globally renowned industrial investment institution, with participation from Boyuan Capital, Orbimed, Hongyuan Capital, and Hankang Capital.