Shanghai Minwei Biotechnology Co., Ltd. has registered a Phase I first-in-human clinical trial of MWN110, a monoclonal antibody targeting activin receptors ActRIIA and ActRIIB, in healthy volunteers and people with overweight or obesity. The study marks the first human trial of the asset, which Minwei, a subsidiary of Lepu Medical Technology (SHE: 300003), said was developed in-house and is covered by intellectual property rights held by the company. The study (NCT07779980) is a randomized, dou

The FDA on Friday approved Takeda and Protagonist Therapeutics' Mimrylo (rusfertide) to treat adults with polycythemia vera (PV), making it the first hepcidin mimetic cleared to treat the rare blood disorder. Current treatment options for PV, like hydroxyurea and interferons, as well as Incyte's Jakafi (ruxolitinib), are "ineffective in a majority of patients," Protagonist President and CEO Dinesh Patel previously told FirstWord. Patients have also historically relied on phlebotomies to keep th

In their high-profile competition in the diabetes and obesity markets, Eli Lilly has proven adept at playing catch-up with Novo Nordisk. On Friday, Lilly checked another item off that list as it secured FDA approval for Mounjaro to reduce the risk of major adverse cardiovascular events (MACE), including CV death, heart attack or stroke, in at-risk adults with Type 2 diabetes. With the nod, Lilly matches the 2020 approval Novo received for its diabetes treatment, Ozempic, to lower the risk of ad

Aug. 28, 2026 -- InxMed Co., Ltd ("InxMed"), a clinical-stage biotechnology company dedicated to developing innovative therapies targeting cancer treatment resistance and metastasis, today announced that the clinical results of ifebemtinib (IN10018), a highly selective focal adhesion kinase (FAK) inhibitor, in combination with garsorasib (D-1553), a potent KRAS G12C inhibitor, in previously treated KRAS G12C-mutant metastatic colorectal cancer (CRC), have been published online in The Lancet Onco

MZ‑1866 Phase 1/2 UNITE Study is now more than 50% enrolled Aug. 25, 2026 -- Mahzi Therapeutics Inc., a clinical-stage biotechnology company developing precision therapies for neurogenetic disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to MZ-1866, Mahzi's investigational gene therapy for the treatment of Pitt Hopkins syndrome. The designation was granted by the FDA's Office of Orphan Products Development and Off

Aug. 21, 2026 -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Opamtistomig (LBL-024), the Company's proprietary PD-L1/4-1BB bispecific antibody, as a monotherapy for the treatment of previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). Opamtistomig is the first PD-L1/4-1

GSK is looking to expand its COPD biologics franchise beyond IL-5 blockade, kicking off two Phase III studies of its long-acting anti-TSLP antibody felcorekibart (GSK5784283/AIO-001). Sanofi and Regeneron's IL-4/IL-13 inhibitor Dupixent (dupilumab) and GSK's IL-5 inhibitor Nucala (mepolizumab) are currently the only approved biologics for the condition. Earlier this year, CEO Luke Miels singled out felcorekibart as one of the pipeline programmes that could help GSK raise its game (see – Spotli

If at first you don’t succeed in gene therapy, then try, try again. That's the lesson Ultragenyx likely took home this week as it pocketed its first FDA nod in the class just over a year after a separate program stalled on manufacturing grounds. Late Wednesday, the FDA gave an accelerated go-ahead to pariglasgene brecaparvovec-opnr, Ultragenyx’s AAV gene therapy for the rare genetic disorder glycogen storage disease type Ia (GSDIa), which will now head to market with the brand name Genglycos.

Pumitamig plus B7H3-targeting elfetabart drozuntecan delivers the first data in lung cancer for any PD-(L)1xVEGF bispecific immunomodulator combined with an antibody-drug conjugate, underscoring BioNTech’s leadership in novel-novel combination treatment strategies Updated overall survival data for gotistobart from the PRESERVE-003 Phase 3 clinical trial will add to the growing body of evidence for this chemotherapy-free treatment approach in the second- and later-line treatment of advanced squam

Aug. 21, 2026 -- Dizal (SSE: 688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today that the latest clinical data on its novel epidermal growth factor receptor (EGFR) inhibitor ZEGFROVY® (sunvozertinib) in non-small cell lung cancer (NSCLC) will be presented at the 2026 World Conference on Lung Cancer (WCLC) from September 12 to 15 in Seoul, Republic of Korea. ZEGFROVY is approved in China and the U.S.