On May 26, 2026, Henlius (2696.HK) announced that the first patient has been dosed in China in the randomized, double-blind, multicenter, parallel-controlled Phase II/III clinical study evaluating pimurutamab (HLX07), the Company’s proprietary recombinant anti-EGFR monoclonal antibody, in combination with H药 汉斯状®…
The Parkinson’s disease candidate drug from Biogen and Denali Therapeutics failed to significantly slow disease progression in a Phase IIb study, leading the partners to discontinue the drug. BIIB122, also known as DNL151, is an oral small-molecule LRRK2 inhibitor. LRRK2…
Following the failure of a Category 2.2 improved drug application for the same product, Zhejiang Baidai’s improved new drug, Amlodipine Besylate Granules, has once again received a rejection notice, shattering the industry’s wishful thinking. Amlodipine Besylate was originally developed by…
SHR4640, a Category 1 new drug independently developed, is the first domestically approved URAT1 selective inhibitor in China. It is indicated for the treatment of gout with hyperuricemia. URAT1 is a urate transporter specifically expressed in renal tubular epithelial cells,…
Saiduomingji Injection, a Category 1 new drug independently developed by Northland Biotech, is the world’s first approved plasmid-based gene therapy drug. It is indicated for the treatment of ulcers caused by severe limb ischemia (CLI) in patients who are not…
Annitumab Injection, co-developed by Shanghai Jinmante Biotechnology Co., Ltd. and Jiangsu Kangning Jierui Biopharmaceutical Co., Ltd., has been approved for marketing. It is a recombinant humanized anti-HER2 biparatopic antibody. The approved indication is in combination with chemotherapy for the treatment…
The concentrated solution for injection of fosnetupitant/palonosetron (AKYNZEO®, NEPA), a novel antiemetic combination drug for chemotherapy introduced by Fosun Pharma/Helsinn Group, covers two major areas: oncological supportive care and pain management supportive treatment, further enriching clinical treatment options in China.…
Naldemedine, developed by Shionogi and commercialized in China by Chia Tai Tianqing, has been officially approved for marketing by the NMPA (acceptance number: JXHS2500060). It is specifically indicated for the treatment of opioid-induced constipation (OIC), filling a gap in precise…
On May 29, according to the announcement on the NMPA official website, the Topiramate Oral Solution (Category 3 generic drug) submitted by Renhe Yikang Group was officially approved for marketing and was deemed to have passed the consistency evaluation. Topiramate…
On June 2, it was announced that the supplemental New Drug Application (sNDA) for Roche’s core investigational SERD product Giredestrant, for a new indication, has been accepted by the FDA. The new indication targets adjuvant treatment of estrogen receptor (ER)-positive,…