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,…
Recently, on May 25, 2026, the NMPA (National Medical Products Administration) released the latest drug notification letter delivery information, which included GlaxoSmithKline’s (GSK) investigational new drug Bepirovirsen injection (Bepirovirsen, GSK3228836, GSK836) for the treatment of chronic hepatitis B, with acceptance…
Lupeng Pharmaceutical’s BTK inhibitor Rocbrutinib granted priority review and conditional approval. Rocbrutinib is the world’s first fourth-generation BTK inhibitor with a dual covalent and non-covalent binding mechanism. It was developed by Lupeng Pharmaceutical using its proprietary BeyondX® platform and is…
The drug’s New Drug Application (NDA) was formally accepted and subsequently approved by the NMPA via priority review and conditional approval mechanisms. VC004 is the first approved Category 1 innovative chemical drug from Jiangsu Vcare PharmaTech. It is specifically designed…
The National Medical Products Administration (NMPA) recently granted conditional approval to Otsuka Pharmaceutical Co., Ltd. for Sibeprenlimab Injection (subcutaneous injection) (brand name: Voyxact) through a priority review and approval process. The drug is indicated for reducing proteinuria in adult patients…