-
AIM Vaccine Leverages DeepSeek AI to Optimize mRNA Shingles Vaccine Design
•
China-based AIM Vaccine Co., Ltd (HKG: 6660) has filed its mRNA-based shingles vaccine with the U.S. Food and Drug Administration (FDA), marking a milestone for the company’s entry into the global vaccine market. The submission follows promising preclinical data and positions AIM as a pioneer in mRNA shingles vaccine development,…
-
Innovent Biologics’ Ipilimumab NDA Accepted by CDE with Priority Review for Colon Cancer
•
China-based Innovent Biologics, Inc. (HKG: 1801) announced that the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA), has accepted the New Drug Application (NDA) for ipilimumab, an anti-CTLA-4 monoclonal antibody (mAb), and granted it Priority Review designation. The application covers the drug’s use in combination with sintilimab as…
-
Roche’s Tecentriq Wins Japan Approval for Alveolar Soft Part Sarcoma
•
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) and its Japanese partner Chugai Pharmaceutical Co., Ltd. (TYO: 4519) announced that the Ministry of Health, Labour and Welfare of Japan has approved Tecentriq (atezolizumab) for the treatment of unresectable alveolar soft part sarcoma. This marks the first approval of an immune…
-
GSK’s Nucala Receives NMPA Review for COPD Treatment
•
GSK plc (LON: GSK, NYSE: GSK) announced that the National Medical Products Administration (NMPA) has accepted another indication approval filing for its anti-interleukin-15 (IL-15) biologic Nucala (mepolizumab) for review. The UK-based company is seeking approval for the drug’s use as an add-on maintenance treatment for patients with chronic obstructive pulmonary…
-
Nuwacell Biotech’s NCR101 Approved for ILD Clinical Study by China’s CDE
•
According to the Center for Drug Evaluation (CDE) website, China-based Nuwacell Biotechnology Co., Ltd. has obtained approval for its NCR101 to conduct clinical trials in interstitial lung disease (ILD). Drug ProfileNCR101 is an induced pluripotent stem cell (iPSC)-derived mesenchymal-like cells (MSCs) therapy. The product has achieved large-scale production and ensures…
-
Bristol-Myers Squibb’s Opdivo Shows Survival Benefit in CheckMate-816 Study
•
Bristol-Myers Squibb (BMS, NYSE: BMY) announced the final analysis of overall survival (OS) data from the Phase III CheckMate-816 study for its Opdivo (nivolumab) in patients with resectable non-small cell lung cancer (NSCLC). Study HighlightsThe CheckMate-816 study evaluated Opdivo in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult…
-
Corxel Pharmaceuticals to Test JX10 in Acute Ischemic Stroke Patients with NMPA Approval
•
China-based Corxel Pharmaceuticals (CORXEL) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study evaluating the functional recovery of acute ischemic stroke (AIS) patients treated with JX10 within a time window of 4.5 to 24 hours from the “last known well.” Drug ProfileJX10 is an…
-
Gilead’s Livdelzi Receives Conditional EC Approval for Primary Biliary Cholangitis
•
US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that it has received conditional approval from the European Commission (EC) for its liver disease drug Livdelzi (seladelpar). The drug is approved for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in adults who have an inadequate response…
-
Boehringer Ingelheim Launches LENTICLAIR Study for CF Gene Therapy BI 3720931
•
German pharmaceutical company Boehringer Ingelheim announced the initiation of the Phase I/II LENTICLAIR study for its gene therapy candidate BI 3720931 in cystic fibrosis (CF). The study is being conducted in collaboration with IP Group, the UK Respiratory Gene Therapy Consortium (GTC), and OXB. Study DetailsBI 3720931 is an inhaled…
-
Huadong Medicine’s Biosimilar Tresiba Accepted by NMPA for Review
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar version of Denmark-based Novo Nordisk A/S’s (NYSE: NVO) Tresiba (insulin degludec) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is adult type 2 diabetes. Drug ProfileInsulin degludec, a…
-
Innogen Pharmaceutical Launches Efsubaglutide Alfa for Type 2 Diabetes in China
•
China-based Guangzhou Innogen Pharmaceutical Group Co., Ltd, a biopharma focused on metabolic diseases, announced the global launch of its efsubaglutide alfa, a next-generation ultra-long-acting glucagon-like peptide 1 (GLP-1) receptor agonist for the treatment of type 2 diabetes (T2D), in Changshu, Jiangsu province. Drug ProfileEfsubaglutide alfa, with an average half-life of…
-
Bayer’s AskBio Receives RMAT Designation for AB-1005 in Parkinson’s Disease
•
German pharmaceutical giant Bayer (ETR: BAYN) announced that its gene therapy subsidiary AskBio Inc. has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational gene therapy AB-1005 as a treatment for Parkinson’s disease (PD). Drug ProfileAB-1005 is an investigational gene therapy…
-
Phanes Therapeutics Doses First Patient in Peluntamig Study for SCLC and NEC
•
Sino-US biotech Phanes Therapeutics Inc. announced that the first patient has been dosed in a clinical study evaluating peluntamig (PT217) in combination with chemotherapy. The trial focuses on patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC). Drug ProfilePeluntamig is a bispecific antibody (BsAb) targeting DLL3 and CD47.…
-
Boehringer Ingelheim’s Zongertinib NDA Accepted by FDA for HER2-Mutated NSCLC
•
Germany-based Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for zongertinib (BI 1810631). The drug is indicated for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations who have received prior systemic therapy. The…
-
Hepalink Pharmaceutical’s H1710 Heparanase Inhibitor Approved for Phase I Study
•
China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study of its proprietary drug candidate H1710, a heparanase (HPA) inhibitor, for the treatment of advanced solid tumors. Drug ProfileH1710 is designed…
-
Henlius Biotech’s Avastin Biosimilar Hanbeitai Approved in Bolivia
•
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that its biosimilar of Roche’s Avastin (bevacizumab), Hanbeitai, has received marketing approval in Bolivia. This marks the first approval for the drug outside of China. The product will be marketed under the trade name Longiva in the Latin American country. Licensing DealHenlius entered…
-
Astellas Pharma’s Xospata Wins Regular NMPA Approval for FLT3-Mutated AML
•
Japan-based Astellas Pharma Inc. (TYO: 4503, OTCMKTS: ALPMY ) announced that the National Medical Products Administration (NMPA) has converted the conditional approval for its Xospata (gilteritinib) into regular approval. The decision is based on data from the COMMODORE study, a Phase III trial comparing gilteritinib to salvage chemotherapy in patients…
-
Hanx Biopharmaceuticals’ HX009 Receives NMPA Clearance for TNBC Study
•
Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clearance from the National Medical Products Administration (NMPA) for its HX009, a bifunctional macromolecule targeting PD-1 and CD47. The company plans to test the investigational cancer immunotherapy in combination with an antibody drug conjugate (ADC) for triple-negative breast cancer (TNBC)…
-
Biogen Licenses Stoke Therapeutics’ Zorevunersen for Dravet Syndrome Outside Americas
•
US-based Biogen Inc. (NASDAQ: BIIB) has entered into a licensing agreement with Stoke Therapeutics, Inc. (NASDAQ: STOK), securing exclusive commercialization rights to zorevunersen, a drug for Dravet syndrome, in all territories outside the United States, Canada, and Mexico. Drug ProfileZorevunersen is an antisense oligonucleotide (ASO) targeting the SCN1A gene, the…
-
TAHO Pharma’s TAH3311 Oral Film Shows Bioequivalence to Eliquis in Study
•
Taiwan-based TAHO Pharmaceuticals announced positive preliminary results from a pivotal study for its TAH3311 oral dissolving films, a generic version of Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban). The study demonstrated that TAH3311 was bioequivalent to the reference drug under fasting conditions. Study ResultsThe trial involved 60 healthy subjects, with 48 completing the…
