-
Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA
•
China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for its combination therapy of anlotinib and penpulimab in first-line advanced hepatocellular carcinoma (HCC). Phase III Study Data Supports NDA FilingThe filing is supported by data from…
-
Sihuan Pharmaceutical’s Huisheng Pharm Strikes Exclusive Deal for Semaglutide Biosimilar in China
•
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced an exclusive licensing agreement between its subsidiary Huisheng Pharm and MEIYOUNG. The deal pertains to Huisheng’s biosimilar version of Denmark-based Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide (Ozempic/Wegovy) for the treatment of overweight or obesity in China. Terms of…
-
Innovent Biologics’ IBI354 Earns Breakthrough Therapy Designation for Ovarian Cancer Treatment
•
The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG: 1801) is set to obtain breakthrough therapy designation (BTD) for its antibody drug conjugate (ADC) IBI354, which targets HER2, for the treatment of platinum-resistant ovarian cancer. Phase I/II Clinical Study ResultsThe Phase I/II clinical study…
-
CDE Includes Double-Crane’s Hydroxocobalamine and Sanofi Genzyme’s Fitusiran in Rare Disease Care Plan
•
China’s Center for Drug Evaluation (CDE) has announced the inclusion of China Resources Double-Crane Pharmaceutical Co., Ltd’s (SHA: 600062) hydroxocobalamine and Sanofi (NASDAQ: SNY) Genzyme’s fitusiran in its patient-centered rare disease drug development pilot program, known as the Care Plan. Hydroxocobalamine for Metabolic Disorders in Children with MMAHydroxocobalamine, also referred…
-
Apeiron Therapeutics Initiates Phase Ia/B Study for GTA182 in Solid Tumors with MTAP Deficiency
•
Apeiron Therapeutics, a biomarker-driven cancer therapy developer with operations in Shanghai, China, and San Francisco, US, has announced the enrollment of the first patient in the Phase Ia/B study for its investigational drug GTA182. The dosage escalation study aims to assess the safety, efficacy, and pharmacokinetics of the small molecule…
-
BI Partners with Sinopharm for Promotion of Sifrol and Pradaxa in China
•
German pharmaceutical major Boehringer Ingelheim (BI) has entered into a partnership with China-based Sinopharm Group Co., Ltd (HKG: 1099), granting the latter the rights to promote Boehringer Ingelheim’s Sifrol (pramipexole) and Pradaxa (dabigatran) in China effective from January 1, 2025. Boehringer Ingelheim will retain ownership and manufacturing responsibilities for both…
-
Medtronic Receives US Approval for InPen App with Missed Meal Dose Detection
•
US-Irish firm Medtronic (NYSE: MDT) has announced US market approval for its new InPen app, which features missed meal dose detection. This innovation marks a significant step in the launch of Medtronic’s Smart MDI system, integrated with the Simplera continuous glucose monitor (CGM). InPen App: A Pioneer in Real-Time Insulin…
-
CStone Pharmaceuticals Partners with Pharmalink for Suemalimab Commercialization in MENA and South Africa
•
China-based CStone Pharmaceuticals (HKG: 2616) has announced a strategic commercial collaboration with Pharmalink Store – L.L.C – O.P.C (Pharmalink), a prominent pharmaceutical company based in the United Arab Emirates (UAE), concerning its anti-PD-L1 monoclonal antibody (mAb) sugemalimab. Commercial Rights and Deal TermsUnder the agreement, Pharmalink will acquire the commercial rights…
ADC / XDC AstraZeneca Auto-immune AZ Biosimilars Biotech BMS Bristol-Myers Squibb Cancer CAR-T Cell-therapy Clinical trial approval / initiation Clinical trial results Combination therapy CRO / CMO / CDMO CVD Diabetes Eli Lilly Finance Finanical Reports Gene therapy Hengrui Medicine J&J Johnson & Johnson Market approval filings Merck MSD Multi-specific antibodies NASDAQ: AZN NMPA Novartis NYSE: BMY NYSE: JNJ NYSE: LLY NYSE: MRK NYSE: NVS Obesity Ophthalmology PD-1/L1 Potential first-in-class Product approvals Rare / orphan disease drugs SHA: 600276 TKIs (EGFR VEGF BTK etc.) Vaccine
