-
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
•
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2 positive advanced colorectal cancer, marking…
-
NMPA Drafts Guidelines for Supervising Online Drug Exchange Platforms
•
The National Medical Products Administration (NMPA) has released draft “Online Third-party Drug Exchange Platforms Inspection Guidelines” for public review, with feedback accepted until September 15, 2023. These guidelines are designed to provide a framework for drug regulatory authorities to supervise and inspect enterprises offering third-party platform services in the pharmaceutical…
-
Genentech Files for FDA Approval of Crovalimab for PNH, Challenging Soliris
•
Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab, to the US Food and Drug Administration (FDA) for the treatment of the rare disease paroxysmal nocturnal hemoglobinuria (PNH). The filing is bolstered by Phase III clinical data that demonstrates crovalimab’s non-inferiority and a similar…
-
uBriGene and YolTech Therapeutics Join Forces to Advance mRNA Therapy and Gene Therapy
•
China-based uBriGene Biosciences Inc., a prominent contract development and manufacturing organization (CDMO) specializing in cell and gene therapy, has announced a partnership with YolTech Therapeutics, a leading developer in mRNA therapy and gene therapy. This collaboration aims to combine YolTech’s expertise in lipid nanoparticles (LNP) technology for nucleic acid drug…
-
CDE’s 2022 Drug Review Report: A Year of Pandemic Response and Regulatory Milestones
•
The Center for Drug Evaluation (CDE) has released its comprehensive 2022 annual drug review report, shedding light on the regulatory activities and statistics from the past year. This report provides a detailed account of the drug approval process amidst the ongoing COVID-19 pandemic and beyond. Pandemic-Related Drug Approvals and Clinical-Value…
-
Hainan Haiyao Concludes Phase I Clinical Study for PaiEnJiaBin, a Novel KCNQ Agonist
•
China-based Hainan Haiyao Co., Ltd (SHE: 000566) has announced the conclusion of Phase I clinical studies for PaiEnJiaBin, a Category 1 chemical drug co-developed with the Shanghai Institute of Materia Medica. PaiEnJiaBin is a next-generation KCNQ potassium channel agonist, with no similar products approved globally, and is being developed to…
-
Sino Medical Sciences Technology to Acquire Majority Stake in US Endovascular Device Firm eLum
•
China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced plans to acquire a 72.73% stake in eLum Technologies Inc., an early-stage endovascular medical device company based in California, US, for USD 20.73 million. Upon completion of the deal, eLum will become the controlling subsidiary of Sino Medical Sciences Technology.…
-
Acotec Scientific Holdings Receives Marketing Approvals for Vericor-14 Microcatheter in Japan and Thailand
•
China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approvals from the Ministry of Health, Labour and Welfare of Japan and the Thailand Food and Drug Administration for its Vericor-14 microcatheter. This regulatory clearance marks a significant milestone for the company’s product, which can now…
ADC / XDC AstraZeneca Auto-immune AZ 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 Pfizer Potential first-in-class Product approvals Rare / orphan disease drugs SHA: 600276 TKIs (EGFR VEGF BTK etc.) Vaccine
