UniXell Bio Secures FDA Approval for UX‑GIP001 – First iPSC Allogeneic Cell Therapy for Epilepsy Enters US Clinical Trials
Shanghai UniXell Biotechnology Co., Ltd. announced that its iPSC‑derived allogeneic cell therapy UX‑GIP001 has received...
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Bio-heart Bio Expands Iberis RDN Registration to Thailand – World’s Only Dual‑Access Renal Denervation System
Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced Thailand regulatory registration of its Iberis...
Eli Lilly Rolls Out USD 299 Zepbound KwikPen via LillyDirect – Self‑Pay Pricing for Dual‑Target Obesity Drug
Eli Lilly and Company (NYSE: LLY) announced that patients can now access the single‑patient‑use Zepbound...
Peijia Medical Secures First FDA 510(k) Clearance for DCwire Micro Guidewire – US Market Entry Milestone
Peijia Medical Ltd (HKG: 9996) announced that its DCwire micro guidewire has received 510(k) clearance...
Henlius Wins NMPA Approval for HLX07 Combination Trial – Anti-EGFR Biologic Plus Serplulimab Targets Squamous NSCLC
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that subsidiary Shanghai Henlius...
CSPC Pharma Secures Dual NMPA‑FDA Approval for PDE4B Inhaler SYH2059 – First‑in‑Class ILD Candidate Enters Global Clinical Development
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that its highly selective PDE4B inhibitor SYH2059 powder...
Alphamab Oncology Doses First Patient in JSKN027 Phase I Trial – First‑in‑Class PD‑L1/VEGFR2 Bispecific ADC Enters Clinic
Alphamab Oncology (HKG: 9966) has successfully dosed the first patient in the Phase I clinical...
PegBio Inks RMB10 Billion Paidakang Commercialization Deal with Tenry Pharma – Exclusive China Partnership for Weekly GLP‑1 Diabetes Drug
PegBio Co., Ltd. (HKG: 2565) has entered into a strategic cooperation agreement with Shanghai Tenry...
Ascentage Pharma and Haisco Secure CDE SPARK Inclusion for Pediatric Oncology Candidates – APG‑115 and HSK42360 Target High‑Unmet‑Need Childhood Cancers
China’s Center for Drug Evaluation (CDE) has selected two innovative oncology assets for its Support...
Roche Deploys 2,176 NVIDIA GPUs in Global AI Factory – Largest Pharma GPU Footprint Expands to 3,500+ Blackwell Units
Roche (SWX: ROG, OTCMKTS: RHHBY) announced the expansion of its global AI infrastructure through the...
BeOne Innovation Center and Voyagers Capital Launch Fund – Early-Stage Drug Investment Vehicle Targets Guangzhou Biotech
The BeOne Innovation Center (BIC) and Voyagers Capital jointly announced the establishment of the “BeOne...
Sino Biopharm’s TRD221 Wins NMPA Approval – Novel Polysaccharide Drug Targets Osteoarthritis via Complement Inhibition
Sino Biopharmaceutical Limited (HKG: 1177) announced that TRD221, a Category 1 innovative polysaccharide drug co-developed...
Ab&B Bio-Tech Partners with Walvax for Overseas Push – First China-Approved Trivalent Subunit Influenza Vaccine Targets Global Markets
Ab&B Bio-Tech Co., Ltd. (HKG: 2627) entered into a strategic partnership with Walvax Biotechnology Co.,...
CMS Secures NMPA Approval for Desidustat – First Domestic HIF-PHI for Non-Dialysis CKD Anemia Enters China Market
China Medical System Holdings (CMS; HKG: 0867) announced marketing approval from China’s National Medical Products...
Hengrui’s Irinotecan Liposome (II) Wins NMPA Phase II Approval – Adjuvant Pancreatic Cancer Study vs. Gemcitabine/Capecitabine
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a...
3SBio Wins NMPA Approval for Eltrombopag Generic – TPO-RA Copycat Targets Novartis’ Revolade in China ITP/SAA Market
3SBio Inc. (HKG: 1530) announced NMPA marketing approval for its generic version of Novartis’ Revolade...
Chipscreen Biosciences’ CS08399 Wins NMPA Approval – PRMT5-MTA Inhibitor Targets MTAP-Deficient Solid Tumors and Lymphomas
Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced NMPA clearance to initiate a clinical study...
Novartis’ Cosentyx Wins FDA Pediatric Approval – Only IL-17A Inhibitor for Hidradenitis Suppurativa in Adolescents 12+
Novartis (NYSE: NVS) announced that Cosentyx (secukinumab) received U.S. FDA approval for treating pediatric patients aged...
Cutia Therapeutics’ CU-40105 Wins NMPA Approval – Topical Dutasteride Targets Androgenetic Alopecia with Reduced Systemic Exposure
Cutia Therapeutics announced NMPA clearance to initiate a clinical study for CU-40105, a topical dutasteride...
J&J’s Erda-iDRS Shows 89% Complete Response in NMIBC – Intravesical Erdafitinib System Advances to Phase II/III
Johnson & Johnson (J&J, NYSE: JNJ) announced positive Phase I results for Erda-iDRS, an investigational...