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BioPharma Drug Approval

JW Therapeutics Secures Macao Approval for CAR-T Therapy Carteyva®, Marking First Overseas Market Entry

JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunother...

June 05, 2025 | News

Akeso’s Cadonilimab Secures NMPA Approval for First-Line Treatment of Cervical Cancer

Akeso, Inc. is pleased to announce that the National Medical Products Administration (NMPA) has approved the company's first- in-class PD-1/CTLA-4 bispecif...

June 05, 2025 | News

Singapore Approves Astellas’ VEOZA™ (Fezolinetant) for Moderate to Severe Menopausal Vasomotor Symptoms

Astellas Singapore has announced that the Health Sciences Authority (HSA) of Singapore has approved VEOZA™ (fezolinetant) 45 mg for the treatment of ...

June 04, 2025 | News

Mabwell Wins NMPA Approval for China’s First Albumin-Fused Long-Acting G-CSF Therapy MAILISHENG

Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that Albipagrastim alfa for Injection (trade name...

June 02, 2025 | News

Kexing Biopharm’s GB18 Receives IND Approval in China and U.S. for Cancer Cachexia Treatment

Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) applica...

May 30, 2025 | News

Adalvo Inks Licensing Deal with Formosa Pharmaceuticals for Novel Ophthalmic Steroid in Europe and Brazil

Adalvo announces the signing of an exclusive licensing agreement with Formosa Pharmaceuticals for the commercialisation of Clobetasol propio...

May 29, 2025 | News

Eisai’s DAYVIGO® Approved in China to Treat Insomnia, Targeting Over 170 Million Adults

Eisai Co., Ltd. announced that the in-house-discovered and developed orexin receptor antagonist DAYVIGO® (generic name: lemborexant) has been app...

May 29, 2025 | News

RemeGen’s Telitacicept Approved in China as First Dual-Target Biologic for Generalized Myasthenia Gravis

RemeGen Co., Ltd.(688331.SH / 09995.HK) announced that Telitacicept has officially been approved for marketing in China by the National Medical Produc...

May 28, 2025 | News

AnnJi Reports Promising Phase 1/2a Results for AJ201 in Rare Neuromuscular Disease SBMA

AnnJi Pharmaceutical Co., Ltd., a clinical-stage Taiwanese biotechnology company focused on addressing unmet medical needs in dermatology, neurology, and r...

May 22, 2025 | News

Kelun-Biotech's Fourth Indication for ADC sac-TMT Accepted for Priority Review in China

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new indication application (the "Application") for the Company's trophob...

May 22, 2025 | News

Singapore Approves Dupixent as First Biologic Treatment for Uncontrolled COPD with Raised Eosinophils

The Health Sciences Authority (HSA) has approved Dupixent (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic obstru...

May 14, 2025 | News

BioDlink Supports Junshi Biosciences in Achieving IND Approval for JS212, Its First Bispecific ADC

BioDlink congratulates Junshi Biosciences on receiving IND approval from China's NMPA for JS212, the company...

May 09, 2025 | News

China Grants Full Approval to Everest Medicines’ NEFECON® as First and Only Etiological Treatment for IgA Nephropathy

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, a...

May 07, 2025 | Regulatory

IGI’s Trispecific Antibody ISB 2001 Receives FDA Fast Track Designation for Relapsed Multiple Myeloma

IGI, a global, fully integrated, clinical-stage biotechnology company focused on multi-species™ oncology product development, announced that th...

May 06, 2025 | News

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