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Drug Approval

RemeGen’s Telitacicept Secures EMA Orphan Drug Designation for Myasthenia Gravis, Advancing Global Development

RemeGen Co., Ltd. ("RemeGen", stock symbols: 688331.SH/09995.HK) announced that telitacicept (RC18; brand name: 泰爱®) has received Orphan Drug Desig...

June 18, 2025 | News

Harrow Secures Exclusive U.S. Rights to BYQLOVI for Post-Surgical Eye Care Following FDA Approval

Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, and Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW), today a...

June 10, 2025 | News

ZEISS CLARUS® 700 Receives NMPA Approval in China, Enhancing Retinal Diagnostics

ZEISS Medical Technology announced that the CLARUS® 700 from ZEISS has received National Medical Products Administration (NMPA) approval in China,...

June 06, 2025 | News

Innovent and HUTCHMED’s Sintilimab-Fruquintinib Combo Accepted for NMPA Review in Advanced Renal Cell Carcinoma

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality me...

June 05, 2025 | News

Innovent Secures Second NMPA Breakthrough Therapy Designation for IBI363 in Advanced Lung Cancer

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality m...

June 05, 2025 | News

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

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