SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that the National Medical Products Administration (NMPA) of the People’s Republic of China (“PRC”) has approved its clinical trial application for a potential new indication for pirfenidone in oncology-related pulmonary complications. The trial will...Read more
First and only EZH2 inhibitor approved by the NMPA HUTCHMED’s fourth product, and its first approval in hematological malignancies HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 21, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for TAZVERIK® (tazemetostat) has been granted conditional approval in China for the treatment of adult...Read more
SHANGHAI & CAMBRIDGE, Mass. / Mar 12, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. “In China, cervical cancer is a serious...Read more
ROCKVILLE, Md. and SUZHOU, China, March 05, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company engaged in discovering, developing, and commercializing therapies to address global unmet medical needs primarily for hematological malignancies, today announced that its drug, olverembatinib, has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of...Read more
WALTHAM, Mass., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced the approval of a New Drug Application (NDA) by China’s Center for Drug Evaluation of the National Medical Products Administration for tenapanor to control serum phosphorus...Read more
ALPHARETTA, Ga., Feb. 20, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) (“Clearside” or the “Company”), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), reported that Arctic Vision’s New Drug Application (NDA) for ARCATUS® for the treatment of uveitic macular edema (UME) has been formally accepted for review by the Center for...Read more
Vibativ® is a life-saving antibiotic for pneumonia and serious skin infections Approval in China paves the way for launch in world's second-largest market NASHVILLE, Tenn. and SHANGHAI, Feb. 18, 2025 /PRNewswire/ -- Specialty pharmaceutical companies Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) and SciClone Pharmaceuticals (Holdings) Limited ("SciClone Pharmaceuticals" or "SciClone") today announced the NMPA (National Medical...Read more
Seeks to expand regulatory approval in China where IceSense3 has already been approved CAESAREA, Israel, Jan. 27, 2025 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has submitted a regulatory filing with China's National Medical...Read more
SHANGHAI & CAMBRIDGE, Mass. / Jan 17, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults. “There are more than 8 million patients living with schizophrenia in China who face significant unmet needs due to the limited efficacy and undesirable side...Read more
Indication expands to include treatment-naïve patients The 2021 conditional approval in previously treated patients converted to full approval HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 14, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the supplemental New Drug Application for ORPATHYS® (savolitinib) has been granted approval by the China...Read more
MADISON, Wis., Jan. 13, 2025 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the company's Radixact SynC™ System and CyberKnife® S7™ System have been approved by the Chinese National Medical Products Administration (NMPA). With these approvals medical care teams can provide patients in China the most advanced Accuray radiation therapy solutions. The CyberKnife S7 System is the latest generation CyberKnife platform...Read more
GARDASIL is the first HPV vaccine approved for the prevention of certain HPV-related cancers and diseases in Chinese males RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the National Medical Products Administration (NMPA) of China approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males 9-26...Read more
Taletrectinib will be marketed in China by Innovent Biologics Approval is based on the pivotal Phase 2 TRUST-I study, demonstrating taletrectinib's durable responses and prolonged progression-free survival NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that China’s National Medical Products Administration (NMPA) has...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 02, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer...Read more
SAN FRANCISCO and SUZHOU, China, Dec. 20, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, today announced that China's National Medical Products Administration (NMPA) has approved a New Drug...Read more
China is the fourth major market where Kisunla has received approval Kisunla was first approved in the United States in July 2024, approved in Japan in September 2024 and then in Great Britain in October 2024 INDIANAPOLIS, Dec. 17, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the National Medical Products Administration (NMPA) in China has approved Kisunla™...Read more
This approval marks the fourth non-small cell lung cancer (NSCLC) indication and the first indication in earlier stages of NSCLC for KEYTRUDA in China RAHWAY, N.J. / Dec 16, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with locally advanced or...Read more
Approval triggers fourth and final US$5.9 million milestone payment to Conavi Medical, which it will use to extinguish the promissory note owed by it to EOM Conavi Medical eligible to receive future tiered royalty payments, ranging from 5.0%-10.0%, on net EOM coronary imaging system sales in China TORONTO, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Conavi Medical Corp. (TSXV: CNVI) (“Conavi Medical” or the “Company”), a...Read more
BEIJING, Dec. 9, 2024 /PRNewswire/ -- Concord Medical Services Holdings Limited ("Concord Medical" or the "Company") (NYSE: CCM), a healthcare provider specialized in cancer treatment, research, education and prevention in China, today announced that the National Medical Products Administration of the People's Republic of China has granted approval to the application for the Registration Certificate for Medical Device for the proton...Read more
ST. LOUIS and SHANGHAI, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS) and Shanghai MicroPort EP Medtech Co., Ltd. (688351.SH, “MicroPort EP”), today announced that the Magbot™ Magnetic Navigation Ablation Catheter has received regulatory approval from China’s National Medical Products Administration (NMPA). The Magbot™ Catheter is a single-use magnetic saline-irrigated radiofrequency ablation catheter designed and developed...Read more
SAN FRANCISCO, U.S. and SUZHOU, China, Dec. 3, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13)，jointly announce that the...Read more
First regulatory approval for fruquintinib combination therapy with an immune checkpoint inhibitor HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab...Read more
ST. LOUIS and SHANGHAI, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS) and Shanghai MicroPort EP Medtech Co., Ltd. (688351.SH, “MicroPort EP”), today announced regulatory approval of the Genesis RMN® System by China’s National Medical Products Administration (NMPA). This approval is a significant milestone, making available the latest advances in minimally-invasive robotic technology to physicians and patients in China....Read more
WELIREG is the first and only systemic therapy approved in China for adult patients with certain VHL disease-associated tumors Decision marks first approval for WELIREG in China and 17th approval of WELIREG for these patients globally RAHWAY, N.J. / Nov 22, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the National Medical Products Administration (NMPA) in China...Read more
First and only NMPA-approved treatment for patients with CIDP in China Third approval for efgartigimod franchise in China demonstrating Zai Lab’s deep expertise developing innovative treatments across a broad range of diseases SHANGHAI & CAMBRIDGE, Mass. / Nov 11, 2024 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & Nasdaq: ARGX) today announced that China’s National Medical Products...Read more
First and only NMPA-approved treatment for patients with CIDP in China Second VYVGART Hytrulo indication approved in China November 11, 2024 – 7:30am ET - Amsterdam, the Netherlands - argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) approved the supplemental Biologics License Application (sBLA) for...Read more
GAITHERSBURG, Md., Oct. 25, 2024 /PRNewswire/ -- LakeShore Biopharma Co., Ltd (Nasdaq: LSB) ("LakeShore Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that it has been granted approval for a Phase III clinical trial (the "Trial") by the National...Read more
BEIJING, CHINA / ACCESSWIRE / October 24, 2024 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) to proceed with a phase 1/2 study of CID-103...Read more
GUANGZHOU, China, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), an innovative company in the field of precision oncology, and Dizal, a global biopharmaceutical company focused on malignant tumors and immunological diseases, jointly announced that the companion diagnostic (CDx) for EGFR exon 20 insertion mutation (exon20ins) for sunvozertinib, developed through their...Read more
Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life COPD is the most prevalent chronic respiratory disease in China, and is a priority within the government’s Healthy China 2030 public health plan Dupixent is now approved in...Read more
MASON, Ohio / Jul 23, 2024 / Business Wire / AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced that it has received regulatory approval from the National Medical Products Administration (NMPA) of China to market and sell several models of its AtriClip® Left Atrial Appendage (LAA)...Read more
RADNOR, Pa. / Jul 18, 2024 / Business Wire / Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that the China National Medical Products Administration (NMPA) has approved ganaxolone oral suspension for the treatment of epileptic seizures in patients two years of age and older with CDKL5 deficiency disorder (CDD). In...Read more
First and only NMPA-approved subcutaneous injectable FcRn blocker for gMG patients in China Consistent clinical benefit and safety profile of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC study July 16, 2024 6:30am CET - Amsterdam, the Netherlands — argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA)...Read more
VASCEPA Approved by the National Medical Products Administration (NMPA) To Reduce the Risk of Cardiovascular Events as an Adjunct to Statin Therapy in Adult Patients with Elevated Triglyceride (TG) Levels (≥150 mg/dL) and Other High-Risk Characteristics as Studied in REDUCE-IT EddingPharm Now Working to Prepare for National Reimbursement and Drug Listing (NRDL) and Enhance the Commercial Launch of VASCEPA Across Mainland...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 04, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for tazemetostat for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) has been accepted for review and granted Priority Review by the China National Medical Products Administration...Read more
SAN DIEGO, July 02, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced that China’s National Medical Products Administration (“NMPA”) has approved Gyre Pharmaceuticals’ (Gyre’s indirectly controlled subsidiary) avatrombopag maleate tablets for the treatment of...Read more
MADISON, Wis., June 12, 2024 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the registration dossier for the Accuray Precision® Treatment Planning System (TPS) has been approved by the Chinese National Medical Products Administration (NMPA). The Accuray Precision TPS is now available for use with the CNNC-Accuray joint venture Tomo® C radiation therapy system and in combination, will provide medical care teams...Read more
Pursuant to the terms of the licensing agreement between Zymeworks and BeiGene, Zymeworks is entitled to receive an $8 million milestone payment from BeiGene and remains eligible to receive up to $164 million based on additional milestones plus royalties on product sales A Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for zanidatamab as a treatment for previously-treated, unresectable, locally...Read more
Separate & Distinct from HARMONi-2 Announcement, HARMONi-A Showed Clinically Meaningful and Statistically Significant Benefit: PFS Hazard Ratio of 0.46 For Subset of Patients Previously Receiving 3rd Generation EGFR-TKI: PFS Hazard Ratio of 0.48 5.6% Treatment Discontinuation of Ivonescimab due to Adverse Events vs. 2.5% Treatment Discontinuation of Placebo HARMONi-A was Featured in Oral Presentation at ASCO 2024 on May 31,...Read more
SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced that the Center for Drug Evaluation (“CDE”) of China’s National Medical Products Administration (“NMPA”) has approved Gyre Pharmaceuticals’ (Gyre’s indirectly controlled subsidiary) Investigational New...Read more
FREMONT, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Today Cytek Biosciences, Inc. (Nasdaq: CTKB) announced that its 1-laser and 2-laser 6-color TBNK reagent cocktails have received China National Medical Products Administration (NMPA) approval for clinical diagnostic use on the Cytek® Northern Lights™-Clinical (NL-CLC™) cell analysis systems in hospitals, laboratories and clinics across China. This is the first clinical 1-laser based...Read more
Drug-resistant Acinetobacter baumannii is a growing global health threat and high priority pathogen needing new antibiotics, according to World Health Organization China NMPA approval based on comprehensive clinical data demonstrating robust activity of SUL-DUR against carbapenem-resistant bacterial strains In China, it is estimated there are approximately 300,000 cases of Acinetobacter infections and approximately 74% of them are...Read more
sBLA submission based on positive results from the ADHERE trial, the first positive global neonatal FC receptor (FcRn) pivotal study for CIDP There are currently no approved therapies available in China for this serious autoimmune disease Milestone underscores Zai Lab’s operational capabilities and deep expertise developing and commercializing innovative treatments in China across a broad range of diseases SHANGHAI & CAMBRIDGE,...Read more
The approval is based on the pivotal TRIDENT-1 trial, in which AUGTYRO achieved a high response rate and durable responses, including robust intracranial responses SHANGHAI & CAMBRIDGE, Mass. / May 12, 2024 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has approved the New Drug Application (NDA) for AUGTYRO™ (repotrectinib) for the...Read more
MARLBOROUGH, Mass. and SHANGHAI, China, May 02, 2024 (GLOBE NEWSWIRE) -- Akoya Biosciences, Inc. (Nasdaq: AKYA), The Spatial Biology Company®, and Shanghai KR Pharmtech, a leading company providing molecular diagnostic solutions in China, have jointly announced that KR-HT5, which Akoya Biosciences co-developed with Shanghai KR Pharmtech utilizing the PhenoImager HT technology as its foundation, has received premarket approval from China's...Read more
Apollomics’ partner in China, Avistone, received approval from National Medical Products Administration of China to expand the use of vebreltinib to the treatment of gliomas with PTPRZ1-MET fusion gene Approval based on results from a randomized Phase 2/3 trial FOSTER CITY, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company developing multiple oncology drug...Read more
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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