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
NDA accepted and both fruquintinib and sintilimab granted Priority Review, following Breakthrough Therapy designation in July 2023 First regulatory filing for fruquintinib for use in combination with a leading immune checkpoint inhibitor HONG KONG, SHANGHAI, China & FLORHAM PARK, N.J., April 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) and Innovent Biologics, Inc....Read more
Oral presentation at the European Lung Cancer Congress 2024 of Phase IIIb data demonstrating median PFS of 13.7 months and median OS not reached in treatment-naïve patients If approved, would confirm 2021 conditional approval and expand indication to more patients HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces...Read more
SHANGHAI & SOUTH SAN FRANCISCO, Calif. / Feb 26, 2024 / Business Wire / Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. (Nasdaq: KZR) announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Kezar’s investigational new drug (IND) application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis (LN)....Read more
Approval Represents an Important Breakthrough in One of the Largest Medical Aesthetics Markets LAVAL, QC / ACCESSWIRE / January 18, 2024 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) and Solta Medical, a global leader in the medical aesthetics market, today announced the approval of Thermage® FLX and the TR-4 Return Pad by China's National Medical Products Administration (NMPA). The TR-4 Return Pad is approved for use by the...Read more
NDA accepted and granted Priority Review following its Breakthrough Therapy designation granted in January 2022 NDA is supported by data from successful Phase III ESLIM-01 trial in patients with adult primary immune thrombocytopenia who have received at least one previous therapy HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 10, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today...Read more
LIVTENCITY Is the First and Only Inhibitor of CMV-specific UL97 Protein Kinase Approved in China for the Treatment of Adults With Post-transplant CMV Infection/Disease Refractory* to Conventional Anti-CMV Treatment Approval Based on Phase 3 TAK-620-303 SOLSTICE Study Demonstrating Maribavir Was Superior to Conventional Therapies at Week 8, for Primary Endpoint1 CMV Is One of the Most Common and Serious Post-transplant Infections and Can...Read more
Expands clinical development of GC012F in rSLE following FDA IND clearance for Phase 1/2 trial in the United States Gracell is pioneering use of a CD19/BCMA dual-targeted CAR-T cell therapy in rSLE, aiming for deeper and wider depletion of disease-causing antibody secreting cells and B-cells FasTCAR-T GC012F has demonstrated a favorable safety profile in clinical investigator-initiated trials in 60 patients with multiple myeloma and...Read more
HAIKOU, China, Nov. 29, 2023 /PRNewswire/ -- China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma", or the "Company"), an NYSE American-listed corporation with a fully-integrated specialty pharmaceuticals subsidiary based in China, today announced that its Dry Eye Disease (DED) therapeutic device has passed third-party testing and is preparing to apply for market launch to the National Medical Products Administration...Read more
STOCKHOLM, Nov. 24, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas') today announced that its partner Everest Medicines (HKEX: 1952.HK) ('Everest') announced that China's National Medical Products Administration (NMPA) has approved Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. China has the highest prevalence...Read more
Apollomics’ partner, Avistone Biotechnology, received approval from Chinese National Medical Products Administration (NMPA) to commercialize vebreltinib (APL-101) in China Compelling clinical data serving as basis of this approval supports continued development of vebreltinib for the rest of world FOSTER CITY, Calif., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a late-stage clinical biopharmaceutical company...Read more
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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