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
NEW YORK / Nov 09, 2023 / Business Wire / Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced it has received National Medical Products Administration (NMPA) approval in China for Motiva® Implants. “Our approval in China marks Establishment Labs’ entry into the second largest global and...Read more
BEIJING, Nov. 8, 2023 /PRNewswire/ -- CASI Pharmaceuticals Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, is thrilled to announce a major milestone in its partnership with Juventas Cell Therapy Ltd. (Juventas). The China National Medical Products Administration (NMPA) has granted market approval for Juventas' investigational cell therapy,...Read more
GUANGZHOU, China, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that the Company and Boehringer Ingelheim officially have signed the Master Service Agreement (MSA) in the field of oncology companion diagnostics. This agreement aims to provide Chinese patients with safer, more efficient, and precise treatment options and diagnostic methods,...Read more
GUANGZHOU, China, Oct. 15, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National...Read more
MADISON, Wis., Oct. 3, 2023 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the registration dossier for the CNNC-Accuray joint venture Tomo® C radiation therapy system for the Type B market has been approved by the Chinese National Medical Products Administration (NMPA). The new, made in China system, is the first joint venture product and represents an important achievement on behalf of cancer patients, many of...Read more
Bionano original equipment manufacturing (OEM) partner Ecobono obtained reagent Class I registration and approval for Bionano’s DNA isolation kits for optical genome mapping (OGM) from China's National Medical Products Administration (NMPA) Reagents can be utilized for in vitro diagnostics (IVD) use in China With this NMPA registration, Ecobono can sell OGM reagents to independent clinical laboratories and Chinese...Read more
SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The...Read more
1st product approval in China represents Amneal’s entry in second largest pharmaceutical market Expects international expansion will be another key vector for long-term growth and impact BRIDGEWATER, N.J. / Sep 06, 2023 / Business Wire / Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received its first product approval in China. Sevelamer carbonate was approved and is expected to...Read more
SHANGHAI, China and CAMBRIDGE, Mass., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for investigational repotrectinib for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with TRK...Read more
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Aug. 28, 2023 (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 savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (“GEJ”)...Read more
Bionano original equipment manufacturing (OEM) partner A-smart MedTech (A-smart) obtained reagent class I registration and approval for DNA isolation and labeling kits for optical genome mapping (OGM) from China's National Medical Products Administration (NMPA) Reagents can be utilized for in vitro diagnostics (IVD) use in reproductive health in China With this NMPA registration, A-smart can sell OGM reagents to independent...Read more
HAIKOU, China, Aug. 9, 2023 /PRNewswire/ -- China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma," the "Company" or "We"), a specialty pharmaceutical company, today announced that its wholly-owned subsidiary Hainan Helpson Medical & Biotechnology Co., Ltd. (hereinafter referred to as "Helpson") has received the "Drug Supplementary Application Approval Notice" for its candesartan tablets by National Medical Products...Read more
BOSTON and SHANGHAI, China and LAUSANNE, Switzerland, July 24, 2023 (GLOBE NEWSWIRE) -- Overland ADCT BioPharma, a joint venture of Overland Pharmaceuticals (CY) Inc. and ADC Therapeutics SA (NYSE: ADCT), today announced that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for ZYNLONTA® (loncastuximab tesirine-lpyl), which is seeking an indication for the treatment of adult...Read more
JERSEY CITY, N.J., July 20, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that China’s National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for oral ibrexafungerp tablets for the treatment of adult and post-menarchal pediatric females...Read more
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., July 20, 2023 (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 fruquintinib and sintilimab (a PD-1 antibody) for the treatment of patients with advanced...Read more
WALTHAM, Mass., July 13, 2023 (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 that a New Drug Application (NDA) for tenapanor has been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) for...Read more
SHANGHAI, China and CAMBRIDGE, Mass., July 10, 2023 (GLOBE NEWSWIRE) -- 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 efgartigimod alfa injection (subcutaneous (SC) injection, 1000mg (5.6ml)/vial) for the treatment of adult patients with generalized myasthenia gravis (gMG). “We are pleased to have the NMPA’s...Read more
Registration with the NMPA, China’s Regulatory Equivalent to the FDA, is a Prerequisite to Marketing and Distribution BEIJING, July 10, 2023 (GLOBE NEWSWIRE) -- Shineco, Inc. (“Shineco” or the “Company”; NASDAQ: SISI), a producer of technologically advanced healthcare products and services, announced today that on June 21, 2023, Changzhou Biowin Pharmaceutical Co., Ltd., a majority-owned subsidiary of the Company ("Biowin"), received...Read more
First-and-only approved FcRn antagonist for gMG patients by NMPA 68% of anti-AChR antibody positive gMG patients treated with VYVGART were responders (n=44/65) on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale compared with 30% of patients treated with placebo (n=19/64) (p<0.0001) during the first treatment cycle in the Phase 3 ADAPT trial Zai Lab to seek National Reimbursement Drug List (NRDL) inclusion for...Read more
First-and-only approved FcRn antagonist for gMG patients by NMPA 68% of anti-AChR antibody positive gMG patients treated with VYVGART were responders (n=44/65) on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale compared with 30% of patients treated with placebo (n=19/64) (p<0.0001) during the first treatment cycle in the Phase 3 ADAPT trial Zai Lab to seek National Reimbursement Drug List (NRDL) inclusion for...Read more
SHANGHAI, China and CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has accepted the New Drug Application (NDA) for repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC). “We are pleased to obtain the NMPA’s acceptance of our NDA...Read more
VASCEPA Approved by the National Medical Products Administration (NMPA) as an Adjunct to Diet to Reduce Triglyceride Levels in Adult Patients with Severe Hypertriglyceridemia (≥ 500 mg/dL) EddingPharm Now Working Towards Preparing for Commercial Launch of VASCEPA Across Mainland China Expected by Year-End DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today...Read more
SHANGHAI, China and CAMBRIDGE, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC). “The CDE’s decision to grant priority...Read more
SHANGHAI, China and PRINCETON, N.J., May 11, 2023 (GLOBE NEWSWIRE) -- LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced that CAMZYOS® (mavacamten) has received marketing approval for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the Pharmaceutical Administration Bureau of the...Read more
BRUKINSA is approved for first-line treatment for CLL/SLL and WM in China and has multiple approved indications in more than 65 markets worldwide BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / May 06, 2023 / Business Wire / BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the China National Medical Products Administration (NMPA) approved four applications for BRUKINSA...Read more
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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