National Medical Products Administration

China Medical System: An Innovative Drug, ILUMETRI 'Tildrakizumab Injection' Approved for Marketing in China

Retrieved on: 
Tuesday, May 30, 2023
The Spring Festival, Maintenance, CMS, Marketing, New Drug Application, NDA, Psoriasis, Spring Festival, Light, Incidence, Patient, Autoimmune disease, National Medical Products Administration, PASI, Chemokine, Polidocanol, NMPA, Safety, Vaccine, Pharmaceutical industry

This is CMS’s second innovative drug approved for marketing in China this year following the approval of Methotrexate Injection.

Key Points: 
  • This is CMS’s second innovative drug approved for marketing in China this year following the approval of Methotrexate Injection.
  • ILUMETRI is CMS’s second innovative drug approved to be marketed in China in 2023, following the recent approval of Methotrexate Injection.
  • ILUMETRI has been approved for marketing in the Hong Kong Special Administrative Region of China in April 2022.
  • Tildrakizumab Injection has also been approved for marketing in the U.S., EU, Japan, UK, Switzerland, Canada, Australia and other countries/regions.

CANbridge Announces Full Enrollment Reached in China Region of the Global LIVMARLI® (CAN108) EMBARK Phase 2 Study in Biliary Atresia

Retrieved on: 
Tuesday, May 30, 2023
Health, Science, Pharmaceutical, Research, Clinical Trials, ALGS, National Medical Products Administration, NDA, PFIC, Biliary atresia, Doctor of Philosophy, MD, Patient, Cholestasis, Policy, Alagille syndrome, NMPA, BA, Cholestatic pruritus, Safety, Disease, Pharmaceutical industry

This global, multi-center, randomized controlled Phase 2 study, evaluating the efficacy and safety of LIVMARLI in patients with BA after Kasai surgery, is sponsored by Mirum Pharmaceuticals, Inc. and has also completed enrollment across the other global locations where the trial is open.

Key Points: 
  • This global, multi-center, randomized controlled Phase 2 study, evaluating the efficacy and safety of LIVMARLI in patients with BA after Kasai surgery, is sponsored by Mirum Pharmaceuticals, Inc. and has also completed enrollment across the other global locations where the trial is open.
  • CANbridge has an exclusive license agreement for the development, commercialization and manufacturing, under certain conditions, of LIVMARLI in Greater China.
  • In this region, CANbridge has the right to develop and commercialize LIVMARLI for three indications: Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA).
  • CANbridge also expects to file an NDA for LIVMARLI for the treatment of PFIC with the NMPA soon.

Ascentage Pharma's Novel Drug Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug

Retrieved on: 
Wednesday, May 31, 2023
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To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.

Key Points: 
  • To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.
  • Drugs that have been granted BTDs are prioritized by the CDE in communications and exchange, and in receiving guidance to advance the drug development progress.
  • Furthermore, BTD-designated drugs will be eligible for Priority Review status and conditional approvals upon submission of a New Drug Application (NDA).
  • Antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor (TKI)–resistant succinate dehydrogenase (SDH)–deficient gastrointestinal stromal tumor (GIST).

Galvanize Announces License Agreement and Partnership with Energenx Medical for its Technologies in China

Retrieved on: 
Tuesday, May 30, 2023
COPD, Bronchitis, Critical Care Medicine (journal), ATP, Quality of life, Digital photography, Medtronic, MD, The China Study, Physician, Patient, National Medical Products Administration, Hospital, Therapy, Health, Arrhythmia, PEF, NMPA, Pharmaceutical industry, Galvanization

Recognizing the potential for its technologies in China, Galvanize worked with its founding investor Apple Tree Partners (ATP) to form Energenx in 2021.

Key Points: 
  • Recognizing the potential for its technologies in China, Galvanize worked with its founding investor Apple Tree Partners (ATP) to form Energenx in 2021.
  • We are also excited to advance our Aliya soft tissue ablation system in China through our relationship with Energenx."
  • Using RheOx as the first collaboration opportunity, together, we are establishing leadership in interventional pulmonology with continued pipelines in China and globally.
  • The procedure was performed using a minimally-invasive approach through a bronchoscope and the patient was discharged soon after without complications.

Junshi Biosciences Announces Acceptance of the Supplemental NDA for Toripalimab in Combination with Chemotherapy for Advanced Triple-negative Breast Cancer

Retrieved on: 
Tuesday, May 23, 2023
Survival rate, LBA, TNBC, Oncology, Progression-free survival, American Society of Clinical Oncology, IDMC, Survival, OS, NDA, Cancer, Prognosis, Chinese, Immunotherapy, PFS, Global Research, ASCO, Incidence, Death, Development, SSE, HKEX, Patient, Risk, National Medical Products Administration, CPS, Annual general meeting, CSCO, Diagnosis, Anthracycline, PD-1, Abstract, Recurrence, Society, PD-L1, Safety, Breast cancer, Pharmaceutical industry

Unfortunately, advanced TNBC does not respond well to targeted therapy and endocrine therapy, and there are currently no specific treatment methods available.

Key Points: 
  • Unfortunately, advanced TNBC does not respond well to targeted therapy and endocrine therapy, and there are currently no specific treatment methods available.
  • In recent years, clinical studies have shown that immunotherapy in combination with chemotherapy for the treatment of advanced TNBC can achieve better efficacy and tolerability.
  • To this day, however, no immunotherapy drugs have been approved for advanced TNBC in China, and chemotherapy remains the primary treatment option.
  • I am delighted to see the acceptance of the NDA for toripalimab in combination with chemotherapy for the treatment of advanced TNBC.

BioRay Filed IND Application for BRY812, a Novel Antibody Drug Conjugate Targeting LIV-1

Retrieved on: 
Wednesday, May 24, 2023
Zinc, Acceptance and commitment therapy, Endocytosis, Clinical trial, EMT, Research, Cell, Chemistry, Investigational New Drug, Patient, Cancer, National Medical Products Administration, ADC, Spacecraft, IND, NMPA, Pharmaceutical industry, Vaccine

LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity.

Key Points: 
  • LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity.
  • BRY812 is a LIV-1 targeting ADC developed on BioRay's CysLink™ technology platform where highly stable conjugation is created through irreversible chemistry.
  • Globally, no LIV-1 targeting ADC has received marketing approval yet, and BioRay's BRY812 is anticipated to be the second LIV-1 ADC that reaches the clinical stage.
  • Dr. Haibin Wang, CEO of BioRay, stated, "Since this January, we have obtained the IND approval of two innovative antibody drug candidates, BR108 and BRY805.

BioRay Filed IND Application for BRY812, a Novel Antibody Drug Conjugate Targeting LIV-1

Retrieved on: 
Wednesday, May 24, 2023
Zinc, Acceptance and commitment therapy, Endocytosis, Clinical trial, EMT, Research, Cell, Chemistry, Investigational New Drug, Patient, Cancer, National Medical Products Administration, ADC, Spacecraft, IND, NMPA, Pharmaceutical industry, Vaccine

LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity.

Key Points: 
  • LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity.
  • BRY812 is a LIV-1 targeting ADC developed on BioRay's CysLink™ technology platform where highly stable conjugation is created through irreversible chemistry.
  • Globally, no LIV-1 targeting ADC has received marketing approval yet, and BioRay's BRY812 is anticipated to be the second LIV-1 ADC that reaches the clinical stage.
  • Dr. Haibin Wang, CEO of BioRay, stated, "Since this January, we have obtained the IND approval of two innovative antibody drug candidates, BR108 and BRY805.

Antengene Announces Claudin 18.2 Antibody-Drug Conjugate ATG-022 Granted Orphan Drug Designations by the U.S. FDA for the Treatment of Gastric and Pancreatic Cancers

Retrieved on: 
Tuesday, May 23, 2023
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To date, Antengene has received 3 ODDs from the FDA for two of its in-house products.

Key Points: 
  • To date, Antengene has received 3 ODDs from the FDA for two of its in-house products.
  • Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions.
  • The Claudin 18.2 isoform is overexpressed in various primary malignant tumors including gastric, esophageal and pancreatic cancers.
  • Moving forward, Antengene will work closely with regulators and clinical investigators to advance the CLINCH trial and fully assess ATG-022's therapeutic potential for solid tumors."

IceCure Medical Reports First Quarter 2023 Financial & Operational Results

Retrieved on: 
Monday, May 22, 2023
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Builds Momentum as ProSense is Featured at Medical Conferences and Educational Courses

Key Points: 
  • Builds Momentum as ProSense is Featured at Medical Conferences and Educational Courses
    CAESAREA, Israel, May 22, 2023 /PRNewswire/-- IceCure Medical Ltd. (the "Company" or "IceCure") (Nasdaq: ICCM) (TASE: ICCM) developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today reported financial results as of and for the three months ended March 31, 2023 as well as operational and recent corporate developments.
  • We believe this momentum in the market is bolstered by a broader trend toward minimally invasive procedures," stated IceCure CEO Eyal Shamir.
  • Company's Ordinary Shares to Trade Exclusively on Nasdaq: IceCure announced its voluntary delisting from the Tel Aviv Stock Exchange ("TASE").
  • In the first quarter of 2023, sales increased in the U.S. and Europe relative to the same quarter last year.

Zai Lab Announces That Repotrectinib Granted Priority Review by China’s NMPA

Retrieved on: 
Thursday, May 18, 2023
Drug, Priority review, Interim, Partnership, Bureau, TKI, Medicine, NSCLC, HKEX, Patient, Approval, CDE, National Medical Products Administration, Center for Drug Evaluation and Research, NMPA, Pharmaceutical industry

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).

Key Points: 
  • 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 review to repotrectinib underscores repotrectinib as a potential next-generation best-in-class treatment for ROS1-positive NSCLC in both TKI-naïve and pretreated patients in China,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab.
  • It is implemented under the Drug Registration Regulation (Bureau Order 27) and the Working Procedure for Priority Review and Approval of Drug Marketing Authorization (Interim, NMPA 2020 No.
  • According to the regulation and guidance, the regulatory authority will prioritize the evaluation resources for applications under priority review to expedite the review and approval timelines.