NMPA

Zai Lab Announces The New England Journal of Medicine Publication Demonstrating Durable Clinical Activity of Repotrectinib in Patients with Advanced ROS1 Fusion-Positive NSCLC

Retrieved on: 
Mittwoch, Januar 10, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Development, Patient, Therapy, Progression-free survival, ROS1, Brain, Index, HKEX, Lung cancer, NSCLC, RECIST, Cancer, Food, PFS, NDA, Safety, NEJM, New Drug Application, TKI, CDE, National Medical Products Administration, MTD, NMPA, Pharmaceutical industry

Repotrectinib is a tyrosine kinase inhibitor (TKI) that has shown robust anti-tumor activity against ROS1+ cancers in preclinical models.

Key Points: 
  • Repotrectinib is a tyrosine kinase inhibitor (TKI) that has shown robust anti-tumor activity against ROS1+ cancers in preclinical models.
  • In the TRIDENT-1 study, repotrectinib demonstrated high response rates and durable activity in patients with ROS1+ NSCLC, including patients with TKI-naïve and TKI-pretreated tumors, ROS1 G2032R resistance mutations and brain metastases.
  • Brain metastases are common among patients with ROS1+ NSCLC and intracranial activity of approved ROS1 TKIs can be suboptimal.
  • In November 2023, the U.S. Food and Drug Administration approved repotrectinib for use in adult patients with locally advanced or metastatic ROS1+ NSCLC in the United States.

Enhancing Leadership in Gynecology, Asieris Pharmaceuticals Appoints Sophia Cao to Lead the Newly-Established Women's Health Business Unit, Accelerating Strategic Expansion

Retrieved on: 
Dienstag, Januar 9, 2024
Action plan, E pluribus unum, Woman, Bladder cancer, Marketing, Health, Elimination, Society, Cancer, Cervical cancer, Infection, World Health Organization, Diagnosis, NMIBC, Comparison, Cervical weakness, Multimedia, Death, ASCO, Breast cancer, Eli Lilly, Tislelizumab, Prevalence, MIBC, Neoadjuvant therapy, HPV, Human papillomavirus infection, LSIL, New Drug Application, NMPA, National Health Commission, Central China, Kidney cancer, Women's health, National Cancer Center, PD-1, WHO, Mortality, HSIL, Conditional sentence, Internet, Weak topology, Patient, Senior, State Council, NDA, Incidence, Head, National Medical Products Administration, Miscarriage

This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.

Key Points: 
  • This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.
  • Asieris Pharmaceuticals will leverage both in-house discoveries and external partnerships to enrich its gynecological portfolio, thereby reinforcing its leadership in women's health.
  • In November 2020, the World Health Organization (WHO) released a Global Strategy to Accelerate the Elimination of Cervical Cancer.
  • To further deliver its strategic vision and commitment in the realm of women's health, Asieris Pharmaceuticals has announced the establishment of the Women's Health Business Unit.

Akeso to Present at the 42nd Annual J.P. Morgan Healthcare Conference and Share Its Corporate & Innovative Clinical Development Roadmap

Retrieved on: 
Montag, Januar 8, 2024
Monoclonal antibody, Immunotherapy, NPC, Atopic dermatitis, Hepatocellular carcinoma, Shanda, Cervical cancer, PD-1, EGFR, CDE, Anemia, NDA, HCC, Cohort, Death, Bevacizumab, NMPA, Ankylosing spondylitis, Summit, Patient, ADC, NSCLC, Hypercholesterolemia, PCSK9, Pembrolizumab, Pharmaceutical industry

Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis.

Key Points: 
  • Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis.
  • Potential initiation of a Phase III clinical trial for manfidokimab (IL-4R) for the treatment of moderate atopic dermatitis.
  • Over the next five years, Akeso has high expectations of launching around 10 internally developed blockbuster drugs, both in China and worldwide, thereby achieving successful commercialization.
  • Akeso has established and continuously advances its integrated and efficient system of discovery, development, production, and sales of its innovative drugs and pipeline candidates.

Pulnovo Medical Announces PADN Receives FDA HUD Designation and US CMS Medicare Coverage Code and NMPA Approval

Retrieved on: 
Dienstag, Januar 2, 2024
Generator, PAH, HUD, Heart failure, American Medical Association, Rooting (Android), NMPA, Medicare, Pulmonary hypertension, HF, CMS

SHANGHAI, Jan. 2, 2024 /PRNewswire/ -- Pulnovo Medical Limited, a globally recognized device pioneer in the treatment of Pulmonary Hypertension (PH) and Heart Failure (HF), recently announced that it has successfully obtained Humanitarian Use Device (HUD) designation from the US FDA and approval from China's National Drug Administration (NMPA) for the PADN Catheter and Generator.

Key Points: 
  • SHANGHAI, Jan. 2, 2024 /PRNewswire/ -- Pulnovo Medical Limited, a globally recognized device pioneer in the treatment of Pulmonary Hypertension (PH) and Heart Failure (HF), recently announced that it has successfully obtained Humanitarian Use Device (HUD) designation from the US FDA and approval from China's National Drug Administration (NMPA) for the PADN Catheter and Generator.
  • The PADN technology is a major revolutionary procedure in the field of global interventional pulmonary arterial hypertension (PAH), which breaks the dilemma in PAH interventional therapy.
  • Meanwhile, PADN Catheter and Generator has recently been endorsed by the American Medical Association (AMA) and approved by the US Medicare & Medicaid Services (CMS) to receive an important Medicare coverage code.

Cryofocus Medtech Obtains NMPA Approval for the AF Cryoablation System

Retrieved on: 
Dienstag, Dezember 12, 2023
Necrosis, Hypertension, Republic, Nitrous oxide, Temperature, NMPA, Femoral vein, National Medical Products Administration, Patient, Safety, NOTES, Atrial fibrillation, Pharmaceutical industry

The AF Cryoablation System of Cryofocus Medtech, consisting of the cryoablation equipment, the balloon cryoablation catheter, the disposable intracardiac mapping catheter and the adjustable curved guide catheter, is the first cardiac product that applies cryoballoon with liquid nitrogen as the refrigerant for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation.

Key Points: 
  • The AF Cryoablation System of Cryofocus Medtech, consisting of the cryoablation equipment, the balloon cryoablation catheter, the disposable intracardiac mapping catheter and the adjustable curved guide catheter, is the first cardiac product that applies cryoballoon with liquid nitrogen as the refrigerant for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation.
  • The approval of the AF Cryoablation System in China markets marks an important milestone in the business development of Cryofocus Medtech in vascular interventional cryotherapy.
  • Meanwhile, the Company's Asthma Cryoablation System and COPD Cryospray System entered into the confirmatory clinical trial phase in March 2023.
  • In addition, as of June 30, 2023, Cryofocus Medtech submitted the registration application for the Cryoadhesion System, and it is expected to obtain approval from the NMPA for the product in the first quarter of 2024.

Narcolepsy Drugs Market, Size, Global Forecast 2024-2030: Industry Trends, Share, Growth, Insight, Impact of Inflation, Company Analysis - ResearchAndMarkets.com

Retrieved on: 
Freitag, Dezember 29, 2023
Health, Pharmaceutical, Novartis, Teva Pharmaceuticals, Quality of life, Sodium oxybate, Food, Risk, Drug development, Takeda Pharmaceutical Company, Roche, Research, Cataplexy, FDA, Instability, Prevalence, NINDS, Incidence, Mazindol, GHB, Stimulant, EDS, NMPA, Narcolepsy, Tobacco, DSM-IV codes, Investment, Patient, Diagnosis, Organization, Somnolence, Neurological disorder, Pharmaceutical industry

The "Narcolepsy Drugs Market, Size, Global Forecast 2024-2030, Industry Trends, Share, Growth, Insight, Impact of Inflation, Company Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Narcolepsy Drugs Market, Size, Global Forecast 2024-2030, Industry Trends, Share, Growth, Insight, Impact of Inflation, Company Analysis" report has been added to ResearchAndMarkets.com's offering.
  • The Global Narcolepsy Drugs Market is poised for substantial growth, with a projected value of US$5.95 billion by 2030
    Several factors contribute to the expansion of the narcolepsy drugs market.
  • The Narcolepsy Drugs Market is expected to grow steadily, with a compound annual growth rate (CAGR) of 8.01% from 2023 to 2030.
  • Combined, these elements make the U.S. narcolepsy drugs market a leader in global healthcare.

Juventas Cell Therapy Announces the Approval of Its First Cell Therapy Product - Inaticabtagene Autoleucel by China NMPA

Retrieved on: 
Freitag, November 10, 2023
Patient, Hope, Survival, Principal, Trial of the century, NDA, New Drug Application, Hematology, NMPA, Juventas, Toxicity, CD19, Diagnosis, Injection, B-ALL, Vaccine

Beijing, China and Tianjin, China and Shanghai, China--(Newsfile Corp. - November 10, 2023) - Juventas Cell Therapy Ltd. announces China National Medical Product Administration (NMPA) has approved its New Drug Application (NDA) for Inaticabtagene Autoleucel (CNCT19 Injection), a CD19-tarrgeted autologous chimeric antigen receptor (CAR)-T cell therapy for adult relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

Key Points: 
  • The approval of Inaticabtagene Autoleucel by NMPA delivers a breakthrough clinical option adult r/r B-ALL patients.
  • Beijing, China and Tianjin, China and Shanghai, China--(Newsfile Corp. - November 10, 2023) - Juventas Cell Therapy Ltd. announces China National Medical Product Administration (NMPA) has approved its New Drug Application (NDA) for Inaticabtagene Autoleucel (CNCT19 Injection), a CD19-tarrgeted autologous chimeric antigen receptor (CAR)-T cell therapy for adult relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
  • Inaticabtagene Autoleucel is a CD19 CAR-T cell therapy product, featured with a unique CD19 scFv (HI19a) and advanced manufacturing processes.
  • Inaticabtagene Autoleucel is the first proprietary CD19-targeted CAR-T product invented in China, and the first commercialized CAR-T cell therapy product for B-ALL in China.

Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Refractory Systemic Lupus Erythematosus

Retrieved on: 
Donnerstag, Dezember 21, 2023
Autoimmune disease, CDE, SLE, IIT, Trial of the century, BCMA, Society, Cancer, Investigational New Drug, B cell, NMPA, NHL, National Medical Products Administration, RRMM, CD19, Patient, Vaccine

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has cleared Gracell's Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus (rSLE).

Key Points: 
  • Under the IND, Gracell plans to initiate a Phase 1/2 clinical study in China to further evaluate GC012F in rSLE patients.
  • As announced Nov. 27, the Company will also commence Phase 1/2 clinical study in the U.S. An IIT is underway to evaluate GC012F for the treatment of rSLE.
  • “This milestone marks our rapid progress in advancing development of GC012F in rSLE, an autoimmune disease with high unmet need,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.
  • GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19 and utilizes Gracell’s proprietary FasTCAR next-day manufacturing platform.

Inventiva announces the randomization of the first patient in China in the NATiV3 clinical trial and provides an update on its clinical development program

Retrieved on: 
Mittwoch, Dezember 20, 2023
Phase, Marketing, GLP1, Food, MRI, Risk, NASH, Euronext Paris, FDA, Breakthrough therapy, DMC, Disease, European, Diabetes, Clinical trial, Glycated hemoglobin, LEGEND, Lipid, Fatty liver disease, NMPA, EIB, Data monitoring committee, Type 2 diabetes, SGLT2, European Investment Bank, BofA Securities, Patient, T2D, Safety, Fibrosis, Data collection, Magnetic resonance imaging, F4, Scan (company), Pharmaceutical industry

The first patient was randomized in China in the NATiV3 Phase III clinical trial, triggering a milestone payment of $3 million from CTTQ to Inventiva.

Key Points: 
  • The first patient was randomized in China in the NATiV3 Phase III clinical trial, triggering a milestone payment of $3 million from CTTQ to Inventiva.
  • Analysis of the baseline characteristics of all patients randomized in the main cohort suggests a patient profile aligned with those of patients randomized in the NATIVE Phase II clinical trial.
  • Lanifibranor continues to show a favorable tolerability profile as confirmed by the third Data Monitoring Committee2 of November 2023.
  • Topline results of the proof-of-concept Phase II clinical trial, LEGEND, evaluating lanifibranor in combination with empagliflozin are expected in the first quarter of 2024.

Paratek Pharmaceuticals Announces Inclusion of Oral NUZYRA® in China’s National Reimbursement Drug List

Retrieved on: 
Mittwoch, Dezember 13, 2023
Food, ABSSSI, Bronchopneumonia, NMPA, Public, NRDL, Patient, Safety, CABP, Pharmaceutical industry

Earlier this year, NHSA added the intravenous (IV) formulation of NUZYRA to the NRDL for the treatment of CABP and ABSSSI.

Key Points: 
  • Earlier this year, NHSA added the intravenous (IV) formulation of NUZYRA to the NRDL for the treatment of CABP and ABSSSI.
  • “The addition of oral NUZYRA to China’s NRDL allows millions of patients increased accessibility, at reduced prices, to the once-daily oral and IV formulations of this life-saving therapy for serious community-acquired infections,” said Evan Loh, M.D., Paratek chief executive officer.
  • “This inclusion further expands China’s antibiotic armamentarium to address antimicrobial resistance, an ever-growing, urgent, global public health crisis.
  • Paratek’s partner in China, Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), received approval of both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration (NMPA) of China for the treatment of CABP and ABSSSI in December 2021.