National Medical Products Administration

Avance Clinical: Latest Analysis Reveals 65% of US Biotechs Struggle to Identify Suitable CRO Partner

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火曜日, 1月 9, 2024

ChromeOS, National Medical Products Administration, Frost, EMA, Investment, FDA, JPM, Pharmaceutical industry

Each site has been accredited by Avance Clinical for data quality, patient centricity, and streamlined processes designed meet rigorous clinical timelines.

Key Points:

Each site has been accredited by Avance Clinical for data quality, patient centricity, and streamlined processes designed meet rigorous clinical timelines.
In addition, the report found a regulatory affairs track-record was a key selection criteria saying in-house regulatory expertise was the most attractive option for biotechs.
Avance Clinical has been recognised by Frost & Sullivan for the past 4 years with the prestigious Frost & Sullivan Asia-Pacific CRO Best Practices Leadership Award.
For more information about the benefits of running your next study with Avance Clinical contact us: [email protected]

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

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水曜日, 1月 10, 2024

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

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火曜日, 1月 9, 2024

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.

Junshi Biosciences Announces Approval of the Supplemental New Drug Application for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients

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火曜日, 1月 2, 2024

This is the first approved perioperative therapy for lung cancer in China and the second worldwide.

Key Points:

This is the first approved perioperative therapy for lung cancer in China and the second worldwide.
In the same year, the number of lung cancer deaths in China amounted to 715,000, accounting for 23.8% of all cancer deaths in China.
Amongst these patients, 20%-25% are surgically resectable at first diagnosis, but even after radical surgical treatment, 30%-55% of these patients suffer from post-surgical recurrence and death.
One of the first domestic pharmaceutical companies to initiate clinical trials for perioperative immunotherapy, Junshi Biosciences entered the perioperative immunotherapy arena very early on and now holds the broadest spectrum of indications in China.

Cryofocus Medtech Obtains NMPA Approval for the AF Cryoablation System

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火曜日, 12月 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.

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

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木曜日, 12月 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.

China Medical System: NDA for Additional RA Indication of Methotrexate Injection Accepted in China

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月曜日, 12月 4, 2023

The New Drug Application for an additional rheumatoid arthritis (RA) indication of Methotrexate Injection has been accepted by NMPA, which is a new milestone following the China approval for psoriasis indication of Methotrexate Injection.

Key Points:

The New Drug Application for an additional rheumatoid arthritis (RA) indication of Methotrexate Injection has been accepted by NMPA, which is a new milestone following the China approval for psoriasis indication of Methotrexate Injection.
The Product is expected to become the first methotrexate (MTX) prefilled injection to treat RA by subcutaneous administration in China.
China Medical System Holdings Limited ( “CMS” or the “Group”) announced that on 4 December 2023, the New Drug Application (NDA) for an additional indication of its innovative product, Methotrexate Injection (the “Product”), has been accepted by the National Medical Products Administration of China (NMPA).
The Product is a small-volume methotrexate injection with various strengths, which is intended to be used to treat active rheumatoid arthritis (RA) in adult patients.

Takeda Announces China NMPA Approval of LIVTENCITY® (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Refractory to Prior Therapies

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木曜日, 12月 21, 2023

Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.

Key Points:

Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
LIVTENCITY is the first and only inhibitor of CMV-specific UL97 protein kinase in China for this indication.
LIVTENCITY was granted Breakthrough Therapy Designation by China Center for Drug Evaluation (CDE) in 2021.
“This approval will help redefine the CMV treatment landscape for transplant patients in China and is a positive step forward toward addressing an unmet need for this community.”
The NMPA approval is based on the results of the Phase 3 SOLSTICE trial, which evaluated the safety and efficacy of maribavir versus conventional antiviral therapies – ganciclovir, valganciclovir, cidofovir or foscarnet – for the treatment of patients with CMV infection/disease refractory* to prior therapies.

Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

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火曜日, 12月 26, 2023

On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.

Key Points:

On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.
Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year.
On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema.
On December 12, FDA has approved a clinical trial for JMKX000197 to treat BCG-unresponsive non-muscle-invasive bladder cancer, and earlier on October 19, NMPA has approved the clinical trial.

Apollomics Announces the First Approval of Vebreltinib for MET Exon 14 Skip Non-Small Cell Lung Cancer

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木曜日, 11月 16, 2023

NDA, National Medical Products Administration, Food, Aviston, Illinois, NMPA, APLM, Patient, FDA, Lung cancer, MET, NSCLC, Partnership, Cancer, Pharmaceutical industry, Hong Kong

FOSTER CITY, Calif., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced that its partner in China, Avistone Biotechnology Co. Ltd., received conditional approval from the National Medical Products Administration (NMPA) of China for the commercialization of vebreltinib to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC).

Key Points:

"The NMPA approval of vebreltinib is an important milestone toward providing a new treatment option for patients with MET exon 14 skipping NSCLC in China.
Apollomics extends its full support and congratulations to Avistone on this significant achievement," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics.
By targeting c-Met dysregulation, vebreltinib offers a potential breakthrough for patients with MET exon 14 skipping NSCLC and other cancers driven by c-Met alterations, i.e.
Patients with MET exon 14 skipping mutations, comprise approximately 3% to 4% of all NSCLC cases, face significant challenges due to limited treatment options.