National Medical Products Administration

AnHeart Therapeutics and Innovent Announce China’s NMPA Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation

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月曜日, 12月 18, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, NDA, Priority review, Ophthalmology, HKEX, Research, National Medical Products Administration, Shirin David, Senior, NMPA, CDE, Patient, ROS1, New Drug Application, TKI, MD, Cancer, NSCLC, Pharmaceutical industry

The CDE accepted the NDA in November 2023.

Key Points: 
  • The CDE accepted the NDA in November 2023.
  • “Taletrectinib’s Priority Review Designation reinforces the urgent need for patients with ROS1-positive NSCLC who were previously treated with ROS1 TKIs in China and the significant clinical advance that taletrectinib may represent for these patients,” said Bing Yan, MD, Chief Medical Officer, AnHeart.
  • “We look forward to working with the regulatory authorities as they conduct their review of taletrectinib to hopefully bring this breakthrough investigational therapy to patients as soon as possible.”
    “Taletrectinib’s potential as a best-in-class precision therapy is further underscored by the Priority Review Designation,” said Dr. Hui Zhou, Senior Vice President of Innovent.
  • Priority Review Designation allows the CDE to prioritize the review process and evaluation resources for NDAs, which helps accelerate the market access of innovative drugs.

FDA Grants Priority Review of ImmunoGen’s Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer

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火曜日, 12月 5, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, National Medical Products Administration, Priority review, Annual general meeting, Food, European Medicines Agency, Spacecraft, Progression-free survival, US Foods, ADC, Patient, IMGN, ASCO, New Drug Application, Medical Affairs Bureau, ImmunoGen, MD, Cancer, Mirvetuximab soravtansine, Society, PDUFA, Pharmaceutical industry, Research

The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 5, 2024.

Key Points: 
  • The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 5, 2024.
  • We look forward to collaborating closely with the FDA throughout the review process."
  • The confirmatory Phase 3 MIRASOL trial of ELAHERE in platinum-resistant ovarian cancer forms the basis of the sBLA.
  • ELAHERE was granted accelerated approval by the FDA in November 2022 based on data from the pivotal SORAYA trial.

AnHeart Therapeutics and Innovent Announce China’s NMPA Has Accepted a New Drug Application for Taletrectinib (ROS1 Inhibitor)

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水曜日, 11月 22, 2023
FDA, Pharmaceutical, Health, Oncology, NDA, Ophthalmology, HKEX, National Medical Products Administration, Senior, NMPA, Brain, Patient, CDE, ROS1, New Drug Application, TKI, MD, Cancer, ELCC, NSCLC, Pharmaceutical industry, Hong Kong

The NDA acceptance in China is based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients.

Key Points: 
  • The NDA acceptance in China is based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients.
  • Results from an interim analysis of TRUST-I were presented at the European Lung Cancer Congress (ELCC) 2023 .
  • “Acceptance of our China NDA marks an important milestone for AnHeart and is the first regulatory submission for taletrectinib globally.
  • We would like to thank all the doctors and patients who participated in the clinical trials that support this submission,” said Bing Yan, MD, Chief Medical Officer, AnHeart.

Avistone Announces the First Approval of Vebreltinib for MET Exon 14 Skipping Non-Small Cell Lung Cancer Opening a New Chapter in MET-targeted Treatment of Lung Cancer

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金曜日, 11月 17, 2023
Research, Medical Devices, Genetics, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, National Medical Products Administration, Progression-free survival, Cell proliferation, NMPA, ESMO, Patient, PFS, Fusion, Lung cancer, Neoplasm, Therapy, TKI, ORR, MET, Survival, Congress, EGFR, Pharmaceutical industry, Hong Kong, NSCLC

MET signaling is implicated in cell proliferation, migration, invasion, and survival.

Key Points: 
  • MET signaling is implicated in cell proliferation, migration, invasion, and survival.
  • Genomic alterations in MET can manifest in driving oncogenesis in the form of MET exon 14 skipping (METex14) or other activating mutations, MET gene amplification, gene fusion and MET protein overexpression.
  • With the NMPA approval of Vebreltinib, we look forward to providing this new treatment option to patients with MET exon 14 skipping NSCLC in China” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone.
  • Avistone is an oncology company focused on developing innovative therapies for patients with significant unmet medical needs globally.

IASO Bio Establishes International CAR-T Diagnostic and Treatment Center in China to Serve MM Patients Worldwide

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火曜日, 11月 21, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Multiple myeloma, Regenerative medicine, National Medical Products Administration, Food, Hope, NMPA, Patient, China International Import Expo, Marketing, Partnership, Orphan drug, Hospital, Regenerative Medicine Advanced Therapy, Pharmaceutical industry

Nanjing IASO Biotechnology Co., Ltd. (IASO Bio) made its debut at the 6th China International Import Expo (CIIE) with FUCASO, the world's first fully-human CAR-T, and entered into a strategic partnership with several international medical institutions, bringing hope for cure to multiple myeloma (MM) patients worldwide.

Key Points: 
  • Nanjing IASO Biotechnology Co., Ltd. (IASO Bio) made its debut at the 6th China International Import Expo (CIIE) with FUCASO, the world's first fully-human CAR-T, and entered into a strategic partnership with several international medical institutions, bringing hope for cure to multiple myeloma (MM) patients worldwide.
  • On June 30, 2023, the China National Medical Products Administration (NMPA) approved the marketing of Equecabtagene Autoleucel Injection (brand name: FUCASO) for the treatment of adult patients with relapsed or refractory multiple myeloma (r/rMM).
  • FUCASO has attracted patients from numerous countries around the world to seek treatment in Chinese hospitals in just 4 months since its approval for marketing in China.
  • In addition, the cost of treatment with FUCASO in China is significantly lower than that of similar products in Europe and America, which has benefited more patients worldwide.

Crystal Pharmatech's CDMO Business Unit successfully passed the dual certification of GMP and GDP conducted by SGS

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月曜日, 12月 4, 2023
National Medical Products Administration, World Health Organization, Research, SGS, GMP, GDP, CDMO, Good manufacturing practice, Recycling, WHO, NMPA, Blister, CFS, Certification, Temperature, Transport, Medical device, Vaccine

SUZHOU, China, Dec. 4, 2023 /PRNewswire/ -- Recently, Crystal Pharmatech's CDMO Business Unit - Crystal Formulation Services (CFS) successfully obtained dual certification in Good Manufacturing Practices (GMP)[1] and Good Distribution Practices (GDP)[2] from SGS, an internationally recognized third-party certification agency, in line with the World Health Organization (WHO) standards.

Key Points: 
  • SUZHOU, China, Dec. 4, 2023 /PRNewswire/ -- Recently, Crystal Pharmatech's CDMO Business Unit - Crystal Formulation Services (CFS) successfully obtained dual certification in Good Manufacturing Practices (GMP)[1] and Good Distribution Practices (GDP)[2] from SGS, an internationally recognized third-party certification agency, in line with the World Health Organization (WHO) standards.
  • During the certification inspection, SGS dispatched experienced certification inspectors for a comprehensive one-week on-site evaluation of CFS.
  • As a leading global third-party independent audit and certification organization, SGS issues compliance certificates based on WHO GMP/GDP guidelines, which are widely acknowledged and esteemed within the industry.
  • We also appreciate the efforts of our team members and the authoritative certification from SGS, which has provided a prestigious endorsement for our clinical supply business.

Innovent Presents Clinical Data Update of IBI351 (KRAS G12C Inhibitor) Monotherapy in Lung Cancer and Colorectal Cancer at ESMO Asia Congress 2023

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金曜日, 12月 1, 2023
NDA, National Medical Products Administration, Principal, Priority review, Trae tha Truth, Ophthalmology, Dor, Safety, HKEX, Senior, Colorectal cancer, CRC, NMPA, Patient, PFS, Weakness, Corr, FDA, Lung cancer, LBA, IRRC, DCR, New Drug Application, Ceylonosticta anamia, ORR, Trial of the century, Cancer, Anemia, Congress, OS, Mutation, Itch, Hospital, NSCLC, Pharmaceutical industry, Palladium, Phosphorus

As data cutoff date (June 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable:

Key Points: 
  • As data cutoff date (June 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable:
    IBI351 demonstrated encouraging antitumor activity.
  • IBI351 as a selective covalent irreversible KRAS G12C inhibitor, its monotherapy has demonstrated outstanding efficacy and manageable safety in advanced colorectal cancer with KRAS G12C mutation.
  • Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2023 ESMO Asia Congress.
  • We will continue to explore the clinical development of IBI351 monotherapy and combination therapy in the fields of lung cancer, colorectal cancer and other solid tumors to benefit more cancer patients ."

Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Hexvix in China

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水曜日, 11月 29, 2023
NDA, RCT, National Medical Products Administration, WLC, NMIBC, Carcinoma, NMPA, Bladder cancer, Patient, SIU, CIS, SSE, Isabella Tree, BLC, Standard of care, Congress, Cystoscopy, Pharmaceutical industry, Medical imaging, Photocure, Hexyl aminolevulinate hydrochloride

OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix® (APL-1706) in China.

Key Points: 
  • OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix® (APL-1706) in China.
  • Hexvix, a pharmaceutical product used in the detection of bladder cancer, was licensed to Asieris by Photocure in January 2021, for the registration and commercialization of Hexvix in mainland China and Taiwan.
  • Moreover, Asieris' Phase III Hexvix trial is the first RCT that was conducted with high definition 4K blue light capital equipment.
  • The acceptance of the Hexvix submission by NMPA is the positive outcome of months of collaboration between the Asieris and Photocure teams," said Dan Schneider, President and CEO of Photocure.

Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Hexvix in China

Retrieved on: 
水曜日, 11月 29, 2023
NDA, RCT, National Medical Products Administration, WLC, NMIBC, Carcinoma, NMPA, Bladder cancer, Patient, SIU, CIS, SSE, Isabella Tree, BLC, Standard of care, Congress, Cystoscopy, Pharmaceutical industry, Medical imaging, Photocure, Hexyl aminolevulinate hydrochloride

OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix® (APL-1706) in China.

Key Points: 
  • OSLO, Norway, Nov. 29, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix® (APL-1706) in China.
  • Hexvix, a pharmaceutical product used in the detection of bladder cancer, was licensed to Asieris by Photocure in January 2021, for the registration and commercialization of Hexvix in mainland China and Taiwan.
  • Moreover, Asieris' Phase III Hexvix trial is the first RCT that was conducted with high definition 4K blue light capital equipment.
  • The acceptance of the Hexvix submission by NMPA is the positive outcome of months of collaboration between the Asieris and Photocure teams," said Dan Schneider, President and CEO of Photocure.

Ascentage Pharma Hosts Ceremony Marking the Launch of Olverembatinib in Newly Approved Indication and the Dispatch of First Batch for the New Indication

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金曜日, 11月 24, 2023
NDA, Bone marrow, Priority review, Safety, National Medical Products Administration, BAT, Leukemia, EFS, New Drug Application, NMPA, TKI, CDE, Patient, BTD, Imatinib, Trust, Nilotinib, Therapy, BCR-ABL, CML, Death, Survival, NRDL, Government, Mutation, HIV disease progression rates, Pharmaceutical industry

Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT).

Key Points: 
  • Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT).
  • Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing Program in China.
  • Ascentage Pharma and Innovent are mutually committed to the commercialization of olverembatinib in the China market.
  • Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up.