National Medical Products Administration

The 2nd Boao International Conference on Real World Studies of Medical Products Held in Hainan

Retrieved on: 
Friday, November 3, 2023
National Medical Products Administration, Real World, RWD, NMPA, Economics, Conference, Merck, Research, Medicine, Pharmaceutical industry, Biostatistics, Epidemiology

HAIKOU, China, Nov. 3, 2023 /PRNewswire/ -- On 31st Oct., the 2nd Boao International Conference on Real World Studies of Medical Products, held in Boao, Hainan, was attended by nearly 1,000 participants from domestic and international pharmaceutical regulatory agencies, academic societies, industrial associations, pharmaceutical enterprises, etc.

Key Points: 
  • HAIKOU, China, Nov. 3, 2023 /PRNewswire/ -- On 31st Oct., the 2nd Boao International Conference on Real World Studies of Medical Products, held in Boao, Hainan, was attended by nearly 1,000 participants from domestic and international pharmaceutical regulatory agencies, academic societies, industrial associations, pharmaceutical enterprises, etc.
  • The conference featured a plenary session and eight sub-forums, and encompassed various fields related to international real-world research, and the scientific development of pharmaceutical product regulation.
  • According to Deputy Director of Biostatistics and Epidemiology, Real World Evidence Department, Merck, Germany, Real world study is a significant institutional innovation in the Hainan Free Trade Port.
  • "We learnt that four drugs and nine medical devices have been approved by National Medical Products Administration (NMPA) using Real World Data(RWD) from Hainan Boao Lecheng.

The 2nd Boao International Conference on Real World Studies of Medical Products Held in Hainan

Retrieved on: 
Friday, November 3, 2023
National Medical Products Administration, Real World, RWD, NMPA, Economics, Conference, Merck, Research, Multimedia, Medicine, Pharmaceutical industry, Biostatistics, Epidemiology

HAIKOU, China, Nov. 3, 2023 /PRNewswire/ -- On 31st Oct., the 2nd Boao International Conference on Real World Studies of Medical Products, held in Boao, Hainan, was attended by nearly 1,000 participants from domestic and international pharmaceutical regulatory agencies, academic societies, industrial associations, pharmaceutical enterprises, etc.

Key Points: 
  • HAIKOU, China, Nov. 3, 2023 /PRNewswire/ -- On 31st Oct., the 2nd Boao International Conference on Real World Studies of Medical Products, held in Boao, Hainan, was attended by nearly 1,000 participants from domestic and international pharmaceutical regulatory agencies, academic societies, industrial associations, pharmaceutical enterprises, etc.
  • The conference featured a plenary session and eight sub-forums, and encompassed various fields related to international real-world research, and the scientific development of pharmaceutical product regulation.
  • According to Deputy Director of Biostatistics and Epidemiology, Real World Evidence Department, Merck, Germany, Real world study is a significant institutional innovation in the Hainan Free Trade Port.
  • "We learnt that four drugs and nine medical devices have been approved by National Medical Products Administration (NMPA) using Real World Data(RWD) from Hainan Boao Lecheng.

Apollomics Announces Report of Activity of Vebreltinib in Glioblastoma Multiforme (GBM) with PTPRZ-MET Fusion

Retrieved on: 
Thursday, October 26, 2023
APLM, National Medical Products Administration, GBM, Temozolomide, NMPA, ESMO, SPARTA, Radiation, Cancer, Partial-response maximum-likelihood, New Drug Application, NDA, European Society for Medical Oncology, Patient, MET, Communication, Aviston, Illinois, Pharmaceutical industry

The patient with GBM with PTPRZ-MET fusion who had previously received radiotherapy and temozolomide, was reported to have an impressive Partial Response (PR) after 8 weeks of treatment with vebreltinib monotherapy during participation in the SPARTA study ( NCT03175224 ) .

Key Points: 
  • The patient with GBM with PTPRZ-MET fusion who had previously received radiotherapy and temozolomide, was reported to have an impressive Partial Response (PR) after 8 weeks of treatment with vebreltinib monotherapy during participation in the SPARTA study ( NCT03175224 ) .
  • “PTPRZ-MET fusions are known to cause aggressive forms of GBM and are associated with poor prognosis.
  • We are pleased to achieve positive clinical results in patients with this deadly disease, further demonstrating the potential of vebreltinib as a new treatment for patients with cancers driven by MET alterations,” said Guo-Liang Yu, Ph.D., co-founder, Chairman and Chief Executive Officer of Apollomics.
  • GBM with MET fusion is an indication pursued by Apollomics and its China partner, Avistone Biotechnology.

LianBio Announces Presentation of Data from Phase 2a Study of Infigratinib in Patients with Gastric Cancer at ESMO Congress 2023

Retrieved on: 
Wednesday, October 25, 2023
Gene amplification, Corr, Stomach, NMPA, ESMO, Trae tha Truth, FGFR2, ATP, DOR, DCR, MOS, FGFR, Congress, Safety, National Medical Products Administration, Disease, Oncology, Hepatotoxicity, RECIST, European Society for Medical Oncology, GC, GEJ, Death, Pharmaceutical industry, Patient

1527P)

Key Points: 
  • 1527P)
    The study enrolled 21 GC and GEJ patients with FGFR2 gene amplification.
  • Among 20 evaluable patients who had post-baseline assessments, cORR was 25.0% (95% CI: 8.7–49.1) and DCR was 80.0% (95% CI: 56.3–94.3).
  • “China has an acute need for new effective treatment options as there is a disproportionately higher number of patients with gastric cancer in the region.”
    FGFR pathway aberrations are common in multiple cancer types, including gastric cancer.
  • Infigratinib received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the treatment of gastric cancer.

LianBio Enters into Agreement with Bristol Myers Squibb for Mavacamten in China and Other Asian Markets

Retrieved on: 
Tuesday, October 24, 2023
Bristol Myers Squibb, Oxford Handbook of Clinical Medicine, NMPA, Jefferies Group, Priority, National Medical Products Administration, BMS, Quality of life, Medicine, Employment, NDA, HCM, Patient, Centerview Partners, Pharmaceutical industry

Under the terms of the agreement, LianBio will receive a one-time payment of $350 million.

Key Points: 
  • Under the terms of the agreement, LianBio will receive a one-time payment of $350 million.
  • In addition, LianBio will be released from payment obligations of up to $127.5 million in remaining milestone payments under the MyoKardia license agreement.
  • LianBio received approval in Macau and Singapore for mavacamten for the treatment of adults with symptomatic oHCM in 2023.
  • The LianBio Board of Directors expects to provide an update on its strategic review in the first half of 2024.

Life Molecular Imaging and Sinotau Pharmaceutical Group Announce the Regulatory Approval of their Amyloid PET Imaging Radiopharmaceutical Neuraceq® in China

Retrieved on: 
Tuesday, October 24, 2023
Alzheimer's disease, Amyloid, FDA, LMI, United Kingdom, Trial of the century, AD, Radiopharmaceutical, NMPA, Plaque, MCI, Food, Medication, Physician, European Medicines Agency, Dementia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, PET, Disease, MHRA, National Medical Products Administration, EMA, Brain, Medicines and Healthcare products Regulatory Agency, GMP, Patient, Diagnosis, Medical imaging

BERLIN and BEIJING, Oct. 24, 2023 /PRNewswire/ -- Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® (with Chinese trade name 欧韦宁®, florbetaben F-18 injection) has received regulatory approval from National Medical Products Administration (NMPA) in China. Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer, is the first radiopharmaceutical targeting β-amyloid approved in China to be used to support diagnosis of Alzheimer's disease (AD). It visualizes beta-amyloid plaque accumulation in the brain, an established biomarker for AD. Neuraceq® (欧韦宁®) will be manufactured by Sinotau and made commercially available. With this diagnostic tool, Chinese physicians will have access to state-of-the-art imaging technology to accurately evaluate patients with cognitive decline. The density of amyloid plaques can be assessed to guide early diagnosis and patient management.

Key Points: 
  • BERLIN and BEIJING, Oct. 24, 2023 /PRNewswire/ -- Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® (with Chinese trade name 欧韦宁®, florbetaben F-18 injection) has received regulatory approval from National Medical Products Administration (NMPA) in China.
  • Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer, is the first radiopharmaceutical targeting β-amyloid approved in China to be used to support diagnosis of Alzheimer's disease (AD).
  • With this diagnostic tool, Chinese physicians will have access to state-of-the-art imaging technology to accurately evaluate patients with cognitive decline.
  • "Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer which can be imaged through PET-CT/MRI is the first approved Aβ-PET tracer in China and the first approved PET tracer in China in recent 20 years.

AnHeart Therapeutics’ Investigational Medicine Taletrectinib Shrank Tumors in More Than 90 Percent of People With ROS1-Positive Non-Small Cell Lung Cancer Who Were ROS1 TKI Naïve in Global Pivotal TRUST-II Trial

Retrieved on: 
Saturday, October 21, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, TKI, ROS1, NSCLC, Corr, Journal of Thoracic Oncology, NMPA, Food, Lung cancer, Dizziness, National Medical Products Administration, Doctor of Philosophy, Incidence, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lung, Disease, Medicine, Interim, Brain, European Society of Gynaecological Oncology, Cancer, Patient, IRC, Pharmaceutical industry

Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated).

Key Points: 
  • Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated).
  • Taletrectinib also showed robust intracranial activity in the subgroup of patients with disease that had spread to the brain.
  • Median progression-free survival (IRC-assessed) was not reached for TKI naïve patients and was 11.7 months for TKI pre-treated patients, respectively.
  • In both trials, taletrectinib shrank tumors in almost every ROS1 TKI naïve person and more than half of people previously treated with a ROS1 TKI, and the responses were durable.

Burning Rock Received Breakthrough Device Designation from China’s NMPA for its Multi-Cancer Early Detection Test

Retrieved on: 
Monday, October 16, 2023
Food, Annals of Oncology, NGS, Risk, National Medical Products Administration, Ageing, Cancer, Rock, US Foods, FDA, LSE, Nucleic acid thermodynamics, NMPA, US FDA, Medical imaging, Water Drops on Burning Rocks

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 Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA.

Key Points: 
  • 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 Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA.
  • OverC™ MCDBT is intended for early detection of multiple cancer types in adults of either sex, aged 50-75 years old, at average risk for cancer.
  • Mr. Yusheng Han, founder and CEO of Burning Rock, said, “We are very inspired that our multi-cancer early detection product has received recognition from both US and China regulatory authorities.
  • We obtained our first Breakthrough Device Designation from China NMPA in 2016 for NGS-based therapy selection test, and the China NMPA Breakthrough Device Designation granted for OverC™ MCDBT would pave the way for a clearer registration path through confirmative performance validation and utility establishment.

Nortech Systems Suzhou Facility Certified to Produce Class II Medical Devices for Asia Market

Retrieved on: 
Wednesday, October 4, 2023
Technology, Surgery, Medical Devices, Hospitals, Engineering, Health Technology, Manufacturing, Health, Electronic Design Automation, CFDA, Medical device, Class, Certification, National Medical Products Administration, FDA, NMPA, Safety

“NMPA certification is a major step forward for Nortech Systems and our customers in the region,” said Nortech Systems CEO, Jay D. Miller.

Key Points: 
  • “NMPA certification is a major step forward for Nortech Systems and our customers in the region,” said Nortech Systems CEO, Jay D. Miller.
  • The certification from the NMPA allows Nortech Systems to produce Class II Medical Devices for customers in China and Asia.
  • The company has been a leading producer of Class II Medical Devices for the United States market in its FDA-registered facility located in Milaca, Minnesota.
  • Nortech Systems Suzhou facility is a state-of-the-art facility that is equipped with the latest technology and equipment.

Apollomics Reports First Half 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, September 28, 2023
APLM, PIPE, NDA, Lung cancer, Mutation, NSCLC, Brain, Trial of the century, AML, Patient, Investment, Cancer, MET, National Medical Products Administration, R, Glycomimetic, Research, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, NMPA, Food, Pharmaceutical industry, Life insurance, Cryptocurrency, Fine chemical, Security (finance)

FOSTER CITY, Calif., Sept. 28, 2023 (GLOBE NEWSWIRE) --  Apollomics Inc. (Nasdaq: APLM) (the “Company”), a late- stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced its financial results for the six months ended June 30, 2023, and provided a corporate update.

Key Points: 
  • ET
    FOSTER CITY, Calif., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (the “Company”), a late- stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced its financial results for the six months ended June 30, 2023, and provided a corporate update.
  • In March 2023, the Company raised $23.7 million in a private placement in public equity (PIPE) financing, before transaction expenses.
  • Apollomics’ management team will host a conference call and webcast Monday, October 2, 2023 at 8:30 a.m.
  • ET to discuss the financial results and provide a corporate update.