National Medical Products Administration

Neuboron Medical Group Advances Cancer Treatment: Introducing Next-Generation Boron Neutron Capture Therapy

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水曜日, 4月 10, 2024
Research, Medical Devices, Neurology, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Neutron, BNCT, Ecosystem, PET, IND, Investigational New Drug, Otorhinolaryngology, Patient, IIT, Clinical trial, National Medical Products Administration, BPA, Medical device, Pharmaceutical industry

Neuboron Medical Group (Neuboron) is pleased to announce significant progress in the commercialization of its comprehensive Boron Neutron Capture Therapy (BNCT) solution, marking a new era in the treatment of refractory tumors.

Key Points: 
  • Neuboron Medical Group (Neuboron) is pleased to announce significant progress in the commercialization of its comprehensive Boron Neutron Capture Therapy (BNCT) solution, marking a new era in the treatment of refractory tumors.
  • On March 26, the Beijing Institute of Medical Device Testing (BIMT) granted Neuboron’s NeuPEX Block-I, an electrostatic accelerator-based BNCT system, its Medical Device Testing Reports.
  • This approval facilitates the commencement of Phase-I Clinical Trials targeting recurrent head-and-neck cancer at the Xiamen Humanity Hospital, the premier operational BNCT Center in China.
  • This solution encompasses the NeuPEX AB-BNCT System, the NeuMANTA Treatment Planning System, treatment boron drug NBB-001 (BPA), and diagnostic NBB-002 (18F-BPA).

FOSUN FOR GOOD, CREATING IMPACT: Fosun International Issued its 2023 ESG Report and the Second Climate Information Disclosures Report

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金曜日, 4月 26, 2024
Carbon, Carbon neutrality, Education, World Health Organization, NMPA, Malaria, HSI, Risk management, Culture, CSA, United Nations Global Compact, Climate, Disclosure, National Medical Products Administration, Sustainability, Create, Task force, Climate change, HKEX, Ecosystem, Health, SCLC, Biophysical environment, Temperature, AA, Cancer, Social, Hope, Policy, Paris Agreement, MSCI, Environment, Patient, Artesunate, ESG, The Bund Finance Center, Renewable energy

HONG KONG , April 26, 2024 /PRNewswire/ -- Fosun International Limited (HKEX stock code: 00656, "Fosun International"), together with its subsidiaries ("Fosun" or the "Group"), today issued the Environmental, Social and Governance (ESG) Report 2023 (the "ESG Report").

Key Points: 
  • HONG KONG , April 26, 2024 /PRNewswire/ -- Fosun International Limited (HKEX stock code: 00656, "Fosun International"), together with its subsidiaries ("Fosun" or the "Group"), today issued the Environmental, Social and Governance (ESG) Report 2023 (the "ESG Report").
  • Facing the increasingly severe challenges of global climate change, Fosun released its second Climate Information Disclosures Report with reference to the disclosure requirements of the Hong Kong Stock Exchange, the Task Force on Climate-Related Financial Disclosures ("TCFD") recommendations and IFRS S2 Climate-related Disclosures.
  • This year, the Group has actively pursued its carbon neutrality goal and issued the second Climate Information Disclosures Report.
  • For more information on Fosun's ESG, please refer to Fosun International's ESG Report 2023 posted on:
    The electronic copy of the 2023 Climate Information Disclosures Report is available on the Company's ESG webpage: ( https://en.fosun.com/esg/ )

GenFleet Therapeutics Announces FDA's Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer

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金曜日, 4月 19, 2024
FDA, Total, Colorectal cancer, Mutation, Immunology, Lung cancer, Priority review, NMPA, National Medical Products Administration, Cetuximab, Progression-free survival, New Drug Application, Irinotecan, Oxaliplatin, Recurrence, RAS, CRC, ESMO, Medicine, ASCO, Canadian International Council, Disease, Incidence, Patient, Liver, Peritoneum, Food and Drug Administration, BTD, Lung, Death, Biology, Clinical trial, EGFR, Therapy, Cancer, NSCLC, Breakthrough therapy, Prevalence, Pharmaceutical industry

"We appreciate the FDA's recognition of GFH925' efficacy and safety profile, as this is our first global phase III monotherapy study in treating advanced stage CRC.

Key Points: 
  • "We appreciate the FDA's recognition of GFH925' efficacy and safety profile, as this is our first global phase III monotherapy study in treating advanced stage CRC.
  • We believe the approval of our proposed trial design highlights the potential of GFH925 monotherapy in this indication, thus bringing more therapeutic options and clinical benefits to the patients.
  • Targeting KRAS G12C Mutation in Colorectal Cancer, A Review: New Arrows in the Quiver, International Journal of Molecular Science, Mar.
  • Disease Burden of Total and Early-Onset Colorectal Cancer in China from 1990 to 2019 and Predictions of Cancer Incidence and Mortality, Clinical Epidemiology, Feb. 2023
    4.

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

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日曜日, 4月 7, 2024
Diagnosis, OS, Nephrectomy, Immunotherapy, DCR, Oncology, Risk, Patient, Shanda, Malignancy, Death, IMDC, Carcinoma, Renal cell carcinoma, Trial of the century, RCC, National Medical Products Administration, ESMO, HKEX, IRC, PFS, Annals of Oncology, Axitinib, Independent Review Committee, Pharmaceutical industry

Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.

Key Points: 
  • Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.
  • There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022.
  • Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy.
  • “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China.

Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates

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金曜日, 3月 29, 2024
CPS, Patient, Lung cancer, IND, Infection, Cancer, Investment, Cisplatin, Paclitaxel, Melanoma, Marketing, RNA, New chemical entity, Gentlemen's agreement, NRDL, Food, Therapeutic Goods Administration, Biologics license application, Insurance, Research, Junshi, National Medical Products Administration, TGA, FDA, NMPA, Tablet, COVID-19, NPC, Spacecraft, DSM-IV codes, Dacarbazine, Axitinib, Total, Pharmaceutical industry

SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.

Key Points: 
  • SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.
  • Total research and development (“R&D”) expenses were approximately RMB1,937 million in 2023, representing a decrease of approximately 19% compared to 2022.
  • Loss attributable to owners was RMB2,282 million in 2023, representing a decrease of RMB104 million compared to the previous year.
  • This application was later approved for marketing in December 2023, marking the first and only approved perioperative therapy for lung cancer domestically.

MAIWEIJIAN, First Approved Biosimilar of Denosumab (120mg) in China

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月曜日, 4月 8, 2024
NMPA, Patient, JAMA Oncology, Denosumab, Disability, RANKL, Plasma protein binding, Nephrotoxicity, National Medical Products Administration, Safety, Pharmacokinetics, Kidney, Marketing, Pharmaceutical industry

MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.

Key Points: 
  • MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.
  • Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines.
  • Doctors and patients have a high level of recognition for denosumab.
  • 3) It has a good safety profile and is not cleared by the kidney, and patients treated with denosumab experience fewer nephrotoxic side effects.

OmniAb Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

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水曜日, 3月 20, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Research, Multiple myeloma, Lung cancer, Partner, NMPA, Growth, NSCLC, CIDP, Partnership, Telephone, GSK, Patient, TED, NASDAQ Biotechnology Index, Epitope, Artificial intelligence, Sale, Myasthenia gravis, Neonatal Fc receptor, Fluorouracil, Graves' ophthalmopathy, Investment, Teclistamab, NBI, National Medical Products Administration, Johnson & Johnson, Drug development, Safety, Chicken, Machine learning, Gastrointestinal cancer, Immunoglobulin G, BLA, Chronic inflammatory demyelinating polyneuropathy, Pharmaceutical industry

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.
  • OmniAb launched two new technologies during 2023 including OmniDeep™ and, during the fourth quarter, OmnidAb™.
  • Fourth quarter 2023 and recent partner highlights include the following:
    Immunovant reported positive initial results for batoclimab in Graves’ disease (GD).
  • OmniAb was added to the Nasdaq Biotechnology Index (NBI) in the fourth quarter.

LIB Therapeutics and Partner Hasten Biopharmaceuticals Announce Lerodalcibep Clinical Trial Application Acceptance by the Center for Drug Evaluation at the National Medical Products Administration in China

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火曜日, 3月 19, 2024
Research, FDA, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Other Science, Science, Cardiovascular disease, NMPA, PCSK9, CVD, MAA, Refrigeration, CMC, EMA, CDE, Clinical trial, Therapy, National Medical Products Administration, Pharmaceutical industry

LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.

Key Points: 
  • LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.
  • In September 2023, LIB announced that it had entered into an agreement granting Hasten the rights to develop and commercialize Lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan) and will be responsible for clinical development and regulatory approval in these territories.
  • The acceptance of the Lerodalcibep clinical trial application by the NMPA was based on the integrated data dossier provided by LIB, including CMC, non-clinical and clinical studies completed in the U.S., Europe, and rest of world as well as the clinical development plan in China proposed by Hasten.
  • “We are preparing our own Lerodalcibep BLA submission to the FDA, to be followed by MAA submission to EMA.

Iliac Stent Market Size, Share & Trends Analysis Report 2024: A USD 1.53 Billion Market by 2030, Projected to Grow at a CAGR of 5.8% from 2024 to 2030 - ResearchAndMarkets.com

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木曜日, 3月 14, 2024
Biotechnology, Health, Surgery, Medical Devices, Hospital, NCBI, Obesity, NMPA, Growth, Prevalence, Peripheral artery disease, Getinge Group, Incidence, Patient, Evaluation, PAD, Plaque, Google Images, National Medical Products Administration, Iliac artery, USD, Marketing, Pharmaceutical industry

The global iliac stent market size is expected to reach USD 1.53 billion by 2030, projected to grow at a CAGR of 5.8% from 2024 to 2030.

Key Points: 
  • The global iliac stent market size is expected to reach USD 1.53 billion by 2030, projected to grow at a CAGR of 5.8% from 2024 to 2030.
  • Furthermore, the growing prevalence of peripheral artery disease (PAD) is expected to propel iliac stents market growth.
  • In 2023, North America held the largest share in the iliac stents market, with a revenue share of 43.7%.
  • Hospitals serve as referral centers where patients receive comprehensive care, including diagnostic imaging, medical management, and interventional procedures like iliac stent placement

Fosun International: Total Revenue for 2023 Reached RMB198.2 billion, Industrial Operation Profit Increased by 20% YoY

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火曜日, 4月 2, 2024
Gene, Artesunate, NMPA, Fosun International, Growth, Cell, Carcinoma, Patient, MSCI, FTG, Rehabilitation, Fosun Pharma, World Health Organization, National Medical Products Administration, Club Med, HKEX, Sustainability, Marketing, SCLC, HSI, AA

During the Reporting Period, the Group achieved a total revenue of RMB198.2 billion, representing a year-on-year increase of 8.6%.

Key Points: 
  • During the Reporting Period, the Group achieved a total revenue of RMB198.2 billion, representing a year-on-year increase of 8.6%.
  • Industrial operation profit reached RMB4.9 billion, representing a year-on-year increase of 20%.
  • Total revenue of the four core subsidiaries, namely Yuyuan, Fosun Pharma, Fosun Insurance Portugal and Fosun Tourism Group (FTG), was RMB142.69 billion, representing a year-on-year increase of 8%, contributing 72% of the revenue.
  • In 2023, Fosun's overseas revenue reached RMB89.2 billion, representing a year-on-year growth of 6% and accounting for 45% of the total revenue.