National Medical Products Administration

Apollomics Announces Approval of Vebreltinib in China as a First-in-Class Treatment for Gliomas with MET Fusion Gene

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木曜日, 4月 25, 2024
Glioma, Shanda, MET, WHO, Temozolomide, Safety, Risk, NMPA, National Medical Products Administration, Glioblastoma, Isocitrate dehydrogenase, Survival, New Drug Application, Cisplatin, Death, Central nervous system, Partnership, Trial of the century, Etoposide, OS, History, CNS, IDH, Patient, Neoplasm, Met, APLM, NSCLC, Lung cancer, Pharmaceutical industry

FOSTER CITY, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage 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. (Avistone), received approval from the National Medical Products Administration (NMPA) of China for vebreltinib (APL-101) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments. This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration, and follows the NMPA’s November 2023 approval of vebreltinib for the treatment of patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC).

Key Points: 
  • "The NMPA’s approval of vebreltinib in gliomas is an important, first-in-class approval as it demonstrates vebreltinib’s CNS penetration ability and c-Met inhibitory activity in the tumors there," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics.
  • Surgery, radiation treatment, and chemotherapy are current standard treatment strategies for gliomas with poor prognoses.
  • These preliminary data support cross-region similarity of patient response to treatment with vebreltinib.
  • This collaboration enables both companies to leverage their strengths and maximize the benefit of vebreltinib worldwide.

China Medical System: New Drug Application of Desidustat Tablets Accepted in China

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火曜日, 4月 23, 2024
CMS, Tablet, Desidustat, NMPA, NDA, National Medical Products Administration, Kidney failure, New Drug Application, Erythropoiesis, Anemia, Chronic kidney disease, CKD, Week, Patient, Dialysis, Prevalence, Marketing, Diagnosis, Advertising, EPO, Medical device

Desidustat Tablets are novel, oral HIF-PHI for treating anaemia in non-dialysis adult chronic kidney disease patients.

Key Points: 
  • Desidustat Tablets are novel, oral HIF-PHI for treating anaemia in non-dialysis adult chronic kidney disease patients.
  • The primary endpoint has indicated that Desidustat is more effective than placebo in increasing Hb level.
  • China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on 22 April 2024, the New Drug Application (NDA) of Desidustat Tablets  (“Desidustat Tablets” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA).
  • Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

Intuitive Announces First Quarter Earnings

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木曜日, 4月 18, 2024
FDA, Investment, Hysterectomy, Nasdaq, Inc., Certification, National Medical Products Administration, Intuition, PDT, SP, Da Vinci, Public expenditure, Patient, COVID-19, Diagnosis, Intuitive Surgical, GAAP, Growth, CE

First quarter 2024 revenue of $1.89 billion increased 11% compared with $1.70 billion in the first quarter of 2023.

Key Points: 
  • First quarter 2024 revenue of $1.89 billion increased 11% compared with $1.70 billion in the first quarter of 2023.
  • First quarter 2024 GAAP net income attributable to Intuitive was $545 million, or $1.51 per diluted share, compared with $355 million, or $1.00 per diluted share, in the first quarter of 2023.
  • First quarter 2024 non-GAAP* net income attributable to Intuitive was $541 million, or $1.50 per diluted share, compared with $437 million, or $1.23 per diluted share, in the first quarter of 2023.
  • First quarter 2024 GAAP income from operations increased to $469 million, compared with $388 million in the first quarter of 2023.

SINOVAC Reports Unaudited Second Half of 2023 Financial Results and Files 2023 Annual Report on Form 20-F

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月曜日, 4月 29, 2024
Biotechnology, General Health, Infectious Diseases, Health, Pharmaceutical, Heng, NMPA, The Twelve Months, Vaccine, Enterovirus, District court, Court, GAAP, Person, EV71, WHO, Hearing, National Medical Products Administration, Hand, Exchange, Complaint, Sinovac Biotech, Privy council, Good, Annual report, Influenza, Infection, OrbiMed, Motion, Foot, Judgement, Rights, GMP, Clinical trial, Government, Appellate court, Medication, Capital, Ageing, Influenza vaccine, Cancer, Trust, Bank statement, HFMD, COVID-19, Growth, Hepatitis

The Company also reported its unaudited financial results for the second half and audited financial for the full year ended December 31, 2023.

Key Points: 
  • The Company also reported its unaudited financial results for the second half and audited financial for the full year ended December 31, 2023.
  • Sales for the second half of 2023 were $307.9 million, compared to $280.5 million in the prior year period.
  • R&D expenses in the second half of 2023 were $193.4 million, compared to $257.7 million in the prior year period.
  • The Company’s financial statements for the second half of 2023 are prepared and presented in accordance with U.S. GAAP.

A Potential First-In-Class Drug: CDE Approved Single-Arm Pivotal Clinical Study of LBL-024, An Anti-PD-L1/4-1BB Bispecific Antibody Developed by Leads Biolabs

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火曜日, 4月 30, 2024
FDA, News, Safety, NMPA, National Medical Products Administration, Immunotherapy, Trial of the century, Tumor microenvironment, CDE, IND, PD-L1, Disease, CD137, Patient, Antibody, Quality of life, Pharmaceutical industry

LBL-024 is a bispecific antibody composed of anti-programmed death ligand-1 (PD-L1) and anti-4-1BB (CD137) antibodies.

Key Points: 
  • LBL-024 is a bispecific antibody composed of anti-programmed death ligand-1 (PD-L1) and anti-4-1BB (CD137) antibodies.
  • It binds to PD-L1 with high affinity, blocking the PD-L1/PD-1 immunosuppressive pathway while conditionally activating the 4-1BB costimulatory pathway in the tumor microenvironment.
  • Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said " The approval of this pivotal clinical study is an encouraging news.
  • The approval of the single-arm pivotal clinical study by CDE will help accelerate the marketing process of LBL-024 and bring more effective treatment options to patients as early as possible."

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.