NMPA

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

Retrieved on: 
Dienstag, März 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.

Kezar Life Sciences Reports Fourth Quarter and Year End 2023 Financial Results and Provides Business Update

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Donnerstag, März 14, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Research, Week, Autoimmune hepatitis, NMPA, ALT, AIH, Patient, CRR, Cohort, G&A, CDE, UPCR, IND, Clinical trial, Therapy, KZR, Safety, Pharmacokinetics, Lupus nephritis, Total, Pharmaceutical industry

(Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update.

Key Points: 
  • (Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update.
  • Research and development (R&D) expenses for the fourth quarter of 2023 increased by $7.7 million to $22.6 million, compared to $14.9 million in the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 increased by $0.6 million to $5.8 million compared to $5.2 million in the fourth quarter of 2022.
  • Restructuring and impairment charges for the fourth quarter of 2023 were $6.2 million.

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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Donnerstag, März 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

IASO Bio Announces U.S. FDA Approval of Investigational New Drug Application for BCMA CAR-T Equecabtagene Autoleucel for Generalized Myasthenia Gravis

Retrieved on: 
Donnerstag, April 4, 2024
Vital capacity, MuSK protein, Glucocorticoid, NMPA, Hormone, GMG, Disease, Chinese, MRS, BCMA, Nervous system, Patient, SAN, Enzyme inhibitor, History, Female, Multiple myeloma, CRS, B cell, Biotechnology, IND, Phenotype, Investigational New Drug, QMG, Safety, Thymectomy, FDA, Food

The Chinese IND for this indication of Equecabtagene Autoleucel was approved by the NMPA in January this year.

Key Points: 
  • The Chinese IND for this indication of Equecabtagene Autoleucel was approved by the NMPA in January this year.
  • The 2 subjects were treated with a single infusion of Eque-cel at the doses of 1.0×106 CAR-T/Kg, respectively.
  • No immunomodulatory therapy other than low dose pyridostigmine (90 mg/day and 60 mg/day, respectively) was used during the follow-up period.
  • Anti-AChR antibodies, anti-Titin antibodies, and anti-MuSK antibodies decreased rapidly and maintained at very low levels in both subjects after infusion.

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

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Dienstag, April 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.

Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Endometrial Cancer with Priority Review Status

Retrieved on: 
Dienstag, April 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, Neoplasm, NDA, Cancer, Breakthrough therapy, Senior, HCM, HKEX, Dor, IRC, Prognosis, PFS, Ophthalmology, Pharmaceutical industry

The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.
  • We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYT® in China."
  • We look forward to bringing this much-awaited treatment advancement to endometrial cancer patients to improve their treatment outcome."
  • The NMPA granted Breakthrough Therapy designation to the combination of sintilimab and fruquintinib for this potential indication in July 2023.

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

Retrieved on: 
Dienstag, April 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.

Baird Medical Granted New Class III Certificate by China's NMPA for Ceramic Thyroid Ablation Needle

Retrieved on: 
Freitag, März 29, 2024
NMPA, Classification, Heat, Risk, Research, Medical device, National Medical Products Administration, Safety, Ceramic, MWA, Printed circuit board

FRISCO, Texas, March 29, 2024 /PRNewswire/ -- Baird Medical Devices, Inc. ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China and the United States, today announced it has been granted a new Class III certificate by the National Medical Products Administration (NMPA) in China for its next generation Ceramic Thyroid Ablation Needle for the treatment of thyroid nodules on March 19, 2024.

Key Points: 
  • FRISCO, Texas, March 29, 2024 /PRNewswire/ -- Baird Medical Devices, Inc. ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China and the United States, today announced it has been granted a new Class III certificate by the National Medical Products Administration (NMPA) in China for its next generation Ceramic Thyroid Ablation Needle for the treatment of thyroid nodules on March 19, 2024.
  • The Ceramic Thyroid Ablation Needle utilizes rare earth ceramic materials that deliver exceptional heat resistance, chemical stability, and electrical insulation properties.
  • "The introduction of the Ceramic Thyroid Ablation Needle signifies another breakthrough innovation in the field of microwave ablation and is a testament to our ongoing commitment to innovation and research," said Ms. Haimei Wu, Founder and CEO of Baird Medical.
  • In 2023, China's NMPA's issued updates to the Medical Device Classification Catalog, and upgraded the Classification of Microwave Ablation Devices from a Class II to a Class III Certificate.

Harbour BioMed Reports Full Year 2023 Financial Results

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Donnerstag, März 28, 2024
GMG, Patient, Stock exchange, Quality of life, Protein engineering, Bank statement, Investment, Therapy, Research, HBM, Biotechnology, Partnership, ITM, Motherboard, Trial of the century, Neonatal Fc receptor, Safety, PD-L1, ADC, Hepatocellular carcinoma, Boston Children's Hospital, U.S. FDA, Longevity, MSLN, Harbor, Hospital, NK, Engineering, NMPA, AstraZeneca, Biology, Ecosystem, Idea, Pharmaceutical industry

We recorded a significant increase in our revenue, demonstrating the Company's excellent global business development capabilities," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

Key Points: 
  • We recorded a significant increase in our revenue, demonstrating the Company's excellent global business development capabilities," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.
  • Harbour BioMed recorded the profit of US$22.8 million for the year ended 31 December 2023.
  • This is the first time that the Company has recorded a net profit on its annual financial statements.
  • Looking to the future, Harbour BioMed will keep driving business growth and accomplishing its mission through two key pillars, Harbour Therapeutics and Nona Biosciences.

CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2023 BUSINESS AND FINANCIAL RESULTS

Retrieved on: 
Donnerstag, März 28, 2024
Agreement, Transplant, CASI Pharmaceuticals, CASI, Patient, Travel, PTCL, Immunoglobulin G, CMC, Depreciation, Bone marrow, Therapy, VCP, Marketing, Research, Cleave, Pralatrexate, MCL, Rituximab, AML, Pembrolizumab, Trial of the century, Myelodysplastic syndrome, Melphalan, MDS, Clinical trial, Follicular lymphoma, Republic, Multiple myeloma, Acute myeloid leukemia, Annual report, National Medical Products Administration, Haematopoietic system, FDA, Cayman, CD19, NMPA, COVID-19, CTA, HKIAC, NHL, Non-Hodgkin lymphoma, MICL, Pharmaceutical industry

BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.

Key Points: 
  • BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.
  • CASI reported fourth quarter 2023 revenue of $6.9 million for EVOMELA®, 33% lower than the same period in 2022.
  • 2023 marks a major milestone for CASI and our partner Juventas; Inaticabtagene Autoleucel (CNCT-19 CAR-T cell therapy) was approved by National Medical Products Administration (NMPA) in November 2023.
  • As of December 31, 2023, CASI had cash, cash equivalents and short term investment of $29.1 million compared to $48.6 million as of December 31, 2022.