National Medical Products Administration

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

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星期日, 四月 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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星期五, 三月 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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星期一, 四月 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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星期三, 三月 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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星期二, 三月 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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星期四, 三月 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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星期二, 四月 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.

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

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星期二, 四月 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.

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

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星期五, 三月 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.

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

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星期四, 三月 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.