National Medical Products Administration

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.

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

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金曜日, 3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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木曜日, 3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.

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

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水曜日, 3月 27, 2024
Gene, Mining, PPT, Cell, RMB, Patient, Rehabilitation, TCFD, Marketing, World Health Organization, HSI, Artesunate, Carcinoma, MSCI, FTG, Telehealth, Lithium, National Medical Products Administration, HKEX, Sustainability, SCLC, AA, KOD, NMPA, Growth, Hope, Fosun Pharma, S&P, Task force, Club Med, Dragon

HONG KONG, March 27, 2024 /PRNewswire/ -- Fosun International Limited (HKEX stock code: 00656, "Fosun International"), together with its subsidiaries ("Fosun" or the "Group"), today announced its annual results for the year ended 31 December 2023 (the "Reporting Period").

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%.
  • Thanks to the Group's global business presence and continuous innovation, 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.

Zai Lab Announces Full-Year 2023 Financial Results and Recent Corporate Updates

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火曜日, 2月 27, 2024
Oncology, Mental Health, Health, Infectious Diseases, Neurology, Pharmaceutical, Biotechnology, NSCLC, TED, Blood pressure, Cervical cancer, Psoriasis, Cetuximab, Infection, New Drug Application, SCLC, MAA, National Medical Products Administration, PMA, CIDP, NTRK, FDA, Nivolumab, Food, GEJ, Shanda, Schizophrenia, PDUFA, CRC, Bristol Myers Squibb, BMS, ADP, Safety, Mirati, TPS, Disease, HKT, Patient, Clinical trial, METIS, Fusion, Pancreatic cancer, NDA, NMPA, Pharmaceutical industry

The New Drug Application (NDA) that Zai Lab submitted to the NMPA for this indication is under priority review.

Key Points: 
  • The New Drug Application (NDA) that Zai Lab submitted to the NMPA for this indication is under priority review.
  • Zai Lab has joined the global Phase 3 FORTITUDE-102 study of bemarituzumab in combination with nivolumab and chemotherapy in first-line gastric or GEJ cancer in Greater China.
  • Zai Lab to submit an sBLA to the NMPA for efgartigimod SC in CIDP in the first half of 2024.
  • Zai Lab to complete patient enrollment in the China bridging study in schizophrenia in the fourth quarter of 2024.

Global Times: How two sessions serve as bridge between people and government, help authorities formulate policies

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金曜日, 3月 8, 2024
CCTV, China National Radio, Motion, The, Student, NRDL, National Medical Products Administration, Education, News, Party school, Hospital, Pediatrics, Peking University, Sun Jie, Dermatology, Parent, Catalog, World Health Organization, Global Times, Hope, CPPCC, University, SMA, Prevalence, Hematology, Sun, CPC, NPC, Patient, Policy, Real-time, Disease, Diagnosis, Child, National Committee, Economics, WeChat, Research, Insurance, Pharmaceutical industry

Various localities in the country are implementing policies on medication, health insurance and research according to the catalog.

Key Points: 
  • Various localities in the country are implementing policies on medication, health insurance and research according to the catalog.
  • In 2021, China also for the first time included a rare disease treatment in its National Reimbursement Drug List.
  • These moves together benefited thousands of Chinese suffering from rare diseases, including spinal muscular atrophy (SMA) patient Zhang Jianuo and his parents.
  • Motions and proposals during the two sessions are crucial pathways for addressing issues impacting people's livelihood, and they're becoming increasingly effective.

Calliditas Year-end report, January - December 2023

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水曜日, 2月 21, 2024
Head, Sustainability, European Commission, Operating cost, Marketing, Food and Drug Administration, USD, National Medical Products Administration, FDA, Food, Risk, MAH, Patent, Patient, Alport syndrome, Trial of the century, NMPA

Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.

Key Points: 
  • Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.
  • Loss per share before and after dilution amounted to SEK 0.34 and SEK 0.07 for the three months ended December 31, 2023, and 2022, respectively.
  • Cash amounted to SEK 973.7 million and SEK 1,249.1 million as of December 31, 2023, and 2022, respectively.
  • Net sales amounted to SEK 1,206.9 million, of which TARPEYO net sales amounted to SEK 1,075.8 million, for the year ended December 31, 2023.

Calliditas Year-end report, January - December 2023

Retrieved on: 
水曜日, 2月 21, 2024
Head, Sustainability, European Commission, Operating cost, Marketing, Food and Drug Administration, USD, National Medical Products Administration, FDA, Food, Risk, MAH, Patent, Patient, Alport syndrome, Trial of the century, NMPA

Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.

Key Points: 
  • Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.
  • Loss per share before and after dilution amounted to SEK 0.34 and SEK 0.07 for the three months ended December 31, 2023, and 2022, respectively.
  • Cash amounted to SEK 973.7 million and SEK 1,249.1 million as of December 31, 2023, and 2022, respectively.
  • Net sales amounted to SEK 1,206.9 million, of which TARPEYO net sales amounted to SEK 1,075.8 million, for the year ended December 31, 2023.

Mycovia Pharmaceuticals, Inc. Announces Partner Jiangsu Hengrui Pharmaceuticals Co., Ltd's Commercial Launch of VIVJOA® (Oteseconazole) Capsules for the Treatment of Severe Vulvovaginal Candidiasis (VVC) in China

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水曜日, 2月 7, 2024
Partnership, Oteseconazole, Vaginal discharge, Red, Candidiasis, Capsule, Irritation, CYP, Fluconazole, Yeast, Patient, National Medical Products Administration, Azole, Enzyme, FDA, Candida albicans, Excipient, Dyspareunia, Vaginal yeast infection, Hypersensitivity, Combustion, Fissure, CYP51, Woman, Pharmaceutical industry

DURHAM, N.C., Feb. 7, 2024 /PRNewswire/ -- Mycovia Pharmaceuticals, Inc. ("Mycovia"), an emerging biopharmaceutical company, today announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd ("Hengrui") has commercially launched VIVJOA® (oteseconazole) in China, making available an innovative oral azole antifungal indicated for the treatment of severe vulvovaginal candidiasis (VVC). VIVJOA is contraindicated for females of reproductive potential, pregnant and lactating women, and patients with known hypersensitivity to active ingredients, excipients, and azoles.

Key Points: 
  • VIVJOA is contraindicated for females of reproductive potential, pregnant and lactating women, and patients with known hypersensitivity to active ingredients, excipients, and azoles.
  • "The disease burden in China is significant, and access to VIVJOA provides health care providers and women suffering with severe VVC a new treatment option."
  • Vulvovaginal candidiasis is an exceedingly common mucosal infection usually caused by Candida albicans but can occasionally be caused by other Candida species or yeasts.
  • In April 2022, the U.S. Food and Drug Administration (FDA) approved VIVJOA (oteseconazole) Capsules as the first medication for Recurrent Vulvovaginal Candidiasis (RVVC, or chronic yeast infection).

Agilis Robotics Unveils Groundbreaking Advancements in Endoluminal Surgery

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月曜日, 2月 5, 2024
Multimedia, Surgeon, Cystoscopy, Robotics, University, CFO, Chapter, System, Patient, Safety, National Medical Products Administration, FDA, Food, NMPA, University of Hong Kong, Food and Drug Administration, Bladder cancer, Learning curve, Gastrointestinal cancer, HKEX, Hospital, Pharmaceutical industry

HONG KONG, Feb. 2, 2024 /PRNewswire/ -- Agilis Robotics, a leading innovator in surgical robotics, is spearheading a paradigm shift in the field of "incisionless" endoluminal surgery.

Key Points: 
  • HONG KONG, Feb. 2, 2024 /PRNewswire/ -- Agilis Robotics, a leading innovator in surgical robotics, is spearheading a paradigm shift in the field of "incisionless" endoluminal surgery.
  • The robotic instruments offer unprecedented possibilities across endoluminal surgery, spanning the upper and lower gastrointestinal (GI) tract, urinary tract, throat, and gynaecology.
  • Agilis Robotics is a spin-off from The University of Hong Kong and has secured more than HKD 90 million in funding from private investors.
  • Furthermore, Agilis Robotics understands the importance of cost-effectiveness, marketability, and market potential, ensuring a successful venture for investors and hospitals.