National Medical Products Administration

China Medical System (00867） Obtained Exclusive License of a First-line Phosphate-lowering Drug Velphoro®

Retrieved on: 
日曜日, 2月 4, 2024
SP, License, Peritoneal dialysis, Patient, National Medical Products Administration, Ageing, Glomerular filtration rate, CKD, NMPA, HD, Dialysis, CMS, Sale, Chronic kidney disease, PB, PD, Pharmaceutical industry

Winhealth Investment and VFMCRP entered into a License Agreement (the “License Agreement”) for the Product on 28 June 2023.

Key Points: 
  • Winhealth Investment and VFMCRP entered into a License Agreement (the “License Agreement”) for the Product on 28 June 2023.
  • Upon the expiration of the aforementioned term, the License Agreement may automatically be renewed for ten years as per certain conditions defined in the License Agreement.
  • There is an issued patent that protects the formulation, usage, particle size and manufacturing methods of the Product in China.
  • Velphoro® is a newly approved innovative drug in China in 2023 and has been successfully included in category B of the National Reimbursement Drug List.

Airdoc Technology (2251.HK) Receives EU CE MDR Certification, Securing Market Access in Multiple Countries

Retrieved on: 
火曜日, 1月 30, 2024
Diabetes, Certification, Patient, MDR, Incidence, Health, Diagnosis, Risk, International, Diabetic retinopathy, Disability, News, Travel, Medical device regulation, Conditional sentence, Finance, Prediabetes, National Medical Products Administration, CE, Prevalence, Medical device

Airdoc Technology (2251.HK) Receives EU CE MDR Certification, Securing Market Access in Multiple Countries

Key Points: 
  • Airdoc Technology (2251.HK) Receives EU CE MDR Certification, Securing Market Access in Multiple Countries
    On January 8th, Airdoc Technology announced that its Airdoc-AIFUNDUS (1.0) has recently obtained the CE marking ("CE MDR") as per the Medical Device Regulation, allowing comprehensive market entry into 27 EU countries, including Belgium, Germany, Italy, France, and more.
  • AI-FUNDUSCAMERA-P has obtained regulatory approval or registration in Indonesia, South Africa, the United Arab Emirates, and Thailand.
  • The company's self-developed AI-FD16 series of fundus cameras is China's first fully automatic, self-service, portable fundus camera to be approved for market release.
  • With market access permits obtained from various countries and regions, China's original AI technology is set to travel across the globe, benefiting local residents and making health ubiquitous.

CORRECTION BY SOURCE: Solta Medical's Thermage(R) FLX and TR-4 Return Pad Receive Registration Certifications in China

Retrieved on: 
月曜日, 1月 22, 2024
Senior, Lupus, Paresthesia, Heat, Diabetes, Face, FLX, Blister, Growth, CPT, Epilepsy, Bausch Health, Genital herpes, Breastfeeding, Burns, Hypoesthesia, Glycine mollis, Eyelid, National Medical Products Administration, BHC, NMPA, Medical device

[See *Correction above: The TR-4 Return Pad is not approved for use by the U.S. Food & Drug Administration.]

Key Points: 
  • [See *Correction above: The TR-4 Return Pad is not approved for use by the U.S. Food & Drug Administration.]
  • "The approval of Thermage FLX, and the TR-4 return pad, marks a significant milestone for Solta Medical," Thomas J. Appio, Bausch Health Chief Executive Officer, said.
  • "The approval from NMPA means we are able to continue the momentum of the growth of Thermage in China," Jiny Kim, Senior Vice President, Solta Medical, said.
  • Ask your doctor for more information about Thermage FLX and see www.thermage.com for additional details.

Orphalan announces China NMPA’s approval of its trientine tetrahydrochloride product for the treatment of Wilson disease

Retrieved on: 
木曜日, 1月 18, 2024
Ageing, Patient, Long-term care, Disease, Wilson's disease, Liver, Triethylenetetramine, HCI, NMPA, DPA, Marketing, Brain, National Medical Products Administration, Diagnosis, Pharmaceutical industry

It offers a new treatment option for Wilson disease in children aged five years and older and adults intolerant to penicillamine therapy.

Key Points: 
  • It offers a new treatment option for Wilson disease in children aged five years and older and adults intolerant to penicillamine therapy.
  • China is home to an estimated 80,000 individuals with Wilson disease, of whom approximately half have their diagnosis confirmed, and 25,000 are receiving regular treatment.
  • Dr Naseem Amin, Chief Executive Officer at Orphalan, said: “We are pleased with the marketing authorisation approval of our trientine tetrahydrochloride product in China, which offers a well-tolerated and effective treatment option for patients with Wilson disease.
  • It is a significant step for those of us living with Wilson disease, representing a much-needed alternative treatment option.

Establishment Labs Announces Commercial Launch of Motiva Implants in China

Retrieved on: 
月曜日, 1月 22, 2024
Medical Devices, Health, Consumer, Surgery, Women, Other Health, Woman, Beauty, ESTA, Conference, Labs, NMPA, National Medical Products Administration, Growth

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced it has launched Motiva® Implants in China.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced it has launched Motiva® Implants in China.
  • “China is the second largest market globally, but has the opportunity to be much larger,” commented Juan José Chacón-Quirós, Establishment Labs Founder and Chief Executive Officer.
  • “Establishment Labs was founded to make profound changes to our industry, and our growth reflects that.
  • Establishment Labs received National Medical Products Administration (NMPA) approval in China for Motiva® Implants in November 2023.

InnoCare Announces First Prescription of Tafasitamab in Combination with Lenalidomide for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Under Greater Bay Area’s Early Access Program

Retrieved on: 
月曜日, 1月 22, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, ASCT, Patient, Incidence, European Medicines Agency, Tafasitamab, HKEX, EMA, Immunotherapy, Food, DLBCL, FDA, Lenalidomide, BLA, Marketing, National Medical Products Administration, NHL, NMPA, Pharmaceutical industry

Through this program, the first prescription of tafasitamab in combination with lenalidomide was filled today at the Guangdong Clifford Hospital for an eligible DLBCL patient.

Key Points: 
  • Through this program, the first prescription of tafasitamab in combination with lenalidomide was filled today at the Guangdong Clifford Hospital for an eligible DLBCL patient.
  • The early access program of the Greater Bay Area allows designated medical institutions in the area to access drugs and medical devices that have been approved by regulatory authorities for marketing in Hong Kong or Macao.
  • Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “We are pleased to provide eligible patients access to tafasitamab in the Greater Bay Area.
  • DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally.

Glenmark, Jiangsu Alphamab Biopharmaceuticals and 3D Medicines announce the signing of a License Agreement for KN035 (Envafolimab) for Multiple Geographies around the World

Retrieved on: 
木曜日, 1月 25, 2024
Patient, Medication, Emerging market, GSSA, Action Replay, Microsatellite, MSI-H, Chinese, MFS, CIS, Cholangiocarcinoma, UPS, Cancer, License, PD-L1, STS, Lung cancer, Neoplasm, Prevalence, Myxofibrosarcoma, National Medical Products Administration, LTD, NMPA

Jiangsu Alphamab will be responsible of manufacturing KN035 within and outside the Territory.

Key Points: 
  • Jiangsu Alphamab will be responsible of manufacturing KN035 within and outside the Territory.
  • 3D Medicines retains the right to develop and commercialize Envafolimab for any purpose outside the Territory.
  • Under the terms of the agreement, GSSA will receive from Jiangsu Alphamab and 3D Medicines, an exclusive license to develop, register, commercialize, Envafolimab for the oncology indication in the Territory.
  • The Licensors' respective entitlement to the payments (including the upfront payment, milestone payment and the royalty fees) under the License Agreement are subject to the agreements between 3D Medicines and Jiangsu Alphamab.

Glenmark, Jiangsu Alphamab Biopharmaceuticals and 3D Medicines announce the signing of a License Agreement for KN035 (Envafolimab) for Multiple Geographies around the World

Retrieved on: 
木曜日, 1月 25, 2024
Patient, Medication, Emerging market, GSSA, Action Replay, Microsatellite, MSI-H, Chinese, MFS, CIS, Cholangiocarcinoma, UPS, Cancer, License, PD-L1, STS, Lung cancer, Neoplasm, Prevalence, Myxofibrosarcoma, National Medical Products Administration, LTD, NMPA

Jiangsu Alphamab will be responsible of manufacturing KN035 within and outside the Territory.

Key Points: 
  • Jiangsu Alphamab will be responsible of manufacturing KN035 within and outside the Territory.
  • 3D Medicines retains the right to develop and commercialize Envafolimab for any purpose outside the Territory.
  • Under the terms of the agreement, GSSA will receive from Jiangsu Alphamab and 3D Medicines, an exclusive license to develop, register, commercialize, Envafolimab for the oncology indication in the Territory.
  • The Licensors' respective entitlement to the payments (including the upfront payment, milestone payment and the royalty fees) under the License Agreement are subject to the agreements between 3D Medicines and Jiangsu Alphamab.

Glenmark, Jiangsu Alphamab Biopharmaceuticals and 3D Medicines announce the signing of a License Agreement for KN035 (Envafolimab) for Multiple Geographies around the World

Retrieved on: 
木曜日, 1月 25, 2024
Patient, Medication, Emerging market, GSSA, Action Replay, Microsatellite, MSI-H, Chinese, MFS, CIS, Cholangiocarcinoma, UPS, Cancer, License, PD-L1, STS, Lung cancer, Neoplasm, Prevalence, Myxofibrosarcoma, National Medical Products Administration, LTD, NMPA

Jiangsu Alphamab will be responsible of manufacturing KN035 within and outside the Territory.

Key Points: 
  • Jiangsu Alphamab will be responsible of manufacturing KN035 within and outside the Territory.
  • 3D Medicines retains the right to develop and commercialize Envafolimab for any purpose outside the Territory.
  • Under the terms of the agreement, GSSA will receive from Jiangsu Alphamab and 3D Medicines, an exclusive license to develop, register, commercialize, Envafolimab for the oncology indication in the Territory.
  • The Licensors' respective entitlement to the payments (including the upfront payment, milestone payment and the royalty fees) under the License Agreement are subject to the agreements between 3D Medicines and Jiangsu Alphamab.

If you were overcharged for certain multi-family dwelling recycling services in Oakland between July 1, 2015, and December 31, 2021, you may be eligible to receive a refund payment from a settlement.

Retrieved on: 
木曜日, 1月 18, 2024
MFD, Person, City, Multimedia, CWS, Settlement, Recycling, Court, National Medical Products Administration, Oakland, California, Lawsuit, Alameda County Superior Court

IRVINE, Calif., Jan. 17, 2024 /PRNewswire/ -- CPT Group, Inc., announces a settlement has been reached in a lawsuit called City of Oakland v. California Waste Solutions, Inc., Case No. RG17853559, Alameda County Superior Court (the "Lawsuit ").

Key Points: 
  • In this Lawsuit, the City of Oakland ("City") sued California Waste Solutions ("CWS") for allegedly overcharging some residents for certain recycling services to recover the overpayments for Oakland residents.
  • The City alleges that CWS overcharged some owners or residents of multi-family dwellings ("MFDs") for certain premium backyard recycling cart services from July 1, 2015, through the end of 2021.
  • Although CWS does not admit to the allegations, CWS chose to settle this case without admitting liability.
  • You cannot receive a refund check without agreeing to give up and release all your claims against CWS and the City.