National Medical Products Administration

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

Retrieved on: 
Thursday, January 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: 
Monday, January 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: 
Monday, January 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: 
Thursday, January 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: 
Thursday, January 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: 
Thursday, January 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: 
Thursday, January 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.

Avance Clinical: Latest Analysis Reveals 65% of US Biotechs Struggle to Identify Suitable CRO Partner

Retrieved on: 
Tuesday, January 9, 2024
ChromeOS, National Medical Products Administration, Frost, EMA, Investment, FDA, JPM, Pharmaceutical industry

Each site has been accredited by Avance Clinical for data quality, patient centricity, and streamlined processes designed meet rigorous clinical timelines.

Key Points: 
  • Each site has been accredited by Avance Clinical for data quality, patient centricity, and streamlined processes designed meet rigorous clinical timelines.
  • In addition, the report found a regulatory affairs track-record was a key selection criteria saying in-house regulatory expertise was the most attractive option for biotechs.
  • Avance Clinical has been recognised by Frost & Sullivan for the past 4 years with the prestigious Frost & Sullivan Asia-Pacific CRO Best Practices Leadership Award.
  • For more information about the benefits of running your next study with Avance Clinical contact us: [email protected]

Zai Lab Announces The New England Journal of Medicine Publication Demonstrating Durable Clinical Activity of Repotrectinib in Patients with Advanced ROS1 Fusion-Positive NSCLC

Retrieved on: 
Wednesday, January 10, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Development, Patient, Therapy, Progression-free survival, ROS1, Brain, Index, HKEX, Lung cancer, NSCLC, RECIST, Cancer, Food, PFS, NDA, Safety, NEJM, New Drug Application, TKI, CDE, National Medical Products Administration, MTD, NMPA, Pharmaceutical industry

Repotrectinib is a tyrosine kinase inhibitor (TKI) that has shown robust anti-tumor activity against ROS1+ cancers in preclinical models.

Key Points: 
  • Repotrectinib is a tyrosine kinase inhibitor (TKI) that has shown robust anti-tumor activity against ROS1+ cancers in preclinical models.
  • In the TRIDENT-1 study, repotrectinib demonstrated high response rates and durable activity in patients with ROS1+ NSCLC, including patients with TKI-naïve and TKI-pretreated tumors, ROS1 G2032R resistance mutations and brain metastases.
  • Brain metastases are common among patients with ROS1+ NSCLC and intracranial activity of approved ROS1 TKIs can be suboptimal.
  • In November 2023, the U.S. Food and Drug Administration approved repotrectinib for use in adult patients with locally advanced or metastatic ROS1+ NSCLC in the United States.

Enhancing Leadership in Gynecology, Asieris Pharmaceuticals Appoints Sophia Cao to Lead the Newly-Established Women's Health Business Unit, Accelerating Strategic Expansion

Retrieved on: 
Tuesday, January 9, 2024
Action plan, E pluribus unum, Woman, Bladder cancer, Marketing, Health, Elimination, Society, Cancer, Cervical cancer, Infection, World Health Organization, Diagnosis, NMIBC, Comparison, Cervical weakness, Multimedia, Death, ASCO, Breast cancer, Eli Lilly, Tislelizumab, Prevalence, MIBC, Neoadjuvant therapy, HPV, Human papillomavirus infection, LSIL, New Drug Application, NMPA, National Health Commission, Central China, Kidney cancer, Women's health, National Cancer Center, PD-1, WHO, Mortality, HSIL, Conditional sentence, Internet, Weak topology, Patient, Senior, State Council, NDA, Incidence, Head, National Medical Products Administration, Miscarriage

This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.

Key Points: 
  • This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.
  • Asieris Pharmaceuticals will leverage both in-house discoveries and external partnerships to enrich its gynecological portfolio, thereby reinforcing its leadership in women's health.
  • In November 2020, the World Health Organization (WHO) released a Global Strategy to Accelerate the Elimination of Cervical Cancer.
  • To further deliver its strategic vision and commitment in the realm of women's health, Asieris Pharmaceuticals has announced the establishment of the Women's Health Business Unit.