Associated tags: Hook effect, Trastuzumab, NMPA, Rituximab, Name, Patient, Cancer, MSI, Adalimumab, GMP, Bevacizumab, ESCC, SCLC, Pharmaceutical industry, Research, Lung cancer, Mab
Locations: CHINA, MAB, UNITED KINGDOM, EC, EUROPEAN UNION, LATIN AMERICA, FRANCE, SPAIN, FINLAND, ARGENTINA, SAUDI ARABIA, EU, AUSTRALIA, NORTH AMERICA, ASIA, GERMANY, EUROPE, THAILAND, OCEANIA, SWITZERLAND, UNITED STATES, ASIA PACIFIC, NEW JERSEY, CANADA, BRAZIL, INDONESIA
SHANGHAI, April 29, 2024 /PRNewswire/ -- Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received approval from the United States Food and Drug Administration (FDA) for HERCESSI™ (HLX02, trastuzumab-strf, biosimilar to Herceptin® trade name: HANQUYOU in China and Zercepac® in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius.
Key Points:
- SHANGHAI, April 29, 2024 /PRNewswire/ -- Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received approval from the United States Food and Drug Administration (FDA) for HERCESSI™ (HLX02, trastuzumab-strf, biosimilar to Herceptin® trade name: HANQUYOU in China and Zercepac® in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius.
- The product has been approved in the United States (U.S.) for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
- HLX02 is a China-developed monoclonal antibody (mAb) biosimilar approved in China, the European Union (EU) and U.S., with previous approvals for commercialisation by the European Commission (EC) and National Medical Products Administration (NMPA) in July 2020 and August 2020, respectively.
- To date, HLX02 has benefited more than 180,000 patients.
Retrieved on:
Wednesday, April 17, 2024
PIC/S,
Idiopathic pulmonary fibrosis,
Adalimumab,
Cancer,
Social,
NRDL,
Certification,
Trastuzumab,
SCLC,
Hand,
Bevacizumab,
Water,
Carcinoma,
Pollution,
European,
Environment,
Rituximab,
RMB,
Patient,
Mental health,
ESG,
Waste management,
GHG,
ALS,
Marketing,
Advertising,
GMP,
Recycling,
Growth,
Nursing In 2023, Henlius was awarded by HR Asia "Best Companies To Work For In Asia" for two years in a row.
Key Points:
- In 2023, Henlius was awarded by HR Asia "Best Companies To Work For In Asia" for two years in a row.
- Henlius strives to build a sustainable supply chain, continues optimizing supply chain operation mechanism, and strengthens supply chain risk management.
- Henlius is committed to giving back to the community while striving for high-quality sustainable development.
- The Company has established a sound four-tier ESG management structure and formulated an ESG management strategy model in line with the corporate development strategy.
Research,
Women,
Clinical Trials,
Biotechnology,
Managed Care,
General Health,
Pharmaceutical,
Consumer,
Health,
Science,
Name,
Patient,
Denosumab,
BMD,
Woman,
Biosimilar,
European,
Fracture,
Osteoporosis,
Safety,
Multimedia,
OGN Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints.
Key Points:
- Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints.
- In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14.
- The agreement covers markets such as the United States, the European Union, and Canada.
- The primary endpoints of this study were met.
Retrieved on:
Thursday, January 11, 2024
Neoplasm,
Lasofoxifene,
National Comprehensive Cancer Network,
Patient,
Incidence,
Fulvestrant,
AIS,
Society,
Breast cancer,
Cancer,
Breast,
Eli Lilly,
Mutation,
CSCO,
NCCN,
Therapy,
ESR1,
Pharmaceutical industry Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights.
Key Points:
- Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights.
- Sermonix received an upfront payment and is further eligible to receive up to $58 million in certain predetermined milestones, in addition to royalties upon Henlius commercialization in China.
- “In Phase 2 clinical trials, investigational lasofoxifene demonstrated its potential for the treatment of ER+/HER2- breast cancer harboring ESR1 mutation,” said Ping Cao, senior vice president and chief business development officer of Henlius.
- “Lasofoxifene will play a critical role in complementing Henlius' pipeline of its breast cancer product.
JAMA,
Name,
FDA,
Trastuzumab,
SCLC,
Policy,
Stomach,
Food,
European Commission,
Cancer,
ESCC,
Intas Pharmaceuticals,
American Medical Association,
Independence,
Lung cancer,
MSI-H,
European Medicines Agency,
MSI,
EC,
Regulation of tobacco by the U.S. Food and Drug Administration,
Carcinoma,
Research,
Commonwealth,
Journal,
Senior,
Civil service commission,
Growth,
Clinical trial,
Partnership,
EMA,
ASEAN,
Patient,
Nature Medicine,
Fosun Pharma,
Pharmaceutical industry,
Accord In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada.
Key Points:
- In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada.
- Ping Cao, Senior Vice President and Chief Business Development Officer of Henlius, said, "Henlius and Intas first entered into a collaboration in 2018.
- Binish Chudgar, Vice-Chairman & Managing Director, Intas Pharmaceuticals Ltd., said, "We are excited to reinforce our long-standing partnership with Henlius.
- This collaboration will further bolster Intas' global oncology portfolio, underlining our commitment to delivering innovative healthcare solutions worldwide.
Retrieved on:
Saturday, September 23, 2023
Up to date, HANSIZHUANG has been approved for the treatment of microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC).
Key Points:
- Up to date, HANSIZHUANG has been approved for the treatment of microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC).
- The approval of ESCC further validates the potential of HANSIZHUANG and demonstrates the innovation capabilities of Henlius.
- We look forward to more positive study results of HANSIZHUANG to make further contributions to cancer treatment for more cancer patients."
- In the field of lung cancer, HANSIZHUANG has been approved for sqNSCLC and ES-SCLC, making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC.
The collaboration aims to expand the application of each company's platform by developing novel cancer immunotherapies, including those tumors resistant to anti-PD-1/L1 immunotherapies, to accelerate their respective pipeline of innovative immunotherapy medicines.
Key Points:
- The collaboration aims to expand the application of each company's platform by developing novel cancer immunotherapies, including those tumors resistant to anti-PD-1/L1 immunotherapies, to accelerate their respective pipeline of innovative immunotherapy medicines.
- Mr. Jason Zhu, Chief Executive Officer, President, and Chief Financial Officer of Henlius, said, "Henlius is dedicated to providing affordable and innovative biologics for patients around the world.
- Taking innovation as a driver, HanchorBio has quickly built its differentiated advantages and stands out in the field of onco-immunotherapy.
- This collaboration will allow Henlius to further accelerate our practice of affordable innovation and benefit more patients worldwide by fully leveraging HanchorBio's leading-edge technology and R&D platform."
Up to date, HANQUYOU has received marketing approvals in 41 countries and regions globally with a cumulative global shipment volume totaling over 3 million units.
Key Points:
- Up to date, HANQUYOU has received marketing approvals in 41 countries and regions globally with a cumulative global shipment volume totaling over 3 million units.
- With world-class quality, clinically-proven safety and efficacy, and high accessibility, HANQUYOU is highly recognized by doctors and patients at home and abroad.
- With the advantages of dual-dosage form, no preservatives and "ready-to-use" formulation, HANQUYOU has been widely used in clinical practice and achieved rapid market acceptance and strong commercial growth.
- They have also donated a total of more than RMB 190,000 to support local hospitals and village clinics.
Retrieved on:
Saturday, January 7, 2023
Lung cancer,
Clinical trial,
Communication,
Partnership,
PD-1,
GMP,
European Medicines Agency,
Quality control,
NMPA,
Mab,
Fosun Pharma,
Uniloc USA, Inc. v. Microsoft Corp.,
R,
Patient,
Union,
HER2,
BRAF,
Senior,
Marketing,
EGFR,
Fine chemical,
Pharmaceutical industry,
EU PRINCETON, N.J., Jan. 7, 2023 /PRNewswire/ -- Fosun Pharma (600196.SH, 02196.HK) has recently entered into an exclusive license agreement with Shanghai Henlius Biotech, Inc. (2696.HK) for the commercialisation of Henlius independently developed anti-PD-1 monoclonal antibody (mAb) serplulimab in the United States (US).
Key Points:
- PRINCETON, N.J., Jan. 7, 2023 /PRNewswire/ -- Fosun Pharma (600196.SH, 02196.HK) has recently entered into an exclusive license agreement with Shanghai Henlius Biotech, Inc. (2696.HK) for the commercialisation of Henlius independently developed anti-PD-1 monoclonal antibody (mAb) serplulimab in the United States (US).
- Fosun Pharma will have the right to commercialise serplulimab upon approval in the US, and Henlius will retain responsibility for development, manufacturing, and supply.
- Mr. Wenjie Zhang, Chairman and CEO of Henlius, said, "We are excited to partner with Fosun Pharma in the United States on serplulimab.
- Henlius' strong R&D capabilities, international-standard quality management system, and production capacity enable Henlius to boost the global commercialisation of its products.
