Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • Vaccine Hub
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
  • Fact Check
  • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Fact Check
      • Bone Health Fact Check
      • Brain Health Fact Check
      • Cancer Related Fact Check
      • Child Care Fact Check
      • Dental and oral health fact check
      • Diabetes and metabolic health fact check
      • Diet and Nutrition Fact Check
      • Eye and ENT Care Fact Check
      • Fitness fact check
      • Gut health fact check
      • Heart health fact check
      • Kidney health fact check
      • Medical education fact check
      • Men's health fact check
      • Respiratory fact check
      • Skin and hair care fact check
      • Vaccine and Immunization fact check
      • Women's health fact check
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Abroad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Fact Check
    • Bone Health Fact Check
    • Brain Health Fact Check
    • Cancer Related Fact Check
    • Child Care Fact Check
    • Dental and oral health fact check
    • Diabetes and metabolic health fact check
    • Diet and Nutrition Fact Check
    • Eye and ENT Care Fact Check
    • Fitness fact check
    • Gut health fact check
    • Heart health fact check
    • Kidney health fact check
    • Medical education fact check
    • Men's health fact check
    • Respiratory fact check
    • Skin and hair care fact check
    • Vaccine and Immunization fact check
    • Women's health fact check
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Abroad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • News
  • Industry
  • Pharma News
  • Intas Pharma to...

Intas Pharma to commercialise Serplulimab in India

Ruchika SharmaWritten by Ruchika Sharma Published On 2023-10-30T15:29:57+05:30  |  Updated On 1 Nov 2023 4:00 PM IST
CDSCO Panel Accepts BE Report, Tells Intas Pharma to Conduct Phase III Trial for Semaglutide
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

Serplulimab will be commercialised by Intas in India and by its subsidiary, Accord Healthcare Ltd, in Europe.

Ahmedabad: Intas Pharmaceuticals Limited has entered into an exclusive license agreement with Shanghai Henlius Biotech, Inc. for the development and commercialisation of serplulimab for Europe and India markets.

"Serplulimab, a recombinant humanised anti-PD-1 monoclonal antibody (mAb) injection, is the first innovative monoclonal antibody developed by Henlius," claimed Intas.

It has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of Small Cell Lung Cancer (SCLC). Its marketing application for the first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) is under review by the EMA.

Serplulimab was launched in China under the trade name HANSIZHUANG in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC).

This collaboration deepens the strategic partnership between the two companies and opens new development opportunities for serplulimab's global layout. Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing, and supply upon launch. Henlius will receive: i) a €42 million upfront payment, ii) up to €43 million in regulatory milestones, iii) up to €100 million in commercial sales milestones, and iv) double-digit royalties on net profit from Intas in the licensed territory.

Serplulimab will be commercialised by Intas in India and by its subsidiary, Accord Healthcare Ltd, in Europe. Accord currently supplies around one in three injectable oncology medicines in Europe.

In June 2018, Henlius and Accord entered into a license agreement, under which Henlius granted Accord exclusive commercialisation rights of HLX02 (trastuzumab for injection, trade name in China: HANQUYOU; trade name in Europe: Zercepac; trade names in Australia: Tuzucip/Trastucip) in certain countries and regions in Europe, the Middle East, North Africa, and the Commonwealth of Independent States. In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada.

HANSIZHUANG (serplulimab) has become the world's first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for 4 indications in China, benefiting over 40,000 Chinese patients. Its marketing application has been validated by the European Medicines Agency (EMA) in March 2023," said Jason Zhu, Executive Director, Chief Executive Officer, and Chief Financial Officer of Henlius. "By continuously partnering with Intas, we hope to accelerate serplulimab's wider accessibility globally and contribute to the improvement of patient outcomes."

Ping Cao, Senior Vice President and Chief Business Development Officer of Henlius, said, "Henlius and Intas first entered into a collaboration in 2018. Over the past 5 years, we have worked closely together and expanded the internationalisation of HANQUYOU (Zercepac in Europe), which has been successfully approved in 40+ of overseas countries, benefiting patients in Europe and MENA. Building on the successful collaboration, we look forward to working with Intas to accelerate the launch of serplulimab in Europe and India, and to continue our mission to offering high-quality and affordable biologics to patients around the world."

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. The forthcoming launch of serplulimab in Europe and India will mark a crucial landmark in our mission to enable access to advanced biologics, ensuring patients across the world receive the high-quality treatments they deserve."

Paul Tredwell, Executive Vice President of EMENA., Accord, said, "I am delighted to strengthen our partnership with Henlius. The launch of serplulimab will further solidify Accord as a leader in providing specialty medicines. This marks our second novel launch in just two years, adding to our existing platform of supplying up to 25% of chemotherapy medicines in our region, exemplifying our commitment to innovation and growth and our mission to improve access to value-based medicines for patients."

Read also: Intas Gets CDSCO Panel Nod To Manufacture, Market Tacrolimus Liquid Tablets

Intas PharmaIntas Pharma newsShanghai Henlius Biotechserplulimablung cancerHANSIZHUANGAccord HealthcareHLX02
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Show Full Article
    Next Story

    Editorial

    National Consensus 2025 on Role of Bisoprolol Across CV Continuum in Women: Top 10 Takeaways

    National Consensus 2025 on Role of Bisoprolol Across CV Continuum in Women: Top 10 Takeaways

    Relevance of Pioglitazone in Indian T2DM Care Continuum

    Relevance of Pioglitazone in Indian T2DM Care Continuum

    Azmarda Outperforms Generic Sacubitril/Valsartan in HFrEF Management, says new study

    Azmarda Outperforms Generic Sacubitril/Valsartan in HFrEF Management, says new study

    First Indian Consensus on Managing Refractory Gastroesophageal Reflux Disease Recommends Vonoprazan

    First Indian Consensus on Managing Refractory Gastroesophageal Reflux Disease Recommends Vonoprazan

    Re-visiting the Role of Pneumococcal Vaccination in Patients with Cardiovascular Diseases

    Re-visiting the Role of Pneumococcal Vaccination in Patients with Cardiovascular Diseases

    View All

    Journal Club Today

    Study Reveals Why Your Immune System Works Better in Daylight

    Study Reveals Why Your Immune System Works Better in Daylight

    View All

    Health News Today

    Health Bulletin 29/May/2025

    Health Bulletin 29/May/2025

    View All
    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok