License out/inPhase 3ImmunotherapyDrug ApprovalClinical Result
ROCKVILLE, Md. and SUZHOU, China, Dec. 12, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that, the National Reimbursement Drug List (2023 Version) ("NRDL") has been updated to renew and include the seventh indication of PD-1 inhibitor TYVYT® (sintilimab injection) in negotiation list, and include the eighth indication of BYVASDA® (bevacizumab injection) in general list. The updated NRDL will officially take effect on January 1, 2024.
TYVYT® (sintilimab injection) is an innovative PD-1 inhibitor co-developed by Innovent and EliLilly and Company in China. TYVYT® has been approved and included in the NRDL for seven indications. It is also the only PD-1 inhibitor for the first-line treatment of five high-incidence cancer types in the NRDL. The updated NRDL reimbursement scope include:
Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "We are pleased that TYVYT® and BYVASDA® successfully expand their NRDL coverage, which will bring benefit to the broad NSCLC patients post EGFR-TKI therapy. As a company with the mission of'developing high-quality biopharmaceuticals that are affordable to ordinary people', Innovent is always committed to supporting 'Healthy China 2030' strategy and public health improvement through the development of innovative therapies. In particular, we are glad that as part of China's medical system reform, the yearly NRDL adjustment helps cover new medicines and indications in a more effective process. We hope to continue to work together with the government to improve drug affordability and accessibility, bring more high-quality drugs to patients and their families, and contribute to the ultimate goal of healthier and better life of people in China."
In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for seven indications. The updated NRDL reimbursement scope of TYVYT® (sintilimab injection) include:
Innovent has also entered into 30 strategic collaborations with EliLilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer CenterCancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives.
Note:
TYVYT® (sintilimab injection) is not an approved product in the United States.
Lilly is a global healthcare leader that unites caring with discovery to create medicines to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.
Lilly entered into a strategic collaboration with Innovent focused on biological medicine in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Lilly and Innovent will co-develop and commercialize oncology medicines, including Tyvyt® (sintilimab injection) in China. In October 2015, the two companies announced the extension of their existing collaboration to include co-development of three additional oncology antibodies targeting oncology indications. In August 2019, Innovent further entered into a licensing agreement with Lilly to develop and commercialize a potentially global best-in-class diabetes medicine in China. Its collaboration with Lilly indicates that Innovent has established a comprehensive level of cooperation between China's innovative pharmaceuticals sector and the international pharmaceuticals sector in fields such as R&D, CMC, clinical development and commercialization. In August 2020, Lilly and Innovent announced a global expansion of their strategic alliance for sintilimab. In March 2022, Lilly and Innovent deepened the strategic partnership in oncology, in which Innovent obtained the sole commercialization rights to import, market, promote, distribute and detail CYRAMZA® (ramucirumab) and Selpercatinib, and a right of first negotiation for potential future commercialization of pirtobrutinib in Mainland China.
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[i] Wang J, Fei K, Jing H, et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451.
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