On December 2, 2021 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 and other major diseases, and Eli Lilly and Company ("Lilly") (NYSE: LLY), reported that the innovative PD-1 inhibitor sintilimab has been successfully included in the updated National Reimbursement Drug List ("NRDL") for all approved indications, according to the latest announcement from the China National Healthcare Security Administration ("NHSA") (Press release, Innovent Biologics, DEC 2, 2021, View Source [SID1234596417]). The updated NRDL will officially take effect on January 1, 2022.

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A total of four approved indications for sintilimab are now included in the updated NRDL:

Three indications for sintilimab have been included in the NRDL for the first time, as follows: in combination with pemetrexed and platinum chemotherapy for the first-line treatment of advanced or recurrent nonsquamous non-small cell lung cancer (nsq NSCLC) without sensitizing EGFR mutations or ALK rearrangements; in combination with gemcitabine and platinum chemotherapy for the first-line treatment of advanced or recurrent squamous non-small cell lung cancer (sq NSCLC); and in combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC).
An indication for relapsed or refractory classic Hodgkin’s lymphoma (cHL) after two lines or later of systemic chemotherapy, which was first included in the NRDL in 2019, has been successfully renewed this year.
Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated, "Two years ago, sintilimab was the first and only PD-1 inhibitor included in the NRDL. This year, three additional first-line indications for sintilimab have been successfully included in the NRDL, further enhancing the accessibility of this anti-cancer drug and alleviating financial burden for Chinese patients and their families. We have witnessed the profound reform and rapid development of pharmaceutical industry in China, driven by the government’s commitment to continuously support innovation and emphasize a healthier and better life for the people of China. Innovent is honored to be a part of the Chinese government’s initiative to improve health, and are devoted to the deepening of the national health care reform. With our company’s mission ‘to develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people,’ we hope to continue to work together with all relevant parties to improve drug affordability and accessibility, and contribute to the ‘Healthy China 2030’ initiative."

Julio Gay-Ger, President and General Manager, Lilly China, stated, "In recent years, China has continued to intensify medical insurance reform, giving strategic priority to safeguarding people’s health. As a multinational pharmaceutical company tied with China for over 100 years, Lilly always adheres to the philosophy of ‘In China, For China’, and actively participates in China’s health reform, especially in the drug supply system. The indication expansion of sintilimab in the National Reimbursement Drugs List (NRDL) can further reduce the burden of healthcare, enabling the patients to afford innovative drugs and have a higher quality of life through persistent treatment. Lilly will continue to keep a close eye on the major healthcare challenges in China in the future, and play an important role in the country’s ‘all-round and full-cycle health’ ecosystem, to support the accelerated implementation of the ‘Healthy China 2030’ initiatives."

Mr. Min Liu, Chief Commercial Officer of Innovent, stated, "Sintilimab is the only PD-1 inhibitor in China with four major indications (1L nsq NSCLC, 1L sq NSCLC, 1L HCC and cHL) approved and included in China’s NRDL. Particularly, lung cancer and liver cancer are two of the most prevalent tumor types in China, accounting for the first and third largest numbers of new cases each year – representing a large unmet medical need. We will proactively support the work of the government departments at all levels, cooperate with the implementation of medical insurance policies in all regions, and help relieve patients’ economic burden to a further extent, to allow this high-quality immunotherapy product to benefit more lives of Chinese patients and their families."

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab worldwide, to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of unresectable or advanced hepatocellular carcinoma
Additionally, Innovent currently has two regulatory submissions under review in China for sintilimab, for the first-line treatment of esophageal squamous cell carcinoma, and the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

Additionally, three clinical studies of sintilimab have met their primary endpoints:

Phase 2 study as second-line treatment of esophageal squamous cell carcinoma
Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy
Phase 3 study in combination with BYVASDA (bevacizumab biosimilar injection) and chemotherapy (pemetrexed and cisplatin) for EGFR-mutated nonsquamous NSCLC following EGFR-TKI treatment
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.