Innovent Announces Inclusion in the China National Reimbursement Drug List of TYVYT® 's Seventh Indication and BYVASDA®'s Eighth Indication

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Innovent Biologics, Inc. (HKEX: 01801) announces the inclusion of TYVYT® and BYVASDA® in the National Reimbursement Drug List (2023 Version) for the treatment of various cancers, expanding their coverage to benefit a broader range of patients. TYVYT® is the first and only PD-1 inhibitor approved for the treatment of EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer post EGFR-TKI therapy, while BYVASDA® is the only bevacizumab approved for the same indication. This update aligns with Innovent's mission of developing affordable high-quality biopharmaceuticals and supports the 'Healthy China 2030' strategy.

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.

In the updated NDRL, TYVYT® expands its coverage to the seventh new indication for the treatment of patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed after EGFR tyrosine kinase inhibitor (TKI) therapy. Meanwhile, BYVASDA® as a combination medicine with TYVYT® for the same indication, has its eighth indication included in the NRDL. TYVYT® is globally the first and only PD-1 inhibitor approved for this indication, as well as the only PD-1 inhibitor in the NRDL for treating NSCLC post EGFR-TKI therapy. BYVASDA® is also the only bevacizumab approved and in the NRDL for treating NSCLC post EGFR-TKI therapy.

TYVYT® (sintilimab injection) is an innovative PD-1 inhibitor co-developed by Innovent and Eli Lilly 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:

• For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy;
• For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
• For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy (new NRDL indication);
• For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
• For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment;
• For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
• For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

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."

About Sintilimab

Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of 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^[i].

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:

• For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy;
• For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
• For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy;
• For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
• For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment;
• For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
• For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

Besides, two clinical studies of sintilimab have met their primary endpoints:

• Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma;
• Phase 3 study of sintilimab monotherapy as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.

About BYVASDA® (bevacizumab injection)

BYVASDA® (bevacizumab injection) is a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF-A selectively with high affinity and blocks its binding to VEGF-2 receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA® produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. In China, BYVASDA® is approved and included in NRDL for eight indications including non-small cell lung cancer, colorectal cancer, glioblastoma, hepatocellular carcinoma (in combination with atezolizumab) , epithelial ovarian, fallopian tube, or primary peritoneal cancer, cervical cancer, hepatocellular carcinoma (in combination with sintilimab), and EGFR-TKI failed non-small cell lung cancer (in combination with sintilimab).

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules ), FUCASO® (Equecabtagene  Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). Additionally, we have 2 NDA under NMPA review, 5 assets in Phase III or pivotal clinical trials, and 19 more molecules in early clinical stage.

Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer 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.
BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.
TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
HALPRYZA® (rituximab biosimilar injection, Innovent)
SULINNO® (adalimumab biosimilar injection, Innovent)
Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.
CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.
Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer: Innovent does not recommend any off-label usage.

About Eli Lilly and Company

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.

About Eli Lilly and Company's strategic cooperation with Innovent Biologics

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.

Innovent Biologics, Inc. Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

^[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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SOURCE Innovent Biologics

FAQ

What is the latest announcement from Innovent Biologics, Inc. (HKEX: 01801)?

Innovent Biologics, Inc. (HKEX: 01801) announced that TYVYT® and BYVASDA® have been included in the National Reimbursement Drug List (2023 Version) for the treatment of various cancers, expanding their coverage to benefit a broader range of patients.

What is the significance of the inclusion of TYVYT® and BYVASDA® in the National Reimbursement Drug List (NRDL)?

TYVYT® is the first and only PD-1 inhibitor approved for the treatment of EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer post EGFR-TKI therapy, while BYVASDA® is the only bevacizumab approved for the same indication, benefiting a broader range of patients.

What is the mission of Innovent Biologics, Inc. (HKEX: 01801)?

Innovent Biologics, Inc. (HKEX: 01801) is committed to developing affordable high-quality biopharmaceuticals and supporting the 'Healthy China 2030' strategy.

How many indications do TYVYT® and BYVASDA® have in the National Reimbursement Drug List (NRDL)?

TYVYT® has been approved for seven indications, including the first-line treatment of five high-incidence cancer types, while BYVASDA® has been included for the treatment of NSCLC post EGFR-TKI therapy, among others.

Who is the Founder, Chairman, and CEO of Innovent Biologics, Inc. (HKEX: 01801)?

Dr. Michael Yu is the Founder, Chairman, and CEO of Innovent Biologics, Inc. (HKEX: 01801).