Innovent Announces Inclusion in the China National Reimbursement Drug List (NRDL) of TYVYT in Two New Indications, Olverembatinib for the First Listing, BYVASDA, HALPRYZA and SULINNO in Multiple New Indications

ROCKVILLE, Md. and SUZHOU, China, Jan. 18, 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, autoimmune, metabolic, ophthalmology and other major diseases, today announced that, five products (including new indications) of the company have been included in the updated National Reimbursement Drug List (2022 Version) ("NRDL"). This includes: two additional indications of PD-1 inhibitor TYVYT^® (sintilimab injection) were included (negotiation list); olverembatinib was included for the first time (negotiation list); multiple additional indications of BYVASDA^® (bevacizumab injection), HALPRYZA^® (rituximab injection), and SULINNO^® (adalimumab injection) were included (general list). The updated NRDL will officially take effect on March 1^st, 2023.

This time, TYVYT^® has been included in the NRDL for two additional indications including gastric cancer and esophageal cancer. TYVYT^® is the first and the only PD-1 inhibitor for gastric cancer in the NRDL, as well as the only PD-1 inhibitor for the first-line treatment of five high-incidence cancer types in the NRDL. Olverembatinib, as an exclusive third generation BCR-ABL inhibitor, has been included in the NRDL for the first time, filling the gap in the treatment of chronic myeloid leukemia (CML) patients harboring the T315I mutation. In addition, all the new indications of BYVASDA^®, HALPRYZA^® and SULINNO^® have been included in the updated NRDL this year, expanding the reimbursement coverage and benefiting broader patient groups.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "Over recent years, China government has been persistently promoting the reform of healthcare system for the healthier and better life of people in China, and has achieved conspicuous success. Against such a backdrop and our company's mission of 'developing high-quality biopharmaceuticals that are affordable to ordinary people', Innovent has been highly responsive to China's drug policy and reform. In merely three years, we are pleased that our company has five products being included in the NRDL and keeps expanding the scope of our drugs' indications. We hope to continue to work together with the government to improve drug affordability and accessibility, and bring more high-quality drugs to patients and their families."

New Products and Indications Included in the Updated NRDL

TYVYT^®: the only PD-1 inhibitor for the first-line treatment of five high-incidence cancer types included in the NRDL

TYVYT^® (sintilimab injection): an innovative PD-1 inhibitor co-developed by Innovent and Eli Lilly and Company. Six indications of TYVYT^® for the treatment of lung cancer, liver cancer, gastric cancer, esophageal cancer, Hodgkin's lymphoma, etc. have been approved and included in the NRDL^[1][i]. In particular, two additional indications of TYVYT^® for the treatment of gastric cancer and the treatment of esophageal cancer have been included in the NRDL for the first time, further enhancing the accessibility of this novel immunotherapy to a wider group of cancer patients. TYVYT^® is the first and the only PD-1 inhibitor for gastric cancer in the NRDL, as well as the only PD-1 inhibitor for the first-line treatment of five high-incidence cancer types (non-squamous non-small cell lung cancer, squamous non-small cell lung cancer, liver cancer, gastric cancer, esophageal cancer) in the NRDL.

The updated NRDL reimbursement scope of TYVYT^® (sintilimab injection) include:

• For the treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
• For the treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
• For the 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 unresectable locally advanced or metastatic squamous non-small cell lung cancer;
• For the treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment;
• For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy.

Olverembatinib: initial listing in the NRDL of the exclusive third generation BCR-ABL inhibitor in China

Olverembatinib: an innovative third generation BCR-ABL inhibitor co-commercialized by Innovent and Ascentage Pharma. Olverembatinib has been included in the NRDL for the first time for adult patients with T315I-mutant chronic-phase chronic myeloid leukemia (CML-CP) and accelerated-phase chronic myeloid leukemia (CML-AP).

The introduction of BCR-ABL tyrosine kinase inhibitors (TKIs) has significantly improved the clinical practice and management of CML, allowing treatment-compliant patients to achieve long-term survival. However, acquired resistance to TKIs remains a major challenge in the treatment of CML. Patients with CML harboring the T315I mutation are resistant to all current first and second generation BCR-ABL inhibitors. Olverembatinib, as the only approved third generation BCR-ABL inhibitor in China and the only therapy for CML harboring the T315I mutation, has been included in the NRDL. This fulfills the treatment gap in T315I-mutant CML, and further improves the accessibility and affordability of the medicine.

Inclusion of New Indications for Three Antibody Drugs in the NRDL 

Several new indications of three antibody drugs, i.e. BYVASDA^® (bevacizumab injection), HALPRYZA^® (rituximab injection) and SULINNO^® (adalimumab injection), have been included in the NRDL, which will benefit a broader group of cancer patients and patients with autoimmune diseases. Details are as follows:

BYVASDA^® (bevacizumab injection):

• A total of seven indications have been approved and included in the NRDL (including three new indications) for the treatment of non-small cell lung cancer, colorectal cancer, glioblastoma, hepatocellular carcinomas (in combination with Atezolizumab), epithelial ovarian, fallopian tube or primary peritoneal cancer (new indication), cervical cancer (new indication), and hepatocellular carcinomas as a new drug (new indication, in combination with sintilimab).

HALPRYZA^® (rituximab injection):

• HALPRYZA^® is newly included in the NRDL for the maintenance therapy for previously untreated follicular lymphoma and the treatment of chronic lymphocytic leukemia. HALPRYZA^® has been approved in China for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia, all of which are included in the NRDL.

SULINNO^® (adalimumab injection): 

• A total of eight approved indications (including two new indications) have been included in the NRDL for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriasis, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, crohn's disease (new indication) and pediatric crohn's disease (new indication).

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^[ii]. Innovent is currently conducting more than 20 clinical studies of sintilimab 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 six indications. Approved indications of sintilimab include:

• For 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 unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
• In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
• In combination with bevacizumab for the first-line treatment of unresectable locally advanced or metastatic hepatocellular carcinoma;
• In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
• In combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

Innovent currently has the regulatory submission for sintilimab in combination with bevacizumab biosimilar and chemotherapy for EGFR-TKI failed EGFR-mutated non-squamous NSCLC under review in the China's NMPA.

Additionally, 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 Olverembatinib

Developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing Program in China, the orally active, third-generation BCR-ABL inhibitor olverembatinib is the first China-approved third-generation BCR-ABL inhibitor targeting drug-resistant CML. Olverembatinib can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation.

In November 2021, olverembatinib was approved by the NMPA of China for the treatment of adult patients with TKI-resistant CML-CP or CML-AP harboring the T315I mutation as confirmed by a validated diagnostic test. In March 2021, it was granted the Breakthrough Therapy designation by the CDE for the treatment of patients with CML-CP who are resistant and/or intolerant of first- and second-generation TKIs.

In July 2021, Innovent and Ascentage Pharma (6855.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China.

About BYVASDA^® (bevacizumab injection)

BYVASDA^® is a bevacizumab biosimilar and 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 seven indications including advanced non-small cell lung cancer, metastatic colorectal cancer, adult recurrent glioblastoma, advanced or unresectable hepatocellular carcinoma, epithelial ovarian, fallopian tube, or primary peritoneal cancer and cervical cancer.

About HALPRYZA^® (rituximab injection)

HALPRYZA^® is rituximab biosimilar injection and a recombinant human/murine chimeric monoclonal antibody drug. Rituximab binds to the CD20 antigen on the surface of B lymphocytes and mediates complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC). Normal and malignant B cells are targeted for destruction by the antibody, thereby achieving anti-tumor and immunosuppressive therapeutic effects^[iii]. In China, HALPRYZA^® has been approved and included in the NRDL for the treatment of various subtypes of non-Hodgkin's lymphoma and chronic lymphocytic leukemia.

About SULINNO^® (adalimumab injection)

SULINNO^® is an adalimumab biosimilar and a fully humanized recombinant human anti-TNF-α monoclonal antibody. TNF, a proinflammatory cytokine mainly produced by activated macrophages, natural killer cells and T lymphocytes, is involved in inflammatory and immune responses. Anti-TNF-α antibody can bind to human TNF-α monomer or trimer, subsequently block the binding of TNF-α to the cellular surface receptor, p55 and p75, and neutralize the cytotoxic effect of TNF-α, ultimately resulting in the inhibition of the release of TNF-α mediated inflammatory factors and cytokines, the adhesion and infiltration of inflammatory cells, the proliferation of fibroblasts and the activation of osteoclasts. In China, SULINNO^® had been approved and included in NRDL for the treatment of eight indications including rheumatoid arthritis, ankylosing spondylitis, psoriasis, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, crohn's disease and pediatric crohn's disease.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 36 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT^® (sintilimab injection), BYVASDA^® (bevacizumab biosimilar injection), SULINNO^® (adalimumab biosimilar injection), HALPRYZA^® (rituximab biosimilar injection) , Pemazyre^® (pemigatinib oral inhibitor), olverembatinib (BCR-ABL TKI) , Cyramza^® (ramucirumab) and Retsevmo^® (selpercatinib). An additional 3 assets are under NMPA NDA review, 5 assets are in Phase 3 or pivotal clinical trials, and 20 more molecules are in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

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 www.lilly.com and http://newsroom.lilly.com/social-channels.

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.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.

Note:

TYVYT^® (sintilimab injection) is not an approved product in the United States.

BYVASDA^®, SULINNO^®, and HALPRYZA^® are not approved products in the United States.

TYVYT^® (sintilimab injection, Innovent)

BYVASDA^® (bevacizumab injection, Innovent)

HALPRYZA^® (rituximab injection, Innovent)

SULINNO^® (adalimumab 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.

Selpercatinib (Eli Lilly). Selpercatinib was discovered by Eli Lilly and licensed to Innovent for commercialization 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.

SOURCE Innovent Biologics