SAN FRANCISCO and INDIANAPOLIS and SUZHOU, China, March 27, 2022 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ("Lilly", NYSE: LLY) today announced that in light of both parties' shared commitment to continue bringing innovative medicines to benefit Chinese patients and to leverage the strengths of each party in a win-win manner, parties will now expand the strategic partnership through:

i) an agreement for Innovent to obtain the sole commercialization rights to import, market, promote, distribute and detail Cyramza® (ramucirumab) and Retsevmo® (selpercatinib) once approved in Mainland China, andii) a right of first negotiation granted to Innovent for potential future commercialization of Pirtobrutinib in Mainland China.

Cyramza® (ramucirumab) was the first U.S. Food and Drug Administration (FDA) approved treatment for patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior chemotherapy and the first FDA approved biomarker-driven therapy in patients with advanced hepatocellular carcinoma (HCC). In China, Cyramza® (ramucirumab) in combination with paclitaxel was approved by National Medical Products Administration (NMPA) for second-line treatment in patients with advanced or metastatic GEJ adenocarcinoma in March 2022, making it the first and only drug approved for the second-line treatment of advanced gastric cancer in China. The New Drug Application (NDA) for Cyramza® (ramucirumab) as second-line treatment in patients with HCC with baseline alpha-fetoprotein (AFP) ≥400ng/mL following first-line sorafenib was accepted by NMPA in September 2021. Gastric cancer and liver cancer are the third and fifth largest cancers in terms of incidence with a total of approximately 900,000 new cases yearly in China. Most of the patients experience disease progression on or after first-line treatment. There is an unmet medical need for new treatment options to improve outcomes in these patients.

Retsevmo® (selpercatinib) is a highly selective and potent rearranged during transfection (RET) inhibitor. It was approved by FDA, under the brand name Retevmo, as the first therapy specifically indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and  who are radioactive iodine-refractory (if radioactive iodine is appropriate). In China, the NDA for Retsevmo® (selpercatinib) for the above indications was accepted by NMPA and granted priority review in August 2021.

According to the agreement, Innovent has the sole commercialization rights for both Cyramza® and Retsevmo®, once approved in China, of which Innovent will be fully responsible for the pricing, importation, marketing, distribution and detailing of these two products. With a further expanded oncology product portfolio, Innovent intends to use its experienced oncology commercial team to leverage its broad commercial coverage in hospitals and pharmacies at various tiers to make these novel treatment options available to cancer patients in China.

In addition, Lilly has granted a right of first negotiation to Innovent for the potential future commercialization of pirtobrutinib in China. Pirtobrutinib is an investigational, oral, highly selective, non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor being studied globally for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL).

Under the terms of the agreement, upon regulatory approvals of Cyramza® in the hepatocellular carcinoma indication and Retsevmo® in the non-small lung cancer indication, Innovent will make payments of US$45 million in total and then intends to commercialize Cyramza® and Retsevmo® in China.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated, "With our long-term strategic partnership with Lilly as a strong foundation, we are excited to further expand our productive relationship through this agreement. Innovent has built up a robust oncology pipeline of over 20 clinical stage assets, an industry-leading medical operations and regulatory affairs team, a broad commercial channel and a professional commercial team of about 3,000 people. Lilly and Innovent have jointly launched and marketed TYVYT® (sintilimab) and HALPRYZA® (rituximab biosimilar) successfully in China. The addition of Cyramza® and Retsevmo®, two potential differentiated products, will potentially further expand our oncology portfolio to seven commercialized products by this year, enabling us to provide integrated patient solutions with strong portfolio synergies while enhancing our franchise in large cancer indications including NSCLC, GC and HCC, and potentially in hematological malignancies as well. With Innovent and Lilly's joint commitment and effort, we hope to make these new treatment options available to benefit more cancer patients in China as soon as possible."

Julio Gay-Ger, President and General Manager of Lilly China, said, "We are very proud of this agreement with Innovent, which is a key long-term strategic partner in China. Oncology is one of Lilly's core therapeutic areas globally, in which the partnership between the two parties has seen rich fruits in the past several years. We are very confident that through this agreement, Innovent can bring forward Lilly's innovative medicines to potentially be able to benefit Chinese patients with gastric cancer and lung cancer, helping them live better lives and help realize the 'Healthy China 2030'goals."

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, metabolic 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 32 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 7 products approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor), olverembatinib (BCR ABL TKI) and Cyramza® (ramucirumab),  1 asset under NMPA NDA review, 5 assets in Phase 3 or pivotal clinical trials, and an additional 19 molecules 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, Adimab, Incyte, MD Anderson Cancer Center, Hanmi 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 intoa 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, whereby Lilly obtained an exclusive license for sintilimab for geographies outside of China and plans to pursue registration of sintilimab in the U.S. and other geographies outside of China. In March 2022, Lilly and Innovent entered into the fifth agreement to expand strategic partnership in oncology.

About Cyramza® (ramucirumab)

In the U.S., CYRAMZA (ramucirumab) has five FDA approvals to treat four different types of cancers. CYRAMZA is being investigated in a broad global development program that has enrolled more than 15,000 patients across more than 110 trials worldwide. These include several studies investigating CYRAMZA in combination with other anti-cancer therapies for the treatment of multiple tumor types.

CYRAMZA is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that binds specifically to VEGFR-2, thereby blocking the binding of the receptor ligands (VEGF-A, VEGF-C, and VEGF-D) – which may slow tumor growth. CYRAMZA inhibited angiogenesis in an in vivo animal model.

U.S. INDICATIONS FOR CYRAMZA

Gastric Cancer

CYRAMZA, as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Non-Small Cell Lung Cancer

CYRAMZA, in combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.

CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.

Colorectal Cancer

CYRAMZA, in combination with FOLFIRI (irinotecan, folinic acid, and fluorouracil), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

Hepatocellular Carcinoma

CYRAMZA, as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.

About Re(t)sevmo® (selpercatinib)

Retsevmo (selpercatinib, formerly known as LOXO-292) is a selective and potent RET kinase inhibitor. Retsevmo may affect both tumor cells and healthy cells, which can result in side effects. In the U.S., Retevmo is an U.S. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (