Innovent Biologics and Lilly Strengthen Strategic Collaboration in Oncology with Exclusive Commercialization Rights for CYRAMZA® and Retsevmo® in China

SAN FRANCISCO, Indianapolis and SUZHOU, China, March 28, 2022 /PRNewswire/ -- Innovent Bio (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative medicines for the treatment of major diseases such as oncology, metabolic disorders, and autoimmune diseases, announced today with Eli Lilly and Company (NYSE: LLY) that, driven by their shared vision of making innovative medicines accessible to more patients in China and leveraging their respective strengths for mutual benefit, both parties will deepen their strategic collaboration and have reached an agreement on the following terms:

i)    Innovent Bio obtains the rights to import, sell, promote, and distribute Cyramza in mainland China.^®(Ramucirumab) and Retsevmo^®(Seputini) exclusive commercial rights after approval, and;

ii) Grant Innovent Bio the right of first negotiation for the future commercialization rights of Pirtobrutinib in China.

Cyramza^®(Ramucirumab) is the first treatment regimen approved by the U.S. Food and Drug Administration (FDA) for patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma after chemotherapy, and it is also the first biomarker-driven therapy approved by the FDA for patients with advanced hepatocellular carcinoma (HCC). In China, the National Medical Products Administration (NMPA) approved Cyramza in March 2022.^®(Ramucirumab) in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma who have experienced disease progression during or after fluoropyrimidine- or platinum-containing chemotherapy, has become the first and only targeted drug approved in China for second-line treatment of advanced gastric cancer, and was accepted in September 2021 as Cyramza.^®(Ramucirumab) New indication marketing application as a second-line therapy for hepatocellular carcinoma patients with alpha-fetoprotein (AFP) ≥400ng/ml who have previously received sorafenib treatment. Gastric cancer and liver cancer are the third and fifth most common cancers in China, with approximately 900,000 new cases annually. Most patients experience disease progression after existing first-line treatments, indicating an unmet need for advanced-stage therapies. Cyramza^®(Ramucirumab) can provide more treatment options for these patients.

Retsevmo^®(Selpercatinib) is a highly selective and potent rearranged during transfection (RET) inhibitor, and it is the first FDA-approved therapy (brand name Retevmo) specifically for treating adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), adult and pediatric patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and patients with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if appropriate). In China, the NMPA accepted Retsevmo in August 2021.^®(Selpercatinib) for the above-mentioned indications has been granted a priority review status for its new drug application.

According to the agreement, Innovent Bio owns Cyramza.^®(Ramucirumab) and Retsevmo^®Innovent Bio has obtained the exclusive commercialization rights for (Selpercatinib) in China. Innovent Bio will be fully responsible for the pricing, importation, marketing, distribution, and sales promotion of these two products. As the oncology pipeline portfolio expands further, Innovent Bio aims to provide these new treatment options to cancer patients in China by leveraging its experienced oncology commercialization team and extensive commercial coverage across all levels of hospitals and pharmacies.

In addition, Eli Lilly has granted Innovent Bio the right of first negotiation for the future commercialization rights of Pirtobrutinib in China. Pirtobrutinib is an investigational oral, highly selective, non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor. Currently, Eli Lilly is conducting multiple global Phase 3 clinical trials of Pirtobrutinib, including treatments for patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL).

According to the agreement arrangements, pending Ceralasertib^®(Ramucirumab) Hepatocellular Carcinoma Indication and Retsevmo^®After the approval and registration of the non-small cell lung cancer indication for (Selpercatinib), Innovent Bio will pay Eli Lilly a total of 45 million US dollars as an upfront payment. Innovent Bio will proceed with Cerena Zee...^®(Ramucirumab) and Retsevmo^®(Selpercatinib) is responsible for sales in China after approval.

Founder, Chairman andCEODr. Dechao YuRepresentation：“Based on the long-term strategic partnership between the two parties, we are pleased to reach this agreement, which includes the exclusive commercialization of two new late-stage products in China and an innovative reversible (non-covalent) BTK.InhibitorThe priority negotiation right for commercialization. Innovent Bio has more than 20 products in clinical stages.ResearchA robust pipeline of anti-tumor products at different stages, a leading clinical development and registration professional team in the industry, extensive commercial channel coverage, and a commercialization team of over 3,000 people. Together with Eli Lilly, we successfully launched and marketed Tyvyt in China.^®(Sintilimab) and Dabohua^®(Rituximab biosimilar). The two differentiated products from this commercial collaboration further expand our oncology portfolio, with the potential to reach seven commercialized products within this year. This enables us to provide patients with comprehensive solutions that have strong combinational synergistic effects, and strengthen our advantages in major cancer types (including non-small cell lung cancer, gastric cancer, and liver cancer) as well as hematological malignancies. Through the joint efforts of Innovent Bio and Eli Lilly, we hope these new treatment options can soon benefit more cancer patients in China.

Mr. Jiri Wen, President and General Manager of Eli Lilly ChinaEli Lilly stated: "We are very pleased to reach this agreement with our long-term partner, Innovent Bio. The field of oncology is one of Eli Lilly's core therapeutic areas globally. Over the past few years, our collaboration has yielded fruitful results in the oncology field. We firmly believe that through this agreement, Innovent Bio has the potential to bring Eli Lilly's innovative drugs to more Chinese patients with gastric and lung cancer, helping them improve their quality of life, and further contributing to the realization of the 'Healthy China 2030' goals."

About Cyramza^®(Ramucirumab)

Ramucirumab is a fully human IgG1 monoclonal antibody that specifically binds to VEGFR-2, efficiently blocking the binding of VEGF-A to VEGFR-2, and is also capable of inhibiting the binding of VEGF-C and VEGF-D to VEGFR-2. The establishment of ramucirumab's therapeutic role in advanced gastric cancer patients is primarily based on two Phase III randomized trials: the REGARD study and the RAINBOW study.

In recent years, studies have shown that the anti-vascular endothelial growth factor (VEGF) pathway is an important signaling pathway involved in tumor angiogenesis. Targeted therapies for gastric cancer have made numerous attempts targeting this pathway. Based on current research findings, drugs targeting the VEGF pathway can provide survival benefits to patients and represent a promising treatment option for advanced gastric cancer.

AboutRetsevmo^®(Selpercatinib)

Retsevmo^®(Retsevmo, previously known as LOXO-292) is a selective and potent RET kinase inhibitor.^®(Retsevmo) may affect both tumor cells and healthy cells, which may lead to side effects. Retsevmo^®(Selpercatinib) is an oral prescription medication approved by the U.S. FDA. Based on body weight (<50 kg or ≥50 kg), it is taken twice daily until disease progression or unacceptable toxicity occurs. Continued approval may depend on clinical benefit demonstrated in confirmatory trials.

Genetic alterations in RET kinase, including fusions and activating point mutations, lead to overactive and uncontrolled RET signaling and cell growth. RET fusions account for approximately 2% of NSCLC, 10-20% of papillary thyroid carcinoma, Hurthle cell carcinoma, anaplastic carcinoma, and poorly differentiated carcinoma. Activating RET mutations account for approximately 60% of sporadic MTC and 90% of germline MTC. RET fusion-positive cancers and RET-mutant MTC primarily rely on this single activated kinase for proliferation and survival. This dependency, often referred to as "oncogene addiction," renders these tumors highly sensitive to small molecule inhibitors targeting RET.

About the Strategic Cooperation between Innovent Bio and Eli Lilly and Company 

Innovent Bio and Eli Lilly and Company reached a biotechnology drug development collaboration in March 2015, which is also one of the largest collaborations between a Chinese biopharmaceutical company and a multinational pharmaceutical company to date. According to the collaboration terms, Innovent Bio and Eli Lilly and Company will jointly develop and commercialize products including Tyvyt in China.^®(Inclisiran Injection) among other oncology drugs. In October 2015, the two parties announced a further expansion of their established drug development collaboration by adding three novel antibody therapies for cancer treatment. In August 2019, the collaboration was extended to the diabetes field, with INNOVENT BIOLOGICS(SUZHOU)CO LTD gaining the rights to develop and commercialize one of Eli Lilly and Company’s potential global best-in-class clinical-stage diabetes drugs in China. These three collaborations with Eli Lilly and Company signify that INNOVENT BIO has established a comprehensive strategic partnership between a Chinese innovative pharmaceutical company and a global pharmaceutical giant. The scope of this partnership covers new drug research and development, clinical studies, production quality, and market sales. In August 2020, INNOVENT BIO and Eli Lilly and Company announced an expansion of their strategic collaboration on Inclisiran. INNOVENT BIO granted Eli Lilly the exclusive license for Inclisiran outside of China, and Eli Lilly will focus on bringing Inclisiran to North America, Europe, and other regions.This is the fifth collaboration between the two parties, further deepening Innovent Bio and Eli Lilly's strategic partnership in the field of oncology.

About Innovent Bio

"Start with trust, achieve through action." Developing high-quality biologics that are affordable for the general public is the ideal and goal of Innovent Bio. Founded in 2011, Innovent Bio is committed to the development, production, and sales of innovative drugs for the treatment of major diseases such as cancer, metabolic disorders, and autoimmune conditions. On October 31, 2018, INNOVENT BIOLOGICS(SUZHOU)CO LTD was listed on the Main Board of the Hong Kong Stock Exchange Limited, stock code: 01801.

Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and internationalized operating model. It has built a product chain comprising 32 new drug varieties, covering multiple disease areas such as oncology, metabolic diseases, and autoimmune diseases, among which seven varieties have been selected for the national "Major New Drug Creation" project. The company already has seven products (Sintilimab Injection, trade name: Tyvyt).^®, English trademark: TYVYT^®; Bevacizumab biosimilar, trade name: Da You Tong^®, English trademark: BYVASDA^®; Adalimumab biosimilar, brand name: SULIXIN^®, English trademark: SULINNO^®; Rituximab biosimilar, brand name: Dabohua^®, English trademark: HALPRYZA^®; pemigatinib oral inhibitor, brand name: Pemazyre^®, English trademark: PEMAZYRE^®; Orelabrutinib, Trade Name: Nulast^®；Ramucirumab, Trade Name: Cyramza^®, English trademark: CYRAMZA^®) has been approved for marketing, one variety is under NMPA review, five new drug molecules have entered Phase III or pivotal clinical trials, and another 19 new drug varieties have entered clinical trials.

Innovent Bio has assembled a team of top-tier biopharmaceutical development and industrialization talents with international advanced levels, including numerous overseas returnee experts, and has established strategic partnerships with international collaborators such as Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, and Hanmi from South Korea. Innovent Bio hopes to work together with everyone to enhance the development level of China's biopharmaceutical industry, in order to meet the public's access to medicines and their aspirations for life and health.

For more details, please visit the company website:www.innoventbio.comOr the company's LinkedIn account: Innovent Biologics.

Statement:

About Eli Lilly and Company

Eli Lilly and Company is a global leading pharmaceutical company dedicated to improving human health through innovation. Eli Lilly and Company was born more than a century ago, with its founder committed to producing high-quality medicines to meet real medical needs. Today, we remain steadfast in this mission and continue our work based on it. Globally, our employees consistently strive to develop drugs that can make a difference in people’s lives and provide them to patients in genuine need. Moreover, we are also committed to enhancing public understanding of diseases and improving disease management. At the same time, we give back to society by engaging in charitable activities and volunteering. For more information about Eli Lilly and Company, please visit:www.lilly.com。

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