Innovent and ImmVirX Enter into Clinical Trial Collaboration to Investigate the Combination of IVX037 and Sintilimab in Difficult-to-treat Cancers

ROCKVILLE, M.D. and SUZHOU, China, February 21，2024 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that it has entered into a clinical trial collaboration and supply agreement with ImmVirX Pty Limited (“ImmVirX”) to evaluate the combination therapy of ImmVirX’s investigational oncolytic virus IVX037 with Innovent’s TYVYT® (sintilimab injection), the Chinese market-leading anti-PD-1 inhibitor. ImmVirX is conducting a first-in-human Phase 1 clinical trial (NCT05427487) of intratumoral IVX037 in Australia. Initial results from Part 1a of the trial indicate that multiple injections of IVX037 have been well tolerated and show early signs of inducing potentially beneficial inflammatory cytokines/chemokines, such as CXCL10, with antitumor activity observed in the injected lesions of some subjects. Part 1b of the trial, set to begin in mid-2024, evaluates the anticancer activity and tolerability of intratumorally administered IVX037 in combination with intravenously injected sintilimab in patients with advanced colorectal, ovarian and gastric cancer. Approximately 45 patients will be enrolled. Under the collaboration agreement, Innovent will provide clinical drug supplies of TYVYT® (sintilimab injection) in this multi-center trial in Australia. Dr. Hui Zhou, Senior Vice President of Innovent, stated: “We believe that there may be potential benefits in combining IVX037 with our anti-PD-1 therapy, TYVYT® (sintilimab injection), because they play complementary roles in mobilizing the immune system to fight cancer. We are pleased to be collaborating with ImmVirX and look forward to seeing encouraging results from this study.” Dr. Malcolm McColl, CEO and Co-Founder of ImmVirX, stated: “We are excited to collaborate with Innovent on this clinical trial to explore the combination of IVX037, our receptor targeted oncolytic virotherapy, with the checkpoint inhibitor TYVYT® (sintilimab injection) in hard-to-treat cancers. We are pleased to have this opportunity to work with a leader in the global oncology field to evaluate the potential synergy of these two immunotherapies in very common cancer types. We believe the cancer killing and immune stimulating activity of IVX037 when used in combination with checkpoint inhibitors has the potential to drive meaningful responses in cancer types that are generally refractory to checkpoint inhibitor monotherapy.” About IVX037 IVX037 is a proprietary oncolytic RNA virus that has been bio-selected to target receptors overexpressed on cancer cells. It is able to target, infect, replicate in and subsequently kill tumor cells, leading to the potential generation of both innate and adaptive immune responses against cancer. The clinical goal is to use IVX037 to enhance the rate, depth and durability of response to immune checkpoints as a therapy with the following characteristics: Highly inflames “cold” tumor types with current low responsiveness to immune checkpoint therapy; Triggers both innate and adaptive immune responses; Infiltrates tumors with immune cells at a high rate; Activates immune stimulating genes to create synergy with immune checkpoint and CAR-T therapies; Favorable safety profile for patients; Off the shelf therapy / no need for personalization. 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. In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for seven indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: 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. In addition, 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 Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable illnesses. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 20 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, “Start with Integrity, Succeed through Action,” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn. Note: TYVYT® (sintilimab injection), 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 ImmVirX ImmVirX is developing novel oncolytic viruses to create powerful new cancer immunotherapy combinations. The first virus is in clinical studies with further agents in pre-clinical development. Its novel oncolytic immunotherapy harnesses the power of viruses to preferentially infect and kill cancer cells and induce local and systemic anti-tumor immune responses. The proprietary bio-selection platform enables the development of RNA viruses targeting specific receptor proteins highly expressed on a range of cancer cell types, allowing them to selectively enter, replicate in, and destroy tumor cells while creating beneficial changes in the tumor micro-environment, potentially leading to the generation of specific innate and adaptive immune responses against cancer cells. In this way, the viral candidates are intended to increase the effectiveness of current immunotherapies, primarily immune checkpoint inhibitors and CAR-T cell therapies, in fighting cancers of high unmet need including colorectal, gastric, ovarian and liver cancer. Forward-looking statement 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 Biologics (“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. Contact Innovent Biologics Media： E-mail：[email protected] Tel：+86 512-69566088 Investors： E-mail：[email protected] Tel：+86 512-69566088 ImmVirX Dr. Malcolm McColl Chief Executive Officer, Acting Chairman and Co-Founder E-mail: [email protected]

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