Innovent Receives Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) as Monotherapy for Advanced Melanoma

SAN FRANCISCO, U.S. and SUZHOU, China, September, 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, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its PD-1/IL-2α-bias Bispecific Antibody Fusion Protein (R&D code: IBI363), for the treatment of unresectable locally advanced or metastatic melanoma (except choroidal melanoma) who progressed on or after at least one line of systemic therapy, which must include a PD-1/L1 inhibitor. Currently, Phase 1/2 clinical studies are conducting in China, the United States and Australia to explore the efficacy and safety of IBI363 in various advanced malignant tumors. At the ESMO Plenary meeting on June 14, 2024, Innovent reported promising efficacy signals observed in melanoma patients who had previously received immunotherapy: 37 patients with melanoma who had previously received immunotherapy received 1mg/kg of IBI363 and underwent at least one tumor evaluation after baseline, and 11 patients achieved objective responses, including 1 CR and 10 PR, with ORR and DCR of 29.7% and 73.0%, respectively. Dr. Hui Zhou, Senior Vice President of Innovent, said, “Melanoma is the most common fatal skin cancer in Europe and the United States. In China, although melanoma is a rare malignant tumor, the case fatality rate is high, and the incidence is increasing year by year. Despite the success of immune checkpoint inhibitors in the treatment of melanoma, there is currently no drug approved for immunotherapy failed melanoma around the world, and the ORR of traditional chemotherapy ± anti-vascular therapy for immunotherapy failed melanoma is only 3.8% to 6.8%, with a median PFS of less than 3 months, and the benefit is very limited[1]-[2]. Therefore, there is an urgent clinical need for patients who have previously failed immunotherapy. As a First in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363 monotherapy has shown encouraging efficacy and a favorable safety profile in melanoma subjects who have previously received immunotherapy. We will continue to explore the efficacy and safety of IBI363 in melanoma to provide more effective clinical treatment for patients with immune-resistant melanoma.” Fast Track Designation (FTD) is a rapid review process designed to facilitate the clinical development of a drug that may treat serious conditions and fulfill an unmet medical need. According to regulations, drug candidates that obtain FTD qualifications will have more opportunities to communicate with the FDA during subsequent drug development and review processes, which will help speed up the clinical development and approval of the drug. About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) IBI363 is a First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics, which has two functions: blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 was modified to retain its affinity for IL-2Rα, but weakened its binding ability to IL-2Rβ and IL-2Rγ, thereby reducing toxicity. The PD-1 binding arm can simultaneously block PD-1 and selectively deliver IL-2. Since the newly activated tumor specific T cells express both PD-1 and IL-2α, this differential strategy allows for more precise and effective targeting and activation of this T cell subpopulation. IBI363 not only showed good antitumor activity in a variety of tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models. Starting from the urgent clinical needs, Innovent Biologics is conducting clinical studies in China, the United States and Australia to explore the efficacy and safety of IBI363 in advanced tumors. About Melanoma Melanoma is a malignant tumor that develops from melanocytes and is the fifth most common cause of cancer in the United States[3]. Although melanoma accounts for only 3% of all types of skin cancer, it has the highest death rate of all types and is the most likely to metastasize. In China, the incidence and mortality rate of melanoma are also increasing over the years. According to the classification of the disease site, melanoma is mainly divided into skin melanoma, acral and mucosal melanoma. Chinese melanoma differs greatly from European and American Caucasian melanoma in pathogenesis, biological behavior, histological morphology, treatment and prognosis[4]. For advanced cutaneous and acral melanomas, for those carrying BRAF V600 mutation, BRAF inhibitor combined with MEK inhibitor is the preferred molecular targeted therapy. For patients without BRAF V600 mutation, chemotherapy combined with anti-angiogenic drugs can be considered as the first-line treatment. Immunotherapy has not been approved as the first-line treatment indication for advanced melanoma in China. For second-line treatment, therapies that have not been used in the first-line treatment are recommended. For those who have not received PD-1 monoclonal antibody in the first-line treatment, PD-1 monoclonal antibody can be chosen for the second-line treatment. For advanced mucosal melanoma, chemotherapy or PD-1 monoclonal antibody combined with anti-angiogenic drugs can be considered first-line treatment, for those with BRAF V600 mutation, BRAF inhibitor ±MEK inhibitor can be selected. Currently, posterior treatment options for melanoma are very limited[5]. 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 diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 11 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 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. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). 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. Innovent 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 Innovent 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 Innovent'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, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent 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 materialize or turn out to be incorrect. Contact: Media: [email protected] +86 512-6956 6088 Investors: [email protected] +86 512-6956 6088 References: [1] Wang X, Xu W, Chi Z, et al. Chemotherapy combined with antiangiogenic drugs as salvage therapy in advanced melanoma patients progressing on PD-1 immunotherapy. Transl Oncol. 2021;14(1):100949. [2] European Journal of Cancer 162 (2022) 22e33； [3] National Cancer Institute Melanoma of the Skin-Cancer Stat Facts: https://seer.cancer.gov/statfacts/html/melan.html. [4] Melanoma Diagnosis and Treatment (2022). [5] Chinese Society of Clinical Oncology (CSCO) Melanoma Diagnosis and Treatment Guidelines (2022).

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