Apatinib Mesylate

Global licensing agreement grants Elevar Therapeutics worldwide rights to develop and commercialize lirafugratinib (RLY-4008) Lirafugratinib is a potential best-in-class FGFR2 inhibitor that has shown differentiated efficacy in FGFR2-driven cholangiocarcinoma and demonstrated durable responses across multiple other types of FGFR2-altered solid tumors Relay Therapeutics has potential to receive up to $500 million in upfront, regulatory and commercial milestone payments, including $75 million in upfront and regulatory milestones, plus up to double digit royalties on global sales CAMBRIDGE, Mass. and FORT LEE, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, and Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and fully integrated biopharmaceutical company dedicated to elevating treatment outcomes for patients who have limited or inadequate therapeutic options, today announced an exclusive global licensing agreement for lirafugratinib (RLY-4008). Lirafugratinib is a selective oral small molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2) that is being developed for patients with FGFR2-driven cholangiocarcinoma (CCA) and other FGFR2-altered solid tumors. The announcement of the partnership follows Relay’s recent positive FDA interaction and previously reported differentiated data in cholangiocarcinoma and data across other solid tumors. “Data to-date show that lirafugratinib has the potential to be an important novel medicine for patients with FGFR2-driven cholangiocarcinoma and other FGFR2-altered solid tumors. We are pleased that Elevar will continue its development and leverage their growing commercial capabilities to bring it to patients in need around the world,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “As a result of this agreement, we are able to remain fully focused on continuing to advance our PI3Kα programs, including initiating the RLY-2608 2L breast cancer pivotal trial and vascular malformations trial next year.” “Lirafugratinib is an NDA-ready therapy that has shown a potential best-in-class profile in both FGFR2-driven cholangiocarcinoma and in other FGFR2-altered solid tumors including in advanced stages where treatment options are limited,” said Saeho Chong, Ph.D., chief executive officer of Elevar Therapeutics. “We are excited to diversify and expand our late-stage oncology pipeline with lirafugratinib, which is a strong strategic fit with our existing oncology portfolio and provides another opportunity to advance our mission of bringing life-changing medicines to cancer patients worldwide.” Lirafugratinib was granted breakthrough therapy designation and orphan drug designation by the FDA. Lirafugratinib is being investigated in the global ReFocus trial in patients with FGFR2-altered tumors. The study includes a pivotal cohort in patients with FGFR2-fusion CCA that was designed to support accelerated approval and is fully enrolled. Interim data from this cohort were presented at the European Society for Medical Oncology Congress in 2022. The study also includes cohorts in patients with other types of solid tumors, including gastric, pancreatic, and head and neck tumors. Interim data from these cohorts were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in 2023 and 2024. Earlier in 2024, Relay Therapeutics met with the U.S. Food and Drug Administration (FDA) to discuss data from the ReFocus trial and potential regulatory pathways. The FDA recommended that the company first file an NDA for FGFR2-driven CCA, followed by a supplemental NDA for FGFR2-altered other solid tumors with data from an expanded cohort of patients. Cholangiocarcinoma (CCA) or bile duct cancer is a rare disease in which malignant cells form in the bile ducts. Approximately 8,000 people in the United States are diagnosed with CCA each year. Terms of the Agreement Under the terms of the agreement, Elevar will be granted global development and commercialization rights for lirafugratinib. Elevar will assume full responsibility for all further development activities, including submission of the NDAs, all subsequent clinical development, and global commercialization for FGFR2-driven CCA and FGFR2-altered other solid tumors. Relay Therapeutics is eligible to receive up to $75 million in upfront and regulatory milestones, plus up to $425 million in potential commercial milestone payments, as well as tiered royalties up to the low-teens percentage. Moelis & Company LLC is serving as exclusive financial advisor to Relay Therapeutics in the transaction. Goodwin Procter LLP is serving as exclusive legal advisor to Relay Therapeutics in the transaction. About Lirafugratinib Lirafugratinib (RLY-4008) is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, lirafugratinib demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models with minimal inhibition of other targets, including other members of the FGFR family. In addition, lirafugratinib demonstrated strong activity against known clinical on-target resistance mutations in cellular and in vivo preclinical models. Lirafugratinib is currently being evaluated in a clinical trial in patients with advanced or metastatic FGFR2-altered solid tumors with a single arm, potentially registration-enabling cohort for FGFRi-naïve FGFR2-fusion CCA. To learn more about the clinical trial of lirafugratinib, please visit here. About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies with the goal of bringing life-changing therapies to patients. As the first of a new breed of biotech created at the intersection of complementary techniques and technologies, Relay Therapeutics aims to push the boundaries of what’s possible in drug discovery. Its Dynamo® platform integrates an array of leading-edge computational and experimental approaches designed to drug protein targets that have previously been intractable or inadequately addressed. Relay Therapeutics’ initial focus is on enhancing small molecule therapeutic discovery in targeted oncology and genetic disease indications. For more information, please visit www.relaytx.com or follow us on Twitter. About Elevar Therapeutics Elevar Therapeutics, Inc. is a fully integrated biopharmaceutical company built on the promise of elevating treatment outcomes for patients who have limited or inadequate therapeutic options. With expertise rooted in oncology, Elevar is focused on identifying and developing promising medicines for complex yet under-treated health conditions. Elevar’s lead proprietary drug candidate is rivoceranib. The NDA for rivoceranib in combination with camrelizumab as a therapy for advanced or metastatic hepatocellular carcinoma (HCC) is currently under review by the FDA with a PDUFA action date scheduled for March 20, 2025. Additional information is available at Press Releases - Elevar Therapeutics. About HLB Group The HLB Group is comprised of HLB Inc. (KOSDAQ:028300) and its affiliates with a diverse portfolio across biopharma, lifestyle, marine business, semiconductor and energy, united by the mission of improving all aspects of human life. Members of the HLB Group include HLB Innovation (KOSDAQ: 024850), HLB BioStep (KOSDAQ:278650), HLB Pharmaceutical (KOSDAQ:047920), HLB Life Science (KOSDAQ:067630), HLB Therapeutics (KOSDAQ:115450), HLB Panagene (KOSDAQ:046210) and HLB Global (KOSDAQ:003580). HLB Group’s overseas affiliates include Elevar Therapeutics, Immunomic Therapeutics, a nucleic acid immunotherapy platform company, and Verismo Therapeutics, a CAR T platform oncology company, all of which are based in the United States. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Relay Therapeutics’ strategy, business plans and focus; the progress and timing of the preclinical and clinical development of the programs across Relay Therapeutics’ portfolio; the expected therapeutic benefits and potential efficacy and tolerability of its programs, including lirafugratinib; the timing and success of interactions with regulatory authorities and any related approvals; the potential market opportunity for lirafugratinib; and the expected strategic benefits under the exclusive global licensing agreement between Relay Therapeutics and Elevar Therapeutics. The words “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of global economic uncertainty, geopolitical instability and conflicts, or public health epidemics or outbreaks of an infectious disease on countries or regions in which Relay Therapeutics has operations or does business, as well as on the timing and anticipated results of its clinical trials, strategy, future operations and profitability; the delay or pause of any current or planned clinical trials or the development of Relay Therapeutics’ drug candidates; the risk that the preliminary or interim results of its preclinical or clinical trials may not be predictive of future or final results in connection with future clinical trials of its product candidates and that interim and early clinical data may change as more patient data become available and are subject to audit and verification procedures; Relay Therapeutics’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of its planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Relay Therapeutics’ most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Relay Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. Relay Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Relay Therapeutics:Contact:Megan Goulart617-322-0814mgoulart@relaytx.com Media:Dan Budwick1AB973-271-6085dan@1abmedia.com Elevar Therapeutics:Media Contact: Jeanette BressiHead, Corporate Communications jbressi@elevartherapeutics.com609-439-3997 Investor Relations Contact:Wade Smith Chief Financial & Business Officer wsmith@elevartherapeutics.com

FDA sets a PDUFA target action date of March 20, 2025Resubmission is supported by the final survival analysis of CARES-310 study, presented at ASCO 2024 FORT LEE, N.J., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the U.S. Food and Drug Administration (FDA) accepted the resubmission of a new drug application (NDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma (uHCC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2025. “We believe rivoceranib plus camrelizumab has the potential to change the clinical practice in the first-line setting for patients with advanced liver cancer. The results of the pivotal CARES-310 trial demonstrated significant improvements in overall survival, with a very manageable safety profile compared with currently approved uHCC therapies. Elevar is committed to working with the FDA to bring this combination to market for patients and healthcare providers,” commented Chris Galloway, M.D., senior vice president of clinical and medical affairs at Elevar Therapeutics. The resubmission included the final analysis of the Phase 3 CARES-310 study presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, which reported median overall survival (mOS) of 23.8 months, the longest mOS for any treatment in a global Phase 3 trial for patients with uHCC, confirming the combination of camrelizumab and rivoceranib continued to show sustained long-term survival as a first-line treatment for patients with uHCC.i With the efficacy results generally consistent across all subgroups, the data suggest the combination has the potential to benefit a global uHCC population. The data also demonstrated consistent efficacy across patients with both viral and non-viral etiologies. About CARES-310 The CARES-310 study, an international, randomized, open-label, Phase 3 trial, with 543 patients with uHCC who had not previously received systemic treatment was the first to demonstrate significant progression-free survival (PFS) and overall survival (OS) benefits with immunotherapy plus an anti-angiogenic tyrosine kinase inhibitor (TKI) over standard TKI as first-line treatment for uHCC. In the primary analysis of PFS (data cut-off [DCO], May 10, 2021) and interim analysis of OS (DCO, Feb. 8, 2022), significant improvements were observed with camrelizumab (C; anti-PD-1 antibody) + rivoceranib (R; VEGFR2-TKI) vs. sorafenib (S). In the final analysis (FA) of the CARES-310 study, after an additional follow-up of ~16 months, median OS was significantly prolonged with C+R vs. S (23.8 mo [95% CI 20.6-27.2] vs. 15.2 mo [95% CI 13.2-18.5]; hazard ratio (HR) 0.64 [95% CI 0.52-0.79]; 1-sided p <0.0001). OS rate with C+R vs. S was 49.0% vs. 32.6% at 24 mo, and 37.7% vs. 24.8% at 36 mo. OS benefits with C+R was generally consistent across subgroups, regardless of geographical region, race, and etiology. Benefits in PFS, objective response rate (ORR) and duration of response (DoR) with C+R vs. S were also sustained after prolonged follow-up. Safety data aligned with the interim OS analysis, with no new signals noted. In the FA, C+R continued to show clinically meaningful survival improvement compared with S, with manageable safety. The extended follow-up further confirmed the favorable benefit-to-risk profile of C+R, supporting it as a new first-line treatment option for uHCC. About Hepatocellular Carcinoma Worldwide each year more than 800,000 people are diagnosed with liver cancerii and the disease is the cause of more than 830,000 deaths.iii Hepatocellular Carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. About Rivoceranib Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFRs), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Several clinical studies were completed in patients with uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf®). Rivoceranib, under the name apatinib (Aitan®), was the first TKI approved in gastric cancer in China (October 2014). It was also approved in China in combination with camrelizumab as a first-line treatment for uHCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted for gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), is the Chinese -territory license-holder of rivoceranib. About Camrelizumab Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer, etc.) and treatment settings. Camrelizumab, under the brand name AiRuiKa®, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for uHCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the European Medicines Agency in August 2024. In October 2023, Elevar licensed camrelizumab, an anti-PD-1 antibody, for commercialization from Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) worldwide excluding Greater China and Korea. To learn more, visit ElevarTherapeutics.com. Media Contact Jeanette Bressi Head, Corporate Communications, Elevar Therapeutics jbressi@elevartherapeutics.com609-439-3997 Investor Relations Contact Wade Smith Chief Financial & Business Officer, Elevar Therapeutics wsmith@elevartherapeutics.com i CARES-310 study final analysisii Key Statistics About Liver Cancer | American Cancer Societyiii Key Statistics About Liver Cancer | American Cancer Society