Alflutinib Mesylate

NEWTOWN SQUARE, PA, USA and SHANGHAI, China I January 21, 2025 I ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP) a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that it has entered into an exclusive license agreement with Lepu Biopharma Co., Ltd (Stock Code: 02157.HK) for MRG007, an antibody-drug conjugate (ADC) that can target several gastrointestinal (GI) cancers. Under the terms of the agreement, ArriVent obtains the exclusive rights to develop and commercialize MRG007 worldwide outside of Greater China which includes mainland China, Hong Kong, Macau and Taiwan. “We believe MRG007 is a potential best-in-class ADC for the treatment of GI malignancies based on preclinical and IND enabling studies,” said Bing Yao, Chairman and Chief Executive Officer of ArriVent. “Expanding our pipeline with MRG007 furthers our mission to develop novel medicines for cancers with high unmet needs worldwide and accelerates our ADC portfolio by adding a program which plans to enter the clinic in the near-term. We look forward to collaborating with Lepu Biopharma in advancing this program globally.” Ziye Sui, Ph.D., Executive Director and Chief Executive Officer of Lepu Biopharma added, “We are very pleased to be working with ArriVent. Lepu Biopharma has been dedicated to promoting the technological advancement of innovative ADCs. We believe MRG007 is one of our potential best-in-class ADC molecules in pre-clinical stage. The agreement is a recognition of our self-dependent R&D capabilities. We look forward to collaborating with ArriVent to advance the development of MRG007 globally and help bring this potential promising therapy to more patients around the world.” MRG007 has shown robust antitumor activity in preclinical models of GI cancers and a favorable therapeutic index based on IND enabling studies. The first IND submission is planned for the first half of 2025 with an initial clinical development focus in CRC, pancreatic and other GI cancers. Under the terms of the agreement, Lepu Biopharma has granted ArriVent exclusive global rights to develop, manufacture and commercialize MRG007 outside of Greater China. Lepu Biopharma will receive a one-time upfront payment and near-term milestone payments totaling $47 million in cash and is eligible to receive up to $1.16 billion in development, regulatory and sales milestones and tiered royalties on net sales outside of Greater China. The upfront payment and projected research and development costs, including potential milestone payments, do not change ArriVent’s previously announced expected cash runway into 2026. About ArriVent ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization. About Lepu Biopharma Co., Ltd. Lepu Biopharma Co., Ltd. (Stock Code: 02157.HK) is an innovation-driven company focusing on oncology therapeutics, in particular, targeted therapy and oncology immunotherapy, with a strong China foundation and global vision. The company is dedicated to developing innovative ADCs through its advanced ADC technology platform. Lepu Biopharma highly values the continuing build-out of its own commercialization capabilities and is determined to pursue the goal towards strong transformation from core technology to drugs and industrialization. At present, the product pipeline of Lepu Biopharma covers three major areas, namely immunotherapies, ADC targeted therapies and oncolytic virus drugs, including one clinical/commercialization-stage drug candidate, seven clinical-stage drug candidates (six of which are ADC drug candidates) and three clinical-stage combination therapies of the key candidates in its pipeline. The company houses the leading ADC drug candidate pipeline in China. SOURCE: Lepu Biopharma

Bing Yao’s ArriVent BioPharma has inked another licensing deal with a Chinese biopharma. The late-stage oncology biotech is picking up a new antibody-drug conjugate from Shanghai-based Lepu Biopharma, according to a Tuesday night disclosure. The deal — for $47 million upfront and up to a hefty $1.16 billion in biobucks — adds to a steady drumbeat of US drug developers acquiring the ex-China rights to therapies initially created or developed by Chinese biotechs. It marks at least the 11th such China-to-US biotech pact in the first three weeks of 2025, according to an Endpoints News tracker. The move is core to the operating model of ArriVent, which debuted in June 2021 with the goal of picking up drug candidates and medicines from Chinese biotechs and bringing them into the US and other geographies. The Pennsylvania biotech also has ADC collaborations with Alphamab and Aarvik Therapeutics. Lepu, meanwhile, has a joint venture with Keymed Biosciences called KYM Biosciences. AstraZeneca licensed an ADC from KYM in February 2023. Keymed has also done multiple China-to-US deals of its own in recent months. ArriVent’s pipeline is led by an oral, brain penetrant EGFR inhibitor known as furmonertinib. The medicine is approved in China, where it’s marketed by ArriVent partner Allist Pharmaceuticals. Global Phase 3 non-small cell lung cancer data are slated for this year, ArriVent said in its most recent quarterly update. With Lepu, ArriVent is staking a bet on MRG007, an experimental medicine for gastrointestinal cancers. ADCs like MRG007 are intended to target tumor cells with cytotoxic payloads and have become darlings among pharma’s oncology dealmaking teams in recent years. MRG007 will enter human trials later this year, the companies said in their announcement on Tuesday evening, or Wednesday morning in China . The move does not change ArriVent’s previously projected cash runway, which should take it “into 2026,” the biotech said. ArriVent said in November that it ended the third quarter with $282.9 million in cash and equivalents. The drug developer went public as $AVBP almost a year ago in a $175 million IPO, and it’s one of the few biotechs to have floated in the last few years that is still trading above its initial pricing. ArriVent is led by Yao, who previously took AstraZeneca spinout Viela Bio to an FDA approval for Uplizna in 2020 and then an M&A exit to Horizon Therapeutics a year later.