Limertinib

From China Leadership to Global Premier: Revenue Surpasses RMB 10 Billion, Entering the Era of Profitability and Globalization SAN FRANCISCO and SUZHOU, China, March 26, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, announces its 2025 annual results and long-term strategic blueprint. Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "2025 marks the most successful year in Innovent's history. We achieved historic breakthroughs across three areas: business scale, financial strength, and global innovation. We successfully upgraded our strategy from an oncology-focused leader to a 'dual-engine growth model' driven by oncology and general biomedicine portfolio. Encouragingly, we delivered our first full year of net profit, marking a formal entry into an era of sustainable profitability. Our robust cash reserves and positive operating cash flow will provide strong support for strategic growth. On the innovation front, three global high-potential assets advanced into or near global registrational clinical development, targeting a combined addressable market value of over US$60 billion. Meanwhile, we accelerated the global value realization of our pipeline through multiple landmark strategic collaborations, laying a solid foundation for global expansion. Total deal value reached over US$22 billion in the past year, accounting for more than 10% of China's innovative pharmaceutical sector outbound licensing value in 2025[1]. These achievements not only validate the foresight of our strategy but also highlight our uniqueness of strong growth and high certainty within China's biopharma industry. Guided by our Vision 2030 to become a global premier biopharmaceutical company, we will continue to drive progress across four core pillars: revenue, profitability, innovative pipeline and organizational capabilities, creating sustainable value for patients, shareholders and society." Revenue Set New Height, Achieved Full-Year Profitability with Strong Cash Position Total revenue reached RMB 13.0 billion, representing a year-on-year increase of 38.4%. Product revenue amounted to RMB 11.9 billion, up 44.6% year-on-year. From the commercial launch of its first product in 2019 to 18 approved products and surpassing RMB 10 billion revenue milestone, Innovent accomplished this in only 7 years, setting a new growth benchmark for China's innovative biopharmaceutical industry. The Company achieved its first full year of net profit. IFRS net profit reached RMB 814 million, and Non-IFRS net profit rose to RMB 1.72 billion, marking a structural inflection in profitability and entry into a sustainable earnings era. Operating efficiency continued to improve. Gross margin improved 2.3 percentage points to 87.2%. Selling and administrative expense ratio declined 2.9 percentage points to 48.0%. EBITDA surged to RMB 1.99 billion (2024: RMB 412 million). As of December 31, 2025, cash reserves totaled RMB 24.3 billion (~US$3.5 billion). Additionally, the Company also generated positive operating cash flow, providing strong financial support for long-term development. [2] Dual-Engine Strategy Fully Implemented, Commercial Foundation Strengthened China Leading Oncology Brand with Synergistic Value of Innovative Portfolio Innovent has established a leading oncology brand in China. Cornerstone products including TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection) and HALPRYZA® (rituximab injection) have benefited millions of Chinese cancer patients. In addition, five small-molecule targeted oncology drugs—Limertinib (EGFR TKI), DOVBLERON® (Taletrectinib, ROS1i), Dupert® (fulzerasib, KRAS G12Ci), JAYPIRCA® (Pirtobrutinib, BTKi), and Retsevmo® (selpercatinib, RETi) — were successfully included in the 2025 National Reimbursement Drug List (NRDL), further strengthening the competitiveness and commercial performance of Innovent's oncology portfolio. General Biomedicine Franchise Emerged as a New Growth Engine Benefiting from forward-looking strategic layout, Innovent's general biomedicine portfolio delivered strong momentum in 2025. SYCUME® (Teprotumumab, IGF-1R antibody), China's first innovative therapy for thyroid eye disease in 70 years; Mazdutide, the world's first and only approved GCG/GLP-1 dual-receptor agonist for obesity and type 2 diabetes; and SINTBILO® (tafolecimab injection), the first China-domestic PCSK9 inhibitor included in the NRDL—all exhibited robust performance. PECONDLE® (picankibart injection, IL-23p19 antibody), the anchor asset in autoimmune diseases, was also approved at the end of 2025. Within a single year, the general biomedicine portfolio has become a second core engine driving high-speed growth. Today, Innovent possesses one of the highest-quality commercial portfolio and pipeline in the industry, supported by a fully established commercial network, reinforcing its solid commercial foundation. Year of Globalization: Pipeline Value Unlocked, Growth Potential Expanded 2025 marked a breakthrough year for the Company's globalization strategy, unlocking substantial long-term growth potential. Innovent successfully advanced three core assets into or near global Phase 3 clinical trials. According to its partner estimates, these late-stage assets target a combined total addressable market (TAM) of over US$60 billion, including: IBI363 (PD-1/IL-2α-bias): Next-gen IO cornerstone, potential TAM over US$40 billion for first wave of indications In collaboration with Takeda, IBI363 is being advanced globally. The first global MRCT Phase 3 in IO-resistant squamous NSCLC has been initiated. PoC in IO-resistant non-squamous NSCLC is completed, with a new global Phase 3 planned subject to the PoC results and regulatory communications. A Phase 3 trial in 3L colorectal cancer (CRC) in China is planned for 2026. A Phase 2 trial in IO-naïve mucosal/acral melanoma is underway in China. PoC studies in 1L NSCLC and 1L CRC are ongoing. IBI343 (CLDN18.2 ADC): Cornerstone for gastrointestinal cancers, potential TAM over US$8 billion Interim analysis from the China-Japan Phase 3 clinical trial in 3L gastric cancer is expected in 2026. Phase 3 in 3L pancreatic cancer in China was initiated in 2025. PoC studies in 1L gastric and 1L pancreatic cancer are ongoing. IBI324 (VEGF/ANG2): Potential best-in-class retinaltherapy, potential TAM US$15 billion Our partner Ollin Biosciences reported positive top-line results from the Phase 1b JADE head-to-head study against faricimab in wAMD and DME patients in the US. Innovent is working closely with Ollin to engage global regulators in 2026 and advance IBI324 into global Phase 3 trials. Diversified Partnerships to Accelerate Global Innovation Total deal value from Innovent's global collaborations reached over US$22 billion in 2025, representing over 10% of China's innovative pharma outbound licensing value. These partnerships not only accelerate global pipeline development but also help build core capabilities for Innovent to become a truly world-class biopharma. With Takeda: Landmark "IO + ADC" collaboration under a co-development and co-commercialization ("Co-Co") model for IBI363 to build its global R&D and commercialization capabilities. With Eli Lilly: Seventh partnership with an end-to-end innovation model to jointly develop novel oncology and immunology molecules, enhancing full lifecycle R&D frameworks and decision-making from a multinational perspective. With Roche: Leveraging global oncology resources to advance IBI3009 (DLL3 ADC) worldwide. With Ollin: Utilizing global ophthalmology expertise to accelerate IBI324's clinical development and market positioning. High-Quality Manufacturing Standards Total operational capacity of 140,000 liters, accounting for 20% of China's total biologic manufacturing capacity. Site 1 houses 60,000 liters of antibody capacity and ADC commercial lines; Site 2 has 80,000 liters of antibody capacity, supporting global supply and CDMO services. Sustainable Development and ESG Commitment 8,000 employees worldwide, with global R&D centers in San Francisco Bay Area, Shanghai and Suzhou. Over 3,000 new cancer patients initiate Innovent therapies daily; more than 6 million patients have benefited to date. Maintained MSCI ESG AAA rating, leading China's biopharmaceutical industry. First innovative biopharma constituent of the Hang Seng Index ("blue-chip" status). Launched community health initiatives including the MV 'Weight Management Made Easy' and documentary 'Down in Weight, Up in Life' to promote science-based healthy weight management. Published patient education materials on thyroid eye disease and weight management to enhance public health awareness. Implemented multiple patient assistance programs, benefiting over 200,000 patients with drug donations valued at over RMB 3.6 billion. Received honors including "Healthcare Public Welfare Pioneer" and "China Public Welfare Enterprise". Created over 2,200 jobs for new graduates. Cumulative taxes and contributions exceeding RMB 6 billion. Vision 2030: From China Leader to Global Premier Biopharma Entering 2026, Innovent celebrates its 15th anniversary. Building on its strong foundation, the Company reaffirms Vision 2030: to evolve into a global premier biopharmaceutical company. Revenue: Target RMB 20 billion by 2027 with continued expansion thereafter. International revenue will become a new growth driver in the future. Profitability: Maintain high-quality growth while steadily improving profit margins benchmarking industry-leading levels. Pipeline: Focus on advancing high-value assets including IBI363, IBI343 and IBI324. Push next-generation oncology and general biomedicine molecules into global early-stage and PoC studies. Target at least 5 molecules in global MRCT Phase 3 by 2030. Organization: Established a US R&D and operating team of nearly 100 people. Through deep partnerships with Takeda, Lilly, Ollin, Roche and others, Innovent is rapidly building global R&D, regulatory and commercial capabilities. These growing global competencies will further support independent development, enabling Innovent to leap forward into a fully independent, world-class biopharmaceutical enterprise. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 5 assets in Phase 3 or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem 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 , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Ramucirumab (Cyramza)，Selpercatinib (Retsevmo) and Jaypirca (pirtobrutinib) were developed by Eli Lilly and Company. 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. SOURCE Innovent Biologics 21% more press release views with Request a Demo

SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that it has entered into an exclusive licensing agreement with ASK Pharm for its proprietary pan-RAS (ON) inhibitor AN9025. Under the terms of the agreement, ASK Pharm will obtain exclusive rights to develop, manufacture, and commercialize AN9025 in mainland China, Hong Kong and Macao (the “Licensed Territory”). Adlai Nortye will retain worldwide rights to the compound excluding the Licensed Territory. Adlai Nortye is eligible to receive total consideration of up to RMB 1.6 billion (approximately USD 230 million), including an upfront payment and near-term milestone payments exceeding USD 20 million, plus tiered royalties ranging from a high single-digit to mid-teens percentage of net product sales in the Licensed Territory. Mr. Jingfei Ma, Director and General Manager of ASK Pharm, stated: “This partnership marks a pivotal milestone in our strategic innovation upgrade, signaling our decisive move into frontier innovation with high entry barriers. By leveraging our complementary strengths in R&D, clinical development, and commercialization, we aim to accelerate the development of AN9025 project while reinforcing our existing pipeline, ultimately delivering high-value therapeutic solutions to patients in China and around the world.” “We are delighted to partner with ASK Pharm on the development of AN9025, a differentiated pan-RAS (ON) inhibitor with the potential to be best-in-class,” said Yang Lu, Chairman and Chief Executive Officer of Adlai Nortye. “This collaboration represents a meaningful step forward in advancing the clinical and commercial potential of AN9025 and underscores the value of our RAS-targeted drug discovery platform. By combining Adlai Nortye’s innovation capabilities with ASK Pharm’s strong development and commercialization expertise in Greater China, we aim to accelerate the delivery of novel treatment options for patients with RAS-mutated cancers who continue to face significant unmet medical needs.” About AN9025 AN9025 is an oral small molecule pan-RAS(ON) inhibitor with best-in-class potential, designed to target a broad spectrum of RAS mutations across various tumor types. Preclinical studies have demonstrated that AN9025 effectively inhibits RAS-mutant cancers with potent and durable efficacy, including pancreatic, lung, and colorectal adenocarcinomas, and shows comparable or superior results relative to a benchmark agent of the same class. The company expects to initiate the phase I clinical study in the first quarter of 2026. About Adlai Nortye Adlai Nortye (NASDAQ: ANL) is a global clinical-stage company at the forefront of discovering and developing innovative cancer therapies. Leveraging our dual R&D presence in the U.S. and China, we are building a robust pipeline of drug candidates focused on two key areas where we believe we can make a significant difference. (1) Next-generation cancer immunotherapies: our candidates, AN8025 (a tri-functional fusion protein of αPD-L1 x CD86 variant x LAG3 variant), a T-cell and antigen-presenting cell modulator, and AN4005 (a first-in-class oral small-molecule PD-L1 inhibitor), are designed to activate cancer immunity in novel ways. (2) RAS-targeting therapies: we are tackling RAS-driven cancers with AN9025, an oral pan-RAS(ON) inhibitor, and AN4035, a CEACAM5-targeting ADC delivering a potent pan-RAS(ON) inhibitor directly to tumors. About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas. ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 10 disclosed key projects focused on innovative chemical and biologic drugs. Among these, Limertinib (the 3rd Gen EGFR TKI) is launched in 2025, while ASKC109 (maltol iron capsules), ASKB589 (Claudin18.2 monoclonal antibody), and ASKC202 (c-MET TKI) are in Phase III clinical trials. ASK Pharm has ranked among the top 20 best industrial enterprises in China’s pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as “Top Ten National R&D Innovators”, “Best National Enterprise for Investment”, and “National Torch Program High-Tech Enterprises”. Forward-Looking Statement This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “potential,” “continue,” “ongoing,” “targets” and similar statements. Among other things, statements that are not historical facts, including statements about the Company’s beliefs and expectations, the business outlook and quotations from management in this announcement, as well as the Company’s strategic and operational plans, are or contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. Factors that could cause the Company’s actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of the Company’s preclinical studies, clinical trials and other therapeutic candidate development efforts; the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results will be predictive of real-world results; the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of the Company’s therapeutic candidates; the Company’s ability to establish, manage, and maintain corporate collaborations, as well as the ability of its collaborators to execute on their development and commercialization plans; the implementation of the Company’s business model and strategic plans for its business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of the Company’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the PRC and United States or elsewhere. Further information regarding these and other risks is included in the Company’s filings with the SEC. All information provided in this announcement and in the attachments is as of the date of this announcement, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law. Company contact:Investor RelationsEmail: ir@adlainortye.com