IBI311

近日，多家药企陆续公布了2024年上半年财务业绩。绿叶制药上半年势头强劲，四大主要治疗领域产品竞争优势明显；信达生物表现出色，产品商业化进程持续提速；药明巨诺平稳发展，持续提升运营效率和优化研发策略。 收入30.7亿元，净利润增长201% 2024年8月28日，绿叶制药（2186.HK）发布2024年截至6月30日的上半年财务业绩。报告期内，公司营业收入30.746亿元，同比增长6%。净利润4.38亿元，同比增长201%。 绿叶制药是一家致力于创新药物研发、生产和销售的国际化制药公司。集团已于中国、美国及欧洲成立研发中心，并拥有强劲的在研产品，包括30多种国内在研产品及10多种其他国际市场在研产品，在包括微球、脂质体、透皮释药系统在内的新型药物递送技术方面维持国际高水平。公司在新分子实体及抗体方面取得多项创新成果，也积极于细胞治疗和基因治疗等领域进行战略开发。 于中国市场，集团主要产品均于其四大主要治疗领域（肿瘤科、中枢神经系统、心血管及代谢）具竞争地位。报告期内，本集团各领域收入情况如下： ▶肿瘤治疗领域的收入增加25.3%，达11.4亿元； ▶中枢神经系统治疗领域的收入增加20.9%达8.227亿元； ▶心血管领域收入减少21.9%至7.633亿元； ▶代谢领域收入减少20.8%至1.957亿元。 作为集团的强势领域，肿瘤治疗领域有潜力在短期内通过五款新产品的上市，为本集团带来超过10亿元的年收入增量，长期的市场增量潜力超过50亿元。 在中枢神经系统治疗领域，本集团有5款新产品（若欣林、瑞可妥、美比瑞、金悠平及利斯的明透皮贴剂）在中国大陆获批，4款新产品（瑞可妥、Erzofri、利斯的明多天贴剂及罗替高汀贴剂）在美国或欧洲获批。 公司抗精神病旗舰药物Erzofri已于2024年7月在美国成功获得批准。Erzofri是首个在美国获批具有自主知识产权且由中国公司开发的棕榈酸帕利哌酮长效注射液。 商业化发力，收入增长46.3%至39.52亿元 2024年8月28日，信达生物（1801.HK）公布2024中期业绩。2024年上半年，信达生物实现总收入39.52亿元，同比增长46.3%；其中产品收入38.11亿元，同比增长55.1%。期内净亏损为1.60亿元，相较于去年同期收窄15.9%。 目前，信达生物商业化产品增至11款；其中靶向小分子创新药物达伯特（氟泽雷塞，KRAS G12C）刚刚在8月获批。信达生物预计2024年下半年将再新增1款肺癌靶向药物他雷替尼（ROS1抑制剂）。报告期内，肿瘤产品线的PD-1单抗达伯舒（信迪利单抗）、FGFR靶向药达伯坦（佩米替尼片）先后在中国澳门获批上市。综合产品线中，心血管及代谢（CVM）领域递交3项新药上市申请（NDA），包括玛仕度肽（GLP-1R/GCGR）治疗肥胖和糖尿病，以及替妥尤单抗（IGF-1R）治疗甲状腺眼病。 信达正在推进“IO+ADC”的研发策略，期内研发投入达到12.94亿元；公司整体财务状况良好，期末现金储备101.12亿元（合计超14亿美金）。在研管线中，CTLA-4单抗IBI310已启动联合达伯舒用于肠癌新辅助治疗的III期临床研究；CLDN18.2 ADC候选产品IBI343此前已取得胃癌适应证的Ib期研究阳性结果，正在准备开展III期临床研究。 收入8680万元，与去年基本持平 2024年8月28日，药明巨诺（2126.HK）发布2024年上半年财务业绩。公司收入8680万元，与去年同期基本持平，主要由于核心产品倍诺达的持续商业化。 报告期内，公司研发开支1.51亿元，同比减少逾30%，主要由于提升运营效率和优化研发策略所致。经调整亏损所窄至2.147亿元。 报告期内，公司领先产品倍诺达在商业化方面持续取得重大进展。国家药监局已批准有关倍诺达用于不符合移植条件的r/r LBCL患者的二线治疗的临床申请，且已开展相关临床试验的患者入组。国家药监局已分别于2024年8月及2023年4月进一步批准倍诺达治疗r/r MCL患者的新适应证上市申请和用于治疗系统性红斑狼疮的IND申请。倍诺达成为首个在中国批准用于治疗r/r MCL患者的细胞治疗产品。公司还启动了JWATM 214治疗晚期肝细胞癌（HCC）的研究者发起试验（IIT）。 为减轻患者负担，公司利用中国多层医疗保险体系的发展，将倍诺达列入更多地方政府的补充医疗保险计划及商业保险产品。截至2024年6月30日，倍诺达已有效列入超过78个商业保险产品及96个地方政府的补充医疗保险计划。为了进一步缓解患者的支付压力，公司继续与行业领先创新支付平台合作，向接受倍诺达的患者提供分期付款或抵押贷款服务。 全球医疗情报领导者 解锁隐藏在数据中的商业潜力  关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。 联系我们 投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写 点击阅读原文，解锁完整双语新闻

Strong commercial performance and significant pipeline milestones support sustained growth and innovation SAN FRANSISCO and SUZHOU, China, Aug. 28, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2024 interim results and major business updates. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "For the first half of 2024, our company's strategy of sustainable growth and global innovation continue executing very well: we achieved strong revenue growth, improved operational efficiency in all areas, and reached significant milestones in our late-stage pipeline to support our sustained growth. We also reported promising data readouts from early-stage assets, reinforcing our confidence in achieving global innovation and contributing to new long-term opportunities. The successful first half of 2024 has laid a solid foundation for achieving our full-year's growth. With strong commercial and financial execution, a high-value late-stage pipeline, and disciplined investments in next-generation innovation, we are well-positioned to deliver long-term value for patients, employees, shareholders and society." Enhanced operational efficiency and strong financial performance S trong revenue growth momentum: total revenue was RMB3,952.3 million in the first half of 2024, with a strong year-over-year growth of 46.3%, reflecting robust demand for our innovative portfolio and the advantage of our sustainable business model. Significantly improved financial performance: EBITDA Loss was significantly reduced, driven by strong revenue growth, enhanced operational efficiency and notable financial improvement. The gross profit margin of total revenue was 84.1%, a year-over-year increase of 1.8 percentage points The selling and marketing expenses of product revenue was 48.6%, a year-over-year decrease of 5.9 percentage points The administration and expenses of total revenue was 5.2%, a year-over-year decrease of 4.9 percentage points R&D expenses were RMB1,293.9 million; cash and short-term financial assets were RMB10,112.3 million, or approximately over USD1.4 billion, which enables us to focus on the long-term sustainable development EBITDA loss was RMB160.8 million, a notable year-over-year decrease of 39.9% Strong product revenue growth; preparing for CVM commercialization Product sales revenue reached RMB3 ,811.4 million in the first half of 2024, a strong year-over-year growth of 55.1%. Expansion of commercial portfolio into new approved products, new indications and broader NRDL coverage [1] , [2] and patient access: Eleven approved products: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, Olverembatinib, CYRAMZA®, Retsevmo®, FUCASO® , SINTBILO® and DUPERT® (new product, KRAS G12C inhibitor) . TYVYT® and PEMAZYRE® were newly approved in the Macau market. TYVYT® and BYVASDA® were included in the NRDL for the treatment of EGFR-mutated NSCLC. Solidify oncology leadership; in active preparation for new commercial opportunities in general biomedicine. Oncology: we strengthened our leadership with a robust product portfolio, including TYVYT® (sintilimab injection), and expanded out oncology business with a 10th product, a ROS1 inhibitor, set for approval in the second half of 2024. General biomedicines: Following the approval of the first CVM product SINTBILO® (tafolecimab injection) in 2023, we have successfully submitted three new drug applications (NDA)—two for mazdutide, targeting obesity/overweight population and T2D, and one for IBI311 (IGF-1R) for thyroid eye disease (TED). As a key strategic priority, we are steadily building our commercialization capabilities in the CVM field with systematic approaches, aiming to unlock substantial commercial opportunities and drive sustainable growth. Material innovation delivery supports strategic goals 7 new assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early-phase clinical studies Substantial milestones delivered for key late-stage assets Encouraging progress in the next wave innovation of "IO+ADC" TYVYT® (sintilimab): submitted an NDA for its eighth indication, 2L endometrial cancer (EMC). New registrational clinical trials for neoadjuvant therapy in colon cancer and perioperative therapy in NSCLC have been initiated. Additionally, we are exploring the potential of combination therapies through multiple collaborations with novel modalities. IBI310 (CTLA-4 )：initiated a Phase 3 clinical trial for IBI310 in combination with sintilimab as neoadjuvant therapy in treating colon cancer. IBI343 (CLDN18.2 ADC)：Phase 1b positive data readout in GC and a Phase 3 trial is in preparation. Accelerating new launch momentum in general biomedicine to unlock significant opportunities Mazdutide (GLP-1R/GCGR) : first NDA for weight management in obese or overweight populations and second NDA for T2D treatment, both under NMPA review. We plan to develop new indications, including adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), obstructive sleep apnea (OSA), and heart failure with preserved ejection fraction (HFpEF). Teprotumumab (IGF-1R) : the NDA for TED is under NMPA review. With a longstanding lack of innovative TED treatments in China, Teprotumumab is set to be a transformative therapy for this significant unmet need once approved. Picankibart (IL-23p19) : the only IL-23p19 that reported over 80% subjects achieving ≥90% improvement in Psoriasis and Severity Index (PASI90) in 16 weeks of treatment, along with strong long-term skin clearance maintenance and quarterly dosing interval advantage. We plan to submit an NDA in the second half of 2024. IBI128 (XOI) : potential best-in-class XOI for the treatment of hyperuricemia in gout patients. It is currently undergoing overseas Phase 3 clinical trials overseas with our partner LG Chem, and we have completed patient enrollment for a Phase 2 clinical trial in China. IBI302 (VEGF/C) : Phase 3 study initiated for the treatment of nAMD, following stable and robust visual benefit observed with an extended dosing interval and potential macular atrophy inhibition in two Phase 2 studies. Abundant early-stage pipeline to support long-term growth and global ambition Encouraging data readouts from multiple oncology assets in Phase 1 studies, eyeing most difficult-to-treat cancers IBI363 (PD-1/IL-2 α -bias ) : preliminary positive signals in multiple IO-failed/cold tumor types; further investigations across different rumor types are ongoing; a Phase 2 clinical trial in the U.S. has been initiated. IBI343 (CLDN18.2 ADC) : encouraging positive signal in pancreatic cancer, with FDA fast track designation granted. Plans are underway for a clinical trial in the U.S. IBI389 (CLDN18.2/CD3) : encouraging and differentiated signals in GC and PDAC in Phase 1 studies; Phase 1b study is continuing. Multiple programs ongoing including IBI3003 (GPRC5D/BCMA/CD3), IBI115 (DLL3/CD3); IBI3004 (DR5/CEA); IBI3001 (EGFR/B7H3 ADC), IBI130 (TROP2 ADC), IBI133 (HER3 ADC) Develop next-generation general biomedicine programs to improve chronic disease treatment IBI3016 （ AGT siRNA ） : a new-generation siRNA drug candidate, entered into a Phase 1 clinical trial for hypertension. IBI355 (CD40L), IBI356 (OX40L) and IBI3002 (IL-4R α / TSLP) : innovative autoimmune molecules entered into first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases. IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) : both are in the Phase 1 stage to explore the potential differentiation clinical values versus existing therapy. Research innovation published in high-impact scientific journals and medical conferences, such as: AACR, ASCO, ESMO GI and ESMO plenary for oncology pipeline innovation, including 10+ oral presentations ADA, APAO, ICE, CSE for general biomedicine pipeline material progress, such as mazdutide and teprotumumab Facilitates and Manufacturing capacity adhering to high-standard quality: Shanghai R&D center (medical) is newly operational in August 2024 First manufacturing site: 60,000L antibody production capacity and ADC production lines in operation Second manufacturing site: first phase of 80,000L completed construction to secure CDMO business Devoted to responsible business practices and enhancing ESG management practices We remain committed to sustainable development, corporate responsibility and ethical business practices. We newly launched our ESG website to enhance our efforts in sustainability, corporate responsibility and ethical business conduct. The new platform highlights our initiatives, policies and performance in key ESG areas, including "Excellent Governance", "Enjoying Good Health", "Ensuring High-Quality Products", "Empowering Employees", and "Embracing Ecology". Innovent is graded 'A' level in MSCI ESG rating, ranking at the forefront of the biotechnology industry. About Innovent 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 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 , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). 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 materialize or is otherwise inaccurate. SOURCE Innovent Biologics