IBI-3003

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

CGT产业何去何从？8月底，北京！九大论坛将直面产业创新与监管挑战。国药集团中国生物副总裁孙京林老师将在本次会议讲解“创新生物药的分段生产管理”。武汉科技大学生命科学与健康学院院长，波睿达生物董事长张同存教授将与会报告“CAR-T细胞治疗现状和展望”。 默沙东再次对中国创新药资产出手，这一次瞄准的不再是ADC药物，而是双抗药物。 8月9日，默沙东与同润生物达成BD交易，以7亿美元首付款的价格，拿下了CD3/CD19双抗药物CN201的全球权益。这也是继百利天恒之后，中国创新药license-out第二高的首付款。 图：中国双抗管线BD一览，来源：锦缎研究院 无论是之前百利天恒的BL-B01D1，还是同润生物的CN201，它们都是基于双抗平台的技术。算上2022年以5亿美金首付款授权给Summit公司的AK112，双抗平台屡现大交易。 中国双抗资产接连获得MNC的青睐，这与前两年MNC扫货中国ADC如出一辙。中国双抗管线，似乎开始接替ADC，成为全球大药企最关注的前沿资产。 1 中国资产崭露头角 截至目前，全球共有15款双抗药物曾获批上市，除首款双抗产品Catumaxomab因市场表现不佳退市外，其他14款产品均正常销售。其中就包括康方生物获批上市的两款双抗产品，中国创新药公司已经在全球双抗赛道中占据一席之地。 2024年上半年，全球双抗药物市场销售额超60亿美元，这还是在没有考量很多2023年刚进入商业化阶段潜力产品的情况下。也就是说，全球双抗药物市场规模将在2024年首次突破百亿美元大关。 图：全球已上市双抗药物一览，来源：锦缎研究院 复盘全球双抗药物发展之路，商业化进程并不平坦。Catumaxomab作为全球首款上市的双抗药物，用于治疗EpCAM阳性肿瘤引起的恶性腹水，率先在癌症领域开启了双抗治疗时代。然而，这款药物售价高昂，副作用大，几乎没有市场。2014年被停止销售，最终在2017年6月正式退市。 受限于首款双抗药物孱弱的市场表现，动摇了药企在双抗赛道中的信心。至2020年之前，全球也仅有两款双抗药物上市，分别是2014年上市的Blinatumomab和2017年上市的Emicizumab。 不过这两款上市的双抗产品很快向市场证明，不是双抗平台不给力，而是Catumaxomab做得太差劲。安进Blinatumomab营收一路增长，有望在今年突破10亿美元大关；罗氏Emicizumab营收更是突破50亿美元，成为药王级别的产品。 受这两款双抗产品带动，药企开始重新关注双抗平台，尤其是2022年更是成为双抗药物的爆发之年，仅当年就有5款产品获批上市。此后，每年均有数款产品获批，双抗赛道真正进入了活跃期，就连早已退市的Catumaxomab，也在凌腾医药的临床管线上又起死回，重启了恶性腹水适应症研发，还试图向胃癌和膀胱癌适应症扩展。 值得一提的是，双抗并非聚焦于癌症技术平台，除了在癌症领域表现出节节攀高的获批数量外，在非癌领域市场显得异常活跃。2024年4月，Nature刊发了CD19/CD3双抗Blinatumomab成功治疗6名难治性类风湿性关节炎患者的研究，为双抗市场又打开了一扇大门。 默沙东巨额拿下CN201的原因，除了看中CN201在恶性肿瘤患者中具有良好的治疗前景外，更重要的是，早期临床数据已有力证明CN201对于靶向并耗竭循环B细胞和组织B细胞具备潜力，默沙东将研究其自免疾病新型可扩展疗法的潜力。 双抗药物的路越走越宽，这也是为何MNC将被目光聚焦于中国双抗资产的原因。 2 康方生物：敢与药王试比高 康方生物无疑是国内双抗龙头，已获批上市了卡度尼利和依沃西两款双抗药物，且每款都有全球首发的头衔。卡度尼利是全球首个肿瘤免疫治疗双抗新药；依沃西是全球首个获批上市的“肿瘤免疫+抗血管生成”机制的双抗新药。 基于双抗药物的放量，康方生物业绩也迎来了暴涨时代。2023年总收入为45.26亿元，同比增长达440%，其中开坦尼（PD-1/CTLA-4）2023年销售额为13.58亿元，占产品总销售额83%，不仅抵消了其他产品51%的销售额下滑，还为总销售额带来高达48%的正增长。 图，康方生物业绩一览，来源：康方生物 除商业化层面的成功外，康方生物亦是BD出海的大赢家之一。依沃西（PD-1/VEGF）还未上市，就在2022年底成功BD给了美股公司Summit，仅首付款就高达5亿美元。也正是凭借依沃西的海外权益，Summit在美股中重新焕发活力，今年股价暴涨仅350%。 今年5月底，康方生物发布依沃西Ⅲ期研究HARMONi-2临床结果，再次将双抗药物推向高潮。数据显示，依沃西单药对比K药单药一线治疗PD-L1表达阳性（PD-L1 TPS≥1%）的局部晚期或转移性非小细胞肺癌（NSCLC）患者，达到无进展生存期（PFS）的主要研究终点，获决定性胜出阳性结果，成为全球首个且唯一在Ⅲ期单药头对头临床研究中证明疗效显著优于K药的药物。 随即，Summit在2024年6月与康方生物修订许可协议，在原美国、加拿大、欧洲及日本的许可地区基础上，扩大至中美洲、南美洲、中东及非洲地区。根据新修订协议，康方生物可获得7000万美元首付款和里程碑款，以及销售提成。 除两款已经上市的药物外，康方生物还有多款潜在全球首创或同类最佳的双抗药物，包括AK129（PD-1/LAG-3）、AK130（TIGIT/TGF-β）、AK131（PD-1/CD73）和AK132（Claudin18.2/CD47）。 3 百利天恒：玩出多抗新花样 双抗是肿瘤免疫的迭代产品，ADC是化疗的迭代产品，而免疫治疗+ADC是未来肿瘤联合治疗的核心方向之一。当多数药企还在尝试开展双抗与ADC联合治疗时，百利天恒已在双抗技术基础上研发双抗ADC，创下出海首付款之最的双抗ADC药物BL-B01D1，正是基于其自研的双抗SI-B001研制而来。 2024年7月，BL-B01D1治疗晚期实体瘤I期临床研究结果在国际顶级杂志《柳叶刀肿瘤》发表，在既往治疗失败的多种实体肿瘤患者中均表现出突破性疗效，特别是在多药耐药后晚期肺癌和鼻咽癌上，客观缓解率（ORR）是目前所有治疗药物中最高的。 临床数据显示，在EGFR突变非小细胞肺癌患者中，BL-B01D1客观缓解率（ORR）达52.5%，疾病控制率（DCR）达87.5%，而目前标准治疗ORR为26.7%—48.1%；在EGFR野生型非小细胞肺癌患者中，BL-B01D1的ORR达30.6%，DCR达87.1%，而目前标准治疗药物有效率仅为16.6%；在鼻咽癌患者中，BL-B01D1的ORR达37.8%，DCR达100%，而标准治疗ORR为23.5%—37.6%。 据百利天恒官网显示，BL-B01D1针对非小细胞肺癌、小细胞肺癌、鼻咽癌、食管鳞癌、乳腺癌等多种癌症开展了单药及联合用药的11项临床试验，其中，EGFR突变型非小细胞肺癌、EGFR野生型非小细胞肺癌、鼻咽癌、食管鳞癌、三阴乳腺癌、HER2-HR+乳腺癌等6项临床试验已处于Ⅲ期阶段。 图：BL-B01D1临床试验开展情况，来源：百利天恒官网 既然双抗能成药，那么多抗理论上也行得通，百利天恒除了在研的SI-B001、SI-B003等双抗外，又开发了GNC-038、GNC-039和GNC-035等3款全新机制创新药，目前均已进入Ⅰ期临床试验阶段，该3款新药是全球前3个进入临床研究阶段的四体分子，此外，还有3款未披露靶点的多抗药物处于临床前阶段。 图：百利天恒多抗临床管线，来源：公司官网 在双抗的赛道上，百利天恒不仅从双抗升级到多抗，且与ADC融合开发双抗ADC，在临床开发上，又进行双抗ADC（BL-B01D1）和双抗（SI-B003）用于多种癌症的临床试验，堪称最具备想象空间的选手。 4 同润生物：起得早又赶得巧 同润生物是药明生物在2018年孵化成立的biotech药企。据CDE官网显示，其从成立以来一共进行了CN201、CN202、CN401和CN1等4款1类新药的临床试验。 在创新药寒冬的持续下，包括MNC在内的药企均受到较大的资金压力，砍管线成了应对寒冬的必要手段，同润生物也不例外。据润生物官网显示，其目前的临床管线上仅剩下CN201和CN808002等两款产品，除了CN201处于临床试验阶段外，CN808002仍处于临床前阶段。 图：同润生物临床管线，来源：公司官网 安进的Blinatumomab作为全球首款且唯一获批的CD3/CD19双抗，至今已过去十年，但仍未有相同靶点的双抗获批上市。虽然安进经营该款药物十年，才有机会将其孵化成“十亿美元分子”，但Blinatumomab自上市以来的市场表现非常稳定，年度销售额一直持续增长，这也为CD3/CD19靶点留下了良好的印象。 国内CD3/CD19双抗管线本就不多，而作为在该赛道“起床”最早的同润生物，在应对创新药寒冬的管线调整上，最终只保留了CN201。2024年美国临床肿瘤学会（ASCO）年会上，同润生物公布了CN201治疗复发/难治性成人急性B淋巴细胞白血病（R/R B-ALL）Ⅰ期研究结果。 临床数据显示，在目标剂量达到20 mg及以上的剂量组，总缓解率达70%以上，且获得缓解的患者90%以上为MRD阴性。此外，在安全性方面，总体CRS发生率不到30%，且以1或2级为主，3级CRS发生率为3.9%，无4级以上CRS发生，入组的51例成人患者，尚未出现ICANS。 对比Blinatumomab治疗R/R B-ALL患者需24 h持续静脉输注，共28天的给药方式，CN201因增加了Fc段，半衰期较长，每周只需给药一次，且每次只需持续2—3h左右，患者依从性得到了显著提高。 优异的临床数据和颠覆市场现有CD19/CD3双抗给药方式的“临门一脚”，让急于布局自免领域的默沙东看中了CN201。 5 信达生物：铁树何时开花？ 信达生物是国内最早布局双抗管线的药企之一，但却并没有实际成绩。 尤其是这些年信达生物在双抗上的布局，略显浮躁。对比2021年以来年报中临床管线规划，不难看出信达生物在双抗布局上的彷徨。2021年报显示，信达共有6款双抗管线；而2022年报中，IBI-321、IBI-319和IBI-315消失不见；2023年报中，之前的IBI-323又消失不见。 图：信达生物双抗管线产品变化，来源：锦缎研究院 加上在2021年消失不见的IBI-318，信达生物一共砍掉了5个双抗管线产品。更有意思的是，信达生物砍双抗管线的同时，可整体双抗管线布局却是增加的。2022年和2023年增加的4款双抗产品中，除了三抗IBI3003用于治疗肿瘤领域，其他3款分布在眼科和自免领域，而此前，其双抗布局为单一的肿瘤领域。 信达之所以这么做，或许是看到了罗氏Faricimab的潜力。Faricimab首个不完整年度的销售额就达到了6.88亿美元，今年上半年更是创下21.54亿美元的销售佳绩，这让信达生物也看到了VEGF双抗在眼科领域的巨大前景。为了在眼科双抗赛道上分一杯羹，信达双抗注意力也逐渐从肿瘤转移到眼科。 同写意媒体矩阵，欢迎关注↓↓↓