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商业化与研发创新双轮驱动公司高质量发展 美国罗克维尔和中国苏州 2024年3月21日 /美通社/ -- 信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、代谢及心血管、自身免疫、眼科等重大疾病领域创新药物的生物制药公司，公布2023年度业绩和公司进展。 信达生物制药集团创始人、董事长兼 CEO 俞德超博士 表示："2023年是公司新十年发展中实现重要转折的一年，实现了多方面高质量进展，包括：收入实现快速增长，营运效益持续提升，财务表现显著改善，ESG管治水平不断提高，保障了我们业务的长期可持续发展。于过去一年，公司创新研发重要进展频出，肿瘤和综合产品线并进，全球创新潜力管线加码布局，加固了我们全球创新的战略定位。公司将在新十年坚定两大发展战略—可持续成长和全球创新，保证商业运营的高质量成长和产品管线的持续拓宽，也希望与业界同仁一起努力，研发出更多的创新药，为我们的患者、员工、股东及社会持续创造价值。" 公司收益显著提升，财务指标大幅改善 收入加速增长，再创新高： 2023年实现总收入人民币 62.06 亿元，同比增长 36.2% ；产品收入人民币 57.28 亿元，同比增长 38.4% ，充分展现公司创新产品组合的强劲市场需求及可持续业务模式优势。 公司收益显著提升 ,财务指标大幅改善： 得益于收入的快速增长，以及精益运营各方面效率持续提高，各项核心财务指标和盈利能力得到大幅改善，2023年实现： 销售费率49.3%，同比下降7.3个百分点 行政开支比率8.8%，同比下降5.3个百分点 研发投入19.75亿元；现金储备109.70亿人民币（折合约15亿美元），为公司持续专注长期发展提供坚实保障 息税折旧及摊销前净亏损（EBITDA Loss）6.00亿元，同比大幅缩减73.0% 注：本文提及的财务数据均采用非国际财务报告准则计量，详情请参阅集团业绩公告。 巩固肿瘤领先地位，构建 CVM领域商业化平台 商业化产品增至十款，持续拓展新适应症、新市场及医保覆盖，提升用药可及性 [1] , [2] ： 达伯舒 ® 、达攸同 ® 、苏立信 ® 、达伯华 ® 、达伯坦 ® 、耐立克 ® 、希冉择 ® 、睿妥 ® 、 信必乐 ® （新增，用于治疗高胆固醇血症和混合血脂异常）、 福可苏 ® （新增，用于治疗复发难治性多发性骨髓瘤）； 达伯舒 ® 七项获批适应症均已成功纳入国家医保药品目录（NRDL），也是目前NRDL中唯一用于治疗一线胃癌及EGFR突变非小细胞肺癌的PD-1抑制剂；亦于2024年2月澳门市场获批； 耐立克 ® 首个适应症成功纳入NRDL，新获批第二项适应症，扩大受益CML患者群体； 达攸同 ® 、苏立信 ® 、达伯华 ® 所有新增适应症纳入NRDL。 打造肿瘤和综合产品线两大增长动力： 肿瘤产品线：达伯舒 ® 在内8款产品、近3,000人成熟商业化团队、覆盖全国、卓越专业的品牌形象，巩固肿瘤领域领导地位； 综合产品线：数年战略性布局，涵盖心血管及代谢（CVM）、自身免疫、眼科等疾病领域，以期为公司长期成长新添增长动力； 在CVM领域系统制定平台架构及商业化策略，有序建立商业化能力、人员和配套支持，保障多款高潜力后期产品管线的价值释放，建立长期品牌形象和竞争优势。 后期开发及早期创新并进，里程碑进展频出 8个产品在上市申请（NDA）或关键注册临床，18个产品进入临床研究 肿瘤：深化协同价值，加速全球创新 两款肺癌靶向药物 NDA优先审评中，预计2024年获批 IBI344 (ROS1，他雷替尼) ：一线及二线ROS1突变肺癌 IBI351 (KRAS G12C，氟泽雷塞) ：二线KRAS G12C突变肺癌 发挥"IO+ADC"双项优势 达伯舒 ® （ PD-1）： 达成多项联合治疗临床试验合作，与多款ADC联用探索治疗实体瘤 IBI343 (CLDN18.2 ADC) ： 将准备开展三线胃癌首个多中心临床3期研究；胰腺癌概念验证（Proof of Concept, PoC）研究进行中 IBI310 (CTLA-4)： 联合达伯舒 ® （PD-1）启动结肠癌新辅助临床3期研究 多款双抗、三抗及 ADC进入早期临床探索 IBI363 (PD-1/IL-2)： 多个IO耐药/不响应瘤种取得初步PoC数据；准备启动美国临床2期研究 IBI389（CLDN18.2/CD3）、IBI334 (EGFR/B7H3)、IBI3003 (GPRC5D/BCMA/CD3)、IBI3001（EGFR/B7H3 ADC）、IBI130  (TROP2 ADC)、IBI133 (HER3 ADC)等一系列具有全球创新潜力的创新分子 代谢与心血管：多款新一代产品取得重要进展 信必乐 ® （ PCSK9) ： 唯一获批中国原研 PCSK9单抗，治疗高脂血症 玛仕度肽 (GLP-1R/GCGR) ： 全球首个处于 NDA阶段的新一代GLP-1R/GCGR双靶点激动剂，首个减重适应症已递交上市申请，五项临床3期研究和更多研究进行中 IBI128 (XOI): 新一代痛风高尿酸血症候选分子，海外 MRCT 3期临床研究进行中，2024年启动中国1/2期临床研究 IBI3016（AGT siRNA）: 新一代高血压小核酸疗法，与圣因生物共同开发， 2024年启动1期 更多早期项目即将进入 IND， 扩大 CVM战略地位和竞争优势 自身免疫：立足全球未满足的临床需求 IBI112 (IL-23p19) ：潜在最佳的疗效优势和延长给药间隔，3期银屑病注册临床2024年将读出数据并申报NDA IBI353 (PDE4） ：口服治疗银屑病及特应性皮炎，海外 2期临床研究读出积极信号 IBI355（CD40L）、IBI356 (OX40L)、IBI3002 (IL-4Rα/TSLP)： 特色创新性免疫分子进入临床，探索全球自免细分领域，包括原发性干燥综合征 (pSS)、系统性红斑狼疮(SLE)、特应性皮炎(AD)、哮喘等疾病的未满足临床需求 眼科：致力提升治疗标准 IBI302 (VEGF/C) ：临床3期研究启动，治疗新生血管性年龄相关性黄斑病变，长间隔给药有望实现优异疗效，潜在改善黄斑萎缩 IBI311 (IGF-1R) ： 临床 3期研究达终点，甲状腺眼病突眼改善显著，安全性良好，计划2024年递交NDA IBI324（VEGF-A/ANG-2）、IBI333（VEGF-C/VEGF-A） ：临床 1期研究探索差异化临床价值 坚持全球创新，保持战略定力 研发引擎—国清院 ： 2023年成功交付8款创新分子进入IND准备阶段 肿瘤及综合产品线立项均衡布局、共同引领创新浪潮 国际顶级国际学术期刊 /会议发表 ,其中： IBI363 (PD-1/IL-2)的临床前研究发表于Nature Cancer IBI334（EGFR/B7H3）,IBI343 (CLDN18.2 ADC), IBI3001 (EGFR/B7H3 ADC) 的临床前研究入选 2024年AACR大会重磅研究（Late-Breaking Research） 大规模产能，坚守高质量生产标准 苏州基地 6万升抗体产能和ADC产业化生产线，保障高质量产能供应 杭州基地 17万升抗体产能（一期8万升已建成，二期9万升规划中），可保证全球供应 上海研发中心 2024年启用 切实践行 ESG承诺，承担企业社会责任 MSCI ESG评级跃升至A，在中国医药行业处于领先水平 加强 ESG管理实践，探索可持续发展道路，积极响应联合国可持续发展目标（SDGs），持续推进"卓越治理"、"惠享健康"、"品质为先"、"以人为本"和"绿色生态" 截止目前，信达生物创新产品已惠及 250万患者，其中患者援助项目已惠及17余万普通患者，药物捐赠总价值超34亿元人民币 积极开展校园招聘，累计为应届生提供 1600多份就业岗位 截至目前，信达生物制药集团共纳税超 30亿人民币，为推动经济发展和社会建设做出贡献 关于信达生物 "始于信，达于行"，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于开发、生产和销售肿瘤、代谢及心血管、自身免疫、眼科等重大疾病领域的创新药物。公司已有10款产品获得批准上市，同时还有3个品种在NMPA审评中，5个新药分子进入III期或关键性临床研究，另外还有18个新药品种已进入临床研究。公司与海内外药企深入合作加速药物创新，与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson癌症中心等国际合作方达成30多项战略合作。 信达生物在不断开发创新药物、谋求自身发展的同时，始终心怀科学善念，坚守"以患者为中心"，心系患者并关注患者家庭，积极履行社会责任。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。 详情请访问公司网站：www.innoventbio.com或公司领英账号www.linkedin.com/company/innovent-biologics/。 声明： 信达不推荐任何未获批的药品 /适应症使用。 前瞻性声明 本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用"预期"、"相信"、"预测"、"期望"、"打算"及其他类似词语进行表述时，凡与本公司有关的，目的均是要指明其属前瞻性表述。本公司并无义务不断地更新这些预测性陈述。 这些前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。 [1] 达伯舒 ® ：一线食管癌、一线胃癌获納入2022年版NRDL（2023年3月生效）；EGFR突变非小细胞肺癌获纳入2023年版NRDL（谈判目录，2024年1月生效）；耐立克 ® 新药首个适应症纳入2022年版NRDL（谈判目录，2023年3月生效）；达攸同 ® 、苏立信 ® 、达伯华 ® 所有适应症纳入NRDL（常规目录）。 [2] 达伯舒 ® 新增的医保支付范围为： 表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗失败的 EGFR 基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC） 患者的治疗； 不可切除的局部晚期、复发或转移性食管鳞癌的一线治疗； 不可切除的局部晚期、复发或转移性胃及胃食管交界处腺癌的一线治疗。

A transformative year of strong performance and material innovation progress ROCKVILLE, M.D. and SUZHOU, China, March 20, 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 2023 annual results and major business updates. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated:"2023 marked a transformative year for Innovent with material progress. We delivered strong revenue growth, improved operational efficiency and financial performance, and enhanced ESG management practices that underline our sustainable business model. Concurrently, we have achieved material innovation progress in both late- and early-stage R&D development, advanced pipeline portfolio across oncology and general biomedicine, and broadened our global pipeline development scope, reinforcing our global innovation strategy. These achievements underscore the dedication to our strategic goals in the second decade – sustainable growth and global innovation. We will continue our high-quality business growth and advance global innovation progress, and create sustainable value for patients, employees, shareholders and society." Solidified business operations with strong revenue performance and improved financials Strong revenue growth: total revenue RMB6,206.1 million in the year of 2023, an increase of 36.2% compared with the year of 2022; product sales revenue RMB5,728.3 million in the year of 2023, an increase of 38.4% compared with the prior year, reflecting robust demand for our innovative portfolio and the advantage of our sustainable business model. Enhanced operational efficiency and financial performance : EBITDA Loss was significantly narrowed, whose key drivers include strong revenue growth, enhanced operational efficiency and remarkable financial improvement. The selling and marketing expenses of total revenue was 49.3%, a year-over-year decrease of 7.3 percentage points The administration and expenses of total revenue was 8.8%, a year-over-year decrease of 5.3 percentage points R&D expenses was RMB1974.9 million; cash and short-term financial assets was RMB10969.6 million, or approximately USD1.5 billion, which enables us to focus on the long-term sustainable development EBITDA loss was RMB600.1 million, a notable year-over-year decrease of 73.0% Note: The financial numbers mentioned above were based on non-IFRS measure. Detailed disclosure can be found at the Company's 2023 annual results announcement. Solidify oncology leadership; build CVM commercialization capability Expansion of commercial portfolio into new approved products, new indications and broader NRDL coverage[1],[2] and patient access: Ten approved products: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, Olverembatinib, CYRAMZA®, Retsevmo®, FUCASO® (new product, for the treatment of RRMM) and SINTBILO® (new product, for the treatment of hypercholesterolemia and mixed dyslipidemia). All seven approved indications of TYVYT® (sintilimab injection) were included in the NRDL. It is also the only PD-1 inhibitor in the NRDL for the treatment of GC and EGFR-mutated NSCLC. As for market expansion, TVYVT® (sintilimab injection) was newly approved in the Macau market in February 2024. Olverembatinib's first indication was included in the NRDL; and its second indication was newly approved to benefit broader CML patients. All indications of BYVASDA® (bevacizumab injection), HALPRYZA® (rituximab injection) and SULINNO® (adalimumab injection) were also included in the NRDL. Oncology and general biomedicines as key growth pillars of the company: Oncology: we have launched eight products including TYVYT® (sintilimab injection), established a mature commercial presence of nearly 3,000 employees, nationwide patient access and a well-recognized brand image. We will continue to solidify leadership and expand business in oncology. General biomedicine: we have made considerable progress in past years advancing and expanding our pipeline in general biomedicine, including cardiovascular and metabolism (CVM), autoimmune, and ophthalmology, which we believe will result in substantially increased commercial opportunities and diversified long-term growth. Therefore, as part of the strategic plan, we have been steadily establishing our commercialization capability in the CVM field with systematic approaches. We plan to implement a comprehensive structure and form strategies for key factors, such as patient access, distribution channels, and marketing activities, to ensure all capabilities, personnel and strategies are in place to facilitate effective operations of our business, and to foster long-term brand image and competitive advantage in this new area. Material innovation progress in both late- and early-stage clinical development 8 assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early Phase 1/2 clinical studies Oncology: robust leadership spanning all phases of R&D and novel modalities Deepened synergies of product portfolio with two target therapies for lung cancer under NDA priority review, which are anticipated to launch in 2024: IBI344 (ROS1, taletrectinib): 1L and 2L ROS1 positive NSCLC IBI351 (KRAS G12C, fulzerasib): 2L KRAS G12C mutated NSCLC Encouraging progress in the next wave innovation of "IO+ADC" TYVYT® (sintilimab): multiple clinical trial collaborations to explore potential of combination therapy with various ADCs for solid tumors IBI310 (CTLA-4)：plan to initiate a Phase 3 clinical trial for IBI310 in combination with sintilimab in treating neoadjuvant colon cancer IBI343 (CLDN18.2 ADC)：preparing for a MRCT Phase 3 clinical trial for IBI343 in 3L GC, subject to regulatory communications; a PoC trial in PDAC is ongoing Advancing multiple bi-/tri-specific antibodies and ADCs with global potential in early-stage clinical trials IBI363 (PD-1/IL-2) : preliminary PoC signals in multiple IO resistant/unresponsive cancer types; plan to initiate a Phase 2 clinical trial in the U.S. Multiple programs ongoing including IBI389(CLDN18.2/CD3), IBI334 (EGFR/B7H3), IBI3003 (GPRC5D/BCMA/CD3), IBI3001(EGFR/B7H3 ADC), IBI130 (TROP2 ADC), IBI133 (HER3 ADC) CVM : multiple new-generation product candidates achieved substantial R&D milestones SINTBILO® (tafolecimab injection): the first domestic self-developed anti-PCSK9 monoclonal antibody, approved for the treatment of hypercholesteremia and mixed dyslipidemia Mazdutide (GLP-1R/GCGR): globally the first GLP-1R/GCGR dual agonist in the NDA stage. First NDA of mazdutide was accepted for chronic weight management. Five Phase 3 registrational trials and more clinical trials are underway. IBI128 (XOI): potential best-in-class XOI for the treatment of hyperuricemia in gout patients. It is undergoing overseas Phase 3 clinical trials conducted by our partner LG Chem. We plan to initiate Phase 1 and Phase 2 clinical trials in China in pace with the global registrational progress. IBI3016（AGT siRNA）: a new-generation siRNA drug candidate to address unmet need in hypertension. We will collaborate with SanageneBio and plan to initiate a Phase 1 clinical trial in 2024. Next-generation projects will enter into IND-enabling stage in 2024, underscoring our dedication to expanding our strategic presence in the CVM field Autoimmune: address global unmet needs in various autoimmune diseases IBI112 (IL-23p19) : potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. We anticipate completing the Phase 3 registrational clinical trial in support of an NDA submission in 2024. IBI353 (PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis attained positive topline results. IBI355 (CD40L) , IBI356 (OX40L) and IBI3002 (IL-4Rα/TSLP): innovative autoimmune molecules entered into first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases, such as primary Sjögren's syndrome (pSS), systemic lupus erythematosus (SLE), atopic dermatitis (AD) and asthma. Ophthalmology: a long-standing commitment to elevate standard-of-care IBI302 (VEGF/C): Phase 3 study initiated for the treatment of nAMD, based on the observed stable and robust visual benefit under extended dosing interval and potential inhibition effect in macular atrophy in two Phase 2 studies. IBI311 (IGF-1R): Phase 3 clinical trial met the primary endpoint, demonstrating favorable safety and excellent efficacy; we plan to submit an NDA in 2024 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. Global innovation as unwavering long-term strategic priority Innovent Academy as the innovation powerhouse: In 2023, Innovent Academy has successfully delivered eight high quality novel molecules into IND enabling stage. A significant portion of preclinical programs lies in key non-oncology areas, including CVM, ophthalmology and autoimmune diseases, forming another important growth pillar of global innovation as oncology counterparts. Research innovation published in high-impact scientific journals and medical conferences, such as: Preclinical results publication of IBI363 in Nature Cancer Preclinical results of IBI334 (EGFR/B7H3), IBI343 (CLDN18.2 ADC), IBI3001 (EGFR/B7H3 ADC) are accepted as Late-breaking Researches by the American Association for Cancer Research (AACR) 2024 Manufacturing capacity adhering to high-standard quality: Suzhou manufacturing site: 60,000L antibody production capacity and ADC production lines in operation Hangzhou manufacturing site: 170,000L production capacity (first phase of 80,000L completed construction, second phase of 90,000L in plan) to secure global supply Shanghai R&D center will be operational in 2024 Devoted to responsible business practices and enhancing ESG management practices Innovent has been upgraded to 'A' level in MSCI ESG rating, ranking at the forefront of the biotechnology industry. In active support of the United Nations' sustainable development goals (SDGs) and in fulfilling our social responsibilities, we continued to enhance ESG management across several key dimensions, including: "Excellent governance", "Enjoying good health", "High-quality as key", "People first" and "Green ecology". About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. 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 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase 3 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. Company Codes: HongKong:1801, OTC-PINK:IVBIY, HongKong:01801