IBI-110

Remarkable achievements with accelerated growth and improved efficiency to underpin sustainable growth ROCKVILLE, M.D. and SUZHOU, China, Aug. 23, 2023 /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, metabolic, autoimmune, ophthalmology and other major diseases, announces its 2023 interim results and major company business updates. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "Today is our 12th anniversary since we incorporated Innovent in 2011. Since last year, we have clearly outlined two strategic goals for the second decade of our business operation, which are to achieve sustainable growth and global innovation. During the first half of 2023, we have made remarkable achievements that solidify our ability to establish a sustainable business foundation as Innovent is growing stronger and healthier. We achieved strong revenue performance and improved operational efficiency that underline our sustainable business model; we continued to develop a more diversified pipeline portfolio and enhanced R&D strategy that ensures sustainable growth; and we improved financial margins and maintained high resilience that help us manage risks and enjoy sustainability in the long run. These significant progresses reinforce our confidence and commitment to our strategic goals, through further expansion of commercial portfolio, improvement of operational efficiency, and innovation through advanced R&D platform for the global market. We will uphold the vision of 'to become a global premier biopharmaceutical company' and create sustainable value for patients, employees, shareholders and the society." Solidified business operations with strong revenue performance and improved financials S trong revenue growth: Total revenue RMB2 , 701 .5 million in the first half of 2023, an increase of 20.6% compared with the first half of 2022; product sales revenue RMB2,457.5 million in the first half of 2023, an increase of 20 .4% compared with the same period of prior year, with particularly stronger growth since Q2, mainly driven by fast ramp-up of product sales volume as we fully leveraged the clinical value of our novel medicines with broad NRDL coverage and a diversified oncology portfolio. Enhanced operational efficiency under a sustainable business model: We further improved the productivity and efficiency of our commercial operations. The agile organization benefits from a scientific and systematic resource allocation system that enables more mature and fast responses to the changing environment. The selling and marketing expenses was 54.5% of total product revenue in the first half of 2023, representing a decrease of 12.2% compared to 66.7% in the first half of 2022. Core financial margins improvements: Loss Before Interest, Taxes, Depreciation and Amortization ("LBITDA") decreased remarkably by 74.2% to RMB267.4 million from RMB1,035.7 million in the same period of 2022, brought by our strong revenue growth and core financials improvement attributable to the enhanced operational efficiency under a sustainable business model. Expansion of commercial portfolio into ten approved products, including: 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). NRDL coverage further expanded, benefiting broader patient groups: two additional indications (1L GC and 1L ESCC) of TYVYT® (sintilimab injection), olverembatinib for the first listing, and multiple additional indications of BYVASDA® (bevacizumab injection), HALPRYZA® (rituximab injection), and SULINNO® (adalimumab injection) were included in the updated NRDL. The updated NRDL has taken effect on March 1st, 2023. Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team: expansive coverage of over 5,000 hospitals and a well-structured commercial team of nearly 3,000 talents. The Company is also strategically establishing commercial presence in certain non-oncology therapeutic areas in light of the first approved drug SINTBILO® in cardiovascular area and accelerated development for multiple high value late-stage candidates, aimed for a more diversified and long-term growth. Broad pipeline across therapeutic areas to deliver differentiated innovation and growth potential We have built a strong pipeline with over 30 innovative drug candidates, among which 10 products are approved, 8 assets are in NDA review or pivotal registrational clinical trials, and approximately 20 assets in early Phase 1/2 clinical studies. Oncology: leverage extensive portfolio and navigate novel modalities and therapies to strengthen our foundation Pioneered the development of three drug candidates for treatment of lung cancer: IBI344 (ROS1): Ongoing pivotal Phase 2 for ROS1 positive NSCLC IBI351 (KRASG12C): Ongoing pivotal Phase 2 for KRASG12C mutated NSCLC IBI126 (CEACAM5 ADC): Ongoing Phase 3 for CEACAM5 highly expressed NSCLC Received preliminary positive data for multiple innovative molecules with global potential ： Bispecific antibodies with global innovation: IBI363 (PD-1/IL-2) and IBI389 (CLDN18.2/CD3) with preliminary positive clinical signals observed, IBI334 (EGFR/B7H3) is planned to enter first-in-human study shortly Monoclonal antibodies in PoC exploration: IBI110 (LAG3) , IBI939(TIGIT), IBI310 (CTLA-4) Deeply invested in ADC proprietary platform as a new wave of global innovation: IBI343 (CLDN18.2 ADC) : Phase 1 multi-regional clinical trial ongoing in Australia and China. IBI343 has potential best-in-class profiles with differentiated design for potential wide therapeutic window and high potency. More than 10 differentiated ADC projects in IND-enabling stage. Cardiovascular and metabolism (CVM) : first product approved and prioritized clinical development of multiple best-in-class assets based on robust data readout 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): potential best-in-class GLP-1 dual agonist. Phase 3 registrational studies of mazdutide 6mg in obesity and type 2 diabetes are ongoing. The Phase 2 clinical study of mazdutide higher-dose 9mg met the 24-week primary endpoint, showing bariatric surgery-equivalent 15.4% weight loss efficacy for moderate to severe obesity and a consistently favorable safety profile. IBI128 (XOI): potential best-in-class XOI for the treatment of hyperuricemia in gout patients, with overall superior efficacy and good safety profile. Autoimmune: select novel targets to treat unmet needs in various autoimmune diseases IBI112 (IL-23p19) : potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. The Phase 3 registrational clinical study is ongoing. IBI353 (PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis reached positive topline results. IBI355 (CD40L) and IBI356 (OX40L): innovative autoimmune molecules will enter first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases. Ophthalmology: accelerate two Phase III trials for two important assets IBI302 (VEGF/C) : Phase 3 study ready to start in the second half of 2023 for the treatment of nAMD, based on the observed longer durability and potential effect in anti-macular atrophy in Phase 2 studies. IBI311 (IGF-1R): quickly advanced into Phase 3 registrational study, eyeing on urgent unmet need in the treatment of TED in China. IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) are in the Phase 1 stage. The potential differentiation versus existing therapy brought by their innovative mechanisms and molecule designs as bispecific antibodies will be explored. Global innovation continues as core long-term strategy Innovent Academy as the innovation powerhouse continues to advance science to deliver differentiated molecules in oncology and non-oncology areas: In the first half of 2023, Innovent Academy has successfully delivered four high quality novel molecules into IND enabling stage. Further investment in our ADC platform and antibody platform, as preliminary differentiated efficacy and safety signals are observed for the FIC and BIC molecules generated from the platforms. A significant portion of preclinical programs lies in key non-oncology areas, including CVM, ophthalmology and autoimmune diseases, as another important growth pillar of global innovation as oncology counterparts. P roduct development platform utilizes scientific and efficient approaches to scout opportunities for innovative pipeline in early-stage MRCT clinical development Exploring the early-to-mid stage pipeline with global potential in ongoing PoC studies, with several molecules in the oncology and ophthalmology fields. Further explore the early clinical development of novel molecules with global potential, such as PD-1/IL-2, CLDN18.2 ADC in Phase 1 multi-regional clinical trials with preliminary differentiated clinical data observed 140,000L GMP certified production capacity which is currently one of the largest stainless steel bioreactor production capacity in China, adhering to high-standard quality compliance to GMP and providing cost advantage further strengthen our market competitiveness. Compliance and governance continued strengthening in active support to social responsibilities In active support to the sustainable development goals (SDGs) of the United Nations, we continued to adhere to the people-oriented principle, operate with integrity, take high quality as the cornerstone, follow green ecological guidance, drive development with innovation, effectively protect the rights and interests of all stakeholders, and proactively fulfill our social responsibilities. We also paid more attention to governance upgrade compliance operation, operational efficiency improvement, high-quality innovation, diversification and empowerment of employees and low-carbon development, and strived to promote inclusive healthcare, enabling more patients to have equal access to affordable, high-quality and innovative medicines. Financial Highlights for the First Half of Year 2023 Total revenue was RMB2,701.5 million, an increase of 20.6% compared to the same period of prior year. LBITDA for the reporting period was RMB267.4 million, a notably decrease of 74.2% or RMB 768.3 million from RMB1,035.7 million for the same period of prior year. Loss for the reporting period was RMB190.4 million, a notably decrease of 82.5% or RMB 894.9 million from RMB 1,085.3 million for the same period of prior year. *The remarkably decrease was mainly due to our strong revenue growth and core financials improvement attributable to the enhanced operational efficiency under a sustainable business model. *The Loss for the reporting period was mainly due to continuous investment in R&D to support our long-term strategic goal of global innovation. R&D expenses was RMB826.3 million; cash and short-term financial assets was RMB8,526.5 million, or approximately USD1.2 billion, which enables us to focus on the long-term sustainable development. About Innovent "Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. Innovent has 10 products in the market. These include: TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). In addition, one assets are under NMPA NDA review, seven assets are in Phase III or pivotal clinical trials, and 17 more molecules are in clinical studies. Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. Disclaimer: Innovent does not recommend any off-label usage. Note: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, olverembatinib, FUCASO® and SINTBILO® are not approved products in the United States. TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab injection, Innovent) HALPRYZA® (rituximab injection, Innovent) SULINNO® (adalimumab injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab injection, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Retsevmo® (selpercatinib capsules, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. 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

关键词Loncastuximab tesirine；R/R DLBCL；研究进展日前，瓴路药业（上海）有限责任公司的「注射用Loncastuximab tesirine」被CDE拟纳入优先审评，用于治疗二线或多线系统治疗后复发或难治性大B细胞淋巴瘤成年患者。Loncastuximab tesirine（Lonca，商品名Zynlonta）是一款抗体偶联药物（ADC），由与CD19结合的人源化单克隆抗体与吡咯苯二氮平（PBD）二聚体毒素偶联构成。一旦与表达CD19的细胞结合，Lonca就会被细胞内化，随后释放出细胞毒素，该毒素能不可逆地与DNA结合，从而产生阻止DNA链分离的强力链间交联，从而破坏复制等必要的DNA代谢过程，最终导致细胞死亡。2021年4月，Lonca被FDA加速批准，单药治疗经过二线或以上全身系统性治疗的复发/难治性大B细胞淋巴瘤（R/R DLBCL）成人患者，成为FDA批准的首款CD19靶向ADC。据悉，在关键性注册临床试验LOTIS-2研究中，Lonca单药治疗既往接受过≥2次治疗的R/R DLBCL 的客观缓解率（ORR）为48.3%，完全缓解率（CR）为24.1%。此外，Lonca联合利妥昔单抗（即Lonca+R方案）针对DLBCL二线及以后且不符合移植条件的患者的确证性3期临床试验LOTIS-5正在进行中。已公布的临床试验数据显示：截止2022年2月28日，随访时间中位数为5.83个月，Lonca+R疗法的ORR为75%，CR为40%。值得一提的是，LOTIS-5试验是全球首个在R/R DLBCL二线治疗中利用ADC替代化疗方案的3期注册性临床试验。Lonca由ADC Therapeutics开发的。2020年，瓴路药业与ADC Therapeutics成立合资公司瓴路爱迪思（Overland ADCT BioPharma），负责在大中华区和新加坡开发和商业化包括Lonca在内的四款ADC。2023年4月，瓴路爱迪思宣布评价Lonca单药治疗复发/难治性弥漫大B细胞淋巴瘤（R/R DLBCL）中国患者的2期注册临床试验OL-ADCT-402-001达到主要研究目的。基于该研究结果，公司向NMPA递交上市申请。关于复发/难治性弥漫性大B细胞淋巴瘤弥漫性大B细胞淋巴瘤（DLBCL）是一种来源于成熟B细胞的侵袭性肿瘤，是最常见的非霍奇金淋巴瘤类型，约占全部非霍奇金淋巴瘤的25%～50%。DLBCL患者通常表现为进行性淋巴结肿大和/或淋巴结外病变，大多数患者就诊时已为III期或IV期，60%左右的早期患者可通过R-CHOP（利妥昔单抗、环磷酰胺、多柔比星、长春新碱和泼尼松）免疫化疗方案治愈。但仍有大约30-40%患者最终进展为复发或难治性DLBCL（R/R DLBCL）。已获批的R/R DLBCL新疗法近年来，全球监管机构批准了多款R/R DLBCL新疗法，详见下表。这些新疗法涉及抗体偶联药物（ADC）、CAR-T疗法、双抗、单抗和化药，作用靶点包括CD19、CD79b、CD20、CD3和XPO1。近年来全球获批的R/R DLBCL新药来源：药渡数据库（不完全统计）Yescarta、Polivy和Zynlonta属于ADC，但作用靶点不同。其中Yescarta于2017年10月被FDA批准用于治疗既往接受二线或多线系统治疗的R/R LBCL成人患者，包括DLBCL、原发纵膈大B细胞淋巴瘤（PMBCL）、高级别B细胞淋巴瘤（HGBL），以及源于滤泡性淋巴瘤（FL）的DLBCL。Polivy于2019年6月被FDA加速批准联合苯达莫司汀和Rituxan（利妥昔单抗）用于治疗既往已接受至少2种疗法的R/R DLBCL患者，2023年4月被FDA扩大批准用于联合R-CHP方案治疗未经治疗的DLBCL患者。Zynlonta于2021年4月被FDA加速批准单药用于治疗经过二线或以上全身系统性治疗的R/R DLBCL成人患者。Kymriah、Breyanzi和瑞基奥仑赛属于CAR-T疗法，均作用于CD19靶点。其中Kymriah于2018年5月被FDA批准用于治疗接受2种或多种系统疗法后的R/R LBCL成人患者。Breyanzi于2021年2月被FDA批准用于治疗至少接受过2种其他全身疗法后无应答或者复发的大B细胞淋巴瘤成人（LBCL）患者，2022年6月被FDA扩大批准作为二线疗法，用于治疗成人LBCL，包括未指定的DLBCL（包括由惰性淋巴瘤引起的DLBCL）、高级别B细胞淋巴瘤、原发性纵隔大B细胞淋巴瘤和3B级滤泡性淋巴瘤。瑞基奥仑赛于2021年9月被NMPA批准用于治疗经过二线或以上系统性治疗后成人患者的R/R LBCL，包括DLBCL非特指型、滤泡淋巴瘤转化的DLBCL、3b级滤泡淋巴瘤、原发纵膈大B细胞淋巴瘤、高级别B细胞淋巴瘤伴MYC和BCL-2和/或BCL-6重排（双打击/三打击淋巴瘤）。Epkinly和Columvi均属于CD3/CD20靶向双抗，其中Epkinly是FDA批准的首款治疗DLBCL的双特异性抗体疗法，2023年5月被FDA加速批准用于治疗R/R DLBCL，包括由惰性淋巴瘤发展而成的DLBCL以及高级别B细胞淋巴瘤（HGBL），这些患者已经接受过两种或多种系统治疗。Columvi于2023年3月获加拿大卫生部授权，有条件用于R/R DLBCL、起源于滤泡性淋巴瘤（trFL）的DLBCL或原发性纵隔B细胞淋巴瘤（PMBCL）成人患者的治疗，患者需已接受过二线或以上的全身治疗，不适合接受或不能接受CAR-T细胞治疗或既往接受过CAR-T细胞治疗。值得一提的是，Columvi是加拿大和全球首个获批的固定治疗时间、现货型CD20/CD3 T细胞衔接双特异性抗体。Minjuvi/Monjuvi是一种新型人源化Fc结构域优化的溶细胞性CD19靶向性免疫增强单克隆抗体，2020年7月被FDA加速批准，联合来那度胺用于治疗不符合自体干细胞移植（ASCT）条件的R/R DLBCL成人患者，包括源于低级别淋巴瘤的DLBCL。值得一提的是，Monjuvi是第一个获FDA批准用于一线治疗期间或治疗后病情进展的R/R DLBCL成人患者的二线疗法。Xpovio是一种全球首创、口服、选择性核输出蛋白抑制剂，通过结合并抑制核输出蛋白XPO1发挥作用，促使肿瘤抑制蛋白在细胞核内积累，从而重新启动和放大其肿瘤抑制的功能，导致癌细胞的凋亡，同时很大程度上让正常细胞免受损伤。2020年6月，该药被FDA批准用于治疗接受过至少2种系统疗法的R/R DLBCL成人患者，包括滤泡性淋巴瘤（FL）引起的DLCBL。在研R/R DLBCL药物此外，目前全球还有多款新药被开发用于治疗R/R DLBCL，如再生元的Odronextamab、强生的JNJ-67856633、嘉葆药银的JDB175、信达生物的IBI110、倍特药业的BT-1053、默沙东的MK-2140、百利药业的GNC-038。OdronextamabOdronextamab是一种铰链稳定、基于人IgG4的CD20×CD3双特异性抗体（Ab），可结合B细胞表面的CD20和T细胞表面的CD3，从而触发T细胞介导的恶性B细胞毒性。在ELM-1研究（Ph1，NCT02290951）中，Odronextamab在既往接受≥2线治疗（LOT）的DLBCL患者中表现出令人鼓舞的活性。接受剂量≥80mg Odronextamab治疗的DLBCL患者的ORR为53%，CR率为53%。12个月时持续缓解率为88%。JNJ-67856633JNJ-67856633是强生开发的一款MALT1抑制剂，MALT-1是一种参与T细胞和B细胞淋巴细胞活化的蛋白质。目前，强生正在开展多项JNJ-67856633单药或与其它药物联合治疗的临床研究，针对的适应症包括非霍奇金淋巴瘤、慢性淋巴细胞白血病等。JDB175JDB175是一个具有高选择性的第二代BTK口服抑制剂，BTK是B细胞受体通路中的关键蛋白分子，参与B细胞的增殖、运输、趋化和黏附，在不同类型血液系统恶性肿瘤中广泛表达，抑制其活性可产生明显的抗肿瘤效应。临床前试验表明：与同类药物相比，JDB175具有良好的BTK选择抑制性，且安全性与耐受性表现良好，在DLBCL中具有很好的抗癌活性。MK-2140MK-2140是一款ROR1靶向ADC，最早由VelosBio主导开发，2020年VelosBio被默沙东以27.5亿美元收购后，并入默沙东研发管线。评估MK-2140（2.5mg/kg）单药治疗R/R DLBCL患者有效性和安全性的开放标签、单臂2期临床试验WaveLINE-004的早期结果显示：经MK-2140治疗后，患者的ORR为30%（6/20），包括2例CR和4例PR。GNC-038GNC-038是百利药业基于GNC平台开发的四特异性结构的“靶向免疫”抗体，具有靶向CD19、CD3、PD-L1和4-1BB四个抗原的结构域，可激活T细胞的第一信号和第二信号，通过抗CD19、PD-L1结构域靶向并杀伤肿瘤细胞。随着新疗法的兴起，复发或难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）的治疗迎来更多新选择。整体来看，目前已获批的新疗法作用靶点相对集中，主要是CD19、CD3/CD20，药物类型比较多样，涉及ADC、CAR-T疗法和双抗。此外，目前全球还有多款在研R/R DLBCL疗法，这些在研疗法作用靶点新颖，涉及MALT1、ROR1等，而且在研新疗法还涉及新的药物类型，如四特异性抗体。期待未来R/R DLBCL领域早日批准更多新药，给患者提供更多的治疗选择。END👇关注药渡数据媒体矩阵