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给阿基米德一个支点，他就能撬起整个地球。德琪医药恰是学到了阿基米德的精髓，在AI技术如日中天的当下，给市场送出了“转型AI”的支点，换来的则是股价一度超500%的爆发上涨。AI技术最终能否顺利落地尚未可知，但被市场长期看衰的德琪医药，却已经通过“AI概念”实现股价层面的逆天改命。不过，制药行业多年的发展历程证明，热点从来都无法改变医药行业本身发展节奏。更为扎心的是，当热点过后，往往落地一地鸡毛。就如5年前疯狂立项的PD-1/L1、3年前火爆的ADC，热度消失之后便是盲目上马项目的阵痛以及不得不砍掉管线的懊悔。紧跟AI制药热点的德琪医药，会重蹈前辈们的覆辙吗？01壮志未酬遥想当年，德琪医药也算是资本市场的一颗明星。自2017年成立到2020年的短短三年时间，德琪医药便完成了三轮融资，累计融资金额2.38亿美元。带着一众投资人的期许，德琪医药顺利在2020年完成IPO。纵观德琪医药IPO时的基石投资者，不乏药明康德、博裕资本、启明创投等业界大佬。一家Biotech的成败，取决于多个方面，科研人才、资金储备、研发战略以及时势变化等，不过最终这些因素都会汇集到研发管线的布局上。可这么多年过去了，眼看着其他在同一时期成立与发展的Biotech，如康方生物、诺诚健华、亚盛医药的核心产品一个接一个地获批，而德琪医药的管线推进则显得后劲不足。目前，德琪医药的研发管线专注于肿瘤学及免疫学，包括一款商业化阶段产品、5个临床及多个临床前阶段项目。其中，6款产品具有全球权益，3款产品具有包括大中华区在内的亚太权益。图：德琪医药在研管线，来源：公司财报塞利尼索是德琪医药的拳头产品，也是全球首款被美国FDA获批的XPO1抑制剂，用于治疗难治复发多发性骨髓瘤和难治复发弥漫性大B细胞淋巴瘤。该药自Karyopharm公司引进，其全新的作用机制是真正意义上的First-in-Class。然而，机制层面的独家却并没有转化为营收层面的放量，塞利尼索在商业化第三个完整年度，仅贡献0.92亿元营收。尽管塞利尼索已在中国内地、韩国、新加坡、澳大利亚、马来西亚、泰国、中国台湾、中国香港、中国澳门及印度尼西亚获批上市，而且已经有2种适应症4种给药方式获批，但这款药物的销售却始终没有放量，致使大批投资者悻悻而归。但好的一方面是，商业化层面遇到的阻力，并没有打击德琪医药对于未来的布局。除塞利尼索外，德琪医药还拥有Claudin 18.2 ADC药物ATG-022、mTORC 1/2抑制剂ATG-008、PD-L1/4-1BB双特异抗体ATG-101等临床管线。而在临床前，德琪医药通过TCE（T细胞衔接器）技术平台AnTenGager开发了9个临床前项目，主要是围绕CD3靶点开发的双抗药物。图：AnTenGager技术平台作用机理，来源：公司官网虽然TCE已经在血液瘤领域展现出良好疗效，但由于不理想的疗效和较高的CRS风险，TCE在实体瘤治疗中的应用仍非常有限。而德琪医药的新型“2+1”TCE技术平台AnTenGager可通过诱导疾病相关抗原（DAA）依赖的T细胞结合和激活，在实现较强活性的同时降低发生CRS的风险，还可实现与DAA（包括表达水平较低的DAA）的二价结合。正所谓，单抗看靶点，双抗看平台。德琪医药在AnTenGager平台的布局，显然是考虑了企业长远发展的，但可惜这并不能拯救德琪医药岌岌可危的股价。今年年初的时候，德琪医药股价一度暴跌至0.5港元，几乎被市场完全边缘化。02壮士断臂引进塞利尼索，德琪医药就是希望借助XPO1靶点的稀缺性，跑通国内市场的商业化网络。但从最终的结果看，塞利尼索显然并没有完成这样的目标。德琪医药长期挣扎的根源，就在于塞利尼索的商业化成绩上。塞利尼索于2021年12月在中国获批，首个适应症为与地塞米松联用，用于治疗既往接受过治疗且对至少一种蛋白酶体抑制剂，一种免疫调节剂以及一种抗CD38单抗难治的复发或难治性多发性骨髓瘤；2024年7月，新增获批用于治疗复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）成人患者。商业化后的首个完整年度（2022年），塞利尼索实现收入1.6亿元，但当时德琪医药用于产品市场推广的费用却高达2.19亿元。考虑到德琪医药是从零开始建立商业化网络，因此这样“赚钱买吆喝”的做法也是能够理解的，只要塞利尼索能够持续放量，那么德琪医药的早期投入是能够有所回报的。图：塞利尼索商业化情况，来源：锦缎研究院不过，德琪医药并没有持续坚持这种策略，而是在2023年就主动“壮士断臂”。2023年，德琪医药为了让塞利尼索顺利进入国家医保目录，主动下调了塞利尼索的价格，降价幅度高达37%。同时，德琪医药猝不及防地将塞利尼索的商业化权利交给了翰森制药，获得2亿元首付款，以及最高达5.35亿元的里程碑付款。这一无奈的决定，实际上是德琪医药基于现实的理性考量。一款创新药如果无法顺利进入医保，就无法触及最广大的患者，很快就会被其他方案替代。但如果进入医保，作为需要从头建立销售网络的Biotech，成本压力巨大，需要投入更多的人力成本和资源，下沉到各级省市乃至县镇，光是销售费用能不能捞回来都不好说。而且塞利尼索并没有展现出“爆款”实力，与其重仓押注这款药物，倒不如将其商业化交给BigPharma，一方面回流了资金，另一方面又可以聚焦于自身更擅长的研发领域。但是这么做也是有代价的，那就是大幅度削减了市场对于德琪医药未来产品商业化的预期，就算德琪医药后续产品能够顺利上市，也极有可能会继续委身他人。在资本寒冬里，任何负面消息都会被市场放大，这种预期的下调，造成了德琪医药股价的持续暴跌。过多的精力放在塞利尼索的商业化上，浪费点钱培养商业化渠道倒是小事，最怕的是分心之后，时间流逝了就再也追不回来。所以，德琪医药放弃商业化的做法，虽然很痛，但其实也并没有太多问题。03用AI做药引子德琪医药本想大展宏图，但被现实狠狠打脸。在放弃塞利尼索商业化权利后，德琪医药短期投资价值消失殆尽，而其AnTenGager技术平台又是布局长远，因此德琪医药急需做的事情就是如何重新吸引市场的注意力。今年2月9日，DeepSeek横空出世，成为现象级产品。仅仅十天之后，德琪医药就突然宣布计划加大投入，整合资源成立专门的AI部门，包括本地部署DeepSeek以加速具有空间位元阻遮蔽效应的T细胞衔接器（TCE）平台后续管线研发。“AII IN AI”的做法，果然吸引了市场的目光，德琪医药股价在随后持续拉升，直至今日依然势头未减。对于加大AI投资，德琪医药解释称，早在2021年就以天使投资人身份投资杭州德睿智药AI药物发现平台，切入AI药物发现赛道，并利用AI能力开发出若干小分子产品，还通过AI资料模型结合多组学分析，发现全新肝癌相关抗原（TAA），并将其开发为TCE候选药物进入临床前验证阶段。虽然德琪医药介绍了公司与AI技术的渊源，但其最后还是落脚于TCE平台的验证，言外之意就是我兜里还有被市场忽视的TCE平台。正所谓，项庄舞剑意在沛公。德琪医药布局AI，本意在重新激活市场对于TEC平台的关注。以创新药BD趋势看，时代的脚步已走到TCE双抗爆发的前夜。2024年下半年以来，诸多重磅TCE双抗License-out，相较于当年ADC出海盛况有过而无不及。2024年8月，嘉和生物授出GB261（CD20xCD3双抗）、同润生物授出CN201（CD3xCD19双抗）；2024年9月，岸迈生物授出EMB-06（BCMA×CD3双抗）；2024年10月，恩沐生物授出（CD3xCD19xCD20三抗）；2024年11月，维立志博授出（CD19xBCMAxCD3三抗）、康诺亚授出CM336（BCMA x CD3）。与常规IgG相比，TCE被认为比Fc介导的ADCC（细胞杀伤作用）更有效；与ADC相比，TCE的细胞毒性依赖于宿主的免疫系统，而不是化学有效载荷的细胞毒性，且主要攻击休眠状态和积极分裂的癌细胞，安全性更好；与CAR-T相比，则更具便利性、可及性和成本优势。图：TCE双抗原理示意图，来源：开源证券面对TCE这个风口，德琪医药显然是并不想错过的。通过AnTenGager技术平台，德琪医药已经储备了9个临床前项目，这可是一系列拥有BD潜能的资产，也是德琪医药扭转乾坤的关键。热点终有一天会过去，但有价值的资产则不会。随着AI风口的消退，人们会逐渐忘却德琪医药今天“蹭热点”的行为，会记住德琪医药拥有的“TCE资产”。AI制药这剂药引子，或许真的能盘活整个德琪医药的大盘。 喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~免责声明“汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。信息来源：医曜往期推荐本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

SHANGHAI and HONG KONG, March 21, 2025 /PRNewswire/ -- Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) today announced its full-year results for the period ending December 31, 2024, along with several significant milestones achieved in recent months. Dr. Jay Mei, Antengene's Founder, Chairman, and CEO, stated, "To Antengene, 2024 was indeed an extraordinary year in which we achieved remarkable progress on multiple fronts, including clinical development, R&D and commercialization. ATG-022, our Claudin 18.2 antibody-drug conjugate that is being evaluated in a Phase II study in Australia and China, has shown highly differentiated clinical potential, demonstrating efficacy not only in gastric cancer patients with mid to high Claudin 18.2 expressions, but also unprecedented clinical benefit for patients with low or ultra-low expressions. Furthermore, AnTenGagerTM TCE 2.0, Antengene's proprietary platform incorporating steric hindrance-masking technology, has shown impressive capabilities, with its preclinical data demonstrating a significantly more favorable safety profile than those of the first-generation TCE platforms, and potential clinical efficacy covering solid tumors, hematologic malignancies and autoimmune diseases. We will seek various forms of collaboration with global partners around this technology platform in order to fully unlock its potential value. ATG-201, a CD19 x CD3 TCE 2.0 developed on the AnTenGageTM TCE 2.0, is poised to enter clinical development in the second half of 2025. In addition to the rapid progress in R&D and clinical development, we also achieved impressive results in commercialization. Our first approved product, XPOVIO®, has clearly picked up momentum in its global expansion while having its second indication approved and included in the NRDL in China. Also during the reporting period, XPOVIO® was included for reimbursement in South Korea and Taiwan China, and approved for commercialization in Malaysia, Thailand, and Indonesia. To date, XPOVIO® has been approved in 10 APAC markets and included for reimbursement coverage in 5 of those markets. Currently, the company has a cash reserve of RMB 900 million which is sufficient to fund its continued operations over the next three years even without future revenue income. We look forward to updating you all on our progress in 2025, with the next one being the latest results on the AnTenGageTM TCE 2.0, scheduled for release at this year's AACR Annual Meeting." 1. Claudin 18.2 ADC Demonstrates Significant Clinical Value, with Multiple Programs Advancing Steadily at the Clinical Stage ATG-022（Claudin 18.2 Antibody-Drug Conjugate, ADC） Unique Therapeutic Potential: ATG-022 is a highly differentiated ADC demonstrated efficacy across the broadest range of CLDN18.2 expression levels. Clinical data show that ATG-022 not only effectively targets gastric cancer patients with high CLDN18.2 expression but is also effective in tumors with low and ultra-low CLDN18.2 expression. Additionally, ATG-022 has shown better safety profile without accumulative systemic toxicities, and much fewer dose-limiting toxicities and lower high grade adverse effects compared to other CLDN 18.2 ADCs in similar clinical development stages. It also has received two Orphan Drug Designations (ODDs) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric and pancreatic cancer. Ongoing CLINCH study: As of November 22, 2024, among 21 gastric cancer patients in the dose expansion phase with CLDN18.2 expression at IHC 2+ ≥ 20% achieved an Objective Response Rate (ORR) of 42.9% and a Disease Control Rate (DCR) of 95.2% (9 patients had Partial Responses [PR], 8 of which were confirmed; 11 patients had Stable Disease [SD]). Additionally, 10 patients with CLDN18.2 expression at IHC 2+ < 20% treated at efficacious doses of 1.8 – 2.4 mg/kg had an ORR of 30.0% (1 patient achieved a Complete Response [CR], 2 achieved PR, and all confirmed CR/PR cases had CLDN18.2 expression IHC 2+ < 5%), with a DCR of 50.0%. The patient who achieved a CR has demonstrated sustained remission and has been in the study for over 14 months as of the data cut-off date. The Phase II CLINCH study is progressing smoothly in China and Australia. Other Clinical Stage Programs ATG-037 (CD73 Small Molecule Inhibitor): ATG-037 has demonstrated pre-clinically the ability to overcome the "hook effect" that can limit efficacy and is commonly seen in anti-CD73 antibodies. Antengene entered into a global clinical collaboration with MSD and is currently evaluating this molecule in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with anti-PD-1 resistant melanoma and non-small cell lung cancer (NSCLC). At the 2024 European Society of Medical Oncology (ESMO) Congress, clinical data from the ongoing Phase I STAMINA dose-escalation study were presented in a Mini Oral session. As of the latest data cut-off date on November 27, 2024, among the 26 evaluable patients with prior anti-PD-1 resistance who received ATG-037 in combination with pembrolizumab, 9 had NSCLC and 11 had melanoma. Among these patients, the ORR is 35% and DCR is 85%. These data indicate that ATG-037 has the potential to reverse anti-PD-1 resistance during the dose-escalation phase. Currently, the Phase II STAMINA dose optimization and expansion study is progressing smoothly in China and Australia. ATG-031 (Anti-CD24 Monoclonal Antibody): ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter clinical trials for cancer in the U.S. ATG-031 works by blocking CD24-Siglec10 and enhancing macrophage-mediated phagocytosis of cancer cells. Key study sites of ATG-031 include four renowned cancer centers in the United States: MD Anderson Cancer Center at the University of Texas, University of California, San Francisco (UCSF), University of Colorado, and Yale Cancer Center. The Phase I PERFORM study is progressing smoothly in the U.S. 2. The Exciting Proprietary AnTenGagerTM TCE 2.0 with Steric Hindrance-masking Technology Next-Generation TCE Platform: The AnTenGagerTM TCE 2.0 is Antengene's proprietary "2+1" TCE platform which features a steric hindrance-masking technology designed to enable disease-associated antigen (DAA)-dependent T-cell activation. This approach is intended to achieve potent therapeutic activity while reducing the risk of cytokine release syndrome (CRS). Compared to first-generation TCE platforms, AnTenGagerTM TCE 2.0 offers better safety and has broader applicability in different indications such as in solid tumors, hematological malignancies, and autoimmune diseases. Additionally, AnTenGagerTM TCE 2.0 has a longer half-life, which allows for reduced dosing frequency and improved clinical convenience. The company will continue to advance the development of AnTenGagerTM TCEs. Global Collaborations: Antengene will seek a range of collaborations with its global partners for the AnTenGageTM TCE 2.0, through platform access, co-development, and out-licensing, in order to enable the accelerated development of an ecosystem around TCE therapeutics and maximize the value of the technology platform. ATG-201 (CD19 x CD3 TCE 2.0): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed using the AnTenGagerTM TCE 2.0 for the treatment of B cell related autoimmune diseases. In preclinical studies, ATG-201 demonstrated superior B-cell depletion compared to benchmark molecules, along with reduced cytokine release. The company expects ATG-201 to enter clinical development in the second half of 2025. Antengene will continue to advance other preclinical programs, including ATG-042 (a selective PRMT5 inhibiting targeting MTAP-null tumors), ATG-106 (CDH6 x CD3 TCE 2.0) for ovarian and renal cancer, and ATG-110 (LY6G6D x CD3 TCE 2.0) for microsatellite stable (MSS) colorectal cancer. 3. Accelerating Global Expansion: Covering 10 APAC Markets Mainland of China: In July 2024, XPOVIO® received approval for a second indication in Mainland China, providing a new treatment option for Chinese DLBCL patients. In November 2024, this indication was included in the National Reimbursement Drug List (NRDL). As of now, both approved indications of XPOVIO® in China are covered under national insurance, further expanding patient access. South Korea: In June 2024, XPOVIO® received national reimbursement approval in Korea, effective from July 1, 2024. In October 2024, XPOVIO® was approved for an additional third indication in Korea. The company is actively working to expand reimbursement coverage for more indications in Korea. Taiwan Market: In February 2025, XPOVIO® received national reimbursement approval in Taiwan market, making it the fifth APAC market to secure reimbursement coverage after mainland of China, South Korea, Australia, and Singapore. ASEAN Markets: Since August 2024, XPOVIO® has been successively approved in Malaysia, Thailand, and Indonesia, marking significant progress in Antengene's commercialization strategy across the APAC region. XPOVIO® is now approved in 10 countries and regions across APAC for multiple indications. 4. Strong Cash Reserves to Support Continuous Growth As of December 31, 2024, the company held RMB 900 million in cash and bank balances, which is sufficient to fund the company's continuous growth and operations over the next three years even without additional financing. To learn more about the annual financial results of 2024, please see the full announcement on the "Investor Relations" section of the website. About Antengene Antengene Corporation Limited (" Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of " Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted new drug applications (NDAs) in 11 Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2024, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED