PD-1 x TGF-β x VEGF

2025年9月22日，华检医疗发布公告，公司及公司附属公司ETHK Inc及ETHK HOLDINGS LIMITED与创胜集团医药有限公司Transcenta Holding Limited(创胜集团及其附属公司Transcenta Oncology Inc. (US)(统称创胜方)就潜在的创新药管线资产RWA代币化相关事项订立战略合作协议。 公告指出，此次合作涵盖创胜集团六条核心创新药管线资产——TST003、TST005、TST786、TST105、TST106 和 TST013——这些资产均已整合纳入创胜方美国实体 Transcenta Oncology Inc.，并计划通过华检医疗构建的 ETHK 全球创新药知识产权 RWA 交易所，推动这些高价值资产的代币化探索。 根据公告，该等核心创新药管线资产总估值超过 15亿美元，代表全球肿瘤治疗领域的最前沿科研方向与高技术壁垒。华检医疗将为这些资产提供从数字化发起、可信上链、合规发行到流动性对接的全流程技术解决方案，以支持该等管线资产在资本市场进行潜在的 RWA 发行。 华检医疗于7月底宣布与华大共赢（华大基因旗下投资平台）合作设立全球首个“创新药知识产权代币化基金”（IVD-BGI CoWin），计划将创新药专利收益权通过区块链代币化。自7月14日行情启动至8月12日，股价累计涨幅超500% ，市值突破150亿港元。 创胜集团目前为一家处于临床阶段的生物医药公司，具备抗体药物发现、研发、生产与临床转化的完整能力，并在肿瘤及部分非肿瘤适应症（如骨科、肾脏病）领域布局多个抗体类药物项目。集团在美国与中国均设有研发中心和临床基地，以支持其管线的高效推进。 若代币发行成功，本次合作的融资所得将重点支持以下六项创新肿瘤项目中一项或多项选定项目的开发： TST005：双特异性抗体，靶向PD-L1与TGF-β。已在美国和中国完成一期临床剂量爬坡研究。在临床前试验中，相较单独使用检查点抑制剂展现出显著更强的抗肿瘤活性，尤其是在高TGF-β肿瘤中。临床前和临床试验中展示了良好的安全性和耐受性； TST003：单克隆抗体，靶向GREMLIN-1。已在美国和中国完成一期临床剂量爬坡研究。GREMLIN-1已被证实与促进转移相关，并在多种癌症中与总体生存率呈负相关。TST003在PD-1耐药的食管癌和结直肠癌模型中作为单药显示显著抗肿瘤活性，并在前列腺癌模型中与雄激素剥夺治疗联合使用时展现出协同效应； TST786：三特异性抗体，靶向PD-1与VEGF（均在多种类型肿瘤中已获临床验证），并联合GREMLIN-1，一个促进肿瘤生长和转移的调控蛋白。TST786以同时抑制包括肿瘤转移和免疫抑制通路，有望进一步改善在PD-1×VEGF双特异性抗体已观察到的生存获益； TST105：双特异性抗体偶联药物（ADC），靶向FGFR2b和另一未公开靶蛋白，现处于临床前阶段。此双特异性ADC能偏向结合表达FGFR2b的肿瘤细胞，采用位点特异性偶联及中等强度毒素载荷，在疗效和安全性方面均优于早期的传统单抗； TST106：双特异性抗体偶联药物（ADC），靶向CLDN18.2和另一未公开靶蛋白，现处于临床前阶段。此双特异性ADC能偏向结合表达CLDN18.2的肿瘤细胞，旨在提升现有CLDN18.2靶向疗法的治疗指数，同时有望改善疗效与安全性； TST013：单靶点抗体偶联药物（ADC），靶向LIV-1，现处于临床前阶段。LIV-1是在多种类型肿瘤中已获临床验证的生物标志物。TST013具备对表达LIV-1的肿瘤细胞的更高亲和力、更低非靶点毒性，以及更强效载荷，以克服早期疗法的耐药问题。 本次战略合作不仅有望为创胜方的创新管线提前锁定价值，并在不稀释股权的前提下为研发注入新资金，也将为全球专业投资者提供一个透明、合规且高效参与全球肿瘤创新药知识产权配置的新通道。同时，该合作若能成功落地，还将加速创新疗法的可及性，使患者更早从科研突破中受益。 华检医疗董事会表示，本战略合作协议目前为意向性／非具法律约束力的框架性安排。双方将依据适用法律法规、监管审批程序及市场与技术条件，推动潜在代币发行等后续事宜正式落实。华检医疗将依照香港联合交易所上市规则及其它适用披露义务，于合适时机向市场发布进一步公告。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。 转载/商务/投稿 | 联系微信15618157102（sum_Gmi） 商务合作 稿件征集 点击了解详情 往期回顾 BD十年回顾：跨国药企的交易趋势与逻辑洞察 行业观察：裁员浪潮为什么还在席卷生物医药？ End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。 转载/商务/投稿 | 联系微信15618157102（sum_Gmi） 商务合作 稿件征集 点击了解详情 往期回顾 BD十年回顾：跨国药企的交易趋势与逻辑洞察 行业观察：裁员浪潮为什么还在席卷生物医药？

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 自願公告 有關與華檢醫療控股有限公司及其兩間子公司的戰略合作協議 探索首創真實世界資產代幣化潛在融資用於 創新腫瘤療法研發的業務進展 • 若代幣發行成功，未來的融資所得將用於加速多項創新腫瘤抗體項目的臨床 及臨床前研發 • 該創新融資模式依託於近期監管改革，借助區塊鏈技術推動創新投資機會的 普惠化 本公告由創勝集團醫藥有限公司（「本公司」）自願作出，旨在告知本公司股東及潛 在投資者有關最新業務進展。本公告所用但並無另行界定的詞彙應與本公司日期 為2021年9月14日的招股章程中所賦予該等詞彙的涵義相同。 本公司董事會（「董事會」）欣然公佈，於2025年9月21日，本公司及本公司全資子 公司Transcenta Oncology Inc.（「Transcenta Oncology」）已與華檢醫療控股有限 公司（香港聯合交易所有限公司主板上市公司，股份代號：1931）及其兩間子公司 ETHK Inc.及ETHK HOLDINGS LIMITED （統稱為「ETHK」）簽署不具法律約束 力的戰略合作協議（「合作協議」）。根據合作協議，各方同意開展戰略合作，探索 通過以太坊區塊鏈潛在發行真實世界資產代幣，以資助六項潛在「同類首創」及╱ 或「同類最佳」的腫瘤創新療法中一個或多個選定項目的臨床前及臨床開發工作。 這是生物醫藥領域首例此類融資模式。該模式得益於中美兩地近期監管政策改 革，於完成後將支持創新藥物的加速開發、更具成本效益的資本募集，並拓展投 資機會至傳統機構投資者生態之外的更廣泛的群體。 「我們非常高興能夠率先探索這一開創性的區塊鏈融資方式，加速推進公司創新的 早期腫瘤產品管線的開發，」本公司創始人、董事長兼首席執行官錢雪明博士表 示。「感謝中美監管部門所推動的前瞻性政策，我們很榮幸能夠引領生物醫藥創新 領域的普惠化投資，並加快潛在新療法的研發進程，以更快惠及患者。」 若代幣發行成功（須遵守適用法律及法規），本次合作的融資所得將重點支持以下 六項創新腫瘤項目中一項或多項選定項目的開發： • TST005：雙特異性抗體，靶向PD-L1與TGF-β。已在美國和中國完成一期臨 床劑量爬坡研究。在臨床前試驗中，相較單獨使用檢查點抑制劑展現出顯著 更強的抗腫瘤活性，尤其是在高TGF-β腫瘤中。臨床前和臨床試驗中展示了 良好的安全性和耐受性； • TST003：單克隆抗體，靶向GREMLIN-1。已在美國和中國完成一期臨床劑 量爬坡研究。GREMLIN-1已被證實與促進轉移相關，並在多種癌症中與總體 生存率呈負相關。TST003在PD-1耐藥的食管癌和結直腸癌模型中作為單藥 顯示顯著抗腫瘤活性，並在前列腺癌模型中與雄激素剝奪治療聯合使用時展 現出協同效應； • TST786：三特異性抗體，靶向PD-1與VEGF（均在多種類型腫瘤中已獲臨床 驗證），並聯合GREMLIN-1，一個促進腫瘤生長和轉移的調控蛋白。TST786 以同時抑制包括腫瘤轉移和免疫抑制通路，有望進一步改善在PD-1xVEGF雙 特異性抗體已觀察到的生存獲益； • TST105：雙特異性抗體偶聯藥物(ADC)，靶向FGFR2b和另一未公開靶蛋 白，現處於臨床前階段。此雙特異性ADC能偏向結合表達FGFR2b的腫瘤細 胞，採用位點特異性偶聯及中等強度毒素載荷，在療效和安全性方面均優於 早期的傳統單抗； • TST106：雙特異性抗體偶聯藥物(ADC)，靶向CLDN18.2和另一未公開靶蛋 白，現處於臨床前階段。此雙特異性ADC能偏向結合表達CLDN18.2的腫瘤 細胞旨在提升現有CLDN18.2靶向療法的治療指數，同時有望改善療效與安 全性；及 • TST013：單靶點抗體偶聯藥物(ADC)，靶向LIV-1，現處於臨床前階段。 LIV-1是在多種類型腫瘤中已獲臨床驗證的生物標誌物。TST013具備對表達 LIV-1的腫瘤細胞的更高親和力、更低非靶點毒性，以及更強效載荷，以克服 早期療法的耐藥問題。 關於Transcenta Oncology Transcenta Oncology Inc.註冊於美國特拉華州，是本公司的全資子公司，專注於 針對臨床驗證靶點快速開發創新生物藥物，以推動腫瘤治療的變革。 警示聲明：我們無法保證我們將能成功開發及最終成功銷售TST005、TST003、 TST786、TST105、TST106及TST013。本公司股東及潛在投資者在買賣本公司股 份時務請審慎行事。 一般事項 本公司股東及潛在投資者應注意，合作協議僅列明各方對可能合作之意向，並不 具法律約束力。如達成及╱或簽訂具法律約束力之正式協議，本公司將遵照香港 聯合交易所有限公司證券上市規則之規定於適當時候作出進一步公告。 本公司股東及潛在投資者於買賣本公司股份時務請審慎行事。 承董事會命 創勝集團醫藥有限公司 執行董事、主席兼首席執行官 錢雪明 香港，2025年9月22日 於本公告日期，本公司董事會成員包括執行董事、主席兼首席執行官錢雪明博 士，非執行董事徐莉博士以及獨立非執行董事唐稼松先生、張志華先生、Kumar Srinivasan博士及陳瑋女士。

Akeso CEO Michelle Xia, who worked in the lab during the biotech’s initial stages after founding. Courtesy Akeso From a small team of researchers and skipped salaries, CEO Michelle Xia has steered Akeso to become one of the most exciting companies in the industry today. When Akeso was starting out some 13 years ago, the leadership team had $3 million and a bold goal to move China’s drug industry toward innovation. “When Akeso was first established, China’s biopharmaceutical industry was still in its infancy,” CEO Michelle Xia told BioSpace in an email interview. “To put it simply, very few were engaged in innovative drug discovery at that time; the sector was overwhelmingly dominated by generics. Against this backdrop, pursuing innovative drug development required tremendous effort.” As Xia tells it, China during the early 2010s had no “mature ecosystem for innovation.” The local industry amounted to companies that made generic versions of drugs that had already launched in Western countries years earlier. Over the years, however, Akeso has grown explosively to become one of the leading faces of an ascendant Chinese biotech industry. Today, the company is worth more than $15 billion—a far cry from the $3 million angel fundraising that kicked things off for Xia and her team. In large part, Akeso’s recent worldwide renown is thanks to its partnership with California-based Summit Therapeutics, which in December 2022 paid $500 million upfront plus up to $5 billion in potential milestones to partner with the rising Chinese star. At the heart of this partnership is ivonescimab, an asset that in the past year has not only arrested the attention of the biopharma industry but has also come to symbolize an emerging approach to cancer. Ivonescimab is a bispecific antibody that targets two key cancer pathways. It blocks PD-1 signaling, preventing cancer cells from evading the immune system, and inhibits the VEGF cascade, which tumors use to create new blood vessels to supply nutrients and oxygen, supporting unchecked growth. In September last year, Akeso and Summit announced that ivonescimab bested Merck’s Keytruda, a cornerstone cancer therapy, in a Phase III study of non-small cell lung cancer (NSCLC). That clinical win cemented Akeso as a serious global contender, but Xia insists that the biotech is much more than ivonescimab and a signal of China’s biotech boom. Akeso’s beginnings may have been humble, but Xia’s dreams for the company are big. A ‘Natural’ Choice When Xia returned to China in 2008, striking out on her own was never part of the plan. A biochemistry graduate of Sun Yat-sen University, Xia had spent more than two decades away from home. She had picked up postgraduate degrees from Newcastle University and Glasgow University in the U.K. before finding her way to the United States in 1996 to focus on cancer immunotherapy at the University of Louisville. Akeso CEO Michelle Xia/ Courtesy Akeso Eventually, Xia decided to leave the confines of academia and test her mettle in industry. She went through a couple of companies—Bayer among them, as a senior scientist in 2006—before settling down at Crown Bioscience, a contract research organization focused on oncology and immuno-oncology. There, she climbed the ranks until 2008, when Crown decided to open a subsidiary in China. With Xia’s help, Crown marked the Asian giant’s “first-ever comprehensive outsourced collaboration” for antibody drug development with a global pharma company, she said. Aside from allowing her to flex her executive skills, Xia’s return to China opened up her eyes—not just to the biomedical needs of the domestic market, but also to its promise. “My return to China represented a significant transition in my career,” she said. “It provided me with valuable insights into the landscape of innovative drug development and clinical needs in the Chinese market.” Even so, Xia didn’t exactly expect to become the CEO of her own biotech. “Before returning to China, I hadn’t seriously considered launching my own venture,” she said. But the experience with Crown made her realize that China could be a world leader in drug discovery. “Choosing China felt natural,” Xia said. “We saw tremendous unmet needs and opportunities.” Taking inspiration from the name of the Greek goddess of healing, Xia and three other co-founders launched Akeso in 2012, confident in their abilities. “Each of us had already gained substantial international experience in our respective fields,” Xia said, which helped provide a “solid foundation” for their new venture. Yet Akeso’s early days proved to be a struggle. China’s biopharma industry at the time was “still in its infancy,” Xia said. Talent and capital were wanting, and infrastructure was poor. Patients were severely underserved, with treatments lagging decades behind other countries. There was little confidence in what they were trying to do, too. Doctors, investors and regulators were all skeptical, Xia told BioSpace . “We had to work tirelessly to earn the trust of physicians and key stakeholders,” she said. “Every idea was new, and nothing came easily.” Xia and her team rented out a small office space, hired a handful of researchers and, when needed, went without salary for a couple of months. The origins of Akeso were a far cry from the cushy, well-resourced corporations that they were used to. Thirteen years later, Xia’s gamble has paid off. From its unpolished beginnings in the 2010s, China’s biotech sector has grown rapidly and systematically. At the heart of this transformation is a change in the country’s regulatory regime; the government after 2015 updated drug regulations to meet international standards, giving drugmakers the chance to play on the global stage. Over the years, private equity and venture capital in China likewise gained momentum, providing companies that all-important financial bloodline with which to run their operations. It hasn’t all been smooth—other biotech companies operating in China have told BioSpace that the region has experienced a similar drop in financing in recent years as companies in America. This has pushed them to seek licensing agreements with multinational corporations. But according to Xia, the Chinese biotech sector provides a “conducive ecosystem for biopharma innovation .” The talent pool has grown and the country’s capital market system has matured. China’s size is also an advantage, with a large patient population to power clinical trials and a market hungry for novel and effective therapies. “These elements contribute to rich clinical resources essential for drug development,” Xia said. China has a “sizable market with strong demand, efficient capital utilization, and clinical outcomes as well as regulatory reviews that meet the rigorous requirements of markets such as the United States and Europe.” Looking back on Akeso’s journey, Xia is glad she stuck with it. “Every bit of that perseverance has been worth it,” she said. The 2.0 Era Like the rapid and major evolution of the Chinese biotech industry, Akeso’s business and pipeline have grown from a domestic view to a global mindset. There’s ivonescimab, of course, which in April won Chinese approval as a first-line treatment in patients with PD-L1-positive NSCLC. Over in the U.S., though, the treatment has run into issues after missing the overall survival target in a global Phase III study, an outcome that the FDA had deemed crucial for an approval. Even so, ivonescimab is the first-ever PD-1/VEGF therapy to reach the market. Summit intends to Biologics License Application for the drug and to push forward with ivonescimab’s Phase III development. The biotech is running HARMONi-3 and HARMONi-7 , which are pitting the bispecific against Keytruda. The studies are expected to complete in 2028 and 2029, respectively. Xia wants it known, however, that Akeso is much more than ivonescimab. In June, cadonilimab became what she characterized as “the world’s first cancer immunotherapy bispecific antibody” when China’s health authority approved the drug—and included it for insurance coverage—for patients with cervical cancer. Like ivonescimab, the drug targets two key cancer markers, PD-1 and CTLA-4, both of which allow tumors to evade the immune response. These two are “foundational assets” for Akeso, according to Xia, emblematic of the company’s growth strategy of pushing immuno-oncology “into the 2.0 era.” Akeso is the only biopharma player so far to have two approved immuno-oncology bispecifics, Xia pointed out. Akeso also has a single U.S.-approved product in penpulimab, indicated in a combo with cisplatin or carboplatin and gemcitabine as a first-line option for recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. The approval, granted in April this year , also allowed the use of penpulimab monotherapy in patients who had progressed on or after platinum chemotherapy. Following in the footsteps of these pipeline leaders is AK146D1, a bispecific antibody-drug conjugate (ADC)—a molecule that can simultaneously target two cancer markers while also carrying a toxic payload. The asset, according to Xia, is being studied both in China and abroad, testing its therapeutic potential in advanced cancers. Other pipeline assets include bispecific antibodies targeting PD-1/LAG-3 and TIGIT/ TGFβ, as well as what Xia calls “dual-payload” ADCs. Of course, partnerships remain top-of-mind for Akeso, though Xia wouldn’t provide specifics. “We consistently adopt an open approach to seek more international collaborations,” she said. And while Akeso is currently putting much of its energy into cancer, the company is also leveraging its bispecific technology in other therapeutic areas like autoimmune and neurodegenerative diseases. In February, Chinese regulators accepted the investigational new drug application for AK139, which Xia said is “the world’s first IL-4R/ST2 bispecific antibody” to enter the clinic. It’s being tested in respiratory and skin conditions. Farther into the future, Xia revealed that Akeso also wants to break out of the bispecific space and explore other modalities, such as mRNA and siRNA therapies, as well as cell and gene editing. “We aim to become a globally influential pharmaceutical innovator,” Xia said.