Group 1: Novo Nordisk - Novo Nordisk's oral semaglutide (Rybelsus) has received FDA approval for a new indication to reduce cardiovascular risk in high-risk adults with type 2 diabetes, making it the first oral GLP-1 drug to do so [1] - The company has also submitted a supplemental new drug application for its once-daily oral semaglutide (Wegovy) for obesity treatment, with approval expected later this year [1] - The approval of the new indication for oral semaglutide is expected to further solidify Novo Nordisk's market position in the GLP-1 segment [1] Group 2: Sunshine Guohe - Sunshine Guohe plans to invest 15 million yuan to acquire an 8.20% stake in Yuanma Zhiyao, focusing on CAR-T cell therapy and nucleic acid drugs [2] - Yuanma Zhiyao specializes in the innovation and research of circular mRNA CAR-T nucleic acid drugs and is advancing towards clinical research [2] - This investment aligns with Sunshine Guohe's strategic layout in the CAR-T field and is expected to create synergies between the two companies [2] Group 3: Pian Zai Huang - Pian Zai Huang reported a 28.82% year-on-year decline in net profit for Q3, with revenue of 2.064 billion yuan, down 26.28% year-on-year [3] - For the first three quarters, the company recorded a revenue of 7.442 billion yuan, a decrease of 11.93%, and a net profit of 2.129 billion yuan, down 20.74% [3] - The decline in performance is attributed to reduced sales in the pharmaceutical manufacturing industry and a decrease in gross margin [3] Group 4: Kelun Pharmaceutical - Kelun Pharmaceutical's subsidiary, Kelun Botai, received approval for its core product, trastuzumab deruxtecan (舒泰莱), for treating HER2-positive breast cancer [4] - The product showed significant improvement in progression-free survival (PFS) compared to T-DM1 in interim analysis, indicating strong clinical efficacy [4] - This approval marks a key breakthrough for Kelun Botai in the breast cancer field and highlights the ongoing advancements of domestic ADCs in high-end oncology treatment [4]

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。 OptiTROP-Lung04 共 有376名患者被隨機(1:1)分配接受蘆康沙妥珠單抗(sac-TMT)治療或化 療。於 數 據 截 止 時 間（2025年7月6日），中 位 隨 訪 時 間 為18.9個 月。蘆康沙 妥珠單抗(sac-TMT)組的中位無進展生存期(PFS)為8.3個 月，化 療 組 為4.3個 月。蘆康沙妥珠單抗(sac-TMT)較化療顯著改善了PFS，疾 病 進 展 或 死 亡 風 險降低51%（風 險 比(HR) 0.49；95%置信區間(CI): 0.39-0.62；P<0.0001）。在 預 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 ...

Core Viewpoint - Kelong Pharmaceutical's subsidiary Sichuan Kelong Botai Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its antibody-drug conjugate (ADC) A166 (also known as Trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [1] Group 1 - The approved drug targets the human epidermal growth factor receptor 2 (HER2) [1] - The indication is specifically for adult patients with a history of treatment with one or more anti-HER2 agents [1] - This approval represents a significant advancement in the treatment options available for HER2-positive breast cancer patients [1]

Core Viewpoint - The approval of the antibody-drug conjugate (ADC) by the National Medical Products Administration (NMPA) for treating HER2-positive breast cancer represents a significant advancement in targeted therapy for patients who have previously received one or more anti-HER2 treatments [1] Group 1: Company Developments - Kolun Pharmaceutical's subsidiary, Kolun Botai, received NMPA approval for the ADC, Bodu Trastuzumab, aimed at treating unresectable or metastatic HER2-positive adult breast cancer patients [1] - The approval is based on the results of a multicenter, randomized, open-label, controlled Phase III study (KL166-III-06), which demonstrated significant statistical and clinical improvement in progression-free survival (PFS) compared to T-DM1 [1] Group 2: Industry Implications - The approval of Bodu Trastuzumab highlights the growing importance of targeted therapies in oncology, particularly for patients with specific genetic markers such as HER2 [1] - This development may enhance competition in the market for HER2-targeted therapies, potentially impacting pricing and accessibility for patients [1]

Core Viewpoint - The approval of the antibody-drug conjugate (ADC) Bodo-Tuzumab (A166) by the National Medical Products Administration (NMPA) for the treatment of HER2-positive breast cancer represents a significant advancement in targeted therapy for patients with previously treated, unresectable, or metastatic conditions [1][2]. Group 1: Product Approval - The NMPA has approved Bodo-Tuzumab for adult patients with HER2-positive breast cancer who have received one or more prior anti-HER2 therapies [1]. - The approval is based on the results of a multicenter, randomized, open-label, controlled Phase III study (KL166-III-06) comparing Bodo-Tuzumab to Trastuzumab Emtansine (T-DM1) [2]. Group 2: Clinical Study Results - The study demonstrated a statistically and clinically significant improvement in progression-free survival (PFS) for Bodo-Tuzumab compared to T-DM1, as assessed by blinded independent central review (BICR) [2]. - A trend towards improved overall survival (OS) with Bodo-Tuzumab was also observed, with results set to be presented at the 2025 European Society for Medical Oncology (ESMO) conference in Berlin [2]. Group 3: Product Characteristics - Bodo-Tuzumab is a differentiated HER2 ADC designed for the treatment of advanced HER2-positive solid tumors, featuring a drug-antibody ratio (DAR) of 2 [3]. - The drug specifically targets HER2 on tumor cells, leading to internalization and release of the cytotoxic agent Duo-5, which induces cell cycle arrest and apoptosis in tumor cells [3]. - Bodo-Tuzumab also exhibits antibody-dependent cell-mediated cytotoxicity (ADCC) activity and inhibits HER2-mediated signaling pathways [3].

Core Insights - The company Kolonbo Tai Biotech-B (06990) has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) A166 (also known as Bodo Trastuzumab) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (BC) who have previously received one or more anti-HER2 therapies [1][2] Group 1 - The approval is based on a multicenter, randomized, open-label, controlled Phase 3 study (KL166-III-06) that evaluated the efficacy and safety of Bodo Trastuzumab compared to T-DM1 in HER2-positive patients with unresectable or metastatic BC who had previously received trastuzumab and taxane treatments [1] - In the pre-specified interim analysis, Bodo Trastuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to T-DM1, as assessed by blinded independent central review (BICR) [1] - A trend towards improved overall survival (OS) with Bodo Trastuzumab was also observed, with results set to be presented at the 2025 European Society for Medical Oncology (ESMO) conference in Berlin [1] Group 2 - The company has initiated an open-label, multicenter Phase 2 clinical study of Bodo Trastuzumab for the treatment of HER2-positive unresectable or metastatic BC previously treated with an effective payload of topoisomerase inhibitor ADC [2] - Bodo Trastuzumab is a differentiated HER2 ADC designed for the treatment of advanced HER2-positive solid tumors, featuring a drug-antibody ratio (DAR) of 2 [2] - The drug specifically binds to HER2 on the surface of tumor cells, leading to internalization and release of the cytotoxic molecule Duo-5, which induces cell cycle arrest in the G2/M phase and triggers apoptosis in tumor cells [2]

Core Insights - Lepu Biotech's MRG006A, a targeted GPC3 antibody-drug conjugate (ADC), has successfully completed the first patient enrollment in a Phase II clinical trial for advanced hepatocellular carcinoma (HCC), marking it as the first GPC3 ADC to enter this stage globally [1][2] - MRG006A utilizes Lepu Biotech's Hi-TOPi ADC technology platform, which allows for precise targeting of GPC3-positive tumor cells, thereby releasing toxins specifically within the tumor to achieve targeted cell destruction [1] - GPC3 is a cancer embryonic antigen that is highly expressed in 70%-80% of HCC cases but has minimal expression in normal tissues, making it a promising target for precision therapy [1] Clinical Development - The Phase I clinical trial of MRG006A showed promising results, with significant tumor shrinkage observed in GPC3-positive patients during the dose-escalation study, indicating strong therapeutic potential [2] - The advancement of MRG006A into Phase II clinical research represents a significant breakthrough in Lepu Biotech's ADC pipeline and has the potential to address unmet clinical needs in HCC treatment [2]

7MW4911是基于公司自主知识产权的IDDC™抗体偶联技术平台开发的靶向钙黏蛋白17(CDH17)的创新 抗体偶联药物(ADC)。CDH17作为经泛癌种多组学验证的潜力治疗靶点，在正常组织中局限于肠上皮基 底外侧膜表达，而在结直肠癌、胃癌及胰腺癌等消化道恶性肿瘤中呈现显著过表达，其异常高表达与肿 瘤侵袭转移及不良预后密切相关，为精准干预提供了理想靶点。 智通财经APP讯，迈威生物(688062.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的 《药物临床试验批准通知书》，注射用7MW4911的临床试验获得批准。 ...

Core Viewpoint - The announcement indicates that Maiwei Biotech (688062.SH) has received approval from the National Medical Products Administration for the clinical trial of its innovative antibody-drug conjugate (ADC) 7MW4911, targeting CDH17, a promising therapeutic target in various cancers [1] Company Summary - Maiwei Biotech has developed 7MW4911 based on its proprietary IDDC antibody conjugation technology platform [1] - The ADC targets calcium adhesion protein 17 (CDH17), which is significantly overexpressed in colorectal cancer, gastric cancer, and pancreatic cancer, making it an ideal target for precise intervention [1] Industry Summary - CDH17 has been validated as a potential therapeutic target through multi-omics studies across various cancer types, indicating its relevance in cancer treatment [1] - The abnormal high expression of CDH17 is closely associated with tumor invasion, metastasis, and poor prognosis, highlighting its importance in oncology [1]

Core Viewpoint - The ADC market in China is expected to exceed 100 billion RMB in the next five years, positioning it as the second-largest ADC market globally, driven by advancements in technology from Chinese companies like Innovent Biologics-B [1][1][1] Company Summary - Innovent Biologics-B's stock rose over 5% during trading, currently at 308.4 HKD with a trading volume of 104 million HKD [1][1][1] - The company's DB-1419 (B7-H3/PD-L1 dual antibody ADC) has shown excellent efficacy in clinical trials for solid tumors, indicating a significant technological breakthrough in the dual antibody ADC field [1][1][1] - Innovent plans to submit applications for DB-1303 (HER2 ADC) for endometrial cancer in the U.S. and for breast cancer in China by 2025 [1][1][1] - The DB-1311 (B7-H3 ADC) shows potential as a best-in-class treatment for prostate cancer, while DB-1310 (HER3 ADC) is expected to follow suit [1][1][1] - The company is leading global advancements in the exploration of combination therapies involving DB-1305 (TROP2 ADC) and dual antibodies [1][1][1] Industry Summary - According to Frost & Sullivan, the global ADC market was approximately 10.4 billion USD in 2023 and is projected to reach 115.1 billion USD by 2032 [1][1][1] - The ADC market in China is anticipated to grow significantly, reflecting the increasing investment and innovation in the biopharmaceutical sector [1][1][1]