抗体偶联药物(ADC)
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科伦博泰生物-B(06990)核心产品TROP2 ADC芦康沙妥珠单抗(SAC-TMT)联合免疫疗法帕博利珠单抗一线治疗PD-L1阳性局部晚期或转移性非小细胞肺癌获NMPA突破性疗法认定
智通财经网· 2026-01-05 00:08
此前,公司公布了芦康沙妥珠单抗(sac-TMT)联合帕博利珠单抗一线治疗PD-L1阳性NSCLC的3期 OptiTROP-Lung05临床试验结果,其在主要终点无进展生存期(PFS)显示出统计学意义和临床意义的显 著改善,并在总生存期(OS)方面观察到获益趋势。OptiTROP-Lung05研究是首个免疫联合ADC在一线治 疗NSCLC上达到主要终点的3期临床研究。此次在一线治疗PD-L1阳性NSCLC获得突破性疗法认定,将 为加速芦康沙妥珠单抗(sac-TMT)在此适应症审评与上市进程提供助力。 智通财经APP讯,科伦博泰生物-B(06990)公布,公司靶向人滋养细胞表面抗原2(TROP2)的抗体偶联药 物(ADC)芦康沙妥珠单抗(sac-TMT,亦称SKB264/MK-2870)(佳泰莱)联合默沙东的抗程序性细胞死亡蛋 白1(PD-1)单克隆抗体帕博利珠单抗(可瑞达)一线治疗程序性细胞死亡配体1(PD-L1)肿瘤比例分数 (TPS)≥1%的表皮生长因子受体(EGFR)基因突变阴性和间变性淋巴瘤激酶(ALK)阴性的局部晚期或转移 性非小细胞肺癌(NSCLC),已获NMPA药品评审中心授予突破性疗法认定。 突 ...
百力司康港股IPO招股书失效
Zhi Tong Cai Jing· 2025-12-29 11:24
| | 29/06/2025 整體協調人公告 - 委任 歴 | | --- | --- | | 29/06/2025 | BlissBio Inc. - B 29/06/2025 申請版本(第一次呈交)全文檔案 [四]多檔案 > | BlissBio Inc.(简称:百力司康)于6月29日递交的港股招股书满6个月,于12月29日失效,递表时高盛、华泰国际及建银国际为联席保荐人。 招股书显示,百力司康是一家处于临床阶段的生物制药公司,致力于开发下一代抗体偶联药物(ADC),以解决目前肿瘤治疗中重要的未满足的需求。公司核 心产品BB-1701(核心产品)是一种人类表皮生长因子受体2(HER2)靶向型艾立布林ADC候选药物,主要针对乳腺癌(BC)、非小细胞肺癌(NSCLC)和潜在的其他 HER2表达癌症。 ...
新股消息 | 百力司康港股IPO招股书失效
智通财经网· 2025-12-29 11:19
招股书显示,百力司康是一家处于临床阶段的生物制药公司,致力于开发下一代抗体偶联药物(ADC),以解决目前肿瘤治疗中重要的未满足的需求。公司核 心产品BB-1701(核心产品)是一种人类表皮生长因子受体2(HER2)靶向型艾立布林ADC候选药物,主要针对乳腺癌(BC)、非小细胞肺癌(NSCLC)和潜在的其他 HER2表达癌症。 智通财经APP获悉,BlissBio Inc.(简称:百力司康)于6月29日递交的港股招股书满6个月,于12月29日失效,递表时高盛、华泰国际及建银国际为联席保荐 人。 | | 29/06/2025 整體協調人公告 - 委任 歴 | | --- | --- | | 29/06/2025 | BlissBio Inc. - B 29/06/2025 申請版本(第一次呈交)全文檔案 [四]多檔案 | ...
新股消息 | 石药创新递表港交所 为全球最大化学合成咖啡因生产商
智通财经网· 2025-12-10 14:07
Company Overview - The company, Shiyao Innovation Pharmaceutical Co., Ltd. (stock code: 300765.SZ), has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities as the sole sponsor [1] - The company focuses on the research, production, and commercialization of biopharmaceuticals, functional raw materials, and health foods [4] Business Development - In 2024, the company acquired control of Giant Bio, expanding its main business into the biopharmaceutical sector, marking a key step in its strategic transformation [5] - The company is engaged in the development of innovative therapies targeting unmet clinical needs in significant disease areas such as tumors, autoimmune diseases, and infectious diseases [5] - The company has a strong technical foundation in antibody drugs, antibody-drug conjugates (ADC), and mRNA vaccines, with plans to commercialize two antibody drugs in the second half of 2024 [5] Product Pipeline - As of December 1, 2025, the company has 15 drugs in clinical or late-stage development, including 9 ADCs and 1 mRNA vaccine [5] - The company’s mRNA vaccine products, including the first domestically developed COVID-19 mRNA vaccine, have been included for emergency use in China [5] Financial Performance - The company's revenue for the fiscal years ending July 31 for 2022, 2023, 2024, and the first seven months of 2025 were approximately RMB 2.838 billion, RMB 2.539 billion, RMB 1.980 billion, and RMB 1.241 billion respectively [8] - The company's profit for the same periods was approximately RMB 294 million, RMB 126 million, a loss of RMB 304 million, and a loss of RMB 226 million respectively [8] - The gross profit margin for these years was approximately 46.8%, 45.6%, 41.8%, and 38.3% [9] Industry Outlook - The global pharmaceutical market is expected to grow from USD 1,324.5 billion in 2019 to USD 1,542 billion in 2024, with a compound annual growth rate (CAGR) of 5.0% from 2024 to 2030 [11] - The Chinese pharmaceutical market is projected to grow from RMB 1,629.7 billion in 2024 to RMB 2,129.7 billion in 2030, with a CAGR of 4.6% from 2024 to 2030 [11] - The global oncology drug market is expected to expand from USD 143.5 billion in 2019 to USD 253.3 billion in 2024, with a CAGR of 12.0% [12] Market Position - The company is positioned as a significant player in the biopharmaceutical sector, focusing on innovative therapies and addressing unmet clinical needs [5][11] - The company has established a solid partnership with leading beverage companies, leveraging its expertise in caffeine production and health food products [6]
科伦博泰生物-B(06990)与Crescent Biopharma建立战略合作伙伴关系,共同开发和商业化肿瘤治疗手段
Zhi Tong Cai Jing· 2025-12-04 11:56
Core Viewpoint - The company has established a strategic partnership with Crescent Biopharma to jointly develop and commercialize cancer treatment methods, including novel combination therapies [1][2]. Group 1: Partnership Details - The collaboration involves the company's antibody-drug conjugate (ADC) SKB105, which targets integrin β6, and Crescent's bispecific antibody CR-001, which targets PD-1 and VEGF [1]. - Both candidate drugs are being developed for the treatment of solid tumors, with clinical trials for monotherapy expected to begin in Q1 2026 [1]. Group 2: Rights and Financial Terms - The company grants Crescent exclusive rights to research, develop, manufacture, and commercialize SKB105 outside of the Greater China region, while Crescent grants the company exclusive rights for CR-001 in the Greater China region [2]. - The financial terms include an upfront payment of $80 million from the company to Crescent, potential milestone payments of up to $1.25 billion, and tiered royalties based on SKB105's net sales [2]. - Conversely, Crescent will pay the company an upfront payment of $20 million and potential milestone payments of up to $30 million, along with tiered royalties based on CR-001's net sales [2]. Group 3: Strategic Benefits - The board believes the partnership aligns with the best interests of the company and its shareholders, enhancing the differentiated oncology pipeline and advancing the global development of SKB105 [3]. - The collaboration aims to leverage both parties' resources to explore new monotherapy and combination therapy strategies in cancer treatment, maximizing the therapeutic potential of both candidate drugs in China and globally [3].
“出身”礼来、恒瑞医药!这位复旦学霸的公司要上市了!
IPO日报· 2025-11-28 13:10
Core Viewpoint - Mingyu Pharmaceutical is preparing for an IPO on the Hong Kong Stock Exchange, with a current valuation of approximately 3.936 billion yuan and a cumulative loss of 587 million yuan over two and a half years [1][2]. Company Overview - Founded in 2018, Mingyu Pharmaceutical is a biotechnology innovation company nearing commercialization, focusing on antibody-drug conjugates (ADC) and a novel PD-1/VEGF bispecific antibody [5]. - The company has a pipeline of 13 candidate products, with 10 in clinical stages, and aims to generate revenue from its autoimmune projects soon [5]. Product Pipeline - The core product MHB036C targets the TROP-2 ADC market, projected to grow from $1.5 billion in 2024 to $42.5 billion by 2035, with a CAGR of 35.4% [5]. - MHB088C is in Phase III trials for small cell lung cancer and has a partnership with Qilu Pharmaceutical worth 1.345 billion yuan [6]. - MHB018A is a first-in-class IGF-1R antibody in Phase III trials, showing strong potential [6]. - MH004 is a first-in-class JAK inhibitor for atopic dermatitis, with a new drug application submitted for 2025 [6]. Financial Performance - Revenue projections for 2023, 2024, and the first half of 2025 are 0 yuan, 0 yuan, and 264 million yuan, respectively, primarily from a licensing agreement with Qilu [7]. - R&D expenses for the same periods are 182 million yuan, 281 million yuan, and 98 million yuan, with net losses of 137 million yuan, 283 million yuan, and 167 million yuan [7]. Funding and Ownership - Mingyu Pharmaceutical has completed five rounds of financing, with the latest post-money valuation at approximately 3.936 billion yuan [10]. - The founder, Cao Guoqing, has extensive experience in drug research and development, having previously worked at Eli Lilly and Hengrui Medicine [10]. Intellectual Property - The company holds 23 issued patents and 107 patent applications, with a significant number related to its core products [7].
明宇制药冲击IPO,“肿瘤+自免”双轨并行,面临制药巨头的竞争
Ge Long Hui A P P· 2025-11-27 10:25
Core Insights - The innovative drug sector is currently focused on GLP-1 weight loss drugs and PD1/VEGF bispecific antibodies, both expected to reach a global market size of over $100 billion [1] - Mingyu Pharmaceutical Co., Ltd. has filed for an IPO on the Hong Kong Stock Exchange, seeking to capitalize on its dual growth engines in oncology and autoimmune diseases [1][2] Company Overview - Mingyu Pharmaceutical was established in March 2018 and operates with dual headquarters in Shanghai and Hangzhou, China [1] - The company has raised approximately $240 million through five rounds of financing, with a post-money valuation of about 3.936 billion yuan ($0.54 billion) as of July 2025 [2][3] Leadership - The largest shareholder group holds approximately 36.27% of voting rights, including founder Dr. Cao Guoqing and his wife [3] - Dr. Cao has over 30 years of experience in drug development and management, previously working at Eli Lilly and Hengrui Medicine [4] Product Pipeline - Mingyu has 13 candidate products, with 10 in clinical stages, including 5 in Phase II or later [4][6] - Key oncology product MHB036C (TROP-2 ADC) has shown a 43% objective response rate in a Phase I trial for triple-negative breast cancer [6] - The TROP-2 ADC market is projected to grow from $1.5 billion in 2024 to $42.5 billion by 2035, with a CAGR of 35.4% [6] Competitive Landscape - The company faces competition from several multinational pharmaceutical companies in the ADC space, with three TROP-2 ADCs already approved globally [6][7] - Mingyu's MHB039A (PD-1/VEGF bispecific antibody) is positioned to potentially replace PD-(L)1 monoclonal antibody therapies, with a projected market size of $12.61 billion by 2035 [11] Financial Performance - Mingyu has not yet commercialized any products, reporting cumulative losses of 587 million yuan ($82 million) over two and a half years [14] - The company recorded revenues of 264 million yuan ($37 million) in the first half of 2025, with significant R&D expenditures [14][15] Future Outlook - The company is focused on advancing its clinical trials and commercialization efforts in both oncology and autoimmune disease sectors, which require substantial funding [19] - The ability to navigate competitive pressures and successfully bring products to market will be critical for the company's future [20]
中国生物制药涨超4% 旗下正大晴天自研HER2双抗ADC新辅助治疗乳腺癌取得重要突破
Zhi Tong Cai Jing· 2025-11-26 02:39
Core Viewpoint - China Biologic Products (01177) saw a stock increase of over 4%, currently trading at 7.16 HKD with a transaction volume of 174 million HKD, following the publication of positive Phase II clinical trial results for TQB2102 in the treatment of HER2-positive breast cancer [1] Group 1 - The Phase II clinical study results for TQB2102, a targeted antibody-drug conjugate (ADC) developed by China Biologic's subsidiary, Zhengda Tianqing, were published online in the Journal of Clinical Oncology [1] - TQB2102 targets two non-overlapping epitopes, ECD2 and ECD4, of HER2, demonstrating good efficacy and safety in the neoadjuvant treatment phase for breast cancer [1] - The study was led by Professor Shao Zhimin's team from Fudan University Shanghai Cancer Center, marking the first evidence of dual-epitope HER2 ADC TQB2102's effectiveness in this treatment stage [1] Group 2 - A Phase III registration clinical study for TQB2102 is currently underway, indicating ongoing development and potential future market introduction [1]
映恩生物-B早盘涨近9% 公司公布首款BDCA2靶向ADC药物DB-2304健康受试者数据
Zhi Tong Cai Jing· 2025-11-26 02:21
映恩生物首席科学官兼美国总经理邱杨博士表示,DB-2304作为全球首个进入临床的靶向BDCA2的免疫 调节ADC,其Ⅰ期健康受试者数据验证了我们基于生物学的药物设计理念,我们将加快推进该创新药 在SLE及CLE患者中的临床开发进度,期待早日为自身免疫疾病治疗带来ADC新突破。 消息面上,2025年第53界秋季免疫学会议(AIC2025)在美国芝加哥举办,映恩生物在会议上以口头报告 形式公布了首创BDCA2靶向免疫调节抗体偶联药物(ADC)DB-2304的Ⅰ期随机对照研究数据。研究结果 显示,DB-2304在健康受试者中整体安全耐受性良好,药代动力学(PK)特征呈线性,并可有效结合靶 点,验证了其药理机制。 映恩生物-B(09606)早盘涨近9%,截至发稿,涨7.17%,报349.6港元,成交额1.18亿港元。 ...
明慧医药冲刺港交所:「肿瘤+自免」双轮驱动,启明创投、OrbiMed为股东
IPO早知道· 2025-11-25 04:57
Core Viewpoint - Minghui Pharmaceutical Co., Ltd. is positioned as a near-commercial biotechnology innovation company with dual growth engines, focusing on proprietary antibody-drug conjugate (ADC) platforms and a novel PD-1/VEGF bispecific antibody [2][4]. Pipeline Overview - As of November 16, 2025, Minghui has 13 candidate products in its pipeline, with 10 in clinical stages. The autoimmune projects are expected to generate revenue soon, while the oncology projects aim to innovate first-line cancer treatments through ADC monotherapy and combination therapies with PD-1/VEGF bispecific antibodies [3][4]. Key Products - The core product MHB036C targets the TROP-2 antigen for solid tumors and is in I/II phase trials for non-small cell lung cancer (NSCLC) and II phase trials for breast cancer. Another key product, MHB088C, is a B7-H3 ADC for small cell lung cancer (SCLC) and is currently in III phase trials [4][5]. Market Potential - The global ADC market is projected to grow from $13.5 billion in 2024 to over $216.3 billion by 2035, with a compound annual growth rate (CAGR) of 28.7%. The market for treatments of thyroid eye disease (TED) is expected to grow from $3.4 billion in 2024 to $13.4 billion by 2035, and the atopic dermatitis market is anticipated to expand from $14.9 billion to $29.5 billion in the same period [6]. Strategic Partnerships - Minghui has established a strategic collaboration with Qilu Pharmaceutical for MHB088C in Greater China, valued at 1.345 billion RMB. The clinical data for MHB088C has been selected for presentation at major oncology conferences, indicating strong interest from the medical community [7]. Funding and Valuation - Following the last round of financing in July, Minghui's valuation reached 3.936 billion RMB. The funds raised from the IPO will primarily support the development of core and key products, manufacturing, quality control, and commercialization capabilities [8].