Core Insights - Cloud-based innovative pharmaceutical company, CloudTop New Horizon, has successfully enrolled its first patient in a global multi-center Phase I clinical trial for its universal on-demand tumor therapeutic vaccine EVM14 in the United States, following the approval of its Investigational New Drug (IND) application by the National Medical Products Administration of China [1][2] Group 1: Vaccine Development - EVM14 targets five tumor-associated antigens (TAA) and is intended for the treatment of various squamous cell carcinomas, including non-small cell lung squamous carcinoma and head and neck squamous cell carcinoma [2] - The vaccine is based on CloudTop's self-developed mRNA technology platform, addressing unmet medical needs in current squamous carcinoma treatments [2] Group 2: Clinical and Market Potential - EVM14 has shown the ability to induce immune memory in preclinical studies, potentially reducing tumor recurrence and offering patients the possibility of "long-term cancer-free survival" [2] - As a universal on-demand vaccine, EVM14 has advantages such as no need for HLA screening, on-demand supply, lower production costs, and applicability to multiple tumor types, indicating a broad application prospect in tumor treatment [2] Group 3: Future Developments - Besides EVM14, CloudTop has several other promising products, including the autologous CAR-T project EVM18, which is expected to initiate clinical trials by the end of the year, and the personalized tumor therapeutic vaccine EVM16, which has already started its first human clinical trial in China [2]

Company News - China Metallurgical Group Corporation (01618.HK) reported a new contract amount of 760.67 billion yuan for the first nine months, a year-on-year decrease of 14.7%. The overseas contract amount was 66.9 billion yuan, showing a year-on-year increase of 10.1% [1] - China General Nuclear Power Corporation (01816.HK) achieved a total power generation of approximately 182.822 billion kWh in the first nine months, representing a year-on-year growth of 2.67% [1] - "Jiao Ge Peng You" Holdings (01450.HK) recorded a cumulative GMV of approximately 9.53 billion yuan for the first three quarters, a year-on-year increase of 7.56%. However, the GMV for the third quarter was about 2.55 billion yuan, reflecting a year-on-year decline of approximately 12.07% [1] - China Resources Land (01109.HK) reported a cumulative contract sales amount of approximately 154.4 billion yuan for the first nine months, a year-on-year decrease of 10.4% [1] - Times China Holdings (01233.HK) reported cumulative contract sales of 3.933 billion yuan for the first nine months, a year-on-year decline of 37.1% [1] - ZhongAn Online P&C Insurance (06060.HK) achieved cumulative original insurance premium income of 26.934 billion yuan in the first nine months, a year-on-year increase of 5.64% [1] - COFCO Joycome (01610.HK) reported a pig slaughter volume of 468,000 heads in September, a month-on-month decrease of 6.02% [1] - Kingsoft Cloud Holdings (01548.HK) received a new payment under a licensing agreement related to PD-1 monoclonal antibodies, which will enhance cash reserves for new molecular discovery and development [2] - China National Building Material Group (03323.HK) expects a net profit of 2.95 billion yuan for the first three quarters, turning from loss to profit, mainly due to a decrease in sales costs of cement and ready-mixed concrete [2] - Lifen Holdings (01125.HK) issued a profit warning, expecting a year-on-year increase of no less than 50% in annual losses attributable to owners [2] - China Property Investment (00736.HK) signed a cooperation framework agreement to tokenize high-quality photovoltaic new energy assets [2] - Dali Pu Holdings (01921.HK) established a direct sales warehouse and sales office in Oman to strengthen its strategic layout in the Middle East [2] - Beijing Machinery Electric Co., Ltd. (00187.HK) faced bankruptcy liquidation application from creditors for its subsidiary Tianhai Cryogenic [2] Financing and Buyback Activities - Jihai Resources (02489.HK) successfully placed 400 million shares at 1.18 HKD per share, raising approximately 466 million HKD for potential gold mine acquisitions and general working capital [2] - China Galaxy Securities (06881.HK) was approved to issue short-term corporate bonds not exceeding 15 billion yuan [3] - Kuaishou Technology (01024.HK) repurchased 1.3146 million shares for approximately 98.4067 million HKD at prices ranging from 74.55 to 75.1 HKD [3] - Xiaomi Group (01810.HK) repurchased 4 million shares for approximately 19.5 million HKD at prices ranging from 48.44 to 49 HKD [4]

Core Insights - Kingsray Biotechnology (01548) announced that CARVYKTI® is expected to generate net trade sales of approximately $524 million for the quarter ending September 30, 2025, based on the collaboration and licensing agreement established with Legend and Janssen Biotech, Inc. on December 21, 2017 [1] Group 1 - Kingsray Biotechnology's CARVYKTI® is projected to achieve significant sales figures, indicating strong market potential [1] - The collaboration with Janssen Biotech, Inc. highlights strategic partnerships in the biotechnology sector [1] - The timeline for the projected sales extends to the end of Q3 2025, suggesting a long-term outlook for revenue generation [1]

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分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。 Genscript Biotech Corporation （於開曼群島註冊成立的有限公司） （股份代號：1548） 自願性公告 傳奇宣佈截至2025年9月30日止季度 CARVYKTI®的初步銷售額 本公告以英文發佈，並附有中文翻譯。如中英文版本有任何不一致或歧義，應以英文 版為准。 本公司股東及潛在投資者務請注意投資風險，並於買賣或擬買賣本公司證券時審慎行 事。 承董事會命 Genscript Biotech Corporation 孟建革 主席及執行董事 關於前瞻性陳述的警示性說明 本公告中關於未來預期、計劃和前景的陳述，以及關於非歷史事實事項的任何其他陳 述，均構成《1995年私人證券訴訟改革法案》所界定的「前瞻性陳述」。這些陳述包 括但不限於與CARVYKTI®有關的陳述，包括傳奇對CARVYKTI®貿易銷售淨額和由此 產生的毛利的預期。「預期」、「相信」、「繼續」、「可能」、「估計」、「期 望 ...

Core Viewpoint - The economic burden on patients with rare diseases is significant, and addressing this issue requires a multi-layered social mechanism rather than solely relying on individual patients [1][2]. Group 1: Rare Disease Treatment and Insurance - Biogen's Asia-Pacific President emphasizes the need for a collective approach to cover treatment costs for rare diseases, advocating for public awareness of risk-sharing and the importance of commercial insurance [1][2]. - The inclusion of diseases like ALS in insurance coverage is crucial, as 90% of ALS cases are sporadic, highlighting the need for broader public understanding and insurance participation [2]. - The role of commercial insurance is to mitigate large medical expenses, and its coverage should extend beyond just the listed drugs to effectively support patients [2]. Group 2: Biogen's Strategic Direction - Biogen is open to potential mergers and acquisitions in the Asia-Pacific region, focusing on internal innovation while also collaborating with Chinese innovative pharmaceutical companies [3]. - The company has already launched several groundbreaking treatments in China, including the first drug for spinal muscular atrophy (SMA) and a targeted drug for Alzheimer's disease [3]. - Biogen aims to achieve clinical cures for SMA and is advancing another drug in clinical trials that could significantly improve treatment outcomes [3].

Core Viewpoint - China Antibody-B (03681) has successfully completed the first cohort of the SM17 subcutaneous injection bridging trial, demonstrating good tolerability and no reported adverse events, indicating a positive outlook for the drug's safety and efficacy in treating allergic conditions [1][3]. Group 1: Clinical Trial Results - The SM17 bridging trial aims to assess the safety, tolerability, and pharmacokinetic characteristics of the subcutaneous injection formulation, with a total of 30 healthy subjects planned for enrollment by November 2025 and follow-up completion by March 2026 [1]. - The phase 1 clinical trial in the U.S. showed that SM17 has good safety and tolerability, with no serious drug-related adverse reactions reported [3]. - The phase 1a bridging trial in China also confirmed SM17's good tolerability and safety, with pharmacokinetic characteristics comparable to those in Caucasian populations [3]. Group 2: Drug Mechanism and Market Potential - SM17 is a novel humanized IgG4-κ monoclonal antibody targeting the IL-25 receptor, which plays a crucial role in regulating type II allergic responses, potentially offering a new therapeutic avenue for conditions like atopic dermatitis (AD) [1][2]. - The subcutaneous formulation of SM17, developed by the company, boasts high protein stability, ease of injection, and low pain upon administration, with a preclinical bioavailability exceeding 90% [2]. - There is a significant market opportunity for SM17, as existing therapies for AD do not adequately meet the clinical demand for rapid itch relief, skin lesion recovery, and good safety profiles [2]. Group 3: Efficacy and Competitive Advantage - In the phase 1b proof-of-concept study, 91.7% of patients in the high-dose group achieved itch relief, 75% reached skin lesion recovery, and 41.7% achieved near-complete resolution of AD symptoms, outperforming IL-4/IL-13 monoclonal antibodies and showing better safety and tolerability than Janus kinase inhibitors [3]. - Research results have been published in reputable international journals, demonstrating that SM17's efficacy in treating animal models of AD is comparable to JAK1 inhibitors, with some indicators showing superior performance [4]. - The company believes that targeting upstream pathways of Th2 inflammatory cytokines, such as the IL-25 receptor, will have broad implications for skin inflammation, positioning SM17 as a safer and more effective treatment option with differentiated advantages in AD therapy [4].

Core Viewpoint - The company has successfully completed the first cohort of a bridging study for the subcutaneous formulation of SM17, demonstrating good tolerability and no reported adverse events among healthy subjects, indicating a positive outlook for the drug's safety and efficacy in treating atopic dermatitis (AD) [1][3]. Group 1: Clinical Trial Progress - The bridging study for SM17 aims to assess the drug's safety, tolerability, and pharmacokinetic characteristics, with a total of 30 healthy subjects planned for enrollment by November 2025 and follow-up completion by March 2026 [1]. - The first phase clinical trial in the U.S. showed good safety and tolerability for SM17, with no serious drug-related adverse events reported [3]. - Positive topline results from the Phase 1b proof-of-concept study indicated that 91.7% of patients in the high-dose group achieved itch relief, and 75% reached skin lesion recovery, outperforming existing IL-4/IL-13 monoclonal antibodies [3]. Group 2: Drug Characteristics and Market Potential - SM17 is a novel humanized IgG4-κ monoclonal antibody targeting the IL-25 receptor, which plays a crucial role in type II allergic responses, potentially offering a safer and more effective treatment for AD [1][4]. - The subcutaneous formulation of SM17, developed in-house, boasts high protein stability, ease of injection, and low pain upon administration, with a pharmacokinetic bioavailability exceeding 90% in preclinical studies [2]. - There remains a significant market opportunity for AD therapies that can provide rapid itch relief, skin lesion recovery, and good safety profiles, as current treatments do not fully meet these clinical needs [2]. Group 3: Research Publications and Efficacy - Research results for SM17 have been published in reputable international journals, demonstrating its efficacy comparable to JAK1 inhibitors in animal models of AD [4]. - The clinical findings published in the journal "Allergy" and "Frontiers in Immunology" highlight SM17's excellent safety, tolerability, and pharmacokinetic performance in healthy subjects [4]. - The company believes that targeting upstream pathways of Th2 inflammatory cytokines, such as the IL-25 receptor, will have broad implications for skin inflammation, indicating SM17's significant potential in AD treatment [4].

Core Insights - The company announced positive preliminary data from two ongoing clinical trials for its proprietary Trimer-Tag vaccine platform, focusing on the RSV+hMPV±PIV3 candidates [1] Group 1: Clinical Trials Overview - In Australia, a Phase I trial compared SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3) against SCB-1019 (RSV) in elderly participants who had not previously received any RSV vaccine [1][2] - The trial showed that both SCB-1022 and SCB-1033 induced neutralizing antibody responses for RSV-A and RSV-B with a mean fold increase of approximately 6-8 times, comparable to the control group [2] - The hMPV neutralizing antibody responses were also significant, with mean fold increases of about 6-7 times for hMPV-A and 8-9 times for hMPV-B [2] Group 2: Safety and Tolerability - Both SCB-1022 and SCB-1033 demonstrated good overall tolerability, with adverse events being mild and comparable to the control group [4] - No serious adverse events related to the vaccines were reported, indicating a favorable safety profile [4] Group 3: U.S. Clinical Trial Insights - A Phase I trial in the U.S. is assessing the immunogenicity of SCB-1019 in elderly participants who previously received the GSK RSV vaccine (AREXVY) [5] - Preliminary results indicated that SCB-1019 induced RSV-A and RSV-B neutralizing antibody responses with a mean fold increase of approximately 3.0-3.3 times, significantly higher than the 1.8-1.9 times observed with AREXVY [6][7] - The proportion of participants showing at least a 2-fold increase in neutralizing antibodies was about 69-75% for SCB-1019, compared to 33-40% for AREXVY [6][7] Group 4: Future Plans - Based on the positive Phase I results, the company plans to advance SCB-1022 and SCB-1033 to Phase II clinical trials in the first half of 2026 [4][8]

Core Insights - Wuhan's innovative pharmaceutical companies are gaining attention in the capital market, with Wuhan Heyuan Bio (688765.SH) starting its subscription on October 14, and another company, Wuhan Binhui Biotechnology Co., Ltd., seeking a listing on the Hong Kong Stock Exchange [1][2] Company Overview - Binhui Bio, established in November 2010, focuses on oncolytic virus therapy and aims to discover, develop, and commercialize innovative cancer immunotherapies [2][3] - The company has undergone seven rounds of investment, totaling approximately 1.04 billion RMB, with a post-investment valuation of about 3.22 billion RMB as of December 2023 [4] Leadership and Experience - The largest shareholder group, led by Dr. Liu Binlei, holds 26.32% of the company. Dr. Liu has extensive experience in drug research and development, having been a core member of the team that developed the first FDA-approved oncolytic virus drug, IMLYGIC [5][6][7] Product Pipeline - Binhui Bio has established a differentiated pipeline focusing on three strategic series: oncolytic viruses, nucleic acid therapies, and protein biologics, with oncolytic viruses as the core [7][14] - The core product, BS001, is in Phase III clinical trials and has shown an objective response rate of 34.48% in advanced melanoma patients [15][19] Market Potential - The global oncolytic virus market is projected to reach approximately $7.5 billion by 2030, with the Chinese market expected to reach 9.2 billion RMB, driven by increasing clinical applications and investment [12][27] Financial Performance - Binhui Bio has not yet commercialized any products, reporting revenues of 981,000 RMB in 2023 and a cumulative loss of 267 million RMB over two and a half years [22][23] - The company had cash and cash equivalents of approximately 166 million RMB as of June 2025, indicating sufficient operational funding for the next 12 months [25][26]

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，並明確表示概不就因本公告全部或 任何部分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。 SinoMab BioScience Limited 中 國 抗 體 製 藥 有 限 公 司 （於香港註冊成立的有限公司） （股份代號：3681） 自願公告 本公司在美國進行了1期首次人體臨床試驗(NCT 05332834)，以評估SM17在健康受 試者中的安全性及耐受性。臨床報告於二零二四年第一季度獲得，其顯示出SM17 具有良好的安全性，並未報告任何與藥物相關的嚴重不良反應。於二零二四年五 月，本公司在中國完成1a期橋接試驗，顯示SM17具有良好的耐受性及安全性，其 藥代動力學特性與白種人群相當。於二零二五年四月，SM17 1b期概念驗證研究 的 積 極 頂 線 結 果 已 發 佈 。 資 料 顯 示 ， 高 劑 量 組 的 91.7 % 的 患 者 實 現 瘙 癢 緩 解 指 標(NRS -4)，75 %達到皮損恢復(EASI 75) ...