Core Viewpoint - The company, Qianxin Biotechnology-B (02509.HK), announced that its subsidiary, Jiangsu Saifusi Biotechnology Co., Ltd., successfully passed the EU Qualified Person (QP) audit, achieving compliance with EU GMP standards [1] Group 1: Audit and Compliance - The audit was conducted by a senior QP over a three-day period, reviewing Saifusi's quality management system, advanced facilities, and professional technical team [1] - The audit team recognized the high standards of Saifusi's quality management system and confirmed that both hardware and software management meet EU GMP requirements [1] - Passing the QP audit provides a strong proof of compliance with international GMP standards, which is a prerequisite for products entering the EU market [1] Group 2: Strategic Implications - The successful QP certification marks an important milestone in the company's strategy for international expansion and product innovation [1] - This achievement lays a solid foundation for the company's future innovative products to enter global markets [1]

Core Viewpoint - The company’s subsidiary, Jiangsu Saifusi Biotechnology Co., Ltd., successfully passed the Qualified Person (QP) audit, achieving compliance with EU GMP standards, which is crucial for its international market strategy [1] Group 1: Audit and Compliance - The QP audit was conducted over three days by a senior QP, who reviewed the quality management system and production capabilities of Saifusi [1] - The audit team recognized Saifusi's high standards in quality management, advanced facilities, and professional technical team, confirming compliance with EU GMP requirements [1] - A compliance statement issued by the QP serves as a strong proof of the company's adherence to international GMP standards, essential for entering the EU market [1] Group 2: Strategic Importance - Passing the QP audit is a significant milestone for the company's product export strategy and global expansion plans [1] - This achievement lays a solid foundation for the company's future innovative products to enter international markets [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。 Qyuns Therapeutics Co., Ltd. 江蘇荃信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 ） （股份代號：2509） 歐 盟GMP於1975年首先引入QP制 度，近 五 十 年 的 實 踐 成 功 經 驗 表 明，該 制 度 是 先 進 的 質量管理 模式，能有效保障藥品 質 量，並成為歐盟GMP體系的核心之一。 歐盟對QP資 質 的 要 求 十 分 嚴 格，歐 盟 委 員 會 指 令DIRECTIVE 2001/83/EC和良好生 產 質量管理 規範指南附錄16《質 量 受 權 人 的 認 證 與 批 放 行》中 詳 細 定 義 了QP的法律 地位，資質和責任等，其專業水準和豐富經驗使得QP成為製藥行業的專家和權威。 荃信生物產業化基地成功通過歐盟QP審 計 本 公 ...

致：香港交易及結算所有限公司 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 公司名稱: 江蘇荃信生物醫藥股份有限公司 呈交日期: 2025年10月8日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02509 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 227,071,600 | RMB | | 1 RMB | | 227,071,600 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 227,071,600 | RMB | | 1 RMB | | 227,071,600 | 本月底法定/註冊股本總額： RMB 227,071,600 FF3 ...

Group 1 - Tianfeng Securities initiates coverage on Qianxin Biologics-B (02509) with a "Buy" rating, projecting revenue of RMB 3.22 billion, RMB 4.41 billion, and RMB 5.93 billion for 2025-2027 respectively, and sets a target price of RMB 36.85, equivalent to HKD 40.25 for 2025 [1] - The autoimmune disease biopharmaceutical market in China is expected to reach RMB 36.3 billion by 2024, with biologics' market share projected to increase to 65.6% by 2030. The psoriasis market is anticipated to reach RMB 30.65 billion by 2030, while the ankylosing spondylitis market is expected to reach approximately RMB 46.3 billion by 2030 [1] - Current first-line treatments for autoimmune diseases like psoriasis and ankylosing spondylitis primarily involve corticosteroids, immunosuppressants, and non-steroidal anti-inflammatory drugs, which have limitations such as short treatment duration and systemic side effects [1] Group 2 - The company has a robust pipeline in monoclonal antibodies for autoimmune diseases, with QX001S being the first approved biosimilar of ustekinumab in China, significantly improving accessibility for psoriasis treatment [2] - QX008N has completed Phase II enrollment for chronic obstructive pulmonary disease, leading the domestic market, while QX005N has received breakthrough therapy designation and completed Phase III enrollment for nodular prurigo [2] - QX002N has completed Phase III trials for ankylosing spondylitis, with a BLA submission expected in H2 2025, and QX004N has shown significant efficacy and safety for psoriasis, initiating Phase III trials [2] Group 3 - The company is advancing differentiated long-acting bispecific antibodies and actively pursuing overseas business development and licensing collaborations [3] - The rabbit antibody development platform enables high-activity antibody screening and early commercial feasibility assessments, focusing on key signaling pathways in autoimmune diseases [3] - The company has multiple bispecific antibody pipelines, including QX030N, which has completed its first overseas New Co transaction, and QX027N and QX035N, which are set for IND submissions in China and the U.S. [3] Group 4 - The company is diversifying its commercialization efforts through strategic partnerships, including collaborations with Huadong Medicine for QX001S and QX005N, and exclusive licensing agreements with Hansoh Pharmaceutical and Health元 for various products [4] - An exclusive licensing agreement has been signed with Caldera Therapeutics for the global development and commercialization of long-acting bispecific antibody QX030N [4]

Core Viewpoint - Tianfeng Securities initiates coverage on Qianxin Biologics-B (02509) with a "Buy" rating, projecting revenue of RMB 3.22 billion, RMB 4.41 billion, and RMB 5.93 billion for 2025-2027, respectively, and setting a target price of RMB 36.85, equivalent to HKD 40.25 [1] Group 1: Market Potential - The autoimmune disease biopharmaceutical market in China is expected to reach RMB 36.3 billion by 2024, with the share of biological agents increasing to 65.6% by 2030 [1] - The psoriasis market is projected to reach RMB 30.65 billion by 2030, while the ankylosing spondylitis market is expected to grow to approximately RMB 46.3 billion by 2030, with 3.9 million patients reported in 2022 [1] Group 2: R&D and Product Pipeline - The company has a robust pipeline in autoimmune monoclonal antibodies, including QX001S (IL-23p40), the first approved biosimilar in China for ustekinumab, enhancing accessibility for psoriasis treatment [2] - QX008N (TSLP) has completed Phase II enrollment for chronic obstructive pulmonary disease, leading the domestic market, while QX005N (IL-4Rα) has received breakthrough therapy designation and completed Phase III enrollment for nodular prurigo [2] - QX002N (IL-17A) has completed Phase III trials for ankylosing spondylitis, with a BLA submission expected in H2 2025, and QX004N (IL-23p19) has shown significant efficacy and safety for psoriasis, initiating Phase III trials [2] Group 3: Strategic Collaborations - The company is advancing commercial partnerships both domestically and internationally, collaborating with East China Pharmaceutical on QX001S and QX005N for strategic market development [4] - An exclusive licensing agreement has been established with Hansoh Pharmaceutical for QX004N in Greater China, while a partnership with Health元药业 for QX008N focuses on respiratory indications in mainland China and Hong Kong [4] - An international licensing agreement with Caldera Therapeutics for the long-acting dual antibody QX030N has been signed, granting global exclusive rights for development and commercialization [4]

Group 1 - The report highlights the narrowing space for convertible bond adjustments, with a focus on individual bond adjustment intentions as the market enters a period of increased redemption and maturity [1][24][25] - The overall market valuation of convertible bonds has decreased, with the average conversion value dropping to 100.36 yuan, while the weighted average premium rate has increased to 38.89% [1][26] - The report suggests monitoring convertible bonds with strong fundamentals and relatively low valuations, particularly in technology growth sectors and industries benefiting from cyclical recovery [1][25] Group 2 - The logistics supply chain industry is experiencing significant growth through value realization, with companies extending their business models from logistics to trade and manufacturing [8] - New business segments within supply chain companies are showing high growth rates, with annualized gross profit growth rates of 22% and 21% for specific companies [8] - The report anticipates a rebound in supply chain profits, driven by rising commodity prices and a potential decline in the US dollar index due to Federal Reserve interest rate cuts [8] Group 3 - The medical device company, 惠泰医疗, reported a 21.26% year-on-year increase in revenue to 1.214 billion yuan in the first half of 2025, with a net profit growth of 24.11% [28][29] - The company has focused on its core PFA products, achieving significant milestones in the treatment of atrial fibrillation and expanding its product line [28][29] - The report projects revenue growth for 惠泰医疗 to reach 2.682 billion yuan in 2025, with net profits expected to be 930 million yuan [28][29] Group 4 - 荃信生物 reported a remarkable 359.69% increase in revenue to 206 million yuan in the first half of 2025, although it faced a net loss [35][36] - The company is focusing on the autoimmune disease market, which is projected to grow significantly, with a market size of 363 billion yuan by 2024 [35][36] - 荃信生物 has a diverse pipeline of monoclonal antibodies targeting various autoimmune diseases, with several products in advanced clinical stages [35][36][37]

Investment Rating - The report assigns a "Buy" rating for the company with a target price of 40.25 HKD, based on a 26x PS for 2025 [6]. Core Insights - The company, established in 2015, focuses on autoimmune and allergic diseases, with a comprehensive product pipeline covering skin, respiratory, digestive, and rheumatic diseases. The founder has nearly 30 years of experience in biopharmaceutical research [1][14]. - The autoimmune disease drug market in China is projected to reach 363 billion CNY by 2024, with a significant increase in the share of biological agents, expected to rise to 65.6% by 2030 [2][29]. - The company has a robust pipeline of monoclonal antibodies targeting key autoimmune disease pathways, with several products in advanced clinical stages [3][50]. Summary by Sections 1. Company Overview - The company has established a strong presence in the autoimmune and allergic disease sectors, with a focus on innovative therapies and a fully integrated production capability [14][17]. - The company has successfully integrated R&D, production, and sales through strategic partnerships, enhancing its market position [14][25]. 2. Market Potential - The global autoimmune disease drug market is expected to grow from 833.7 billion CNY in 2019 to 1,260.2 billion CNY by 2030, with biological agents gaining a larger market share [29][30]. - The Chinese market for autoimmune disease drugs is also expanding rapidly, with projections indicating a market size of 1,355 billion CNY by 2030 [29][30]. 3. R&D and Product Pipeline - The company has developed a comprehensive R&D platform that includes high-throughput antibody discovery and dual-antibody design capabilities, which significantly shortens development timelines [42][43]. - The company’s lead products include QX001S, the first approved biosimilar of ustekinumab in China, and QX002N, which is in the final stages of clinical trials for ankylosing spondylitis [3][25][50]. 4. Clinical Progress and Collaborations - The company has made significant progress in clinical trials, with multiple products entering critical phases, including QX005N and QX004N, which are advancing in their respective indications [25][50]. - Strategic collaborations with major pharmaceutical companies have been established to enhance the commercialization of key products [5][25]. 5. Financial Performance - In the first half of 2025, the company reported revenues of 206 million CNY, a year-on-year increase of 359.69%, although it recorded a net loss of 30.93 million CNY [1][25].

Group 1 - The Hong Kong pharmaceutical stocks showed a strong performance on September 29, with most companies experiencing significant gains [1] - Yiming Anke-B (01541.HK) increased by 18.98%, reaching HKD 13.48 [1] - Chuangxin Biotechnology-B (02509.HK) rose by 12.11%, trading at HKD 32.96 [1] - Jingtai Holdings (02228.HK) saw an increase of 8.55%, priced at HKD 13.2 [1] - Gakosi-B (01167.HK) gained 7.58%, with a price of HKD 9.94 [1] - Rongchang Biotechnology (09995.HK) experienced a rise of 6.37%, reaching HKD 108.5 [1]

Group 1 - The pharmaceutical stocks have shown a strong performance, with notable increases in share prices for companies such as Yiming Anke-B (up 18.98%), Quansheng Biotechnology-B (up 12.11%), and others [1] - On September 25, Trump announced a 100% tariff on patented and branded drugs, with the only exemption for companies that are "IS BUILDING" pharmaceutical factories in the U.S. [1] - According to CMB International, the impact on China's innovative drug industry chain is limited, and there is no need for excessive concern [1] Group 2 - Guojin Securities noted recent fluctuations in the innovative drug sector due to a lack of authoritative academic conferences in July and August, leading to a decrease in business development (BD) events [2] - Historically, significant BD transactions tend to cluster towards the end of the year, and upcoming authoritative academic meetings in October, such as the ESMO conference, are expected to boost BD events [2] - The outlook remains positive for the global competitiveness of Chinese innovative drugs, driven by operational improvements and an increase in BD collaborations [2]