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依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） 自願公告 魯塞奇塔單 抗（QX002N）強 直 性 脊 柱 炎 III期臨床研究成果亮相2025年ACR年 會 本 公 告 乃 由 江 蘇 荃 信 生 物 醫 藥 股 份 有 限 公 司（「本公司」）自 願 刊 發，以 向 股 東 及 潛 在投資者提供本公司最新的業務發展狀況。 本 公 司 董 事 會（「董事會」）欣 然 宣 佈，2025年10月27日，本 公 司 自 主 研 發 的 魯 塞 奇 塔 單 抗（QX002N）治 療 強 直 性 脊 柱 炎（ankylosing spondylitis, AS）的 中 國III期臨床研究 成果以口頭報告形式 ...

Market Overview - The Hong Kong stock market saw a rebound with the Hang Seng Index rising by 0.72% to close at 25,967 points, the National Enterprises Index up 0.83% returning to 9,300 points, and the Hang Seng Technology Index increasing by 0.48% to 5,951 points [1] - Major technology stocks experienced gains, with Meituan leading at a 4.06% increase, Alibaba up 1.67%, Tencent and JD.com both up 1.5%, and Baidu rising by 1.22% [1][3] - Financial stocks also contributed to the market's rise, with Agricultural Bank of China increasing by approximately 2% to reach a new high [1] Technology Sector - Alibaba announced the pre-sale of its AI-powered smart glasses, Quark AI Glasses, priced at 4,699 RMB, set to start delivery in December [3] - The technology sector showed a mixed performance, with major players like Meituan, Alibaba, Tencent, and JD.com seeing positive movements, while Apple-related stocks remained sluggish [1][3] Energy Sector - The energy sector saw a broad increase, with notable gains in oil and gas stocks, particularly Yanchang Petroleum International rising over 6% [6] - The U.S. government imposed sanctions on Russian oil companies, which may impact global oil supply dynamics [5] Gambling Sector - The gambling sector showed strong performance, with Sands China rising over 4% and other companies like MGM China and Galaxy Entertainment also experiencing gains [8] - Sands China reported a 7.5% increase in net revenue for Q3 2025 compared to Q3 2024, with total gaming revenue in Macau expected to grow by 9% and 5% in the next two years [7] Aluminum Sector - The aluminum sector was active, with companies like China Hongqiao and Nanshan Aluminum International both rising over 4% [10] - Citic Securities noted supply constraints in the aluminum industry, particularly due to production cuts at Century Aluminum's Grundartangi smelter, which could lead to increased prices [9] Semiconductor Sector - The semiconductor sector faced declines, with stocks like Qorvo and North Sea Kangcheng dropping significantly [12] - Ansys Semiconductor China issued a statement opposing misinformation from its current management and reaffirmed compliance with Chinese regulations [11] Biopharmaceutical Sector - The biopharmaceutical sector underperformed, with stocks like Qianxin Biopharmaceutical dropping over 13% [14] - Analysts noted that the pharmaceutical index lagged behind the market due to tariff impacts and underwhelming external authorizations [13] Apple-Related Stocks - Apple-related stocks declined, with companies like FIH Mobile and Lens Technology experiencing significant drops [16] - Analyst Ming-Chi Kuo indicated that demand for iPhone Air is below expectations, leading to reduced shipments and production capacity [15] Investment Trends - Southbound funds recorded a net inflow of 5.345 billion HKD, indicating strong interest in Hong Kong stocks [19] - Goldman Sachs projected a fundamental shift in investment logic in the Chinese stock market, predicting a potential 30% increase in key indices by the end of 2027 [21]

Core Viewpoint - The pharmaceutical stocks continue to rise, reflecting positive market sentiment and investor interest in the sector [1] Group 1: Stock Performance - Zai Lab Limited (荃信生物-B, 02509.HK) increased by 7.04%, reaching HKD 29.2 [1] - Junshi Biosciences (复宏汉霖, 02696.HK) rose by 6.84%, trading at HKD 75 [1] - I-Mab (映恩生物-B, 09606.HK) saw a gain of 5.41%, with shares priced at HKD 331 [1] - Rongchang Biologics (荣昌生物, 09995.HK) experienced a 5.53% increase, now at HKD 96.3 [1] - CanSino Biologics (康方生物, 09926.HK) grew by 5.25%, with a share price of HKD 128.4 [1]

Core Viewpoint - The pharmaceutical sector continues its upward trend, driven by upcoming catalysts and significant clinical data expected from the European Society for Medical Oncology (ESMO) conference in October 2025 [1] Group 1: Stock Performance - Pharmaceutical stocks have shown notable increases, with specific companies like Qianxin Biotech-B (02509) rising by 7.04% to HKD 29.2, and Fuhong Hanlin (02696) increasing by 6.84% to HKD 75 [1] - Other companies such as Ying'en Biotech-B (09606), Rongchang Biotech (09995), and Kangfang Biotech (09926) also reported gains of 5.41%, 5.53%, and 5.25% respectively [1] Group 2: Market Trends - The pharmaceutical sector has experienced significant stock price volatility since October, with a slight decrease in the proportion of domestic capital holding pharmaceutical stocks through the Hong Kong Stock Connect [1] - Foreign investment has also shown a declining trend since mid-year, although the overall direction of increasing investment in innovative drugs remains unchanged [1] Group 3: Upcoming Catalysts - The ESMO conference, scheduled for October 17-21 in Berlin, is expected to present critical clinical research results and related clinical data, which will be a focal point for the market [1] - Analysts suggest that the upcoming third-quarter earnings reports and the national medical insurance negotiations in November will also be significant events to watch [1] Group 4: Industry Outlook - The Chinese innovative drug sector is anticipated to undergo a transformation driven by quantitative changes leading to qualitative improvements over the next 5-10 years [1] - Factors such as business development (BD) overseas, continuous data catalysts, and the ramp-up of new product sales are expected to drive the rise of innovative drugs [1]

Group 1 - The pharmaceutical sector continues its upward trend, with notable stock increases for companies such as Qianxin Biotech-B (up 7.04%), Fuhong Hanlin (up 6.84%), and others [1] - The upcoming European Society for Medical Oncology (ESMO) conference from October 17 to 21, 2025, in Berlin is expected to showcase significant clinical research results and related clinical data [1] - Despite a slight decrease in the proportion of domestic capital holding pharmaceutical stocks through the Hong Kong Stock Connect, the overall trend of increasing investment in innovative drugs remains unchanged [1] Group 2 - The ESMO annual meeting is anticipated to highlight clinical data for Chinese innovative drugs, which is expected to be a major focus for the market [2] - The third-quarter earnings reports and the national medical insurance negotiations in November are also recommended for attention [2] - The trend of Chinese innovative drugs is expected to undergo a transformation driven by factors such as international business development, continuous data catalysts, and the ramp-up of new product sales over the next 5-10 years [2]

Group 1 - The stock of Qianxin Biopharmaceuticals-B (02509) rose over 6%, reaching 29.04 HKD with a trading volume of 15.28 million HKD [1] - Tianfeng Securities forecasts that the market size for autoimmune disease drugs in China will reach 36.3 billion RMB by 2024, with the share of biological agents increasing to 65.6% by 2030 [1] - The market size for psoriasis in China is expected to reach 30.65 billion RMB by 2030, while the market for ankylosing spondylitis is projected to be approximately 46.3 billion RMB by 2030 [1] Group 2 - The company has a rich product pipeline in the autoimmune monoclonal antibody sector, including QX001S (IL-23p40), the first approved biosimilar of ustekinumab in China, which significantly improves the clinical accessibility of psoriasis treatment [2] - QX008N (TSLP) has completed Phase II enrollment for chronic obstructive pulmonary disease, leading among domestic products [2] - 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 the second half of 2025 [2] - QX004N (IL-23p19) has shown significant efficacy and safety in treating psoriasis and has initiated Phase III trials [2] - QX013N is the first c-kit targeted biologic in China, having completed Phase I trials for chronic spontaneous urticaria [2]

Core Viewpoint - The report highlights the growth potential of the autoimmune disease drug market in China, with significant contributions from biopharmaceuticals, particularly in the treatment of psoriasis and ankylosing spondylitis [1][2]. Industry Summary - The Chinese autoimmune disease drug market is projected to reach 36.3 billion yuan by 2024, with biopharmaceuticals' market share expected to increase to 65.6% by 2030 [1]. - The psoriasis market is anticipated to reach 30.65 billion yuan by 2030, while the market for ankylosing spondylitis is expected to grow to approximately 46.3 billion yuan by 2030 [1]. - Current first-line treatments for autoimmune diseases primarily include glucocorticoids, immunosuppressants, and non-steroidal anti-inflammatory drugs, which have limitations such as short treatment duration and systemic side effects [1]. Company Summary - The company has a diverse product pipeline in the autoimmune monoclonal antibody sector, including QX001S (IL-23p40), the first approved biosimilar of ustekinumab in China, which significantly improves the clinical accessibility of psoriasis treatment [2]. - QX008N (TSLP) has completed Phase II enrollment for chronic obstructive pulmonary disease, leading the progress among domestic products [2]. - 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 the second half of 2025 [2]. - QX004N (IL-23p19) has shown significant efficacy and safety in treating psoriasis and has initiated Phase III trials [2]. - QX013N is the first c-kit targeted biopharmaceutical in China, having completed Phase I trials for chronic spontaneous urticaria [2].

Major Events - Yuan Da Zhu Gong (02163) plans to apply for bankruptcy reorganization at Changsha Intermediate People's Court [1] - Yi Li Holdings (00076) subsidiary intends to issue blockchain vouchers V76, redeemable for bulk commodities on the platform [1] - Peijia Medical-B (09996): National Medical Products Administration accepts registration application for GeminiOne® transcatheter edge-to-edge repair system [1] - Paggen Biopharmaceutical-B (02565) proposes to grant exclusive license for VISEPEGENATIDE (PB-119) in the Middle East and Africa [1] - Beijing Enterprises Environment Group (00154) bids for Hong Kong I·PARK 2 project [1] - Fangda Holdings (01521) plans to acquire Shanghai Guanhua Medical Technology Co., Ltd. for 270 million yuan to enhance global laboratory service capabilities [1] - Lianzhong (06899) focuses on female user value, driving new entertainment through content [1] - Global New Materials International (06616) increases stake in CQV to 50.75%, strengthening global business collaboration [1] - Qianxin Biotechnology-B (02509): Qianxin's industrialization base successfully passes EU QP audit [1] - China Energy Construction (03996) subsidiary signs three new energy general contracting agreements, totaling approximately 19.554 billion yuan [1] - Yongyi International (01218) plans to sell all issued shares of Zhuoyi to Gaoshan (00616) [1] - Bohai Bank (09668) plans to list high capital-occupying debt assets for sale, with an initial pricing of no less than 48.883 billion yuan [1] - Chuangsheng Holdings (02680) plans to receive a premium of about 6% for full acquisition offer, resuming trading on October 13 [1] - Kelun-Botai Biopharmaceutical (06990): Core product TROP2ADC, Lukan-Satuzi (SAC-TMT) approved by National Medical Products Administration for third indication, treating EGFR mutation non-small cell lung cancer after EGFR-TKI progression [1] Operating Performance - Zhaojin Mining (01818) reports net profit of approximately 2.117 billion yuan for the first three quarters, a year-on-year increase of 140.43% [2] - Sunny Optical Technology (02382): September mobile phone camera module shipments reach 48.524 million units, a month-on-month increase of 15.3% and a year-on-year increase of 32% [2] - Yuexiu Property (00123) reports cumulative contract sales of approximately 79.812 billion yuan for the first nine months, a year-on-year increase of about 2.8% [2] - Qiu Tai Technology (01478) reports September camera module sales of 46.654 million units, a month-on-month decrease of 7.6% but a year-on-year increase of 45.1% [2]

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]