Core Viewpoint - The company, Qianxin Biologics-B, has experienced a significant stock price increase following the announcement of its impressive financial performance for the first half of 2025, with a revenue growth of 359.69% year-on-year and a substantial reduction in losses [1][2] Financial Performance - Qianxin Biologics-B reported a revenue of RMB 206 million for the first half of 2025, marking a year-on-year increase of 359.69% [1] - The company incurred a loss of RMB 30.93 million, which represents an 83.11% decrease in losses compared to the previous year [1] Revenue Sources - The substantial revenue growth is attributed to income from external licensing project upfront payments, milestone payments, clinical research service fees, and CDMO (Contract Development and Manufacturing Organization) revenues [1] Market Position and Opportunities - Qianxin Biologics-B is recognized as a leader in the domestic self-immune innovative drug sector, with a strong foundation in this field [1] - The company’s mature pipeline is entering a monetization phase, enhancing its revenue-generating capabilities, while its innovative pipeline is poised for international expansion opportunities [1] Product Commercialization - The company has successfully commercialized its first product, a biosimilar of Ustekinumab named Seluxin, which received approval from the National Medical Products Administration for market launch in October 2024 [2] - As of June 2025, Qianxin Biologics-B has shipped over 60,000 units of Seluxin to its major shareholder, Huadong Medicine [2] Sales and Distribution - Huadong Medicine, which has a sales network covering over 30 provinces in China and employs more than 10,000 sales personnel, will facilitate the distribution of Qianxin Biologics-B's products, accelerating the commercialization process [2] - In the first half of the year, Seluxin has been prescribed in over 1,200 hospitals, indicating a gradual acceleration in market sales [2]

Core Insights - The stock of Zai Lab Limited (荃信生物-B) has seen a significant increase of over 10%, currently trading at HKD 27.74 with a transaction volume of HKD 18.69 million [1] - The company reported a revenue of RMB 206 million for the first half of 2025, marking a year-on-year increase of 359.69%, while the loss narrowed to RMB 30.93 million, a decrease of 83.11% year-on-year [1] - The substantial revenue growth is attributed to upfront payments from licensing agreements, milestone payments, clinical research service fees, and CDMO revenue [1] - Zai Lab is recognized as a leader in the domestic autoimmune innovative drug sector, with a mature pipeline entering a monetization phase and innovative pipelines exploring international opportunities [1] Product Commercialization - Zai Lab has successfully commercialized its first product, a biosimilar of Ustekinumab named Seluixin, which received approval from the National Medical Products Administration for market launch in October 2024 [2] - As of June 2025, Zai Lab has delivered over 60,000 units of Seluixin to East China Pharmaceutical, a wholly-owned subsidiary of Huadong Medicine [2] - Huadong Medicine, being the second-largest shareholder of Zai Lab, has a nationwide sales network covering over 30 provinces, with more than 10,000 sales personnel, facilitating Zai Lab's product commercialization [2] - The number of hospitals prescribing Seluixin has exceeded 1,200 in the first half of the year, indicating a rapid acceleration in market sales [2]

Core Viewpoint - The company, 荃信生物-B, has shown significant growth in its mid-year performance, with a substantial increase in revenue and a notable reduction in losses, indicating strong potential for future development in the biopharmaceutical sector [1][2]. Financial Performance - The company reported a revenue of RMB 206 million for the first half of the year, representing a year-on-year increase of 359.69% [1]. - The net loss for the period was RMB 30.93 million, which is a decrease of 83.11% compared to the previous year [1]. Revenue Sources - The revenue growth was primarily driven by upfront payments from licensing agreements, milestone payments, clinical research service fees, and CDMO (Contract Development and Manufacturing Organization) income [1]. Product Pipeline - The company has five key pipeline products: QX001S, QX005N, QX002N, QX004N, and QX008N, targeting various therapeutic areas with established drug approval in the global market, indicating a high probability of successful commercialization [1]. - Except for QX002, the remaining products have established partnerships with domestic pharmaceutical companies for commercialization, which is expected to accelerate market potential realization [1]. Internationalization Strategy - The company aims to internationalize its dual-antibody pipeline, with QX027N and QX031N expected to submit IND applications simultaneously in China and the U.S. in Q3 2025 and H2 2025, respectively [2]. - QX035 is projected to submit its IND application in H2 2026, with no significant competing dual-antibody products currently available in the autoimmune field, suggesting a strong opportunity for clinical value realization [2].

Group 1 - The core viewpoint of the news highlights the significant revenue growth and reduced losses for Qianxin Biologics, with a reported revenue of RMB 206 million, a year-on-year increase of 359.69%, and a loss of RMB 30.93 million, a decrease of 83.11% [1] - The revenue increase is primarily attributed to upfront payments from licensing projects, milestone payments, clinical research service fees, and CDMO income [1] - The company has five pipeline products with advanced clinical progress, which have established partnerships with domestic pharmaceutical companies for commercialization, enhancing market potential [1] Group 2 - The company aims to internationalize its dual-antibody pipeline, with QX027N and QX031N expected to submit IND applications simultaneously in the US and China in Q3 2025 and H2 2025, respectively [2] - QX035N is projected to submit its IND application in H2 2026, indicating a strategic timeline for product development [2] - There are currently no major dual-antibody products in the autoimmune field globally, suggesting that the company's innovative pipeline has the potential for rapid clinical value realization [2]

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8月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 江蘇荃信生物醫藥股份有限公司 呈交日期: 2025年9月4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 | | | 222,071,600 | RMB | | 1 RMB | | 222,071,600 | | 增加 / 減少 (-) | | | 5,000,000 | | | RMB | | 5,000,000 | | 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： ...

Core Viewpoint - The recent mid-year performance announcement from Qianxin Biotech shows a significant revenue increase, indicating strong market confidence and the company's successful internationalization strategy [1][4]. Financial Performance - For the first half of 2025, Qianxin Biotech reported revenue of 206 million yuan, a year-on-year increase of 359.69% [1][4]. - The company's loss narrowed significantly to 30.93 million yuan, a reduction of 83.11% compared to the previous year [4]. - Cash and cash equivalents reached 559 million yuan, indicating a healthy cash flow situation [4]. Capital Market Recognition - TruMed Health Innovation Fund LP completed a rapid subscription for 5 million shares of Qianxin Biotech, raising 99 million HKD, reflecting strong institutional confidence in the company's long-term value [3][4]. - The funds raised will be used for debt repayment, accelerating the development of new pipelines, and supplementing working capital [3]. Product Development and Pipeline - Qianxin Biotech has developed a differentiated product pipeline targeting various autoimmune and allergic diseases, including the recently approved biosimilar drug, QX001S (赛乐信®) [2]. - The company has entered into an overseas NewCo transaction with Caldera Therapeutics, receiving an upfront payment of 10 million USD and a 24.88% equity stake, marking a significant step in its internationalization efforts [2]. Globalization Strategy - The company aims to accelerate its overseas business development, with a target of completing two projects for international markets in 2025 [5]. - Qianxin Biotech plans to collaborate with top-tier international pharmaceutical companies for "first in class" or "best in class" products, while also targeting markets in countries along the Belt and Road Initiative [5][6]. Market Context - The global autoimmune market is projected to grow from approximately 107.9 billion USD in 2024 to 137.59 billion USD by 2033, indicating a significant opportunity for growth in this sector [1][2]. - The international environment necessitates that Chinese innovative pharmaceutical companies pursue globalization as a survival strategy, with strong demand for high-quality innovative drugs in the European and American markets [6].

Core Viewpoint - The company, TruMed Health Innovation Fund LP, has successfully completed a placement agreement with a total of 5 million shares at a price of HKD 20.0 per share, representing approximately 2.25% of the issued shares prior to the placement and about 2.20% after the placement [1] Group 1 - The placement agreement conditions have been fulfilled, and the placement is set to be implemented on August 25, 2025 [1] - The placement agent has successfully allocated the shares to the designated subscriber [1]

Core Viewpoint - The company, 荃信生物-B (02509), has successfully completed a placement agreement, with all conditions met as of August 25, 2025 [1] Group 1: Placement Details - The placement agent has successfully placed a total of 5 million shares at a price of HKD 20.0 per share to a single subscriber, TruMed Health Innovation Fund LP [1] - The shares placed represent approximately 2.25% of the total issued shares immediately before the completion of the placement and approximately 2.20% of the total issued shares after the placement [1]

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 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8月25日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 普通股 | 股份類別 | H | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) 02509 | 說明 | H股 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | | ...

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