Core Insights - The company Kintor Pharmaceutical announced the long-term follow-up results of its CAR-T cell product, Zevor-cel, at the 22nd International Myeloma Society (IMS) annual meeting [1] Group 1 - The long-term follow-up results of the Phase I clinical trial for Zevor-cel were presented in a poster session at the IMS annual meeting [1] - The presentation was titled "Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma" [1]

Core Viewpoint - The long-term follow-up results of the CAR-T cell product Zevor-cel (赛恺泽®) for treating relapsed/refractory multiple myeloma were presented at the 22nd International Myeloma Society Annual Meeting [1] Group 1: Product Information - Zevor-cel is an autologous CAR-T cell product targeting BCMA, specifically designed for the treatment of multiple myeloma (MM) [1] - The product received approval from the National Medical Products Administration on February 23, 2024, for use in adult patients with relapsed or refractory multiple myeloma who have progressed after at least three lines of treatment [1] - Zevor-cel was granted Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designation by the FDA in 2019 [1] Group 2: Clinical Trial Updates - The updated results of the Phase I clinical trial were presented on September 17, 2025, at the IMS annual meeting, focusing on long-term follow-up for patients treated with Zevor-cel [1] - The presentation was titled "Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma" [1]

香港交易及結算所有限公司、香港聯合交易所有限公司及香港中央結算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。 CARsgen Therapeutics Holdings Limited 科濟藥業控股有限公司 （於開曼群島註冊成立的有限公司） （股份代號：2171） 賽愷澤®是一種用於治療多發性骨髓瘤(MM)的全人抗自體BCMA CAR-T細胞產 品。國家藥品監督管理局於2024年2月23日批准賽愷澤®新藥上市申請，用於治 療復發或難治性多發性骨髓瘤成人患者，既往經過至少3線治療後進展（至少使用 過一種蛋白酶體抑制劑及免疫調節劑）。澤沃基奧侖賽注射液於2019年獲得美國 FDA的再生醫學先進療法(RMAT)及孤兒藥稱號。 1 關於本公司 科濟藥業是一家生物製藥公司，專注於開發創新CAR-T細胞療法，以滿足未滿足 的臨床需求，包括但不限於血液惡性腫瘤、實體瘤及自身免疫性疾病。科濟藥業 建立了從靶點發現、臨床前研究、產品臨床開發到商業規模生產的CAR-T細胞研 究與開發的端到端能力。科濟藥業通過 ...

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry as of September 15, 2025 [1] Core Insights - The trend of Chinese innovative drugs going overseas continues, with a focus on selective opportunities. The report highlights that the global pharmaceutical transaction volume reached 456 deals in the first half of 2025, a 32% year-on-year increase, with upfront payments totaling $11.8 billion, a 136% surge, and total transaction value hitting $130.4 billion, up 58% year-on-year [2] - The report emphasizes the promising clinical data from Chinese innovative drugs presented at the World Lung Cancer Conference, particularly in the ADC (Antibody-Drug Conjugate) field, showcasing significant efficacy advantages [3] - The report discusses the potential of small nucleic acid drugs and innovative delivery systems, indicating new market opportunities arising from strategic collaborations between Chinese companies and multinational corporations [4] - The CXO (Contract Research Organization) sector is expected to gradually recover, with a notable increase in orders anticipated in the third quarter of 2025, driven by improved innovation environments and funding from license-out transactions [5] - The 2025 medical insurance negotiation and commercial insurance innovative drug directory work has commenced, with a focus on orphan drugs and breakthrough treatment varieties [6] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry underperformed the CSI 300 index by 1.75% in the past week, with a recent one-month increase of 3.32%, lagging behind the CSI 300 by 5.81% [22][26] - The medical device sector showed the highest weekly increase of 2.23%, while the chemical pharmaceutical sector experienced a decline of 2.57% [31] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical industry index's current PE (TTM) stands at 40.60, above the five-year historical average of 31.60 [46] - The report notes that the pharmaceutical sector has shown a 15.06% increase over the past three months, outperforming the CSI 300 by 16.11% [43] 3. Recent Research Achievements - The report outlines recent research achievements by the Huaxin pharmaceutical team, including various in-depth and commentary reports on innovative drug developments and market trends [50] 4. Recent Industry Policies and News - The report details recent policy updates from the National Healthcare Security Administration regarding the 2025 drug directory adjustments and the approval of new drug applications [52][55]

Core Insights - The China Cell and Gene Therapy Conference (CSGCT) was held in Beijing, focusing on regulatory frameworks and global collaboration in the CGT sector [1] - The establishment of the CSGCT alliance aims to create an international platform for scientific research and collaboration in cell and gene therapy [1] - The conference highlighted the importance of building a global incubation platform for future pharmaceutical and health industries, particularly in Beijing [1] Group 1: Conference Overview - The conference attracted nearly 2,000 participants, including over 10 international leaders in CGT, scientists, clinicians, entrepreneurs, and investors [1] - The event featured one main forum, 15 sub-forums, and two project roadshows, covering various aspects of cell and gene therapy [1][2] - The release of the "Blue Book on the Development and Regulatory Policy Interpretation of China's Cell and Gene Therapy Industry" provided a significant resource for industry dialogue [1] Group 2: Expert Discussions - International experts discussed global opportunities and challenges in CGT, with a focus on international collaboration [2] - Key topics included advancements in gene editing and the historical impact of the HEK 293 cell line [2] - A roundtable discussion on "China's CGT Ecological Practices and Global Competitiveness" involved prominent figures from various sectors, aiming to strategize for China's CGT global development [2] Group 3: Sub-Forums and Project Roadshows - The gene therapy sub-forum focused on CNS diseases, ophthalmology, and cardiovascular metabolic diseases, while the immune cell therapy forum addressed major directions in oncology and autoimmune diseases [3] - The project roadshows facilitated connections between innovative companies and international capital, with participation from well-known investment firms [3] - CSGCT is recognized as one of the most influential international conferences in China's CGT field, promoting collaboration across the entire value chain from research to global cooperation [3]

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" [6] Core Insights - The report highlights the promising clinical data of BaiLi Tianheng's EGFR/HER3 dual antibody ADC, iza-bren, for treating EGFR mutation lung cancer, which shows potential for further clinical advancement [2][3][20][21][23] Summary by Sections Weekly New Drug Market Review - From September 8 to September 14, 2025, the top five gainers in the new drug sector were: - Saintno Pharmaceutical (+32.00%) - Junshengtai (+23.73%) - Canaan Bio (+20.43%) - Rongchang Bio (+16.52%) - Hengrui Medicine (+11.91%) - The top five losers were: - Basestone Pharmaceuticals (-18.90%) - Laika Pharmaceuticals (-18.12%) - Gilead Sciences (-16.93%) - Maiwei Bio (-14.41%) - Yifang Bio (-12.46%) [1][15] Recommended Stocks to Watch - The report suggests focusing on several potential catalysts in the sector, including academic conferences, business development realizations, and insurance negotiations. Key stocks to watch include: 1. Potential overseas licensed MNC heavyweights: - Differentiated GLP-1 assets: Zhongsheng Pharmaceutical, Gilead Sciences, Borui Pharmaceutical, Kangyuan Pharmaceutical - Upgraded PD-1 products: Kangfang Bio and other PD-1/VEGF assets, Innovent Biologics - Breakthroughs in autoimmune fields: Yifang Bio, China Antibody - Innovative target ADCs: Fuhong Hanlin, Shiyao Group 2. MNC-certified products with high overseas volume certainty: - Upgraded PD-1 products: Sanofi Pharmaceutical - GLP-1 assets: Lianbang Pharmaceutical - ADC assets: Kelong Botai, BaiLi Tianheng 3. Products likely to benefit from insurance negotiations and innovative drug directories [2][20] New Drug Industry Focus Analysis - At the recent 2025 World Lung Cancer Conference (WCLC), BaiLi Tianheng presented results from two studies on its EGFR×HER3 dual antibody ADC, iza-bren, showing excellent clinical data in both first-line and second-line treatments for advanced or metastatic EGFR mutation NSCLC. The results indicate a promising future for its application in relevant indications [2][20][21] New Drug Approval and Acceptance Status - No new drug or new indication applications were approved this week, but seven new drug or new indication applications were accepted [3][25] Clinical Application Approval and Acceptance Status - This week, 41 new drug clinical applications were approved, and 46 new drug clinical applications were accepted [9][28]

Core Insights - FTSE Russell updated its FTSE Global Equity Index Series, including several Hong Kong stocks in the FTSE China Small Cap Index, effective after market close on September 19 [1] - The inclusion of stocks like Ninebot Holdings (09636) reflects international capital market recognition of their future growth potential and long-term investment value [1] - This adjustment is expected to attract additional capital inflows, enhance liquidity in the secondary market, and increase global market visibility for the companies involved [1] Company Impact - Ninebot Holdings (09636) and others included in the index are likely to benefit from increased attention and credibility in the global capital markets due to the endorsement by a well-known index [1] - The inclusion in the FTSE Russell indices signifies a positive outlook for these companies, potentially leading to a rise in stock prices and investor interest [1] - The FTSE Russell indices are widely used by global institutional and retail investors, with approximately $20 trillion in assets benchmarked to these indices, indicating significant market influence [1]

Core Viewpoint - The inclusion of stocks such as 九方智投控股 (09636) and others in the FTSE Global Equity Index Series reflects international capital market recognition of their future development potential and long-term investment value [1] Group 1: Index Inclusion - 九方智投控股 (09636), 和誉-B (02256), 第四范式 (06682), 科济药业-B (02171), and 顺丰同城 (09699) have been added to the FTSE China Small Cap Index, effective after market close on September 19 [1] - The FTSE Russell is a leading player in the global index industry, providing benchmarks, analytics, and data solutions widely used by institutional and retail investors [1] Group 2: Market Impact - The inclusion in the FTSE Russell Global Equity Index Series is expected to bring more potential incremental capital inflows to the companies' stocks, enhancing liquidity in the secondary market [1] - The endorsement from a globally recognized index is likely to increase the companies' visibility and recognition in the global capital markets, aiding in the realization of their long-term investment value [1]

Core Insights - The China Cell and Gene Therapy Conference (CSGCT) will be held on September 12-13, 2025, in Beijing, focusing on regulatory frameworks and global collaboration in the cell and gene therapy (CGT) sector [2][10] - The conference aims to gather nearly 2,000 participants, including leading scientists, clinicians, entrepreneurs, and investors, to discuss the future of CGT [2][10] Industry Overview - Beijing has the highest number of approved medical device products in China over the past three years, with the pharmaceutical and health industry reaching a scale of 1.06 trillion yuan in 2024, marking an 8.7% year-on-year growth [3] - The Haidian District benefits from a strong educational and clinical resource base, with 37 universities and 57 hospitals, fostering innovation in CGT [3][4] Policy and Infrastructure - Haidian District is enhancing its CGT industry by implementing action plans and measures to support full-chain development, including establishing specialized CGT industrial zones and a one-stop service platform for pharmaceutical and medical device innovation [4][5] - The establishment of a trusted data space for the pharmaceutical and health sector aims to integrate diverse data sources to drive innovation in CGT [5] Conference Highlights - The CSGCT will feature a main forum, 15 sub-forums, and two project roadshows, covering various cutting-edge topics such as gene therapy, immunotherapy, and AI in drug development [10] - The conference will also facilitate discussions on global CGT opportunities and challenges, with participation from international experts [7][8] Future Directions - CSGCT aims to create an open, authoritative, and efficient global dialogue mechanism to enhance China's participation in global innovation and standard-setting in the CGT industry [11]

Core Viewpoint - The article highlights the remarkable rise of Baili Tianheng, a Chinese biopharmaceutical company, which has seen its stock price surge over 1,000% since its IPO, driven by significant licensing deals and a shift towards innovative drug development [3][9][13]. Company Overview - Baili Tianheng's stock reached a historical high of 38.8 yuan, with a market capitalization exceeding 150 billion yuan, marking a more than tenfold increase from its IPO price of 24.70 yuan [3][7]. - The company was founded by Zhu Yi, a Sichuan entrepreneur, who transitioned from traditional pharmaceuticals to innovative drug research, establishing a cash flow system for R&D through previous successes in generic drugs [5][6]. Key Developments - In June 2023, Baili Tianheng's clinical data for its ADC drug BL-B01D1 generated significant interest, leading to a landmark licensing deal with Bristol-Myers Squibb worth approximately 84 billion yuan [9][10]. - The company reported a revenue of 5.823 billion yuan in the previous year, a staggering increase of 936.31%, and turned a profit with a net income of 3.708 billion yuan, a 575.02% year-on-year growth [10]. Market Context - The Chinese biopharmaceutical sector is experiencing a resurgence after a period of downturn, with several companies successfully listing and achieving significant stock price increases [13][14]. - The market is witnessing a shift where innovative drug companies are gaining recognition and valuation, as evidenced by the performance of Baili Tianheng and other firms in the sector [14][15]. Future Outlook - Zhu Yi aims for Baili Tianheng to become a multinational pharmaceutical company within five years, focusing on global commercialization of its products [11]. - Despite the current success, the company faces challenges in sustaining growth due to the high costs and risks associated with innovative drug development [10][12].