Group 1 - The company reported a revenue of 106 million RMB for the six months ending June 30, 2025, representing a year-on-year increase of 22.5% [1] - Gross profit reached 65.12 million RMB, showing a year-on-year increase of 48.86% [1] - Research and development expenses amounted to 92.04 million RMB, indicating a focus on innovation and product development [1] Group 2 - The leading product, Benaoda®, has made continuous progress in commercialization [2] - The company completed patient enrollment for a clinical trial of Benaoda® as a second-line treatment for relapsed or refractory large B-cell lymphoma (LBCL) patients [2] - The National Medical Products Administration granted Benaoda® "Breakthrough Therapy Designation" in January 2025, and a supplemental new drug application (sNDA) was submitted in May 2025 [2] - The company developed its own platform technology and successfully produced lentiviral vectors for Benaoda®, reducing product costs [2] - Clinical studies have shown comparable results to existing lentiviral vectors, and patient enrollment for the investigational new drug application (IND) has been completed [2] - Significant progress has been made in developing innovative products with global commercialization potential [2]

Financial Performance - Revenue for the six months ended June 30, 2025, was RMB 1,063 million, an increase of 22.5% compared to RMB 868 million for the same period in 2024[3] - Gross profit increased by 48.9% to RMB 651 million from RMB 437 million, with a gross margin improvement from 50.4% to 51.1%[3] - Selling expenses for the six months ended June 30, 2025, were RMB 585 million, accounting for 72.0% of product revenue, down from 87.7% in the same period of 2024[4] - General and administrative expenses decreased by 45.7% to RMB 322 million from RMB 592 million, primarily due to organizational streamlining[4] - Research and development expenses decreased by 39.0% to RMB 920 million from RMB 1,510 million, attributed to operational efficiency improvements[4] - Loss for the period was RMB 2,673 million, compared to RMB 2,403 million for the same period in 2024, with a recurring operating loss of RMB 1,140 million, down from RMB 2,405 million[4] - Adjusted loss under non-IFRS measures decreased to RMB 1,033 million from RMB 2,147 million, reflecting improved revenue and cost control[6] Cash and Assets - Cash and cash equivalents as of June 30, 2025, were RMB 6,469 million, compared to a net cash outflow of RMB 1,369 million for the same period in 2024[5] - Total current assets as of June 30, 2025, were RMB 747.0 million, including cash and cash equivalents of RMB 646.9 million[72] - The current ratio as of June 30, 2025, was 1.6, compared to 1.7 as of December 31, 2024[74] - Total liabilities to total assets ratio increased from 0.3 as of December 31, 2024, to 0.4 as of June 30, 2025[74] - The company had uncollateralized bank borrowings of RMB 339.8 million as of June 30, 2025[72] Product Development and Commercialization - The company achieved significant milestones in commercialization and has submitted a supplemental new drug application for its lead product, demonstrating progress in clinical trials[7] - The company plans to submit a supplemental New Drug Application (sNDA) for Beiduo as a second-line treatment for r/r LBCL in January 2025, following the achievement of primary endpoints in its clinical trial[12] - The company has initiated a Phase I clinical trial for relma-cel in treating systemic lupus erythematosus (SLE) as of May 2024, with patient enrollment completed by Q1 2025[12] - The company is focusing on international expansion and innovative pipeline products targeting hematological cancers, solid tumors, and autoimmune diseases[14] - The company is expanding its product pipeline to include treatments for solid tumors and autoimmune diseases, with ongoing clinical development for relma-cel in SLE patients[28] Clinical Trials and Results - The objective response rate (ORR) for the CAR-T therapy, Beinuoda®, in the Phase II clinical trial for LBCL was 77.6%, with a complete response rate (CRR) of 53.5%[32] - In the RELIANCE study for r/r FL, the ORR was 100.0% at three months and 92.6% at six months, with a CRR of 85.2% at three months and 77.8% at six months[34] - The safety profile of Beinuoda® showed a severe cytokine release syndrome (sCRS) rate of 5.1% and severe neurotoxicity (sNT) rate of 3.4% in the LBCL trial, with no treatment-related deaths reported[32] - The overall survival rate for patients treated with Beinuoda® in the LBCL trial was 69.3% at two years and 66.7% at four years[32] Strategic Partnerships and Licensing - A licensing agreement with Juno was established on April 18, 2025, with a total consideration not exceeding $10 million for the non-exclusive license of JW sLVV production technology[17] - The company has entered into a licensing agreement with Juno, with a total consideration not exceeding USD 10 million, recognizing RMB 25.1 million in revenue for the six months ended June 30, 2025[55] - The strategic alliance with 2seventy bio focuses on developing and commercializing cell therapy products targeting MAGE-A4, with Regeneron's acquisition of 2seventy bio not affecting collaboration progress[45] Governance and Compliance - The company has adopted a corporate governance code to ensure shareholder rights and enhance corporate value and accountability[126] - The board structure includes one executive director, four non-executive directors, and three independent non-executive directors, ensuring adequate checks and balances[127] - The Audit Committee has been established by the Board, chaired by independent non-executive director Mr. He Jianchang, with two other members including another independent non-executive director and a non-executive director[130] Future Plans and Allocations - The company aims to maximize the commercial potential of its approved drugs and local production capabilities over the next twelve months[18] - The company plans to allocate part of the unutilized net proceeds to fund product discovery activities for new treatment areas, enhancing its R&D capabilities[122] - The board has decided to reallocate HKD 29.69 million (9.59% of unutilized net proceeds) for working capital and general corporate purposes[124]

Group 1 - The biotechnology sector in the Hong Kong stock market experienced a significant decline, with several companies reporting substantial drops in their stock prices [1] - Notable declines include Clover Biopharmaceuticals, which fell by 14.13%, and Beigene, which dropped by 8.33% [2] - Other companies such as Innovent Biologics and WuXi Biologics also saw declines exceeding 5%, indicating a broader trend of negative performance in the sector [1][2] Group 2 - The following companies reported specific percentage declines: Clover Biopharmaceuticals (-14.13%), Beigene (-8.33%), and Innovent Biologics (-6.50%) [2] - Additional companies with notable declines include Kintor Pharmaceutical (-6.38%), CanSino Biologics (-5.98%), and Zai Lab (-5.50%) [2] - The overall trend suggests a challenging environment for biotechnology stocks in the Hong Kong market [1]

Group 1 - The majority of Hong Kong biotech stocks experienced declines, with notable drops in several companies [1] - Specifically, Gilead Sciences fell by 15.06%, while Yunkang Group and Pigeon BioPharma dropped over 14% and 9% respectively [2] - Other companies such as China Antibody and Jiahua Bio also saw declines exceeding 7% [1][2] Group 2 - The latest market prices and total market capitalizations for the affected companies include: - Gilead Sciences at 15.510 with a market cap of 14.946 billion - Yunkang Group at 2.300 with a market cap of 1.429 billion - Pigeon BioPharma at 31.760 with a market cap of 12.258 billion - Tengsheng BioPharma at 2.210 with a market cap of 1.590 billion - China Antibody at 3.210 with a market cap of 4.371 billion - Jiahua Bio at 4.460 with a market cap of 2.347 billion [2]

Summary of Key Points Core Viewpoint - The Hong Kong biotechnology sector experienced a significant decline, with most stocks falling sharply, indicating a bearish trend in the market [1]. Company Performance - **Gilead Sciences (歌礼制药-B)**: Decreased by 15.06%, latest price at 15.510, market cap at 14.946 billion [2]. - **Yunkang Group (云康集团)**: Fell by 14.18%, latest price at 2.300, market cap at 1.429 billion [2]. - **PAG Pharmaceuticals (派格生物医药-B)**: Dropped by 9.15%, latest price at 31.760, market cap at 12.258 billion [2]. - **Tengsheng Boao (腾盛博药-B)**: Declined by 8.30%, latest price at 2.210, market cap at 1.590 billion [2]. - **China Antibody (中国抗体-B)**: Decreased by 7.49%, latest price at 3.210, market cap at 4.371 billion [2]. - **Jiahua Biotech (嘉和生物-B)**: Fell by 7.08%, latest price at 4.460, market cap at 2.347 billion [2]. - **Sillod Pharmaceuticals (思路迪医药股份)**: Dropped by 6.06%, latest price at 7.910, market cap at 2.042 billion [2]. - **Tiger Med (泰格医药)**: Decreased by 5.73%, latest price at 54.250, market cap at 46.711 billion [2]. - **Kangji Medical (加科思-B)**: Fell by 5.69%, latest price at 8.120, market cap at 6.404 billion [2]. - **WuXi AppTec (药明巨诺-B)**: Dropped by 5.14%, latest price at 5.720, market cap at 2.382 billion [2]. - **Three Leaf Clover Biotech (三叶草生物-B)**: Decreased by 5.13%, latest price at 0.740, market cap at 0.960 billion [2]. - **Yiming Oncology (宜明昂科-B)**: Fell by 4.76%, latest price at 12.810, market cap at 5.218 billion [2]. - **Junshi Biosciences (君实生物)**: Decreased by 4.69%, latest price at 34.540, market cap at 35.462 billion [2]. - **Zhonghui Biotech (中慧生物-B)**: Fell by 4.39%, latest price at 51.150, market cap at 20.125 billion [2]. - **Zhaoyan New Drug (昭衍新药)**: Decreased by 4.38%, latest price at 23.140, market cap at 17.343 billion [2].

Group 1 - The company WuXi AppTec (02126.HK) has scheduled a board meeting on August 27, 2025, to consider and approve its unaudited interim results for the six months ending June 30, 2025 [1] - The board meeting will also address any other matters that may arise [1]

董事會會議通告 藥明巨諾（開曼）有限公司*（「本公司」，連同其附屬公司，統稱「本集團」）董事 （「董事」）會（「董事會」）謹此宣佈，本公司謹訂於2025年8月27日（星期三）舉行 董事會會議，藉以（其中包括）(i)考慮及批准本集團截至2025年6月30日止六個 月之未經審核中期業績及其發佈；及(ii)處理任何其他事項。 承董事會命 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 因依賴該等內容而引致的任何損失承擔任何責任。 JW (Cayman) Therapeutics Co. Ltd 藥明巨諾（開曼）有限公司* （於開曼群島註冊成立的有限公司） （股份代號：2126） 中國上海，2025年8月15日 於本公告日期，董事會包括主席兼執行董事劉敏先生、非執行董事Yiping James Li（李怡平）醫 生、高星女士、Sungwon Song博士及劉誠博士以及獨立非執行董事何建昌先生、Debra Yu醫生 及陳炳鈞先生。 * 僅供識別 JW (Cayman) Therapeutics Co. L ...

Core Viewpoint - The investment bank maintains a cautiously optimistic outlook on the Chinese pharmaceutical industry, noting a significant average increase of 137% in Hong Kong biotech stocks since early 2025, driven by cash returns from innovative drug licensing deals and unaffected by upcoming U.S. tariffs [1] Group 1: Market Performance - The biotech sector has recently experienced some pullback due to disappointing sales figures from major companies in the first half of 2025, including Hutchison China MediTech [1] - Concerns have arisen regarding Trump's phased implementation of drug tariffs, which could escalate to 150% within a year and ultimately reach 250% [1] Group 2: Company Recommendations - The bank's top pick is BeiGene (06160), with a target price set at HKD 230 and a rating of "Outperform," citing strong performance in the first half of 2025 and an improved gross margin guidance despite U.S. tariff impacts [1] - CanSino Biologics (09926) is expected to report adjusted earnings of RMB 23 million for the first half of 2025, benefiting from revenue growth from its drugs AK104 and AK112, also rated "Outperform" [1] - The target price for Innovent Biologics (01801) has been raised by 10% from HKD 100 to HKD 110, with a rating of "Outperform," reflecting confidence in the company's projected 37% year-on-year revenue growth [1] Group 3: Focus on Innovative Drugs - The bank continues to pay attention to licensing deals for Chinese innovative drugs, with expectations of increased subsidies for high-priced innovative drugs, which may drive sales growth for companies such as Kintor Pharmaceutical (02171), Fosun Pharma (02196), WuXi AppTec (02126), and Kelun-Biotech (06990) [2]

Core Insights - The recent government policies aim to support innovative drugs, including "first launch price protection" for CAR-T therapies, which will not be included in centralized procurement for the first five years post-launch [1] - Despite these policies, the payment challenges for CAR-T therapies remain significant, with prices ranging from 999,000 to 1,290,000 RMB, far exceeding the implicit thresholds of 300,000 RMB for basic medical insurance [1][2] - The focus for the 2025 negotiations will be on the long-term competitiveness of companies, assessing their ability to manage price pressures, cost control, and commercialization efficiency [2] Group 1: CAR-T Products and Pricing - Six CAR-T products will participate in commercial health insurance negotiations in September 2025, but basic medical insurance access is unlikely [3] - The current pricing for the listed CAR-T products is as follows: - Axicabtagene ciloleucel (Fosun Kite): 1,200,000 RMB - Relmacabtagene autoleucel (WuXi AppTec): 1,290,000 RMB - Nanjing Biomedicine's product: 999,000 RMB - Others range from 1,280,000 to 1,290,000 RMB [4] Group 2: Economic Evaluation and Price Pressure - Only three of the six CAR-T products have published cost-effectiveness analysis reports for the Chinese market, which will influence their negotiation positions [5] - The incremental cost-effectiveness ratios (ICER) for these products are as follows: - Axicabtagene ciloleucel: 463,000 RMB/QALY - Relmacabtagene autoleucel: 203,000 RMB/QALY - Other products show varying ICERs, indicating different levels of price pressure [6] Group 3: Competitive Strategies and Market Dynamics - The negotiation dynamics will depend on the companies' ability to demonstrate cost control and effective commercialization strategies [2][14] - Companies like WuXi AppTec and Legend Biotech have competitive advantages due to their existing ICERs being closer to the expected thresholds, while others may need to prove the reliability of unpublished data or offer price concessions [14] Group 4: Future Market Potential and Insurance Access - The potential for CAR-T therapies to enter the insurance market hinges on their ability to lower costs and expand patient access, particularly in the context of solid tumors [16][22] - The expected patient population for blood cancers is approximately 26,000 to 48,000 annually, while solid tumors could see a much larger patient base, enhancing the long-term viability of CAR-T therapies [20][22] Group 5: Key Observations for Investors - The completeness of health economic data will determine the negotiation eligibility for insurance access, while the feasibility of price reductions and commercialization efficiency will influence the speed of market entry [14][15] - The ability to expand hospital coverage and partnerships with health insurance will be critical for companies to achieve rapid market penetration and revenue growth [15]

FF301 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 致：香港交易及結算所有限公司 公司名稱: JW (Cayman) Therapeutics Co. Ltd 藥明巨諾（開曼）有限公司* 呈交日期: 2025年8月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02126 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,0 ...