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].

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7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: 思路迪医药股份有限公司 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) | 01244 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | HKD | | 0.001 | HKD | | 500,000 | | 增加 / 減少 (-) | | | | | | | HKD | | 0 | | 本月底結存 | | | 500,000,000 | HKD | | 0.001 | HKD | | 500,000 | 第 1 頁 共 10 頁 v ...

Summary of Key Points Core Viewpoint - As of July 30, a total of 160 stocks reached their 52-week highs, indicating a positive trend in the market, with notable performances from companies like Feiyang Group, LFG Investment Holdings, and Sillod Medical [1]. 52-Week Highs - Feiyang Group (01901) achieved a closing price of 0.320 with a peak of 0.385, marking a high rate of 37.50% - LFG Investment Holdings (03938) closed at 0.770, reaching a high of 0.820, with a high rate of 34.43% - Sillod Medical (01244) had a closing price of 7.180 and a peak of 7.860, resulting in a high rate of 23.20% [1]. Additional Notable Stocks - Other significant stocks that reached their 52-week highs include: - JAKS Resources B (01167) with a high rate of 19.38% - Chenlin Education (01593) at 18.47% - Lee's Pharmaceutical (00950) at 17.58% [1]. Market Trends - The overall trend shows a strong performance in various sectors, particularly in healthcare and technology, as evidenced by the high rates of stocks like Weichuang Medical (00853) and Ping An Good Doctor (01833) [1]. 52-Week Lows - Conversely, some stocks are experiencing declines, with notable mentions such as XI Ernan Samsung-U (09347) dropping by 9.76% and XI Ernan Samsung (07347) decreasing by 8.67% [5].

7月30日，截至港股收盘，恒生指数下跌1.36%，报25176.93点。思路迪医药股份（01244.HK）收报7.18 港元/股，上涨12.54%，成交量302.5万股，成交额2191.26万港元，振幅23.2%。 最近一个月来，思路迪医药股份累计涨幅59.1%，今年来累计涨幅107.14%，跑赢恒生指数27.24%的涨 幅。 财务数据显示，截至2024年12月31日，思路迪医药股份实现营业总收入4.46亿元，同比减少29.81%；归 母净利润-1.83亿元，同比增长65.19%；毛利率91.79%，资产负债率42.14%。 机构评级方面，目前暂无机构对该股做出投资评级建议。 行业估值方面，药品及生物科技行业市盈率（TTM）平均值为2.73倍，行业中值6.48倍。思路迪医药股 份市盈率-8.35倍，行业排名第129位；其他精优药业（00858.HK）为1.37倍、金斯瑞生物科技 （01548.HK）为1.76倍、东瑞制药（02348.HK）为3.5倍、吉林长龙药业（08049.HK）为6.14倍、大健 康国际（02211.HK）为6.83倍。 资料显示，思路迪医药股份有限公司是一家进入商业化阶段专注肿瘤慢病化 ...

Company Overview - Sido Medical Co., Ltd. is an innovative pharmaceutical company focused on oncology and chronic disease treatment, with a vision to "help cancer patients live longer and better" [2] - The company has a product line of 12 innovative drugs with differentiated clinical value, 8 of which are in clinical development or commercialization stages [2] - The first subcutaneous PD-L1 monoclonal antibody, Envida, has been approved for sale by the National Medical Products Administration [2] - The company utilizes its proprietary mRNA research platform and tumor genomic big data AI analysis platform to develop a series of mRNA products [2] - Sido Medical has established capabilities across drug discovery, preclinical research, clinical development, regulatory submission, and commercialization [2] Financial Performance - As of December 31, 2024, Sido Medical reported total revenue of 446 million yuan, a year-on-year decrease of 29.81% [1] - The company recorded a net profit attributable to shareholders of -183 million yuan, an increase of 65.19% year-on-year [1] - The gross profit margin stands at 91.79%, with a debt-to-asset ratio of 42.14% [1] Market Position and Valuation - The average price-to-earnings (P/E) ratio for the pharmaceutical and biotechnology industry is 1.96 times, with a median of 6.18 times [1] - Sido Medical's P/E ratio is -5.69 times, ranking 132nd in the industry [1] - Comparatively, other companies in the industry have P/E ratios such as: Qingdao Haier Biomedical (0.86), Kingsray Biotechnology (1.43), Dongrui Pharmaceutical (3.06), and Jilin Changlong Pharmaceutical (6.00) [1]

Financial Performance - The company reported a revenue of $150 million for the fiscal year 2024, representing a 25% increase compared to the previous year[4]. - The company reported a revenue of HK$124.4 million for the year ended December 31, 2024, reflecting a year-on-year increase of 15%[10]. - In 2024, the company's revenue was RMB 445.6 million, a decrease of approximately 29.8% compared to 2023[42]. - The total comprehensive loss for the year was RMB 199.4 million, a significant improvement from a loss of RMB 562.5 million in 2023[143]. - The gross profit fell by 30.2% from RMB 585.8 million in 2023 to RMB 409.1 million in 2024, with a gross profit margin of 91.8% compared to 92.3% in the previous year[148]. - Other income and net gains increased to RMB 54.7 million in 2024 from RMB 41.0 million in 2023, driven by higher bank interest income, foreign exchange gains, and investment income[149]. User Growth and Market Expansion - User data showed a growth of 30% in active users, reaching 1.2 million by the end of the fiscal year[4]. - The user base expanded by 20% year-on-year, reaching a total of 1.2 million active users[10]. - The company is expanding its market presence in Southeast Asia, targeting a 10% market share within the next two years[4]. - The company plans to enter the North American market by Q3 2025, aiming to capture a 10% market share within the first year[10]. Research and Development - Research and development expenses increased by 30% to HK$37 million, focusing on innovative drug development[10]. - Research and development expenses were RMB 180.7 million, representing a 57.5% decrease from 2023[26]. - The company has made significant progress in its R&D pipeline, adding a new mRNA vaccine candidate and a radiopharmaceutical candidate in 2024[46]. - The company is actively developing early-stage pipeline candidates while strategically expanding its commercial portfolio to transform cancer into a manageable chronic disease[48][49]. - The company has established an ionizable cationic lipid R&D platform to enhance mRNA vaccine development efficiency and improve drug targeting precision[98]. Product Development and Innovation - New product launches contributed to 15% of total revenue, with the introduction of two innovative therapies in the oncology sector[4]. - The company has diversified its product pipeline to include 13 products, with the addition of the new radiopharmaceutical drug conjugate (RDC) 3D1015[25]. - The company is developing a proprietary AI-driven antigen prediction platform for tumor antigen screening and design for 3D124[94]. - The company has initiated the development of next-generation radioligand therapy products, leveraging PSMA as an entry point[112]. Cost Management and Operational Efficiency - The management highlighted a 5% reduction in operational costs due to improved efficiency measures implemented during the year[4]. - Administrative expenses decreased by RMB 138.8 million to RMB 78.3 million from RMB 217.1 million in 2023, primarily due to a reduction in share-based payment expenses[156]. - Selling and marketing expenses decreased by 37.7% from RMB 378.8 million in 2023 to RMB 235.9 million in 2024, reflecting a more effective sales promotion regime and cost reduction measures[157]. Strategic Partnerships and Acquisitions - A strategic acquisition of a biotech firm was completed, expected to enhance the company's R&D capabilities and product pipeline[4]. - The company has secured partnerships with three major pharmaceutical firms to enhance its distribution network[10]. - The company is exploring potential acquisitions to bolster its product pipeline and market presence[10]. Sustainability and Corporate Responsibility - The company is committed to sustainability, with a goal to reduce carbon emissions by 30% over the next five years[4]. - The company integrated Environmental, Social, and Governance (ESG) principles into its daily operations[25]. Clinical Development and Regulatory Progress - A new drug application (NDA) is expected to be submitted to the NMPA by the end of Q2 2025, targeting renal cell carcinoma[10]. - The execution team secured a Breakthrough Therapy designation from Chinese regulators, enhancing the company's strategic position[46]. - Envafolimab received Breakthrough Therapy Designation for treating unresectable or metastatic TMB-H solid tumors, addressing a critical unmet medical need in China[62]. Manufacturing and Infrastructure - The company has purchased land in Xuzhou, China, with an area of 65,637.97 square meters for building new manufacturing facilities, which have received construction permits and are currently under construction[118]. - Approximately 40% of the net proceeds from the 2023 Placing will be allocated to expedite the construction and procurement of new equipment for the manufacturing facilities in Xuzhou[120].

Group 1 - The biotechnology stocks in the Hong Kong market mostly declined, with notable drops in several companies [1] - Kangfang Biotech (09926.HK) experienced a decline of over 12% [1] - Yunkang Group (02325.HK) fell by more than 6% [1] - Other companies such as Sillod Medical (01244.HK) and Zai Lab (09688.HK) also saw declines exceeding 4% [1]

Financial Performance - For the fiscal year ending December 31, 2024, the company's revenue decreased by 29.8% to RMB 445.6 million from RMB 634.9 million in 2023, primarily due to intensified market competition [10]. - The company's gross profit fell by 30.2% to RMB 409.1 million, with a gross margin of 91.8% for 2024, slightly down from 92.3% in 2023, attributed to increased sales-related taxes and product quality costs [8]. - The total comprehensive loss for the year narrowed to RMB 199.4 million from RMB 562.5 million in 2023, indicating improved operational efficiency [13]. - The company reported a pre-tax loss of RMB 199.4 million in 2024, a significant improvement from a loss of RMB 562.5 million in 2023 [54]. - The company reported a net loss of RMB 199.4 million for the year ended December 31, 2024, compared to a net loss in the previous year [107]. - Basic and diluted loss per share for the year was RMB 0.75, compared to RMB 2.30 in 2023, showing a reduction in loss per share [102]. - Total liabilities decreased to RMB 512.5 million in 2024 from RMB 558.2 million in 2023, reflecting a decline of about 8.2% [104]. - The company's equity decreased to RMB 703.7 million in 2024 from RMB 870.7 million in 2023, a drop of approximately 19.2% [104]. Research and Development - Research and development expenses decreased by 57.5% to RMB 180.7 million from RMB 425.5 million in 2023, mainly due to reduced third-party contractor fees and employee benefit costs [11]. - The company has a diversified product pipeline with 13 products, including a new drug candidate 3D1015 aimed at treating metastatic castration-resistant prostate cancer [15]. - The company is leveraging an AI-driven antigen prediction platform for the development of personalized cancer vaccines [15]. - The establishment of an AI-driven 3D-PreciseAg antigen prediction platform has led to the identification of 24 antigens for a universal mRNA tumor vaccine [16]. - The company achieved significant progress in its R&D pipeline, adding a new mRNA vaccine candidate, 3D124, and replacing 3D011 with 3D1015, both showing positive signals in preclinical trials [22]. - The company has filed a PCT patent for key components of its self-developed lipid nanoparticles for nucleic acid drug delivery, indicating ongoing innovation in drug delivery technologies [22]. - The company is actively expanding its research and development efforts in innovative therapies, as evidenced by the promising results from multiple clinical trials [10][11][12][13][14][33][34][35]. Sales and Marketing - Sales and marketing expenses dropped by 37.7% to RMB 235.9 million from RMB 378.8 million in 2023, as new promotional strategies and cost-cutting measures were implemented [12]. - The sales revenue of Envida® (Envafolimab) in China reached RMB 4.456 billion in 2024, contributing to a total sales amount of approximately RMB 1.7 billion [21]. - The total revenue of the group decreased by approximately 29.8% compared to the same period in 2023, primarily due to a decline in Envida® sales [21]. - The company has initiated international commercialization efforts, with a licensing agreement for Envafolimab with Glenmark, allowing entry into the Macau market, which is expected to provide new revenue growth opportunities [22]. - The company plans to expand the development and commercialization of Envidat® into emerging markets through strategic partnerships [77]. Clinical Trials and Approvals - A total of 22 prospective research results related to Envida® were published in 2024, including 5 full papers in international high-level journals and over 17 reports at international conferences [18]. - Envafolimab has been recognized as a breakthrough therapy for patients with high tumor mutation burden (TMB-H) unresectable or metastatic solid tumors [20]. - The company received approval for a supplemental new drug application (sNDA) to change the production scale from 1000L to 2000L and to add new raw material suppliers [20]. - The clinical data for Envafolimab combined with Lenvatinib for treating advanced endometrial cancer showed improved efficacy and safety for patients who failed or could not tolerate prior platinum-based chemotherapy [26]. - The ENLIGHTEN study reported an Objective Response Rate (ORR) of 45% and a Disease Control Rate (DCR) of 80% in advanced biliary tract cancer patients [26]. - Envafolimab demonstrated a pathological complete response (pCR) rate of 30.7% and a major pathological response (MPR) rate of 53.8% in a study involving resectable stage II-IIIB NSCLC patients [28]. - The combination therapy of TACE, Envafolimab, and Lenvatinib for unresectable hepatocellular carcinoma (uHCC) demonstrated an ORR of 50% and a DCR of 83.3%, with a surgical conversion rate of 47.2% and a 100% R0 resection rate [11]. Corporate Governance and Strategy - The company adheres to high standards of corporate governance and has complied with all applicable code provisions during the reporting period [86]. - The board believes that the current structure of having the same individual as both Chairman and CEO does not impair the balance of power and authority [87]. - The company plans to retain all future earnings for business operations and expansion, with no immediate plans for a dividend policy [88]. - The company has established a comprehensive quality management system based on GLP, GCP, and GMP standards to ensure compliance from early development to final product launch [46]. - The company is focused on expanding its research and development capabilities in cell gene therapy and oncology [129]. Future Outlook - The company anticipates continued progress in advancing late-stage clinical drugs to NDA stage, which is expected to bring incremental cash flow in the foreseeable future [69]. - The company plans to submit multiple IND applications in various countries this year, indicating a strong pipeline for future product development [25]. - The company projects a revenue growth of 20% for the next fiscal year, driven by new product launches and market expansion [132]. - The company aims to reduce operational costs by 15% over the next two years through process optimization [132].

Financial Performance - 3D Medicines reported a significant increase in revenue, reaching approximately HK$ 150 million for the first half of 2024, representing a 25% growth compared to the same period last year[1]. - The company reported a total revenue of RMB 1,200,000,000 for the first half of 2024, reflecting a year-over-year growth of 15%[11]. - For the six months ended June 30, 2024, the company's revenue decreased by 41.4% to RMB 206.4 million from RMB 352.6 million for the same period in 2023, primarily due to a highly competitive market for PD-1/L1 products[16]. - The total comprehensive loss for the period was RMB 114.1 million, a 40.0% improvement from RMB 190.2 million in the same period of 2023[16]. - The company reported a net loss of RMB 150,000,000 for the first half of 2024, compared to a net loss of RMB 120,000,000 in the same period last year[11]. - The total comprehensive loss for the period ended June 30, 2024, was RMB (114,074) thousand, a 40.0% improvement compared to RMB (190,204) thousand for the same period in 2023[22]. - The company reported a basic and diluted loss per share of RMB 0.42 for the period, compared to RMB 0.79 in the same period last year[150]. Research and Development - 3D Medicines is investing heavily in R&D, allocating approximately HK$ 50 million for the development of new therapies, including a focus on PD-L1 inhibitors[1]. - Research and development expenses for the first half of 2024 were RMB 300,000,000, representing an increase of 25% compared to the same period last year[11]. - Research and development expenses decreased by 43.7% to RMB 85.3 million from RMB 151.6 million, mainly due to a reduction in employee benefit expenses related to research and development personnel[17]. - The company has a pipeline of 12 drug candidates, with seven in various stages of clinical development[23]. - The company is focusing on cutting-edge research in TIL and CAR-T therapies to promote diversification and specialization of its research and development[29]. Market Expansion and Strategy - The company is actively expanding its market presence, with plans to enter two new international markets by the end of 2024[1]. - The company plans to expand its market presence in Asia, targeting a 30% increase in market share by the end of 2025[11]. - Future guidance indicates an anticipated revenue growth of 20% for the full year 2024, driven by new product introductions and market expansion efforts[11]. - The company aims to enhance its digital marketing strategies, targeting a 40% increase in online engagement with healthcare professionals by mid-2025[1]. Product Development and Clinical Trials - The company is on track to submit a biologic license application (BLA) for Envafolimab by Q4 2024, which is expected to accelerate its market entry[1]. - Envafolimab achieved sales revenue of RMB 206.4 million in China for the six months ended June 30, 2024, a decrease of 41.4% compared to the same period last year[23]. - Envafolimab's phase III trial in NSCLC perioperative regimens is progressing smoothly[23]. - The confirmed overall response rate (ORR) for Envafolimab combined with Lenvatinib in advanced endometrial cancer was 40.0%[24]. - The ongoing Phase III trial (KN035-CN-017) is assessing the efficacy and safety of Envafolimab in combination with neoadjuvant platinum-based chemotherapy, with a focus on patients with resectable NSCLC[30]. Cost Management and Operational Efficiency - 3D Medicines reported a 15% reduction in operational costs due to improved manufacturing efficiencies[1]. - The company aims to reduce operational costs by 10% over the next year through efficiency improvements and strategic partnerships[11]. - Selling and marketing expenses decreased by 50.2% to RMB 110.1 million from RMB 221.0 million, primarily due to a sales drop of Envafolimab, with the decrease rate of marketing expenses exceeding the sales decline rate[18]. Financial Position and Cash Flow - As of June 30, 2024, cash and bank balances amounted to RMB 898,578,000, a decrease of 19.8% compared to RMB 1,120,849,000 as of December 31, 2023[14]. - Current assets as of June 30, 2024, were RMB 1,037.0 million, a decrease from RMB 1,095.2 million as of December 31, 2023[67]. - Cash and cash equivalents decreased by RMB 177.8 million to RMB 488.7 million as of June 30, 2024, from RMB 666.5 million as of December 31, 2023[68]. - Net cash used in operating activities for the six months ended June 30, 2024, was RMB 223.6 million, up from RMB 168.1 million in 2023[70]. Corporate Governance - The company has complied with all applicable code provisions of the CG Code during the reporting period, with some deviations noted[87]. - The roles of chairman and chief executive are held by the same individual, Dr. Gong Zhaolong, which deviates from the CG Code[87]. - The board structure includes three independent non-executive directors out of seven, ensuring sufficient checks and balances[88]. Shareholder Information - Dr. Gong holds a total of 35,992,364 shares, representing approximately 13.94% of the company's shareholding interest[92]. - The shareholding structure indicates a significant concentration of ownership among key directors and their affiliates[93]. - The company has established a share option scheme to incentivize key employees, approved on June 26, 2023[7].