GR1501为首个提交 NDA的国产 IL-17A单抗，商业化在即。2023年 3月，赛 立奇单抗注射液 NDA 获受理。2024 年 2 月，赛立奇单抗注射液针对中重度斑 块状银屑病 III 期临床研究结果在国际皮肤病学权威期刊 BJD上正式发表，数据 显示第 52 周 PASI75 应答率 96.5%，PASI90 应答率为 84.1%，PGA0/1 应答 率为 83.7%，表现出了优异且持久的疗效。复发的比例较低，用药第 52周复发 率为 0.4%，这表明 GR1501 可能具有更好的长期疗效。 盈利预测与投资建议。预计公司 2024-2026年实现营业收入分别约为 1.2、3.4、 7 亿元。考虑公司研发实力强劲，自身免疫疾病市场广阔，首款创新药 GR1801 获批在即，维持"买入"评级。 投资要点 西南证券研究发展中心 | --- | --- | |------------------------------------|------------| | | | | | | | | | | 基础数据 | | | [Table_BaseData] 总股本 ( 亿股 ) | 3.67 | | 流通 A 股 ...

智翔金泰-U（688443.SH） 增持 在研管线有序推进，赛立奇单抗获批在即 核心观点 公司研究·财报点评 相关研究报告 45 15 10 资料来源：公司公告、Wind、国信证券经济研究所整理 资料来源：公司公告、Wind、国信证券经济研究所整理 3) GR1603: 系统性红斑狼疮适应症处于 Ph2 临床试验阶段; 请务必阅读正文之后的免责声明及其项下所有内容 投资建议 请务必阅读正文之后的免责声明及其项下所有内容 财务预测与估值 免责声明 | --- | --- | --- | --- | |--------------------------------------------------------------------------------------------------|---------------|-------|----------------------------------------| | 投资评级标准 | 类别 | 级别 | 说明 | | 报告中投资建议所涉及的评级（如有）分为股票评 | | 买入 | 股价表现优于市场代表性指数 20%以上 | | 级和行业评级（另有说明 ...

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-----------------------------------------------|--------------------------------------|------------------------------------------------------------------|------------------|-----------------------------------------------------------|----------------------|------------|-----------------------------------------------------|---------------|-------------------| | [Table_MainInfo] [Table_Title] \n智翔金泰 | -U(688443) | | | | [Table_industryInfo] | | [Ta ...

R&D Investment and Development - The company's R&D investment for the reporting period was CNY 620.40 million, an increase of 36.50% compared to the same period last year, indicating a commitment to ongoing projects in clinical research [2]. - The company is focused on maintaining high levels of R&D investment as core products enter critical registration clinical phases, which may lead to sustained increases in R&D expenses [2]. - The company is actively developing multiple proprietary monoclonal antibodies and bispecific antibodies, enhancing its product pipeline [9]. - The company is focused on innovative drug development based on clinical needs, with an emphasis on new target drugs [41]. - The company has developed a technology platform for monoclonal antibody discovery based on a novel phage display system [44]. - The company has established two technology platforms for monoclonal antibody and bispecific antibody discovery based on a novel phage display system, enhancing its innovation capabilities [96]. - The company has optimized the phage display system to address issues in practical applications, resulting in two proprietary phage display antibody library technologies [97]. - The company has developed an efficient protein purification process platform based on Quality by Design (QbD) principles, enabling rapid development of purification processes for monoclonal and bispecific antibodies [99]. - Several innovative monoclonal and bispecific antibody drugs developed on the technology platforms have entered clinical research stages [107]. - The company has 15 products in the pipeline, with 9 products and 17 indications approved for clinical trials, and 2 indications' NDA accepted [185]. - The company has made significant progress in multiple products, overcoming challenges and seizing opportunities in 2023 [49]. Financial Performance - The net profit for 2023 was impacted by significant R&D expenditures due to multiple new drug products being in the research phase, leading to increased cash outflows from operating activities compared to the previous year [16]. - The company received government subsidies amounting to CNY 93.94 million, which significantly contributed to its financial performance [17]. - Non-operating income from financial investments generated a fair value gain of CNY 19.42 million, reflecting positive market conditions for the company's financial assets [17]. - The company's operating revenue for the current period is 1,211,502.42 million, a significant increase compared to 475,240.96 million in the same period last year, with a change ratio of not applicable [142]. - The company's net loss attributable to shareholders was -80,131.93 million, an increase in loss of 22,495.36 million compared to the previous year, mainly due to increased R&D expenditures [156]. - The net cash flow from operating activities was -377,580,702.25 million, worsening from -177,640,539.81 million in the previous year, mainly due to increased R&D investments [159]. - The net cash flow from investing activities was 120,620,808.83 million, up from 51,396,404.99 million, primarily due to the recovery of investments during the reporting period [159]. - The net cash flow from financing activities surged to 3,099,824,606.32 million, compared to 161,374,159.39 million in the previous year, largely due to funds raised from the initial public offering [159]. - The company's financial expenses decreased by 47.18% to 17,642,312.05 million from 33,397,889.23 million, attributed to interest income from raised funds [157]. Market Strategy and Expansion - The management has indicated a strategic focus on expanding market presence and exploring potential mergers and acquisitions to drive growth [18]. - The company aims to implement a clear market strategy and collaborate with established firms to accelerate new drug market penetration [34]. - The company is focused on the rapid growth of the biopharmaceutical market, particularly in the monoclonal antibody sector, which is expected to drive future development trends [63]. - The company plans to enhance operational management and internal controls to improve efficiency and profitability [151]. - The company is committed to maintaining a stable and continuous profit distribution policy to ensure reasonable returns for investors [131]. - The marketing team will utilize a four-pronged approach (market, medical, sales, and access) to accelerate the commercialization process [198]. Governance and Compliance - The company has not reported any non-operating fund occupation by controlling shareholders or related parties, ensuring financial integrity [5]. - The company has ensured that all board members attended the board meeting, reflecting strong governance practices [3]. - The financial reports have been audited by a reputable accounting firm, ensuring the accuracy and reliability of the financial data presented [17]. - The company is committed to reducing and regulating related party transactions to enhance transparency and compliance [165]. - The controlling shareholder and actual controller have committed to avoiding competition with the company and its controlled enterprises, specifically regarding the CAR-T and CAR-NK drug pipelines, which are in clinical and preclinical stages [115]. Clinical Trials and Product Development - The Phase III clinical study of the company's monoclonal antibody, Salicic, for moderate to severe plaque psoriasis showed a PASI75 response rate of 90.7% at week 12, compared to 8.6% in the placebo group [23]. - The relapse rate for patients treated with Salicic at week 52 was only 0.4%, indicating potential long-term efficacy [23]. - The company is developing GR1802, a recombinant fully human anti-IFNAR1 monoclonal antibody, currently in Phase II clinical trials for systemic lupus erythematosus [24]. - The company has made significant investments in R&D, although specific figures are not provided in the extracted content [189]. - The company is currently in the III phase of clinical trials for GR1802, which targets multiple allergic conditions [170]. - The core product, Celeric monoclonal antibody injection, has 2 indications with NDA accepted, indicating imminent commercialization [198]. Risks and Challenges - The company acknowledges the risk of market promotion and sales not meeting expectations, particularly for its new products [138]. - The pharmaceutical industry is undergoing significant regulatory changes, which may adversely affect the company's operations if it fails to adapt its strategies accordingly [138]. - The company is focusing on therapeutic areas such as autoimmune diseases, infectious diseases, and oncology, but faces risks of being outcompeted by more innovative drugs in these fields [128]. - The company faces financial risks associated with the implementation of its equity incentive plan, which may affect its long-term development [127]. Share Repurchase and Stock Management - The company plans to repurchase shares, ensuring the repurchase price does not exceed the latest audited net asset value per share [80]. - The total amount used for share repurchase in a single accounting year shall not exceed 50% of the net profit attributable to the parent company's shareholders from the previous accounting year [80]. - The stock repurchase plan must be approved by the board and shareholders, requiring a two-thirds majority vote [120]. - The company will prioritize stock repurchase, followed by share purchases by the controlling shareholder and board members, to stabilize stock prices [119].

Financial Performance - The company's operating revenue for Q1 2024 was CNY 6,330.27 million, a significant decrease from CNY 100,013.67 million in Q1 2023[1] - The net loss for Q1 2024 was CNY 163,770.02 million, compared to a net loss of CNY 200,969.11 million in Q1 2023, indicating an improvement[1] - The diluted earnings per share for Q1 2024 was CNY -0.45, an improvement from CNY -0.73 in Q1 2023[3] - The net profit attributable to shareholders of the listed company was CNY -163,770,017.01, representing a decrease of 18.51% compared to the same period last year[21] - The basic earnings per share for the reporting period was CNY -0.45, a decrease of 38.36% year-over-year[21] Cash Flow and Expenses - The company's cash flow from operating activities showed a net outflow of CNY 144,561.28 million in Q1 2024, worsening from a net outflow of CNY 97,070.09 million in Q1 2023[3] - The net cash flow from operating activities was CNY -144,561,278.97, showing an increase of 48.92% compared to the previous year[21] - The company incurred financial expenses of CNY -6,310.97 million in Q1 2024, a notable change from CNY 8,728.43 million in Q1 2023[1] Research and Development - Research and development expenses totaled CNY 129,932.37 million in Q1 2024, down from CNY 146,474.84 million in the same period last year, reflecting a decrease of approximately 11.29%[1] - The company’s cash flow from operating activities increased due to expanded business scale and increased personnel costs, along with higher R&D investments compared to the previous year[39] Assets and Liabilities - Total assets at the end of Q1 2024 were CNY 3,451,396.30 million, down 3.98% from CNY 3,594,596.74 million at the end of the previous year[10] - The total current assets as of March 31, 2024, amounted to CNY 2,899,935,991.02, down from CNY 3,031,857,189.57 at the end of 2023[33] - The total liabilities and shareholders' equity amounted to CNY 3,451,396,299.56, a decrease from CNY 3,594,596,738.24[36] - Total liabilities were reported at CNY 792,604,233.69, down from CNY 810,364,379.85 in the previous period[48] - Current liabilities totaled CNY 120,052,848.55, a decrease from CNY 136,870,271.74 in the previous period[48] Equity and Retained Earnings - The company's total equity attributable to shareholders decreased by 4.51% to CNY 2,658,792.07 million compared to CNY 2,784,232.36 million at the end of the previous year[10] - Owner's equity totaled CNY 2,658,792,065.87, a decrease from CNY 2,784,232,358.39 in the previous period[48] - The company reported a net loss of CNY 1,784,294,412.96 in retained earnings, compared to a loss of CNY 1,620,524,395.95 in the previous period[48] Inventory and Cash Equivalents - Cash and cash equivalents at the end of Q1 2024 were CNY 2,758,128.02 million, a decrease from CNY 41,535.88 million at the end of Q1 2023[5] - The company’s inventory as of March 31, 2024, was CNY 59,886,569.94, compared to CNY 55,450,910.06 at the end of 2023[33] Government Subsidies and Non-Recurring Losses - The company received government subsidies amounting to CNY 769,104.22, which are closely related to its normal business operations[23] - The company reported a non-recurring loss of CNY 6,163.78 from the disposal of non-current assets, including the reversal of previously recognized asset impairment provisions[23] Other Information - The company has a long-term loan of CNY 608,455,615.86, consistent with the previous period[48] - Deferred income tax assets and liabilities were not applicable in this report[40] - The company has not disclosed any new product developments or market expansion strategies in this report[40]

(2) GR1802(IL-4R 靶点):中国进度较快的 IL-4R 靶向生物药之一,目前仅有 再生元和赛诺菲合作的度普利尤单抗获批上市;2023年12月,启动 GR1802 针对特 应性皮炎适应症的 III 期临床试验研究。 (3) GR1603 (IFNAR1 靶点):2023年1月,针对系统性红斑狼疮适应症的 I/II 期临床试验已完成。 (4) GR2002 (TSLP 双表位双抗靶点):2023年9月,哮喘适应症完成Ⅰ期临床 惑者招募工作;2023年12月,完成特应性皮炎的Ⅰ期首例患者招募工作。 感染性疾病类管线:产品竞争格局良好,管线进度较快 (1) GR1801 (RABV-G 靶点):中国进度较快的 RABV 双表位靶向双抗产品, 已于 2023年9月完成针对狂犬病被动免疫适应症 III 期临床的患者入组工作。 (2) GR2001 (TeNT 靶点): 已于 2023 年 3 月完成破伤风适应症的 I/II 期临床试 验首例患者入组工作。 肿瘤管线:基于 CD3 进行双抗药物的全面布局 (1) GR1803 (BCMA×CD3 双靶点): 于 2022年 5 月完成多发性骨髓瘤的Ⅰ期 临床试 ...

海通证券股份有限公司 关于重庆智翔金泰生物制药股份有限公司 2023 年度持续督导现场检查报告 上海证券交易所： 经中国证券监督管理委员会《关于同意重庆智翔金泰生物制药股份有限公 司首次公开发行股票注册的批复》（证监许可〔2023〕725 号）批复，重庆智翔 金泰生物制药股份有限公司（以下简称"智翔金泰"、"上市公司"、"公司"）首 次公开发行股票 9,168.00 万股，每股面值人民币 1 元，每股发行价格人民币 37.88 元，募集资金总额为人民币 347,283.84 万元，扣除发行费用后，实际募集资金净 额为人民币 329,140.14 万元。本次发行证券已于 2023 年 6 月 20 日在上海证券交 易所上市。海通证券股份有限公司（以下简称"海通证券"、"保荐机构"）担任 其持续督导保荐机构，持续督导期间为 2023 年 6 月 20 日至 2026 年 12 月 31 日。 根据《证券发行上市保荐业务管理办法》、《上海证券交易所股票上市规则》 《上海证券交易所上市公司自律监管指引第 11 号——持续督导》《上海证券交易 所科创板股票上市规则》《上海证券交易所科创板上市公司自律监管指引第 1 号 ...

Investment Rating - The report maintains a "Buy" rating for the company, indicating a positive outlook for future performance [6]. Core Views - The company is expected to achieve a revenue of 1.2115 billion yuan in 2023, representing a year-on-year increase of 154.92%, primarily driven by technical service income [6]. - The company anticipates a loss of 800.1 million yuan in 2023, which is a 39.03% increase in loss compared to the previous year [6]. - The research pipeline is progressing efficiently, with core products advancing ahead of competitors, and the company is poised to enter a commercial phase in 2024 [6]. Financial Performance - The company reported a significant increase in R&D expenses, expected to reach 620 million yuan in 2023, up 36.50% year-on-year [6]. - The projected revenue for 2024 is 900 million yuan, reflecting a staggering year-on-year growth of 7324.5% [9]. - The net profit for 2024 is expected to improve to a loss of 556 million yuan, a reduction in loss compared to 2023 [9]. Clinical Development - The company's product GR1501 is anticipated to be the first domestically produced IL-17A monoclonal antibody, with promising clinical efficacy [6]. - GR1501 has shown significant results in clinical trials for moderate to severe plaque psoriasis, with a 90.7% response rate at 12 weeks [6]. - The company has multiple products in clinical stages, including GR1802 and GR2002, which are advancing in autoimmune and infectious disease areas [6]. Market Position - The company is strategically positioned with a forward-looking commercial layout, aiming for a strong market entry in 2024 [6]. - The report highlights the competitive edge of the company's pipeline, suggesting that it is ahead of domestic peers in terms of clinical progress [6].

作者具有中国证券业协会授予的证券投资咨询执业资格或相当的专业胜任能力，保证报告所采用的数据均来自合规渠道，分析 逻辑基于作者的职业理解，本报告清晰准确地反映了作者的研究观点，力求独立、客观和公正，结论不受任何第三方的授意或 影响，特此声明。 [Table_Page] 智翔金泰-U(688443) 本公司利用信息隔离墙控制内部一个或多个领域、部门或关联机构之间的信息流动。因此，投资者应注意，在法律许可的情 况下，本公司及其所属关联机构可能会持有报告中提到的公司所发行的证券或期权并进行证券或期权交易，也可能为这些公 司提供或者争取提供投资银行、财务顾问或者金融产品等相关服务。在法律许可的情况下，本公司的员工可能担任本报告所 提到的公司的董事。 分析师声明 若本公司以外的其他机构（以下简称"该机构"）发送本报告，则由该机构独自为此发送行为负责。通过此途径获得本报告的 投资者应自行联系该机构以要求获悉更详细信息或进而交易本报告中提及的证券。本报告不构成本公司向该机构之客户提供的 投资建议，本公司、本公司员工或者关联机构亦不为该机构之客户因使用本报告或报告所载内容引起的任何损失承担任何责任。 | --- | --- | ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [4][15]. Core Insights - The company is expected to enter a new development phase in 2024, with several key milestones ahead, including the NDA submission for GR1501 for moderate to severe plaque psoriasis, which is anticipated to be the first domestically approved anti-IL-17A monoclonal antibody [1][45]. - The company has a robust pipeline with eight products across 15 indications in clinical research, including GR1801, a dual antibody for rabies, which is expected to be commercialized by 2025 [1][10]. - The company is positioned to become a leading player in the biopharma sector, with a strong leadership team and innovative product pipeline [2][26]. Financial Projections and Valuation - Revenue projections for 2023E-2025E are estimated at 0 million, 110 million, and 437 million yuan respectively, with a DCF valuation suggesting a reasonable stock price of 53.7 yuan and a market value of 197 billion yuan [2][3]. - The peak sales potential for GR1501 is expected to exceed 2 billion yuan, supported by its first-mover advantage in dermatology and rheumatology [6][10]. Product Pipeline and Market Position - GR1501 is on track to become the first approved domestic IL-17A inhibitor, with significant market potential due to the high unmet needs in autoimmune diseases [1][35]. - The company has a competitive pipeline with products targeting autoimmune diseases, infections, and tumors, all derived from in-house research [7][73]. - The company’s dual-specific antibodies, such as GR1801 and GR1901, are positioned to fill significant treatment gaps in the market, particularly in rabies and acute myeloid leukemia [10][58]. R&D and Innovation - The company emphasizes a strong R&D focus, with over 85% of its workforce dedicated to research, and has established advanced platforms for antibody discovery and development [47][80]. - The innovative use of phage display technology allows for rapid development of antibody candidates, significantly shortening the discovery timeline [29][80]. - The leadership team possesses extensive experience in drug development, which is crucial for the company's long-term stability and growth [72][76].