证券时报网讯，来凯医药-B公告称，公司与独家配售代理订立协议，以每股13.36港元的价格配售1763.6 万股股份，较前一交易日收盘价折让15.01%，预计净筹资约2.3亿港元，所得款项将用于加速研发 LAE102等药物资产。 校对：陶谦 ...

Group 1 - The core viewpoint of the article highlights the significant increase in the stock price of Lakai Pharmaceutical-B, which surged by 11% following the initiation of Phase I clinical trials for its LAE102 injection in mid-October [1] - The LAE102 is a monoclonal antibody targeting ActRIIA, aimed at providing new treatment options for overweight and obese patients [1]

2 期试验获得积极疗效，且耐受性良好。2024 年 5 月，临床 3 期试验方案已 获得 FDA 批准。 证券研究报告 | 公司动态点评 2024 年 09 月 02 日 来凯医药-B（02105.HK） ATK 抑制剂乳腺癌 3 期启动，ActRIIA 顺利进入临床 | --- | --- | --- | --- | --- | --- | --- | --- | |--------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------|------------------------|------------------------------------------|--------------|--------------------------------------------|------------------| | 财务指标 | 20 ...

Financial Performance - Laekna, Inc. reported a revenue of $10 million for the first half of 2024, representing a 25% increase compared to the same period in 2023[5]. - The company expects to achieve a revenue growth of 40% for the full year 2024, driven by new product launches and market expansion[2]. - The company reported a net loss of $1 million for the first half of 2024, a reduction from a $1.5 million loss in the same period last year[5]. - The total comprehensive loss for the six months ended June 30, 2024, was RMB 138.5 million, a decrease from RMB 285.8 million in the same period of 2023[19]. - Basic and diluted loss per share for the six months ended June 30, 2024, was RMB 0.40, significantly improved from RMB 2.63 in the same period of 2023[104]. - The loss from operations for the six months ended June 30, 2024, was RMB 142.4 million, a slight improvement from a loss of RMB 145.0 million in the same period of 2023[104]. Research and Development - The company has allocated $2 million for research and development of new therapies in the next fiscal year[5]. - R&D expenses increased by 23.3% to RMB 126.1 million for the six months ended June 30, 2024, primarily due to clinical trial milestones related to the Phase III trial[19]. - The company achieved significant progress in clinical and preclinical development of candidate drug assets as of June 30, 2024[11]. - The company has initiated seven clinical trials targeting unmet medical needs in obesity and cancer as of June 30, 2024[21]. - The company is actively pursuing strategic partnerships to accelerate the development and commercialization of its drug candidates[15]. Product Development and Clinical Trials - The company has initiated clinical trials for its new drug candidate Afuresertib, targeting a market with an estimated value of $5 billion[4]. - Laekna has received regulatory approval for two new drugs, which are expected to launch in Q4 2024[2]. - LAE102, a monoclonal antibody targeting ActRIIA for obesity, received IND approval from CDE and FDA in Q2 2024, with Phase I clinical trials starting in June 2024[12]. - The Phase I trial for LAE102 aims to complete the single ascending dose portion by Q4 2024, focusing on safety, tolerability, and pharmacokinetics[12]. - The Phase III clinical trial AFFIRM-205 for LAE002 (afuresertib) combined with fulvestrant in HR+/HER2- breast cancer patients was initiated in May 2024, ahead of schedule[13]. - The company plans to present clinical data from the Phase I study of LAE002 at the ESMO conference in September 2024[13]. Market Expansion and Strategy - Laekna is planning to expand its market presence in Europe, aiming for a 15% market share by the end of 2025[6]. - The global obesity patient population is projected to exceed 1.2 billion by 2030, highlighting significant market opportunities in obesity and cancer treatment[23]. - The market potential for HR+/HER2- metastatic breast cancer remains substantial, with billions of dollars at stake due to unmet medical needs[28]. - The company is actively enhancing its global network and business development activities with an allocation of HKD 55.1 million, or 7.6% of the net proceeds[53]. Financial Position and Cash Flow - Cash and cash equivalents decreased by RMB 33.5 million or 7.6% from RMB 440.8 million as of December 31, 2023, to RMB 407.3 million as of June 30, 2024[43]. - The group’s current assets amounted to RMB 666.8 million as of June 30, 2024, with cash and cash equivalents of RMB 407.3 million[43]. - The company reported a foreign exchange gain of RMB 11,962,000 for the six months ended June 30, 2024, compared to a loss of RMB 40,350,000 in the same period of 2023[104]. - Operating cash used for the six months ended June 30, 2024, was RMB (143,382) thousand, a decrease from RMB (155,769) thousand for the same period in 2023, representing a reduction of approximately 7.8%[108]. Shareholder Information and Equity - The total number of issued shares as of June 30, 2024, is 390,100,350[61]. - The company has a total of RMB 72,484,000 in accrued expenses and other payables as of June 30, 2024, compared to RMB 68,445,000 as of December 31, 2023[132]. - The company’s authorized share capital is $50,000, divided into 5,000,000,000 ordinary shares with a par value of $0.00001 each[139]. - The total number of stock options granted to employees, directors, and consultants is 33,618,520, with 20% expected to vest after 12 months from the grant date[136]. Governance and Compliance - The company has adopted the corporate governance code as its own, ensuring compliance with all relevant provisions during the reporting period, except for the deviation regarding the separation of the roles of Chairman and CEO[97]. - The audit committee, consisting of two independent non-executive directors and one non-executive director, has reviewed the interim financial report and discussed internal controls and financial reporting matters[99]. - The independent auditor, KPMG, conducted a review of the interim financial report and found no issues that would lead to a belief that the report was not prepared in accordance with the relevant standards[103].

2024 年 08 月 20 日 公司点评 买入/维持 来凯医药-B(02105) 目标价: 15.97 昨收盘:4.68 AKT 抑制剂进入乳腺癌 3 期，持续关注增肌减脂单抗全球进展 走势比较 (80%) (48%) (16%) 16% 48% 80% 23/8/2123/11/124/1/1224/3/2424/6/424/8/15 来凯医药-B 恒生指数 股票数据 总股本/流通(亿股) 3.9/3.9 总市值/流通(亿港元) 18.26/18.26 12 个月内最高/最低价 (港元) 26.45/3.15 相关研究报告 《AKT 抑制剂启动乳腺癌 3 期，推荐 关 注 增 肌 减 脂 单 抗 全 球 进 展 （2024.04.03）》 《PROFECTA-II 未 达主要终点 ， Biomarker 阳性亚组具有显著差异 （2024.01.29）》 《来凯医药（2105.HK）：聚焦肿瘤和 代谢领域的创新先锋（2024.01.13）》 证券分析师：周豫 E-MAIL：zhouyua@tpyzq.com 分析师登记编号：S1190523060002 证券分析师：霍亮 E-MAIL：huoliang@tp ...

Clinical Trials and Drug Development - LAE102, a monoclonal antibody targeting ActRIIA, received IND approval for obesity treatment in Q2 2024, with Phase I clinical trials starting in June 2024, ahead of schedule[1] - The Phase I trial aims to complete the single ascending dose (SAD) portion by Q4 2024, focusing on safety, tolerability, and pharmacokinetics[2] - The Phase III clinical trial AFFIRM-205 for LAE002 (afuresertib) combined with letrozole in HR+/HER2- breast cancer patients was initiated in May 2024, ahead of schedule[3] - The Phase II trial for LAE002 combined with LAE001 in mCRPC patients showed a median rPFS of 8.1 months, significantly better than the 2-4 months seen in historical controls[4] - The Phase II trial PROFECTA-II for LAE002 combined with paclitaxel in platinum-resistant ovarian cancer patients indicated a PFS of 5.4 months in the biomarker-positive subgroup, compared to 2.9 months for paclitaxel alone[5] - The company has initiated seven clinical trials targeting LAE102, LAE002 (afuresertib), LAE001, and LAE005 to address unmet medical needs in obesity and oncology[38] - LAE102, a potential treatment for obesity, has received IND approval in Q2 2024 and the first patient was dosed in June 2024, ahead of schedule[38] - LAE002 (afuresertib) is an AKT inhibitor currently in late-stage clinical development for breast and prostate cancer, with a key Phase III study initiated in May 2024[40] - The combination therapy of LAE002 and fulvestrant has shown promising anti-cancer efficacy and safety in an Ib phase study, with results to be presented at the ESMO conference in September 2024[48] - The company is collaborating with a biopharmaceutical firm to explore a combination therapy with LAE002 for patients with advanced cervical and endometrial cancer who have failed multiple lines of treatment[54] - The company plans to present the results of the Phase I clinical study of LAE002 combined with anti-PD-1 therapy at the IGCS 2024 global conference in October 2024[54] Financial Performance - R&D expenses increased by RMB 23.8 million or 23.3% to RMB 126.1 million for the six months ended June 30, 2024, compared to RMB 102.3 million for the same period in 2023[8] - Administrative expenses decreased by RMB 5.6 million or 15.6% to RMB 30.4 million for the six months ended June 30, 2024, down from RMB 36.0 million for the same period in 2023[9] - The net loss for the six months ended June 30, 2024, was RMB 143.7 million, a decrease from RMB 216.9 million for the same period in 2023[10] - Total comprehensive loss for the six months ended June 30, 2024, was RMB 138.5 million, compared to RMB 285.8 million for the same period in 2023[10] - Other income increased to RMB 14.1 million for the six months ended June 30, 2024, from RMB 3.2 million for the same period in 2023[10] - The company reported a foreign exchange gain of RMB 11.96 million for the six months ended June 30, 2024, compared to a loss of RMB 40.35 million for the same period in 2023[10] - The company reported a net loss attributable to ordinary equity shareholders of RMB 143,706,000 for the six months ended June 30, 2024, down from RMB 216,985,000 for the same period in 2023, indicating improved financial performance[25] - The basic loss per share for the six months ended June 30, 2024, was RMB 0.404, compared to RMB 2.630 for the same period in 2023, reflecting a significant reduction in losses[25] - The company incurred finance costs of RMB 1,323 thousand, an increase from RMB 788 thousand in the same period last year, indicating a 67.5% rise[18] - Other income increased by RMB 10.9 million or 340.6% to RMB 14.1 million for the six months ended June 30, 2024, primarily due to increased bank interest income[58] - Other losses decreased by RMB 9.9 million or 100.0% to RMB 4,000 for the six months ended June 30, 2024, mainly due to a reduction in foreign exchange losses[59] Asset Management - Total assets decreased to RMB 683.9 million as of June 30, 2024, from RMB 812.5 million as of December 31, 2023[11] - The company's net assets amounted to RMB 676.2 million as of June 30, 2024, down from RMB 804.0 million as of December 31, 2023[11] - The company reported a net cash used in operating activities of RMB (143,382) thousand for the six months ended June 30, 2024, compared to RMB (155,769) thousand for the same period in 2023, indicating a decrease of approximately 7.8%[13] - Cash generated from investment activities was RMB 101,835 thousand, a significant improvement from RMB (68,477) thousand in the previous year[13] - The company's cash and cash equivalents decreased by RMB 35,972 thousand during the period, compared to an increase of RMB 508,366 thousand in the previous year[13] - As of June 30, 2024, the group's current assets were RMB 666.8 million, including cash and cash equivalents of RMB 407.3 million, a decrease of RMB 33.5 million or 7.6% from RMB 440.8 million as of December 31, 2023[65] - The group's cash and bank balances decreased by 15.7% to RMB 656.3 million as of June 30, 2024, compared to RMB 778.9 million as of December 31, 2023, primarily due to cash used in operating activities[66] Strategic Initiatives and Future Outlook - The company plans to submit the IND application for LAE103 in Q2 2025 and advance LAE123 to PCC stage by the end of 2024[6] - The company aims to complete the Phase I clinical trial of LAE102 in Q4 2024 and submit the IND application for LAE120 by the end of 2024[7] - The company is actively seeking strategic partners to accelerate the development and commercialization of LAE102[46] - The company aims to expand its drug pipeline through independent research and development, targeting a new candidate drug to enter clinical stages each year[77] - The company is exploring combination therapy opportunities between pipeline products and existing approved drugs for treating mCRPC[76] - The company anticipates a revenue growth of approximately 15% year-over-year, driven by new product launches and market expansion[88] - The management highlighted the importance of maintaining high standards of safety and efficacy in all new treatments[88] - The company is committed to enhancing shareholder value through strategic initiatives and robust financial performance[88] Corporate Governance - The board is reviewing the effectiveness of the corporate governance structure to assess the need for separating the roles of Chairman and CEO[79] - The company confirms compliance with corporate governance codes and standards during the reporting period[78] - The company has established an Audit Committee to provide independent opinions on financial reporting processes, internal controls, and risk management effectiveness[82] - The Audit Committee consists of two independent non-executive directors and one non-executive director, with Mr. Zhou Jian serving as the chairman[82] - No significant events occurred after the reporting period, and the board did not declare an interim dividend for the reporting period[83] - The interim report will include all information required by the listing rules and will be published on the company's website and the Hong Kong Stock Exchange website[84] - The board of directors includes executive directors Dr. Lu Xiangyang, Ms. Xie Ling, and Dr. Gu Xiangju; non-executive directors Dr. Wang Guowei and Mr. Sun Yuanzheng; independent non-executive directors Dr. Yin Xudong, Dr. Li Min, and Mr. Zhou Jian[88] Employee and Operational Insights - The company has established a strong management team with 64 employees, including 15 PhD holders and 33 master's degree holders, to drive its R&D efforts[38] - Employee costs, including salaries and benefits, totaled RMB 57,312 thousand, slightly down from RMB 57,477 thousand in the previous year[19] - Employee benefit expenses for the six months ended June 30, 2024, totaled RMB 57.3 million, slightly down from RMB 57.5 million for the same period in 2023[72] - The company aims to improve operational efficiency and reduce costs through streamlined processes and technology integration[88]

Financial Performance - The company reported a revenue of $150 million for the fiscal year 2023, representing a 25% increase compared to the previous year[4]. - The net loss for the year was RMB 368,814,000, a decrease from a net loss of RMB 781,594,000 in 2022, indicating an improvement of about 53.2%[170]. - The total comprehensive loss for the year was RMB 458,674,000, compared to RMB 902,197,000 in 2022, showing a reduction of approximately 49.1%[170]. - Cash and cash equivalents increased to RMB 440,815,000 in 2023 from RMB 323,070,000 in 2022, reflecting a growth of approximately 36.5%[171]. - The company raised approximately HKD 724.4 million from its IPO on June 29, 2023, enhancing its cash position to RMB 778.9 million as of December 31, 2023[16]. - The company reported a basic and diluted loss per share of RMB 1.68 for 2023, improving from RMB 10.19 in 2022[170]. - The total assets less current liabilities rose to RMB 812,541,000 in 2023, compared to RMB 382,355,000 in 2022, marking an increase of about 112.5%[171]. Research and Development - The company has initiated six clinical trials targeting unmet medical needs in cancer, with three being international multi-center trials[19]. - The company aims to have one candidate drug enter clinical stages each year[10]. - The company has established a comprehensive R&D system to accelerate the process from drug development to registration trials[10]. - The company invested $10 million in new technology for drug development, which is projected to reduce time-to-market by 20%[4]. - The company has advanced seven PCC candidate drugs, including LAE103, through its self-developed platform during the year[10]. - The company is focused on innovative therapies for cancer, liver diseases, and obesity, indicating a strategic emphasis on R&D[165]. Product Development and Clinical Trials - New product launches included a novel cancer treatment that is currently in Phase II clinical trials, with expected market entry in 2025[4]. - The III phase pivotal trial for Afuresertib plus Fulvestrant in HR+/HER2- breast cancer patients has commenced[11]. - LAE102 clinical trials for obesity indications are planned to start in 2024[10]. - The company has initiated six clinical trials targeting breast cancer, prostate cancer, ovarian cancer, and PD-1/PD-L1 resistant solid tumors as of December 31, 2023[10]. - The company plans to submit IND applications for the monoclonal antibody LAE102 targeting ActRIIA for obesity indications to CDE and FDA in Q1 2024[10]. Market Strategy and Expansion - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2025[4]. - The company plans to increase its workforce by 20% to support growth initiatives in the upcoming year[4]. - The company aims to leverage strategic partnerships to accelerate the development and commercialization of LAE102 for various unmet medical needs, including cancer treatment[20]. - The company is actively exploring combination therapy opportunities with existing approved drugs and traditional therapies[53]. Financial Management and Governance - The company has a strong management team with 62 members, including 17 PhDs and 30 master's degree holders, enhancing its drug discovery and development capabilities[19]. - The company is committed to maintaining high standards of corporate governance, as evidenced by the qualifications of its board members and executives[65]. - The board consists of three executive directors, two non-executive directors, and three independent non-executive directors, ensuring a diverse range of business experience and expertise[133]. - The company has established a comprehensive risk management and internal control system to ensure legal compliance, asset security, and the accuracy of financial reporting[154]. Shareholder and Investor Relations - The board approved a share buyback program worth $5 million to enhance shareholder value[4]. - The company has maintained clear and effective communication with shareholders and investors, ensuring timely and accurate information dissemination[159]. - The independent auditor has confirmed that the financial statements reflect the company's financial position as of December 31, 2023, in accordance with international financial reporting standards[161]. Corporate Social Responsibility - The company actively participated in various social welfare activities and donations during the year ending December 31, 2023[80]. - The group has adopted strict environmental protection measures and will continue to develop sustainability policies to reduce environmental impact[123]. Employee Relations and Corporate Culture - The company has maintained stable relations with employees, with no significant strikes or labor disputes affecting business activities during the reporting period[119]. - The company is focused on ensuring gender diversity in recruitment processes for senior staff and providing career development opportunities for female employees[136]. - The company emphasizes the importance of corporate culture as a foundation for long-term business development and economic achievement, aiming to create sustainable performance[134].

2024年04月03日 公 司点评 公 买入 / 维持 司 来凯医药-B(02105) 研 究 目标价:15.43 昨收盘:5.43 AKT 抑制剂启动乳腺癌 3 期，推荐关注增肌减脂单抗全球进展 事件：  走势比较 近日，公司发布2023年年报。公司全年研发费用为2.30亿元（同 比-26.4%），行政开支为0.76亿元（同比-5.4%），年度亏损为3.69亿 80% 元，截止2023年底现金及银行余额为7.79亿元。 太 48% 平 16% 观点： 洋 证 (( 41 86 %% ))92/6/32 32/8/32 71/01/32 11/21/32 4/2/42 03/3/42 研发研 费用发 为费用 2.3同 0比 亿降 元低 ，同， 比现 减金 少及 2银 6.行 4%余 ，主额 要为 由7 于.79 1）亿 L元 AE。 102 2（02 A3 c年 tR公 IIA司 ） 券 (80%) 于 2023 年年初获得 IND 批准，临床前研究已完成；2）CMC 有关的 股 服务开支减少。行政开支为0.76亿元，同比减少5.4%，主要由于上市 份 来凯医药-B 恒生指数 开支减少。公司年度亏损为3.6 ...

Drug Development Progress - Laekna, Inc. achieved significant progress in clinical and preclinical drug development, with key milestones reached by December 31, 2023[2]. - The company advanced the clinical trial of Afuresertib combined with Fulvestrant for HR+/HER2- breast cancer, with promising efficacy and safety data presented at the 2023 SABCS[3]. - A Phase II clinical trial for Afuresertib combined with LAE001 and Prednisone in mCRPC patients was completed in March 2023, showing potential for good therapeutic outcomes[4]. - The company plans to initiate a Phase III trial for Afuresertib combined with Paclitaxel in PROC patients, with data lock scheduled for December 2023[4]. - The company advanced seven PCC candidates in its independent R&D platform as of December 31, 2023[5]. - The company has initiated six clinical trials targeting Afuresertib (LAE002), LAE001, and LAE005 to address unmet medical needs in oncology[44]. - The company has a robust pipeline with a total of 14 internally discovered candidates and has initiated six clinical trials since its establishment in 2016[45]. - Afuresertib is one of only two AKT inhibitors globally in key clinical development stages, demonstrating superior efficacy and safety compared to other AKT inhibitors[45]. - The company plans to submit IND applications for LAE102 for obesity indications to CDE and FDA in Q1 2024[46]. - LAE102 has received IND approval from the FDA in May 2023, with further submissions planned for additional indications[46]. - The company is actively seeking strategic partners to accelerate the development and commercialization of LAE102 for significant unmet medical needs beyond oncology[46]. - The company is developing innovative candidate drugs, including small molecule drugs and bispecific antibodies, to address unmet medical needs in obesity and metabolic diseases[84]. - The company aims to introduce one candidate drug into clinical stages each year as part of its drug development strategy[84]. Financial Performance - The company reported a net loss of RMB 368.8 million for the year, down from RMB 781.6 million in 2022[8]. - Total comprehensive loss for the year was RMB 458.7 million, compared to RMB 902.2 million in 2022[8]. - R&D expenses decreased by 26.4% from RMB 313.4 million in 2022 to RMB 230.5 million in 2023[6]. - Administrative expenses reduced by 5.4% from RMB 80.2 million in 2022 to RMB 75.9 million in 2023[7]. - The fair value change of financial instruments issued to investors was RMB 71.2 million in 2023, down from RMB 387.1 million in 2022[6]. - Total assets decreased from RMB 1,145,586 thousand in 2022 to RMB 812,541 thousand in 2023, a decline of approximately 29%[9]. - Current liabilities increased significantly from RMB 97,509 thousand in 2022 to RMB 119,762 thousand in 2023, representing a growth of about 23%[9]. - Cash and cash equivalents increased from RMB 323,070 thousand at the beginning of the year to RMB 440,815 thousand at year-end, a net increase of RMB 117,210 thousand[12]. - The company reported a net asset value of RMB 803,972 thousand in 2023, recovering from a net loss of RMB (1,905,086) thousand in 2022[9]. - The company’s total liabilities decreased from RMB 2,287,441 thousand in 2022 to RMB 8,569 thousand in 2023, a significant reduction of about 99.6%[9]. - The company’s total equity improved to RMB 803,972 thousand in 2023 from a negative equity position in 2022, reflecting a positive turnaround in financial health[9]. - The company reported a revenue of HKD 1.2 billion for the fiscal year ending December 31, 2023, representing a year-over-year increase of 25%[94]. - The company expects revenue growth of 20% for the next fiscal year, projecting a target of HKD 1.44 billion[94]. - Other income increased by RMB 11.9 million or 247.9% to RMB 16.7 million in 2023, primarily due to increased interest income from bank deposits[65]. - The company reported a significant reduction in operational costs by 10% due to improved efficiency measures implemented in Q4 2023[94]. Clinical Trial Results - The confirmed objective response rate (ORR) for the treatment is 30%, with a disease control rate of 80% and a median progression-free survival (PFS) of 7.3 months[54]. - Among 11 PIK3CA/AKT1/PTEN positive subjects, the confirmed ORR is 45.4%, indicating a strong efficacy in this subgroup[54]. - The confirmed ORR for 17 Chinese patients is 29.4%, with a disease control rate of 82.4%[54]. - The median rPFS for mCRPC patients treated with afuresertib in a Phase II trial is 7.9 months, significantly improved compared to the historical median of 2 to 4 months[57]. - In the Phase II PROFECTA-II trial, afuresertib combined with paclitaxel showed a median PFS of 5.4 months in the biomarker-positive subgroup, compared to 2.9 months for paclitaxel alone[59]. - The company has initiated a Phase III pivotal trial for afuresertib combined with fulvestrant in HR+/HER2- breast cancer patients[55]. - The ongoing I/II study with XinDa Biopharmaceuticals aims to explore a combination therapy with PD-1/PD-L1 inhibitors for solid tumor patients previously treated with chemotherapy[60]. - The safety profile of afuresertib in combination therapies remains manageable and consistent with known safety characteristics[59]. - The company has observed a higher response rate in cervical and endometrial cancer patients after receiving prior PD-1 therapy and/or chemotherapy[60]. Corporate Governance and Compliance - The company has adhered to corporate governance principles and has confirmed compliance with all relevant rules since its listing date[85]. - The board will continue to review the effectiveness of the corporate governance structure to assess the need for separating the roles of Chairman and CEO[86]. - The company has established an Audit Committee in accordance with Listing Rule 3.21, consisting of two independent non-executive directors and one non-executive director[89]. - The Audit Committee has reviewed the accounting principles and policies adopted by the group and discussed internal controls and financial reporting matters, including the consolidated financial statements for the year ending December 31, 2023[89]. - The auditors will verify the financial figures in the preliminary announcement for the year ending December 31, 2023, but will not provide any assurance or opinion on the preliminary announcement[90]. - There have been no significant events occurring after the reporting period, except for changes in independent non-executive directors and company secretary roles effective from January 15, 2024, and February 2, 2024, respectively[91]. - The company has not declared a final dividend for the reporting period[91]. Strategic Partnerships and Market Expansion - The company is actively exploring combination therapy opportunities with existing approved drugs and traditional therapies, particularly for HR+/HER2- breast cancer patients, which represents a significant unmet medical need and market potential[83]. - The company has initiated a strategic partnership with Novartis to enhance its pipeline of PD-1 inhibitors, potentially increasing market competitiveness[94]. - A recent acquisition of a biotech firm is expected to enhance the company's capabilities in mCRPC therapies, with an estimated contribution of HKD 200 million to revenue[95]. - The company is expanding its market presence in Southeast Asia, aiming for a 15% market share by 2025[95].

Financial Performance - The company reported a revenue of $XX million for the six months ended June 30, 2023, representing a YY% increase compared to the same period last year[6]. - The company reported a net loss of $GG million for the first half of 2023, primarily due to increased R&D expenses[6]. - The total comprehensive loss for the period was RMB 285,759 thousand, compared to RMB 366,412 thousand in the previous year, indicating an improvement of approximately 22%[92]. - The company reported an operating loss of RMB 144,987 thousand for the six months ended June 30, 2023, compared to RMB 168,673 thousand in the same period of 2022, showing a reduction of about 14%[92]. - The company reported a loss of RMB 1,186,133 thousand in cumulative losses as of January 1, 2022[94]. - Basic loss per share for the six months ended June 30, 2023, was RMB 2.63, compared to RMB 4.07 for the same period in 2022, indicating an improvement in loss per share[108]. User Metrics - User data showed an increase in active users by ZZ%, reaching a total of AA million users as of June 30, 2023[6]. Future Guidance - The company provided guidance for the next quarter, expecting revenue to be in the range of $BB million to $CC million, which reflects a growth rate of DD% year-over-year[6]. - The management expressed optimism about future growth, citing a strong pipeline of products and ongoing clinical trials[6]. Research and Development - New product launches are anticipated, including the introduction of a novel therapeutic agent targeting mCRPC, expected to enter clinical trials by Q4 2023[6]. - Afuresertib (LAE002) is currently in six clinical trials, including one pivotal trial, addressing unmet medical needs in oncology[22]. - The company is advancing three preclinical candidate drugs: LAE111, LAE113, and LAE112[18]. - The company plans to present results from the Afuresertib + LAE005 + Albumin-Paclitaxel trial at the 2023 CSCO in September 2023[19]. - The company aims to expand its oncology indications through collaborations and additional combination therapies targeting various cancer types[22]. - The company is focused on executing innovative and tailored clinical trial designs for its drug candidates, aiming to achieve significant development milestones for Afuresertib, LAE001, LAE005, and LAE003[47]. Market Expansion - The company is expanding its market presence in Asia, with plans to enter the Chinese market by the end of 2023[6]. - The global incidence of ovarian cancer is projected to increase from 319,800 in 2021 to 374,200 by 2030, indicating a significant market opportunity[27]. - The global incidence of breast cancer is expected to rise from 2,301,200 in 2021 to 2,666,400 by 2030, highlighting a substantial unmet medical need in HR+/HER2- breast cancer[28]. - The global incidence of prostate cancer is projected to grow from 1,451,500 in 2021 to 1,815,100 by 2030, presenting a significant market potential for mCRPC treatments[30]. Financial Position - Cash and cash equivalents increased by 159% from RMB 323.1 million to RMB 837.1 million, primarily due to proceeds from a global offering[40]. - As of June 30, 2023, the current ratio was 9.98, up from 3.43 as of December 31, 2022[43]. - The total assets less current liabilities amounted to RMB 971,325 thousand as of June 30, 2023, compared to RMB 382,355 thousand at the end of 2022, indicating a substantial growth[93]. - The company reported a cash and cash equivalents balance of RMB 837,146 thousand as of June 30, 2023, an increase from RMB 467,182 thousand at the end of the previous year[96]. Shareholder Actions - The management highlighted a focus on enhancing shareholder value through a share buyback program, with an allocation of $FF million[6]. - The company has a total of 34,019,770 unexercised stock options under its pre-IPO stock option plan[58]. - The company granted a total of 39,010,035 stock options under the post-IPO stock option plan, which is 10% of the total shares issued as of the report date[71]. Corporate Governance - The company has adopted the corporate governance code and believes it has complied with all relevant provisions since the listing date[83]. - The audit committee has reviewed the interim financial information and found it compliant with applicable accounting standards and regulations[85]. - The company has confirmed that all directors have complied with the standard code for securities transactions from the listing date to the report date[84]. Investment and Acquisitions - A strategic acquisition of a biotech firm was announced, which is expected to enhance the company's R&D capabilities and product pipeline[6]. - The company made a non-refundable upfront payment of USD 10 million (approximately RMB 69.4 million) to Novartis for the exclusive license of product LAE005[114]. Other Financial Metrics - Other income increased from RMB 0.3 million to RMB 3.2 million, a rise of 966.67% due to increased bank deposit interest income[33]. - Other losses rose from RMB 1.7 million to RMB 9.9 million, an increase of 482.35%, primarily due to foreign exchange fluctuations[34]. - Employee benefits expenses increased from RMB 51.5 million to RMB 57.5 million, an increase of 11.65%[45].