Investment Rating - The report does not specify a clear investment rating for the company [2]. Core Views - As of June 21, 2024, the company received a $75 million equity investment from Takeda, significantly boosting its cash reserves and supporting clinical research in China and the U.S. [2] - The company signed an exclusive option agreement for the global rights to the third-generation BCR-ABL inhibitor, Olverembatinib, outside of China, receiving an upfront payment of $100 million and potential milestone payments totaling up to $1.2 billion [2][3]. - The efficacy of Olverembatinib in patients previously treated with TKI therapies is notable, with a 60.8% complete cytogenetic response (CCyR) rate and a 42.4% major molecular response (MMR) rate, indicating a potential peak sales exceeding $1 billion overseas [3]. - The international progress of APG-2575, a Bcl-2 inhibitor, is accelerating, with multiple indications entering Phase III clinical trials, including a significant milestone with FDA approval for a global registration trial in chronic lymphocytic leukemia (CLL) [3]. - Revenue forecasts for the company are optimistic, with projected revenues of 1.07 billion, 620 million, and 1.18 billion yuan for 2024, 2025, and 2026, respectively, driven by the commercialization of Olverembatinib and APG-2575 [4][8]. Summary by Sections Financial Performance - The company reported revenues of 221.98 million yuan in 2023, with a projected increase to 1.07 billion yuan in 2024, followed by a decrease to 620.49 million yuan in 2025, and a rebound to 1.18 billion yuan in 2026 [4][9]. - The net profit attributable to the parent company is expected to improve from a loss of 925.64 million yuan in 2023 to a loss of 121.92 million yuan in 2024, and further losses of 560.18 million yuan in 2025, and 102.77 million yuan in 2026 [4][9]. - Earnings per share (EPS) are projected to improve from -2.94 yuan in 2023 to -0.39 yuan in 2024, -1.78 yuan in 2025, and -0.33 yuan in 2026 [4][9]. Market Position and Growth Potential - The company is expected to capture market shares of 13.9%, 28.9%, and 41% for Olverembatinib in the treatment of CML from 2024 to 2026, translating to revenues of 3.4 billion, 5.7 billion, and 9.7 billion yuan, respectively [8]. - APG-2575 is anticipated to generate revenues of 0.5 billion yuan in 2025 and 2.1 billion yuan in 2026, with market entry expected in 2025 [8]. Clinical Development - The report highlights the significant clinical efficacy of Olverembatinib, particularly in patients resistant to previous treatments, which supports the company's growth narrative [3]. - APG-2575's entry into critical registration trials marks a significant milestone in the company's international expansion efforts [3].

Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [1]. Core Views - The licensing agreement for the third-generation BCR-ABL inhibitor, Olverembatin, with Takeda marks a significant milestone, with an upfront payment of $1.1 billion and potential total payments of $1.2 billion over the next two years, along with double-digit sales royalties [3]. - Olverembatin is projected to be a best-in-class product with overseas peak sales expected to exceed $1 billion, supported by FDA approval for a global Phase III clinical trial in February 2024 [3]. - Takeda's established sales and clinical team in hematology is expected to maximize the market potential for Olverembatin, leveraging their experience with the first-generation BCR-ABL inhibitor, Ponatinib [3]. - APG-2575 is anticipated to file for NDA this year, potentially becoming the second Bcl2 inhibitor to be launched globally, with significant expansion potential in various indications [4]. - The company is expected to see rapid revenue growth driven by Olverembatin's sales and the $1 billion option payment, with projected revenues of RMB 1.02 billion, RMB 473.52 million, and RMB 918.63 million for 2024, 2025, and 2026 respectively [4]. Financial Forecasts - Total revenue for 2022 was RMB 211.86 million, with a forecasted increase to RMB 225.09 million in 2023, and a significant jump to RMB 1.02 billion in 2024, reflecting a year-on-year growth of 353.84% [2]. - The company is expected to incur net losses, with projected net profits of RMB (882.92) million in 2022, RMB (925.64) million in 2023, and RMB (220.63) million in 2024 [2]. - The earnings per share (EPS) is projected to improve from RMB (2.81) in 2022 to RMB (0.70) in 2024, indicating a potential recovery in profitability [2].

Investment Rating - The report assigns a "Buy" rating for the company, marking the first coverage of the stock [1]. Core Views - The licensing agreement for the third-generation BCR-ABL inhibitor, Olverembatin, with Takeda marks a significant milestone for the company, indicating a transition into a phase of global innovation and value realization [3]. - The potential peak sales for Olverembatin are expected to exceed $1 billion, supported by its recent FDA approval for treating previously treated CML-CP patients [3]. - The partnership with Takeda, which has a strong sales and clinical team in hematology, is anticipated to maximize the overseas market potential for Olverembatin [3]. - The company is also on track to submit a New Drug Application (NDA) for APG-2575, which could become the second Bcl2 inhibitor to be launched globally [4]. - Revenue forecasts indicate rapid growth, with projected revenues of 1,021.53 million yuan in 2024, 473.52 million yuan in 2025, and 918.63 million yuan in 2026 [2][4]. Financial Summary - Total revenue for 2022 was 211.86 million yuan, with a significant year-on-year growth of 655.45% [2]. - The company is expected to incur net losses, with projected net profits of (220.63) million yuan in 2024 and (976.46) million yuan in 2025 [2]. - The earnings per share (EPS) is projected to improve from (2.94) yuan in 2023 to (0.70) yuan in 2024, before declining again to (3.10) yuan in 2025 [2][10]. - The company’s operating cash flow is expected to improve significantly, with a forecasted cash flow of (15.56) million yuan in 2024 [9].

Financial Performance - The company reported a revenue of HKD 1.2 billion for the fiscal year 2023, representing a 15% increase compared to the previous year[6]. - The company reported a significant increase in revenue, reaching $150 million, representing a 25% year-over-year growth[11]. - The company reported a revenue of RMB 1.2 billion for the fiscal year 2023, representing a year-over-year growth of 25%[14]. - Total revenue for 2023 reached RMB 221,984,000, an increase from RMB 209,711,000 in 2022, representing a growth of approximately 5.7%[19]. - For the year ended December 31, 2023, the company's revenue was RMB 222.0 million, an increase of RMB 12.3 million or 5.9% compared to RMB 209.7 million for the year ended December 31, 2022[52][53]. - The total comprehensive loss for the year ended December 31, 2023, was RMB 899.5 million, compared to RMB 821.4 million for the year ended December 31, 2022, representing an increase of RMB 78.1 million or 9.5%[52][64]. - The company's loss for the year ended December 31, 2023, was RMB 925.7 million, an increase of RMB 42.8 million or 4.8% from RMB 882.9 million for the year ended December 31, 2022[64]. User Growth and Market Expansion - User data showed a growth of 25% in active users, reaching 3 million by the end of 2023[6]. - User data showed an increase in active users to 1.2 million, up from 900,000 in the previous year, marking a 33% growth[12]. - User data indicates an increase in active patients to 150,000, up from 120,000 in the previous year, marking a growth of 25%[15]. - The company is expanding its market presence in Southeast Asia, targeting a 20% market share by 2025[6]. - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2025[11]. Product Development and R&D - New product launches included two innovative drugs, APG-115 and APG-125, which are expected to enter the market in Q3 2024[9]. - New product development includes the launch of a novel oral Bcl-2 inhibitor, expected to enter clinical trials in Q2 2024[12]. - New product launches include a PD-1 inhibitor, which is expected to enter the market by Q3 2024[17]. - The R&D expenditure increased to $30 million, accounting for 20% of total revenue, emphasizing the commitment to innovation[11]. - Research and development expenses increased to RMB 300 million, accounting for 25% of total revenue[15]. - The company has a robust pipeline with nine clinical-stage small molecule candidates, including the core product Olverembatin (耐立克®), which targets BCR-ABL mutations, including T315I mutation[25]. - The company is conducting over 40 I/II clinical trials globally, including in China, the US, Australia, and Europe[24]. Strategic Partnerships and Acquisitions - A strategic acquisition of a biotech firm was completed for HKD 500 million, enhancing the company's R&D capabilities[6]. - A strategic acquisition of a biotech firm was announced, valued at $50 million, aimed at enhancing R&D capabilities[13]. - A new partnership with a leading research institution was announced to accelerate the development of next-generation therapies[6]. - A new partnership with a leading pharmaceutical company was established to co-develop therapies, expected to generate $25 million in revenue over the next three years[12]. - The company has initiated a strategic partnership with Unity Biotechnology to enhance its R&D capabilities[16]. Operational Efficiency and Cost Management - The management highlighted a focus on enhancing operational efficiency, targeting a 5% reduction in operational costs by the end of 2024[6]. - The company plans to enhance its manufacturing capacity by 40% to meet growing demand for its core products[13]. - The company plans to invest RMB 500 million in technology upgrades to improve operational efficiency by 20% over the next two years[16]. Financial Guidance and Future Projections - The company provided a forward guidance of 10-12% revenue growth for the next fiscal year[6]. - The company provided guidance for the next fiscal year, projecting revenue between $180 million and $200 million, indicating a potential growth of 20% to 33%[13]. - The company anticipates a revenue guidance of RMB 1.5 billion for the next fiscal year, reflecting an expected growth of 25%[16]. Clinical Trials and Regulatory Approvals - The company received orphan drug designation for its new treatment for NHL, which is anticipated to boost its market potential significantly[18]. - The company received FDA approval to conduct five global pivotal registration clinical trials for Nairike® (Orebatin) and other key assets in 2023[21]. - Lisaftoclax (APG-2575) has been approved for 21 Phase Ib/II clinical studies across various indications, including CLL, NHL, AML, MM, and WM, with over 800 patients treated[29]. - The company received NMPA approval in December 2023 to conduct a pivotal Phase III clinical trial for Lisaftoclax (APG-2575) in newly diagnosed elderly/weak AML patients[30]. - The company expects to continue patient enrollment in the global pivotal Phase III clinical trial for CML-CP (POLARIS-2) in 2024[28]. Employee and Management Insights - The company has 47 employees with medical doctor or PhD degrees, primarily involved in R&D and laboratory work[76]. - The senior management team consists of 159 senior employees with an average of 15 to 20 years of experience in the biotechnology industry[76]. - The company has maintained an employee retention rate of over 80% over the past two years, supporting the continuous development of its knowledge base[76]. - The company actively recruits talent globally by offering a collaborative work environment, competitive compensation, and opportunities to engage in cutting-edge scientific projects[76]. Corporate Governance and Compliance - The company is committed to maintaining high standards of corporate governance and compliance with listing rules[85]. - The independent directors bring a wealth of knowledge and experience, contributing to the company's governance and strategic decision-making[87]. - The board comprises members with diverse backgrounds, including finance, law, and medicine, ensuring comprehensive oversight and governance[88]. Risks and Challenges - The company faces risks related to its financial condition and additional capital needs, including the potential inability to achieve profitability despite one candidate drug being commercialized[99]. - The company relies heavily on the success of its candidate drugs currently in clinical development, with the risk that clinical trials may not succeed[100]. - The company faces significant risks in obtaining regulatory approvals for candidate drugs, which could severely damage its business if not achieved[101]. - The company has experienced challenges in recruiting patients for clinical trials, which could delay or adversely affect clinical development activities[100]. Social Responsibility and Community Engagement - The company is committed to social responsibility, employee welfare, and sustainable development, adhering to environmental laws and regulations[98]. - The company made charitable donations totaling RMB 2.0 million to Peking University Education Foundation, RMB 1.1 million to Beijing Kangmeng Charity Foundation, and RMB 0.9 million to other foundations during the reporting period[112].

Investment Rating - The report does not specify a clear investment rating for the company [1] Core Insights - The company achieved a revenue of 220 million RMB in 2023, primarily from product sales and collaboration milestone income, with product sales contributing 194 million RMB [2] - The approval of new indications for the drug Olverembatin significantly expands the patient population and is expected to enhance its commercial performance, with sales volume increasing by 259% year-on-year and the number of hospitals gaining access rising by 567% [2] - The international progress of APG-2575 has accelerated, with multiple indications entering Phase III clinical trials, marking a significant milestone in its global registration process [2] - The pipeline continues to advance, showcasing the potential of first-in-class (FIC) and best-in-class (BIC) drugs, with notable efficacy and safety advantages observed in clinical trials [2] Revenue Forecast - The company is projected to achieve revenues of 340 million, 620 million, and 1.18 billion RMB for the years 2024, 2025, and 2026 respectively, driven by the growth of Olverembatin and APG-2575 [3][9] - The expected revenue from Olverembatin for 2024-2026 is estimated at 340 million, 570 million, and 970 million RMB, while APG-2575 is projected to generate 50 million and 210 million RMB in 2025 and 2026 respectively [9][10] - The revenue growth rates are forecasted at 55.41%, 79.83%, and 90.33% for the years 2024, 2025, and 2026 respectively [4][10]

Financial Performance - Revenue increased by RMB 12.3 million or 5.9% from RMB 209.7 million for the year ended December 31, 2022, to RMB 222.0 million for the year ended December 31, 2023[2]. - Other income decreased by RMB 7.7 million or 11.5% from RMB 67.0 million to RMB 59.3 million, primarily due to a reduction in government subsidies and fair value gains from financial instruments[2]. - Loss increased by RMB 42.8 million or 4.8% from RMB 882.9 million to RMB 925.7 million for the year ended December 31, 2023[3]. - The company reported a net loss of RMB 925.71 million for the year ended December 31, 2023, compared to a net loss of RMB 882.92 million in 2022[32]. - The total comprehensive loss for the fiscal year ending December 31, 2023, was RMB 899.45 million, compared to RMB 821.43 million for the fiscal year ending December 31, 2022[64]. - The company's total assets decreased to RMB 1,566.22 million in 2023 from RMB 1,949.11 million in 2022, indicating a decline of approximately 19.6%[34]. - The company's total liabilities included a deferred tax credit of RMB (7,150,000) for the year, compared to RMB (4,248,000) in 2022[55]. - The company's basic loss per share for the fiscal year ending December 31, 2023, was RMB 925.64 million, compared to RMB 882.92 million for the fiscal year ending December 31, 2022[57]. Research and Development - R&D expenses decreased by RMB 36.1 million or 4.9% from RMB 743.1 million to RMB 707.0 million, mainly due to a reduction in outsourced services[3]. - The company has conducted over 40 ongoing Phase I/II clinical trials globally, leveraging its proprietary platform for drug development targeting apoptosis and immune modulation[6]. - The core product, Olverembatin (APG-2575), has been approved for commercialization in China, marking a significant milestone in the company's product pipeline[6]. - The company has developed a rich pipeline of nine clinical-stage small molecule candidates, including next-generation multi-kinase inhibitors targeting FAK/ALK/ROS1[6]. - The company is focused on addressing unmet clinical needs for patients globally, aiming to benefit more patients through its innovative therapies[6]. - The company aims to enhance its R&D capabilities to develop innovative therapies that address unmet medical needs[92]. Product Development and Clinical Trials - Cumulative sales of Nairike® (Aorebatin) reached RMB 362.1 million since its launch in November 2021, with a 259% increase in sales volume in 2023 compared to 2022[4]. - The number of patients increased by 123% and the number of hospitals with access increased by 567% for Nairike® (Aorebatin) in 2023[4]. - Nairike® (Aorebatin) was included in the 2022 National Medical Insurance Drug List and received approval for clinical trials in various indications[4]. - The company received clinical trial approvals from the NMPA for the global pivotal Phase III studies of lisaftoclax (APG-2575) for treating newly diagnosed elderly/fragile acute myeloid leukemia (AML) patients in December 2023 and for first-line treatment in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients in October 2023[5]. - Lisaftoclax (APG-2575) has been approved for 21 clinical studies in China, the US, Australia, and Europe, targeting various hematological malignancies and solid tumors, with over 800 patients treated, including more than 400 CLL/SLL patients[12]. - The company is actively pursuing key registration studies for GIST and Ph+ ALL indications[10]. - Recent clinical data presented at the 2023 ASH Annual Meeting showed promising results for Nairike® (Aorebatin) in CML-CP patients resistant to second-generation TKIs[11]. Market and Commercialization - The commercialization team has expanded to approximately 100 members, covering 117 distributors and over 800 hospitals, with 526 hospitals and DTP pharmacies included in 2023[29]. - The product Nairike (Aorebatin) was successfully included in the National Reimbursement Drug List (NRDL) in January 2023, enhancing patient accessibility[29]. - The company aims to expand the commercialization and accessibility of Nairike® (Aorebatin) in both domestic and international markets[8]. - The company is advancing its late-stage commercialization and marketing teams to support its innovative drug development efforts[6]. - The company is investing $20 million in the development of APG-2575, a novel oral Bcl-2 inhibitor, with expected completion in 2025[119]. Financial Position and Assets - The company's production facility in Suzhou has a capacity of 250 million tablets/capsules per year, supporting its transition from Biotech to Biopharma[30]. - The company's net asset value dropped from RMB 408,658 thousand in 2022 to RMB 70,632 thousand in 2023, a decrease of around 82.7%[36]. - The company's long-term payables decreased from RMB 35,331 thousand in 2022 to RMB 18,299 thousand in 2023, a reduction of approximately 48.2%[35]. - The total amount of bank and other borrowings due within one year was RMB 616.4 million, compared to RMB 518.4 million in the previous year[83]. - The group had no significant contingent liabilities as of December 31, 2023[84]. Governance and Compliance - The financial statements were prepared in accordance with International Financial Reporting Standards, reflecting a commitment to transparency and compliance[38]. - The company confirmed compliance with the corporate governance code during the reporting period[93]. - The audit committee has reviewed the financial performance for the year ended December 31, 2023, ensuring compliance with relevant accounting standards[110]. Employee and Organizational Structure - The group employed 583 full-time employees as of December 31, 2023, with 401 (68.8%) in R&D roles[87]. - Employee benefit expenses for the years ended December 31, 2022, and 2023 were RMB 427.6 million and RMB 413.0 million, respectively[88]. - The board of directors includes Dr. Dajun Yang as the chairman and CEO, along with other non-executive and independent directors[124].

Financial Performance - The company reported a significant increase in revenue, reaching HKD 1.2 billion, representing a 25% growth compared to the previous year[6]. - The company reported a revenue of HKD 150 million for the first half of 2023, representing a 25% increase compared to the same period last year[11]. - The company expects to launch two new products by Q4 2023, contributing an estimated HKD 80 million in additional revenue[11]. - The company has set a performance guidance of HKD 300 million in revenue for the full year 2023, reflecting a 20% year-over-year growth[11]. - The company provided guidance for the second half of 2023, expecting revenue to reach between RMB 200 million and RMB 250 million, reflecting a growth rate of 33% to 67% year-over-year[13]. - Total revenue for the six months ended June 30, 2023, was RMB 142,701,000, compared to RMB 95,763,000 for the same period in 2022, representing an increase of approximately 49%[146]. - Revenue from pharmaceutical product sales reached RMB 129,534 thousand, up 63.1% from RMB 79,452 thousand in the prior year[160]. User Growth - User data showed a 15% increase in active users, totaling 3 million users as of the end of the reporting period[6]. - The company reported a user base growth of 15% in the first half of 2023, reaching a total of 200,000 active users[11]. - User data indicates a growth in the patient population for the company's key therapies, with an estimated increase of 30% in new patients diagnosed with NSCLC[14]. Research and Development - New product development includes the launch of APG-115, a novel oral active small molecule MDM2-p53 inhibitor, expected to enter clinical trials in Q4 2023[7]. - The company is advancing its third-generation BCR-ABL inhibitor, HQP1351, aimed at overcoming T315I mutation resistance[11]. - The R&D pipeline includes three new drug candidates expected to enter clinical trials by the end of 2023, focusing on NHL and NPC indications[14]. - The company is investing in R&D, with a budget allocation of HKD 50 million for new product development in 2023[11]. - The company has a robust pipeline with nine clinical-stage small molecule candidates, including the core product, Olverembatinib (耐立克), which targets BCR-ABL mutations, including T315I[24]. - The company is actively pursuing communication with the FDA regarding global pivotal registration clinical trials for Nairik® (Orebatinib)[27]. Market Expansion - The company is expanding its market presence in Asia, targeting a 30% increase in market share by the end of 2024[8]. - The company plans to expand its market presence in Southeast Asia, targeting a 15% market share in the region by 2025[14]. - The company has initiated a new marketing strategy focusing on digital channels, aiming for a 40% increase in online sales[8]. Financial Health - The gross margin improved to 60%, up from 55% in the previous year, indicating better cost management[6]. - The company reported a net loss of RMB 402.3 million, a decrease in loss of RMB 4.4 million compared to the net loss of RMB 406.7 million for the same period in 2022[20]. - The company’s total liabilities as of June 30, 2023, were RMB 2,317.9 million, with current liabilities of RMB 642.9 million and non-current liabilities of RMB 1,675.0 million[64]. - The company’s cash and cash equivalents amounted to RMB 1,581.6 million, an increase of RMB 89.4 million or 6.0% from RMB 1,492.2 million as of December 31, 2022[20]. Strategic Initiatives - A strategic acquisition of a biotech firm was announced, valued at USD 500 million, aimed at enhancing R&D capabilities[8]. - The company has initiated discussions for potential mergers and acquisitions to enhance its product pipeline and market reach[11]. - The management emphasized the importance of sustainability in operations, committing to reduce carbon emissions by 25% by 2025[8]. Shareholder Information - Ascentage Limited, the major shareholder, holds 45.53% of the shares, while HealthQuest Pharma Limited, owned by Dr. Zhai, is also a significant stakeholder[10]. - Major shareholders collectively hold 22.30% of the company's equity, with Li Ju-Yun, Dr. Gao, and Dr. Zhai each having significant interests[73]. - The company has initiated a share buyback program, intending to repurchase up to 5% of its outstanding shares over the next 12 months[14]. Clinical Trials and Approvals - The company obtained FDA approval in August 2023 for a global Phase III clinical trial of lisaftoclax (APG-2575) in previously treated CLL/SLL patients[21]. - Olverembatinib received approval for a pivotal Phase III clinical trial to compare its efficacy with Imatinib in newly diagnosed Ph+ ALL patients[25]. - Alrizomadlin (APG-115) has received six orphan drug designations from the FDA, including for soft tissue sarcoma and AML[31]. Corporate Governance - The board of directors continues to review the effectiveness of the corporate governance structure, particularly the separation of the roles of Chairman and CEO[140]. - The company has adopted its own securities trading code, ensuring compliance with the standard code for all directors during the reporting period[141].

Financial Performance - For the six months ended June 30, 2023, revenue increased by RMB 46.9 million or 49.0% to RMB 142.7 million, primarily due to the sales growth of Nairike® (Orebatin), which increased by 36.7% compared to the same period last year[2]. - Other income and gains decreased by RMB 20.0 million or 54.1% to RMB 17.0 million, mainly due to a reduction in government subsidies and fair value gains from derivative financial instruments[2]. - Sales and distribution expenses increased by RMB 12.0 million or 16.8% to RMB 83.3 million, primarily due to commercialization costs associated with Nairike® (Orebatin) and other products[3]. - R&D expenses decreased by RMB 31.6 million or 9.3% to RMB 309.8 million, mainly due to a reduction in outsourced services and labor costs[3]. - Administrative expenses increased by RMB 9.0 million or 10.9% to RMB 91.3 million, primarily due to increased operational and depreciation costs at the Suzhou base[3]. - As of June 30, 2023, the group recorded a net loss of RMB 402.3 million, a decrease in loss of RMB 4.4 million compared to RMB 406.7 million for the same period last year[3]. - As of June 30, 2023, cash and cash equivalents amounted to RMB 1,581.6 million, an increase of RMB 89.4 million or 6.0% from RMB 1,492.2 million as of December 31, 2022[3]. - Revenue for the six months ended June 30, 2023, was RMB 142,701,000, a significant increase from RMB 95,763,000 in the same period of 2022, representing a growth of approximately 49%[29]. - Gross profit for the same period was RMB 124,547,000, compared to RMB 90,742,000 in 2022, indicating a gross margin improvement[29]. - The company reported a loss before tax of RMB 399,603,000, slightly improved from a loss of RMB 402,252,000 in the previous year[29]. - Total comprehensive loss for the period was RMB 362,569,000, compared to RMB 363,472,000 in the prior year, showing a marginal improvement[31]. Product Development and Clinical Trials - Cumulative sales of Nairike® (Orebatin) reached RMB 303.9 million since its launch in November 2021, with significant progress in global development and commercialization[4]. - In July 2023, Nairike® (Orebatin) received clinical trial approval from the NMPA for a pivotal Phase III study in patients with newly diagnosed Ph+ ALL[4]. - In August 2023, the company obtained FDA approval for a pivotal Phase III clinical trial of Lisaftoclax (APG-2575) in patients with previously treated CLL/SLL[4]. - The company announced the latest Phase I clinical trial data for APG-2449, which overcomes resistance to second-generation ALK inhibitors in non-small cell lung cancer (NSCLC) patients[6]. - The high-potential asset EED inhibitor APG-5918 has received clinical trial approvals for advanced solid tumors and hematologic malignancies in the US and China, expanding into new treatment areas[6]. - The core product, Nairike (Orebatinib), has been approved for commercialization in China[7]. - The company is conducting over 40 Phase I/II clinical trials globally, demonstrating its commitment to addressing unmet clinical needs[7]. - The product pipeline includes candidates targeting various cancers and diseases, with ongoing trials in multiple regions[8]. - The core product, Nairike® (Aorebatinib), is the first and only third-generation BCR-ABL inhibitor approved in China for treating T315I mutation CML patients, marking a significant advancement in the treatment landscape[9]. - Lisaftoclax (APG-2575) is a novel oral Bcl-2 inhibitor, currently undergoing 19 Phase Ib/II clinical trials across various indications, including CLL, NHL, AML, and solid tumors, with over 600 patients treated[12]. Research and Development - The company has a robust pipeline with nine small molecule candidates in clinical stages, including innovative Bcl-2 and dual-target Bcl-2/Bcl-xL inhibitors, and next-generation multi-kinase inhibitors targeting FAK/ALK/ROS1[7]. - The company has established global collaborations with leading biotech and pharmaceutical companies and academic institutions, enhancing its research and development capabilities[7]. - The company aims to accelerate the clinical development of its product pipeline to benefit more patients globally[7]. - The company reported R&D expenses of RMB 341.4 million and RMB 309.8 million for the years ended June 30, 2022, and 2023, respectively[23]. - The company has a single operating segment focused on developing and selling innovative small molecule therapies for oncology and chronic hepatitis B[40]. Financial Position and Liquidity - The financial and liquidity position remained stable during the first half of 2023 despite the impacts of COVID-19[28]. - Current assets increased to RMB 1,760,839,000 from RMB 1,636,488,000, reflecting a growth in liquidity[32]. - The company’s net asset value rose to RMB 600,178,000 as of June 30, 2023, compared to RMB 408,658,000 at the end of 2022[33]. - The current ratio improved to 2.7 as of June 30, 2023, from 1.9 as of December 31, 2022[73]. - The debt-to-equity ratio decreased to 15.7% as of June 30, 2023, down from 73.5% as of December 31, 2022[73]. - Cash and bank balances increased to RMB 1,581.6 million as of June 30, 2023, from RMB 1,492.2 million as of December 31, 2022[82]. Employee and Management - As of June 30, 2023, the company had a total of 565 full-time employees, with 68.0% (384 employees) in R&D, 19.1% (108 employees) in commercial roles, and 12.9% (73 employees) in administrative functions[84]. - The company has a high employee retention rate of over 80% over the past two years, contributing to the continuous development of its knowledge base[84]. - The senior management team consists of 152 senior employees with an average of 15 to 20 years of experience in the biotechnology industry[84]. - The company actively recruits talent globally by offering a collaborative work environment, competitive compensation, and opportunities to work on cutting-edge scientific projects[84]. Corporate Governance and Compliance - The board of directors continues to review the effectiveness of the corporate governance structure to assess the need for separating the roles of chairman and CEO[90]. - The company has established an audit committee to ensure compliance with applicable accounting standards and regulations[108]. - The company’s financial statements were reviewed by external auditors Ernst & Young, ensuring adequate disclosure and compliance with accounting standards[108]. - The board is committed to maintaining transparency and accountability in its operations[121].

Financial Performance - Ascentage Pharma reported a revenue of HKD 850 million for the year 2022, reflecting a significant increase compared to previous years[3]. - The company reported a total revenue of RMB 1.2 billion for the fiscal year ending December 31, 2022, representing a year-over-year increase of 25%[13]. - The company provided an earnings guidance of $200 million in revenue for the next fiscal year, representing a 20% year-over-year growth[11]. - The company projects a revenue guidance of RMB 1.5 billion for the next fiscal year, reflecting an expected growth rate of 25%[16]. - The company reported a 40% increase in revenue from its core product line in the last quarter, reflecting strong market demand[11]. - The group's revenue for the year ended December 31, 2022, was RMB 209.7 million, an increase of RMB 181.8 million or 651.6% compared to RMB 27.9 million for the year ended December 31, 2021, primarily due to the commercialization of the core product, Orelabrutinib[53]. - The group reported a consolidated loss during the reporting period, and no dividends were declared for the years ended December 31, 2021, and 2022[97]. Research and Development - The company is actively developing new products, including APG-115, a novel oral small molecule MDM2-p53 inhibitor, and APG-2575, a new oral Bcl-2 inhibitor[8]. - The management discussed the importance of enhancing R&D capabilities to accelerate the development of innovative therapies for cancer treatment[8]. - The company is investing $50 million in R&D for new product development, focusing on innovative therapies for hematological malignancies[12]. - The R&D budget has been increased by 30% to RMB 500 million to support ongoing and future projects[17]. - The company aims to achieve regulatory approval for two new drug candidates by the end of the year, which could significantly impact future revenue streams[12]. - The company is currently conducting over 40 clinical studies globally, with several key assets receiving recognition at major international conferences[22]. - The company has nine small molecule candidates in clinical development as of December 31, 2022, indicating a robust product pipeline[26]. Market Expansion and Strategy - Ascentage Pharma plans to expand its market presence through strategic partnerships and collaborations, particularly in the Asia-Pacific region[9]. - Future outlook includes plans to expand into new markets, targeting a 30% increase in market share over the next two years[11]. - Market expansion efforts include entering the Southeast Asian market, targeting a market share of 15% within the first two years[18]. - The company has established strategic partnerships to enhance its market presence, aiming for a 15% increase in collaborative projects by the end of the fiscal year[11]. - The company is exploring potential acquisitions to diversify its product portfolio, with a budget of $100 million allocated for this purpose[11]. Corporate Governance and Management - Ascentage Pharma is committed to maintaining high corporate governance standards and transparency in its operations[9]. - The company has a strong leadership team with extensive experience in pharmaceuticals and biotechnology, including Dr. Yang, the CEO, and Dr. Guo, who has over 20 years in drug development[88]. - The board includes independent directors with diverse expertise, ensuring robust governance and strategic oversight[87]. - The company has implemented various employee incentive plans, including pre-IPO and post-IPO share option plans and restricted share unit plans[73]. - The company has a retention rate of over 80% over the past two years, contributing to the continuous development of its knowledge base[72]. Clinical Trials and Drug Development - Lisaftoclax (APG-2575) is undergoing 19 Phase Ib/II clinical trials across multiple regions, with over 500 patients treated, including more than 250 CLL/SLL patients[32]. - Alrizomadlin (APG-115) has received six orphan drug designations from the FDA, including for soft tissue sarcoma and AML[35]. - The company is conducting multiple clinical trials for Alrizomadlin (APG-115) in the US and Australia, including studies for unresectable melanoma and R/R AML[35]. - The company is currently developing a new PD-1 inhibitor, which is expected to enter clinical trials by Q3 2023[17]. - The company aims to commercialize drug strategies and has a strong focus on oncology marketing and business development[90][93]. Financial Management and Capital Raising - In 2023, Ascentage Pharma announced a placement of 22.5 million shares at a price of HKD 24.45 per share to raise additional capital for its operations[7]. - The company raised approximately HKD 550 million in early 2023 to strengthen its balance sheet and support operations[23]. - The net proceeds from the global offering, amounting to approximately HKD 369.8 million, have been fully utilized as planned[186]. - Approximately 42% (around HKD 155.2 million) of the net proceeds are allocated to R&D, specifically for the commercialization of the core product HQP1351[186]. - The company plans to gradually use the remaining net proceeds from the 2021 placement according to actual business needs[195]. Employee and Stakeholder Relations - The company has maintained good relationships with employees, customers, and suppliers, with no significant disputes reported during the reporting period[96]. - As of December 31, 2022, the company had a total of 580 full-time employees, with 67.6% (392 employees) in R&D, 19.5% (113 employees) in commercial roles, and 12.9% (75 employees) in administrative functions[72]. - Employee benefits expenses for the years ended December 31, 2021, and 2022 were RMB 388.2 million and RMB 427.6 million, respectively, reflecting an increase of approximately 10.5%[72]. Risks and Challenges - The group faces significant risks related to financing needs, as it has incurred net losses despite commercializing one candidate drug[99]. - Regulatory approval processes for candidate drugs are lengthy and unpredictable, posing a risk to the business if approvals are not obtained[101]. - The group relies on third parties for clinical trials and manufacturing, which could impact the ability to commercialize candidate drugs if these parties fail to meet obligations[104]. - The group has significant exposure to the Chinese market, where regulatory changes could adversely affect business operations[107].

Revenue Growth - Revenue increased from RMB 279 million for the year ended December 31, 2021, to RMB 2,097 million for the year ended December 31, 2022, representing a growth of 651.6%[2] - Total revenue for the year ended December 31, 2022, was RMB 209,711 thousand, a significant increase from RMB 27,910 thousand in 2021, representing a growth of approximately 651%[50] - The company reported a total revenue of RMB 1.5 billion for the fiscal year 2022, representing a year-over-year growth of 25%[124] - The company projects a revenue guidance of RMB 1.8 billion for the fiscal year 2023, reflecting an anticipated growth of 20%[124] Income and Expenses - Other income decreased from RMB 681 million for the year ended December 31, 2021, to RMB 670 million for the year ended December 31, 2022, a decline of 60.1%[3] - Sales and distribution expenses rose significantly from RMB 477 million for the year ended December 31, 2021, to RMB 1,574 million for the year ended December 31, 2022, an increase of 230.0%[3] - Administrative expenses increased from RMB 1,435 million for the year ended December 31, 2021, to RMB 1,706 million for the year ended December 31, 2022, an increase of 18.9%[3] - The company incurred a net loss of RMB 882.924 million for 2022, compared to a net loss of RMB 782.424 million in 2021, reflecting ongoing investment in R&D[34] - The total comprehensive loss for the year ended December 31, 2022, was RMB 821.4 million, compared to RMB 813.7 million for the year ended December 31, 2021[70] Research and Development - R&D expenses decreased slightly from RMB 7,665 million for the year ended December 31, 2021, to RMB 7,431 million for the year ended December 31, 2022, a reduction of 3.1%[3] - The company is conducting over 40 I/II clinical trials globally, showcasing its robust clinical development pipeline[7] - The product pipeline includes nine clinical-stage small molecule candidates targeting various cancers and diseases[8] - The company aims to advance eight differentiated clinical product candidates to the next clinical stage and apply for NDA globally[95] - The company is committed to enhancing its R&D capabilities to develop innovative therapies that address unmet medical needs and improve patient health[96] Product Development and Market Access - The cumulative sales of the core product, Nairike® (Orebatinib), reached RMB 1,824 million since its launch in November 2021[4] - Nairike® was included in the 2022 National Medical Insurance Drug List, enhancing its market access[4] - The new drug application for Nairike® to treat chronic myeloid leukemia (CML) patients was accepted and prioritized for review in July 2022[4] - The important investigational drug, Lisaftoclax (APG-2575), demonstrated a 98% overall response rate (ORR) in combination therapy for relapsed/refractory CLL/SLL patients[5] - Nairike® (Orebatinib) received FDA orphan drug designation for the treatment of gastrointestinal stromal tumors (GIST) in September 2022[11] Financial Position - Total assets decreased to RMB 3.829 billion in 2022 from RMB 4.439 billion in 2021, while total liabilities increased to RMB 2.428 billion from RMB 1.705 billion[37][38] - The company’s cash and bank balances decreased to RMB 1.492 billion in 2022 from RMB 1.744 billion in 2021, indicating a reduction in liquidity[37] - The current ratio decreased from 5.2 in 2021 to 1.9 in 2022, and the quick ratio also decreased from 5.2 to 1.8 during the same period[83] - As of December 31, 2022, the company had bank loans amounting to RMB 1,775.5 million and lease liabilities of RMB 17.2 million[85] Strategic Partnerships and Collaborations - The company has established global partnerships with leading biotech and pharmaceutical companies and academic institutions to enhance its R&D capabilities[7] - A collaboration with Tanner Pharma Group was established in July 2022 to launch a Named Patient Program for Olverembatinib in over 130 countries[31] - The company plans to actively seek strategic partnerships with global biotech and pharmaceutical companies to capitalize on commercialization opportunities in the global drug market[95] Regulatory and Compliance - The company has adopted corporate governance principles in accordance with the listing rules and has confirmed compliance with the standard code during the reporting period[97] - The company is committed to maintaining compliance with international financial reporting standards, ensuring transparency and accuracy in its financial disclosures[123] Employee and Management - As of December 31, 2022, the company had a total of 580 full-time employees, with 67.6% (392 employees) in R&D, 19.5% (113 employees) in commercial roles, and 12.9% (75 employees) in administrative functions[93] - Employee benefits expenses for the years ending December 31, 2021, and 2022 were RMB 388.2 million and RMB 427.6 million, respectively, reflecting an increase of approximately 10.5%[93] - The senior management team consists of 157 senior employees with an average of 15 to 20 years of experience in the biotechnology industry[93] Future Outlook - The company is developing several new drugs, including APG-115, a novel oral MDM2-p53 inhibitor, and APG-1252, a selective Bcl-2/Bcl-xL inhibitor aimed at restoring apoptosis[121] - The company is exploring strategic acquisitions to bolster its portfolio and enhance its competitive edge in the biopharmaceutical market[122] - The company has reported a robust pipeline with several candidates targeting critical pathways in cancer treatment, reflecting its commitment to innovation[121]