[Financial and Business Summary](index=1&type=section&id=Financial%20and%20Business%20Summary) [Financial Summary](index=1&type=section&id=Financial%20Summary) In H1 2024, revenue decreased by 15.6% to RMB 60.78 million, yet net loss significantly narrowed from RMB 219 million to RMB 167 million due to substantial expense reductions Key Financial Indicators H1 2024 (RMB thousand) | Indicator | H1 2024 (Unaudited) | H1 2023 (Unaudited) | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Revenue | 60,779 | 72,016 | -15.6% | | R&D Costs | (130,841) | (226,093) | -42.1% | | Sales & Distribution Expenses | (56,028) | (88,246) | -36.5% | | Administrative Expenses | (58,478) | (83,756) | -30.2% | | Loss for the Period | (167,033) | (218,694) | +23.6% (Loss narrowed) | | Adjusted Loss for the Period* | (152,567) | (189,437) | +19.5% (Loss narrowed) | - Revenue decline was primarily due to price reductions for core product XPOVIO® (Selinexor) after its inclusion in the National Reimbursement Drug List in December 2023, and transitional impacts from the initial commercialization partnership with Hansoh Pharmaceutical; however, significant sales volume increases largely offset the price decrease[3](index=3&type=chunk) - R&D costs decreased by **RMB 95.3 million** year-on-year, mainly due to reduced employee costs and drug development expenses from improved R&D efficiency, along with lower licensing fees[3](index=3&type=chunk) - Sales and distribution expenses decreased by **RMB 32.2 million** year-on-year, primarily due to no new APAC commercialization milestone payments in 2024 and reduced Greater China-related expenses following the partnership with Hansoh Pharmaceutical[3](index=3&type=chunk) [Business Summary](index=3&type=section&id=Business%20Summary) During the reporting period, the company achieved significant pipeline and operational advancements, including Selinexor's (XPOVIO®) expanded market access in Korea and China, positive data for Onatasertib in cervical cancer, and steady progress across multiple clinical-stage assets - **Commercialization Asset Progress**: * **Selinexor (ATG-010, XPOVIO®)**: * Approved for reimbursement in Korea for rrMM in June 2024, effective July 1 * Received NMPA approval in China for a new indication in rrDLBCL in July 2024[4](index=4&type=chunk) - **Late-Stage Asset Progress**: * **Onatasertib (ATG-008)**: I/II TORCH-2 study results showed an ORR of **53.3%** and DCR of **86.7%** when combined with toripalimab in cervical cancer patients, with good tolerability[4](index=4&type=chunk) - **Other Clinical-Stage Asset Progress**: * **ATG-101 (PD-L1/4-1BB)**: Phase I trials are ongoing in China, Australia, and the US * **ATG-037 (CD73 Inhibitor)**: Phase I trials are ongoing in China and the US * **ATG-022 (Claudin 18.2 ADC)**: Phase II CLINCH trial initiated in China and Australia, with Phase I data showing preliminary efficacy * **ATG-031 (Anti-CD24 mAb)**: Phase I PERFORM trial is ongoing in the US[4](index=4&type=chunk)[5](index=5&type=chunk) - During the reporting period, the company did not engage in any new business development activities, strategically focusing on advancing core R&D projects[5](index=5&type=chunk) [Management Discussion and Analysis](index=5&type=section&id=Management%20Discussion%20and%20Analysis) [Company Overview](index=5&type=section&id=Overview) Antengene is a commercial-stage biopharmaceutical company focused on innovative oncology drugs in APAC, with a 'combination and complementary' R&D strategy encompassing one commercial product and eight clinical-stage programs - The company is positioned as a commercial-stage biopharmaceutical company in the Asia-Pacific region, focusing on innovative oncology drugs[7](index=7&type=chunk) - The company employs a 'combination and complementary' R&D strategy, with a pipeline comprising **one commercial product**, **eight clinical-stage projects**, and multiple preclinical projects[7](index=7&type=chunk) [Product Pipeline](index=6&type=section&id=Product%20Pipeline) The company's oncology-focused pipeline includes 10 drug candidates from preclinical to commercial stages, featuring core product Selinexor (ATG-010) and late-stage asset Onatasertib (ATG-008) in Phase II clinical trials Key Product Pipeline and Status | Investigational Product | Target (Drug Type) | Key Indication | Development Stage | | :--- | :--- | :--- | :--- | | **ATG-010 (Selinexor)** | XPO1 (Small Molecule) | rrMM, rrDLBCL | Commercialized/Phase III | | **ATG-008 (Onatasertib)** | mTORC1/2 (Small Molecule) | Cervical Cancer & Advanced Solid Tumors | Phase II Clinical | | **ATG-022** | Claudin 18.2 (ADC) | Solid Tumors | Phase II Clinical | | **ATG-037** | CD73 (Small Molecule) | Hematologic Malignancies/Solid Tumors | Phase I Clinical | | **ATG-101** | PD-L1/4-1BB (Bispecific Antibody) | Hematologic Malignancies/Solid Tumors | Phase I Clinical | | **ATG-031** | CD24 (Monoclonal Antibody) | Hematologic Malignancies/Solid Tumors | Phase I Clinical | [Business Review](index=7&type=section&id=Business%20Review) H1 2024 saw steady business progress, with core product Selinexor (XPOVIO®) gaining expanded market access in Korea and China, advancing commercial partnerships, and positive clinical data reported for multiple pipeline assets [Commercialization Stage Product: Selinexor (ATG-010)](index=7&type=section&id=Commercialization%20Stage%20Product) Selinexor (XPOVIO®), the company's first commercial product, achieved key advancements during and after the reporting period, including expanded approvals and reimbursement in APAC, and a commercialization partnership with Hansoh Pharmaceutical in mainland China - A collaboration agreement with Hansoh Pharmaceutical for XPOVIO®'s commercialization in mainland China entitles Antengene to an upfront payment of up to **RMB 200 million** and milestone payments of up to **RMB 535 million**[11](index=11&type=chunk) - In December 2023, XPOVIO® was included in China's National Reimbursement Drug List for relapsed/refractory multiple myeloma, effective January 1, 2024[11](index=11&type=chunk) - In June 2024, it received reimbursement approval for rrMM in Korea; in the same month, it was approved for a new indication in rrDLBCL in China[9](index=9&type=chunk) [Late-Stage Candidate Product: ATG-008 (Onatasertib)](index=9&type=section&id=Late-Stage%20Candidate%20Product) ATG-008 (Onatasertib), an mTORC1/2 inhibitor, is undergoing a Phase I/II TORCH-2 study in combination with toripalimab for cervical cancer, with recent positive results presented at ASCO 2024 demonstrating good anti-tumor activity and tolerability - The Phase I/II TORCH-2 study showed that ATG-008 combined with toripalimab achieved an ORR of **53.3%** and a DCR of **86.7%** in CPI-naïve cervical cancer patients[13](index=13&type=chunk) [Other Clinical Candidate Drugs](index=9&type=section&id=Other%20Clinical%20Candidate%20Drugs) Several other clinical candidates are progressing positively, including ATG-101 (PD-L1/4-1BB bispecific) in multi-country Phase I studies, ATG-037 (CD73 inhibitor) completing Phase I, ATG-022 (Claudin 18.2 ADC) initiating Phase II with two FDA Orphan Drug Designations, and ATG-031 (CD24 antibody) completing its first dosing level in Phase I - ATG-101 (PD-L1/4-1BB bispecific antibody) received Orphan Drug Designation from the US FDA for the treatment of pancreatic cancer[13](index=13&type=chunk) - ATG-022 (Claudin 18.2 ADC) has initiated Phase II trials and received two Orphan Drug Designations from the FDA for gastric and pancreatic cancer[14](index=14&type=chunk) - ATG-031 (CD24 antibody) Phase I trial completed first patient dosing in December 2023 and has passed the initial dosing level[15](index=15&type=chunk) [Research and Development](index=10&type=section&id=Research%20and%20Development) The company focuses on differentiated 'combination and complementary' R&D strategies for cancer treatment, with nine clinical studies ongoing and adjusted R&D costs significantly reduced to **RMB 122 million** in H1 2024, while strengthening its intellectual property portfolio - As of June 30, 2024, the company has **nine clinical studies** ongoing in mainland China, the US, and Australia[16](index=16&type=chunk) R&D Cost Comparison (Non-IFRS) | Period | Adjusted R&D Costs (RMB million) | | :--- | :--- | | H1 2024 | Approx. 121.7 | | H1 2023 | Approx. 207.7 | - As of June 30, 2024, the company has filed **nine patent applications** in mainland China and **eleven international applications** under PCT[16](index=16&type=chunk) [Future and Outlook](index=11&type=section&id=Future%20and%20Outlook) The company plans to advance its 'combination and complementary' R&D strategy, developing nine clinical-stage products through a dual-engine approach of external partnerships and internal discovery, while preparing for XPOVIO®'s APAC launch with its experienced commercial team - Continue advancing the development of **nine clinical-stage products** across multiple therapeutic areas[19](index=19&type=chunk) - Continue implementing a dual-engine approach of external collaborations and internal discovery to build a global and APAC pipeline[19](index=19&type=chunk) - Leverage the experience of the core commercial team to prepare for XPOVIO®'s first-in-class launch in the APAC region[19](index=19&type=chunk) [Financial Review](index=24&type=section&id=Financial%20Review) H1 2024 revenue was **RMB 60.8 million**, a 15.6% decrease due to XPOVIO® price adjustments and commercial transition, partially offset by sales volume growth, while significant cost controls led to a narrowed loss from **RMB 219 million** to **RMB 167 million** - Revenue decreased by **15.6%** from **RMB 72 million** to **RMB 60.8 million**, primarily due to price reductions for XPOVIO® after its inclusion in the National Reimbursement Drug List and transitional impacts from the partnership with Hansoh Pharmaceutical[53](index=53&type=chunk) - Other income and gains significantly decreased from **RMB 121 million** to **RMB 27.3 million**, mainly due to net foreign exchange gains falling from **RMB 92.3 million** in the prior period to **RMB 6.2 million** this period[54](index=54&type=chunk) R&D Cost Components (RMB thousand) | Item | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Employee Costs | 51,327 | 86,920 | | Licensing Fees | – | 40,464 | | Drug Development Expenses | 62,479 | 76,812 | | **Total** | **130,841** | **226,093** | Sales & Distribution Expense Components (RMB thousand) | Item | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Milestone Payments | – | 21,286 | | Employee Costs | 12,603 | 42,571 | | Market Development Expenses | 42,729 | 22,754 | | **Total** | **56,028** | **88,246** | - Administrative expenses decreased by **30.2%** from **RMB 83.8 million** to **RMB 58.5 million**, primarily due to reduced employee costs[58](index=58&type=chunk) [Liquidity and Financial Resources](index=29&type=section&id=Liquidity%20and%20Financial%20Resources) As of June 30, 2024, the company held **RMB 1.024 billion** in cash and bank balances, a decrease from **RMB 1.188 billion** at year-end 2023, primarily used for operating expenses, maintaining sufficient liquidity with a current ratio of **572.4%** and a healthy gearing ratio of **32.0%** Financial Position Overview (June 30, 2024) | Indicator | Amount/Ratio (RMB) | | :--- | :--- | | Cash and Bank Balances | 1.024 billion | | Current Assets | 1.113 billion | | Current Liabilities | 194.4 million | | Current Ratio | 572.4% | | Gearing Ratio | 32.0% | - Cash and bank balances are primarily held in US dollars and Renminbi[62](index=62&type=chunk) - As of June 30, 2024, the Group had pledged leased land totaling **RMB 43 million** for bank financing[64](index=64&type=chunk) [Financial Statements](index=12&type=section&id=Financial%20Statements) [Interim Condensed Consolidated Statement of Profit or Loss](index=12&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss) For the six months ended June 30, 2024, the company reported **RMB 60.78 million** in revenue and **RMB 51.92 million** in gross profit, with net loss significantly narrowing from **RMB 219 million** to **RMB 167 million** due to effective cost control, resulting in a basic and diluted loss per share of **RMB 0.27** Profit or Loss Statement Summary (RMB thousand) | Item | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Revenue | 60,779 | 72,016 | | Gross Profit | 51,923 | 59,367 | | Loss Before Tax | (167,033) | (218,694) | | Loss for the Period | (167,033) | (218,694) | | Basic and Diluted Loss Per Share | (0.27) RMB | (0.36) RMB | [Interim Condensed Consolidated Statement of Financial Position](index=14&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2024, the company's total assets were **RMB 1.461 billion**, total liabilities **RMB 468 million**, and net assets **RMB 994 million**, with **RMB 1.113 billion** in current assets, including **RMB 1.024 billion** in cash and bank balances, indicating a robust financial position and ample liquidity Statement of Financial Position Summary (RMB thousand) | Item | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Total Non-Current Assets | 348,737 | 376,763 | | Total Current Assets | 1,112,624 | 1,241,824 | | **Total Assets** | **1,461,361** | **1,618,587** | | Total Current Liabilities | 194,384 | 190,888 | | Total Non-Current Liabilities | 273,369 | 280,315 | | **Total Liabilities** | **467,753** | **471,203** | | **Net Assets** | **993,608** | **1,147,384** | [Notes to Interim Condensed Consolidated Financial Information (Excerpts)](index=16&type=section&id=Notes%20to%20Interim%20Condensed%20Consolidated%20Financial%20Information) Financial notes indicate the company operates in a single segment: R&D and commercialization of pharmaceutical products, with Greater China as the primary revenue source, accounting for **89%** of total revenue, and high customer concentration, as revenue from the largest customer A comprised **88%** of total revenue, while trade receivables increased from **RMB 9.68 million** to **RMB 30.12 million** Revenue from External Customers by Geographical Area (RMB thousand) | Region | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Greater China | 54,044 | 67,255 | | Other Countries/Regions | 6,735 | 4,761 | | **Total** | **60,779** | **72,016** | - During the reporting period, revenue from a single major customer (Customer A) was **RMB 53.57 million**, accounting for **88.1%** of total revenue[31](index=31&type=chunk) - Net foreign exchange gains within other income and gains significantly decreased from **RMB 92.25 million** in the prior period to **RMB 6.18 million**[33](index=33&type=chunk) [Corporate Governance and Other Information](index=31&type=section&id=Corporate%20Governance%20and%20Other%20Information) [Compliance with Corporate Governance Code](index=31&type=section&id=Compliance%20with%20Corporate%20Governance%20Code) During the reporting period, the company largely complied with the Corporate Governance Code, with the only deviation being the Chairman and CEO roles held by Dr. Jianming Mei, an arrangement the Board believes enhances strategic execution and communication, balanced by the board's composition including three independent non-executive directors - The company deviated from Code Provision C.2.1 of the Corporate Governance Code, where the roles of Chairman and Chief Executive Officer are held by the same individual (Dr. Jianming Mei)[65](index=65&type=chunk) - The Board believes this arrangement facilitates effective execution of strategic initiatives and communication, with the Board's structure providing sufficient checks and balances[65](index=65&type=chunk) [Use of Net Proceeds](index=32&type=section&id=Use%20of%20Net%20Proceeds) As of June 30, 2024, approximately **RMB 508 million** of IPO net proceeds remained unutilized, with a reallocation in March 2024 to prioritize preclinical and clinical trial funding, and full utilization expected by December 31, 2025 Use of Net Proceeds (RMB million) | Item | Revised Allocation | Unutilized Amount as of June 30, 2024 | | :--- | :--- | :--- | | Clinical Development & Commercialization of Core Products | 932.63 | – | | Four Other Clinical-Stage Drugs | 117.29 | 3.60 | | Preclinical Research & Clinical Trials | 758.65 | 479.28 | | Pipeline Expansion (BD Activities) | 215.91 | 25.47 | | **Total** | **2,274.70** | **508.35** | - On March 22, 2024, the company reallocated approximately **RMB 554 million** of unutilized net proceeds to 'fund ongoing preclinical research and planned clinical trials for other preclinical candidates in our pipeline'[70](index=70&type=chunk)

Clinical Development - The company received IND approval from the National Medical Products Administration in March 2023 for the ATG-022 treatment for advanced or metastatic solid tumors [26]. - The first patient in Australia was dosed in the CLINCH trial in March 2023, followed by the first patient in mainland China in May 2023 [27][28]. - ATG-022 received orphan drug designation from the FDA for the treatment of gastric cancer and pancreatic cancer in May 2023 [27]. - Preliminary clinical data from the CLINCH trial showed complete response (CR) and partial response (PR) in 2 out of 7 gastric cancer patients [30]. - The clinical pipeline demonstrated promising early results, with four global assets showing positive outcomes in Phase I dose escalation studies [45]. - ATG-008, an mTORC1/2 inhibitor, achieved an objective response rate (ORR) of 53.3% in cervical cancer patients who had not previously used immune checkpoint inhibitors (ICIs) [51]. - ATG-101, a bispecific antibody, showed promising results with partial responses in metastatic colorectal cancer patients, indicating potential for further development [51]. - The first patient in the PERFORM trial for ATG-031 was dosed in December 2023 [119]. - The company received FDA IND approval for ATG-031 to initiate Phase I trials for advanced solid tumors or B-NHL patients in May 2023 [119]. - The first patient was dosed in the I phase study of ATG-017 (ERK1/2 inhibitor) for advanced solid tumors and hematologic malignancies in July 2023 [146]. - Early data from the I phase trial of ATG-101 (a novel PD-L1/4-1BB bispecific antibody) showed partial response in a patient with metastatic colon adenocarcinoma, with ongoing trials in mainland China, Australia, and the US [147]. - The first patient was dosed in July 2023 in mainland China for the I phase trial of ATG-037 (CD73 inhibitor) as monotherapy and in combination with a PD-1 antibody for locally advanced or metastatic solid tumors [148]. - In May 2023, the company announced the latest results of the I/II phase TORCH-2 study for Onatasertib (ATG-008), which were subsequently presented at the ASCO 2023 conference [144]. - The open-label Phase II study of Eltanexor (ATG-016) for high-risk myelodysplastic syndromes was completed in mainland China [145]. Financial Performance - The company reported a cash balance of RMB 1.188 billion, ensuring funding for future drug development pipelines without the need for additional financing [54]. - The company has a 10-year validity period for its 2022 Restricted Share Unit Plan, with approximately 7.5 years remaining [16]. - The company has adopted a dividend policy without a preset payout ratio, considering financial performance, cash flow, and future operations when deciding on dividends [157]. - The company anticipates achieving significant clinical data for each project in its product portfolio and advancing at least one new project into the clinical stage in 2024 [169]. Corporate Governance - The company has adopted the principles and code provisions of the Corporate Governance Code as the basis for its corporate governance practices [33]. - The board consists of seven members, including three executive directors, one non-executive director, and three independent non-executive directors [36]. - The board held six meetings during the fiscal year ending December 31, 2023, exceeding the minimum requirement of four regular meetings per year [86]. - The company aims to maintain at least 10% female representation on the board, currently achieved with one female director among seven members [99]. - The board has delegated the responsibility of selecting and appointing directors to the nomination and corporate governance committee [103]. - The company has established procedures for identifying, handling, and disclosing inside information, including annual reviews of the insider information disclosure policy [93]. - The board is responsible for ensuring effective internal controls to safeguard shareholder investments, with policies in place for ongoing risk identification and assessment [90]. - The board consists of at least one-third independent non-executive directors, aligning with the company's diversity policy [102]. - The nomination and corporate governance committee evaluates the independence of non-executive directors based on criteria outlined in the listing rules [105]. - The company has implemented measures to ensure compliance with corporate governance codes and regularly reviews its governance policies [97]. - The board has reviewed the effectiveness of the risk management and internal control systems and deemed them effective and adequate [117]. Strategic Partnerships and Market Expansion - The commercial business achieved three key milestones, including the commercial partnership for the drug Xivio® in China and its inclusion in the national medical insurance catalog [53]. - The company is focused on expanding the regulatory and reimbursement approval scope for Xivio® in the Asia-Pacific region, aiming for increased market potential [53]. - In August 2023, the company entered a commercialization agreement with Hansoh Pharmaceutical for the drug Xivivo® (Selinexor) in mainland China, with a maximum upfront payment of RMB 200 million, including RMB 100 million upon signing [56]. - Xivivo® (Selinexor) was included in the National Medical Insurance Catalog (2023 version) effective January 1, 2024, for treating adult patients with relapsed/refractory multiple myeloma (rrMM) who have received at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 monoclonal antibody [56]. - In May 2023, the company submitted a New Drug Application (NDA) for Xivivo® (Selinexor) to the Indonesian Food and Drug Authority for treating rrMM and relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) [57]. - In June 2023, Xivivo® (Selinexor) was included in the Pharmaceutical Benefits Scheme (PBS) in Australia for treating adult patients with rrMM who have received at least one prior treatment [57]. - In July 2023, the Hong Kong Department of Health approved the NDA for Xivivo® (Selinexor) for treating adult patients with rrMM who have undergone at least four prior treatments and experienced disease progression [57]. - The company will continue to record revenue from Selinexor sales in mainland China while Hansoh Pharmaceutical will charge service fees [125]. Risk Management and Compliance - The company has established a comprehensive risk management policy to identify, assess, and monitor key risks related to its strategic objectives [112]. - The company has established a strict anti-corruption policy for personnel with external communication functions to ensure compliance with promotional and advertising regulations [140]. - The company has set up an internal audit function, risk management, and internal control systems deemed appropriate for its business operations [140]. - The company has not identified any significant uncertainties that may affect its ability to continue as a going concern [118]. Environmental, Social, and Governance (ESG) - The company emphasizes a corporate culture focused on employee development, workplace safety, and sustainability [32]. - The company has established a management framework for environmental, social, and governance (ESG) strategies, with the board fully responsible for the sustainability strategy and reporting [191]. - A total of HKD 5 million has been deposited as green deposits to support eligible green projects, including green buildings and renewable energy initiatives [200]. - The company plans to establish several ESG-related goals and conduct progress reviews to enhance its sustainability efforts based on actual business conditions [191]. - The company encourages shareholders to provide email addresses for timely and effective communication [170]. - The company received recognition as one of the "Top 10 Most Growth-Oriented Antibody Drug Enterprises" at the 2023 China Biopharmaceutical Innovation Cooperation Conference [190]. - The company aims to maintain strategic thinking with a strong emphasis on quality, integrity, and financial standards in its operations [169].

Financial Performance - Other income and revenue decreased from RMB 293.9 million for the year ended December 31, 2022, to RMB 115.8 million for the year ended December 31, 2023, a decline of 60.6% primarily due to a decrease in net foreign exchange gains[2]. - Loss for the year decreased from RMB 601.5 million for the year ended December 31, 2022, to RMB 581.2 million for the year ended December 31, 2023, a reduction of 3.9%[3]. - Adjusted loss for the year decreased from RMB 550.2 million for the year ended December 31, 2022, to RMB 533.9 million for the year ended December 31, 2023, a decrease of 3.0% attributed to reduced sales and distribution expenses, R&D costs, and administrative expenses[17]. - Total revenue for 2023 was RMB 67,305 thousand, down from RMB 160,135 thousand in 2022, indicating a decline of about 58.1%[66]. - The company reported a pre-tax loss of RMB (581,183) thousand for 2023, an improvement from a loss of RMB (601,488) thousand in 2022[77]. - The company’s gross profit for the year was RMB 55,012 thousand, compared to RMB 132,004 thousand in the previous year[116]. - The adjusted loss for the year was RMB (533,904) thousand, an improvement from RMB (550,184) thousand in the previous year[117]. - The company’s basic loss per share for 2023 was calculated based on a weighted average of 615,438,058 shares, compared to 617,822,464 shares in 2022[79]. - Revenue decreased from RMB 1,601 million in 2022 to RMB 673 million in 2023, a decline of approximately 57.9%[91]. Expenses and Costs - Sales and distribution expenses decreased from RMB 355.4 million for the year ended December 31, 2022, to RMB 192.7 million for the year ended December 31, 2023, a reduction of 45.9% due to commercialization cooperation with Hansoh Pharmaceutical[16]. - Research and development expenses decreased significantly from RMB 307,132,000 in 2022 to RMB 183,269,000 in 2023, a reduction of approximately 40.5%[92]. - Administrative expenses decreased from RMB 167.1 million for the year ended December 31, 2022, to RMB 148.1 million for the year ended December 31, 2023, a reduction of RMB 19.0 million[145]. - Employee costs increased to RMB 151,674,000 in 2023 from RMB 142,137,000 in 2022, representing a rise of about 6.8%[92]. - The company’s share-based payment expenses amounted to RMB 47,279 thousand, down from RMB 51,304 thousand in the previous year[122]. Revenue Growth and Agreements - The company recorded revenue of RMB 359,949 thousand in the Greater China region for 2023, a significant increase from RMB 228,715 thousand in 2022, representing a growth of approximately 57.3%[53]. - The company entered into a commercialization agreement with Hansoh Pharmaceutical for Selinexor in mainland China, with a potential upfront payment of up to RMB 200 million[33]. - In August 2023, the company entered into a commercialization agreement with Hansoh Pharmaceutical for XPOVIO® (Selinexor) in mainland China, with a maximum upfront payment of RMB 200 million, including RMB 100 million upon signing the agreement[41]. - The company expects future revenue growth due to the inclusion of its product in the national medical insurance catalog effective January 1, 2024[91]. Assets and Liabilities - The company’s non-current assets totaled RMB 365,817 thousand in 2023, compared to RMB 237,162 thousand in 2022, representing a growth of approximately 54.2%[53]. - The total liabilities decreased from RMB 363,061,000 in 2022 to RMB 179,766,000 in 2023, a decline of about 50.5%[86]. - Trade receivables as of December 31, 2023, were RMB 9,684,000, significantly lower than RMB 29,767,000 in 2022, indicating a decrease of approximately 67.5%[83]. - The company’s debt-to-asset ratio increased to 29.1% as of December 31, 2023, up from 20.0% in the previous year[125]. - The company has no significant contingent liabilities as of December 31, 2023[150]. Research and Development - The company received IND approval from the FDA in March 2023 to initiate a Phase I trial for ATG-031 in patients with advanced solid tumors or B-NHL[39]. - The new "2+1" T cell engager platform AnTenGagerTM is making steady progress, designed to conditionally activate T cells and reduce the risk of cytokine release syndrome (CRS)[40]. - The company reported a total of 103 employees in R&D, accounting for 51.2% of total employees[123]. - The company plans to allocate approximately 25% of the net proceeds from fundraising to ongoing and planned clinical trials for four other clinical-stage drug candidates, amounting to RMB 568.67 million[182]. Government Grants and Other Income - The company received government grants totaling RMB 29,881 thousand in 2023, compared to RMB 10,426 thousand in 2022, reflecting an increase of approximately 187.5%[59]. - The company’s other income totaled RMB 68,709 thousand in 2023, up from RMB 38,649 thousand in 2022, marking an increase of about 77.9%[59]. - The total other income and gains for the year were RMB 115,786 million, compared to RMB 293,904 million in the previous year[187]. Future Plans and Investments - The company plans to continue recording revenue from the sales of XPOVIO® (Selinexor) in mainland China, while Hansoh Pharmaceutical will charge service fees[41]. - The company has no significant investment or capital asset plans as of December 31, 2023[100]. - The company has pledged a total of RMB 43.4 million of leased land to secure bank financing[127]. - Approximately 14% of the net proceeds from fundraising is planned to be used to expand the pipeline, including the discovery of new drug candidates[136]. - The company plans to invest in expanding its pipeline, including discovering new drug candidates and business development activities, with a budget allocation of 14% of net proceeds, amounting to RMB 318.46 million[191]. Compliance and Governance - The company’s financial performance for the year ended December 31, 2023, has been reviewed and deemed compliant with relevant accounting standards and regulations[192]. - The board of directors includes executive director Dr. Jianming Mei, who also serves as the chairman and CEO, promoting effective execution of strategic initiatives[152]. - The company does not recommend the distribution of dividends for the year ended December 31, 2023[164].

Financial Performance - Revenue increased from RMB 53.96 million in the six months ended June 30, 2022, to RMB 72.02 million in the six months ended June 30, 2023, representing a growth of approximately 33.4%[12] - Other income and gains decreased from RMB 167.82 million to RMB 121.07 million, a decline of about 28.0%, primarily due to a decrease in foreign exchange gains[13] - The company reported a loss of RMB 218.69 million for the six months ended June 30, 2023, compared to a loss of RMB 144.45 million for the same period in 2022, marking an increase in loss of about 51.5%[15] - Adjusted loss increased from RMB 126.26 million to RMB 189.44 million, a rise of approximately 50.0%, mainly due to increased R&D costs and decreased foreign exchange gains[16] - The company's total sales and distribution expenses for the six months ended June 30, 2023, were RMB 66.96 million, a decrease from RMB 90.38 million in the same period of 2022[62] - The company’s cash and bank balances decreased to RMB 1,322.4 million as of June 30, 2023, from RMB 1,789.6 million at the end of 2022, a reduction of 26.1% attributed to operational expenses and milestone payments[71] - The company reported a net cash inflow from investing activities of RMB 725,536,000 for the first half of 2023, compared to an outflow of RMB (164,573,000) in the same period of 2022[175] Research and Development - Research and development costs rose from RMB 179.41 million to RMB 226.09 million, an increase of approximately 26.0%, attributed to higher licensing fees and R&D personnel costs[30] - The company is conducting a Phase I trial of ATG-18 for advanced solid tumors and hematologic malignancies in Australia[20] - The company announced the latest results of the I/II phase TORCH-2 study in May 2023, which were presented at ASCO 2023[35] - The company is conducting an open-label Phase II study of ATG-016 for high-risk myelodysplastic syndromes in mainland China[36] - The company has initiated clinical trials for multiple assets, including ATG-031, ATG-037, and ATG-017, with ATG-031 expected to start patient recruitment in Q4 2023[76] - The company continues to enhance its R&D capabilities and aims to discover and commercialize innovative therapies globally[91] - The company has a pipeline of nine oncology clinical candidates, with various stages of development and indications[106] Product Development and Approvals - The company submitted a New Drug Application (NDA) for XPOVIO® (selinexor) to the Indonesian Food and Drug Authority in May 2023 for the treatment of relapsed/refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma[17] - The company received NDA approval for XPOVIO® (Selinexor) in Hong Kong for treating adult patients with relapsed/refractory multiple myeloma who have received at least four prior therapies[34] - XPOVIO® (Selinexor) received NDA approvals in multiple regions, including South Korea and mainland China, with further applications submitted in Macau, Malaysia, Thailand, and Indonesia[78] - The company is conducting a Phase II registration trial for XPOVIO® as a monotherapy for relapsed/refractory diffuse large B-cell lymphoma[126] - ATG-022 received orphan drug designation from the FDA for the treatment of gastric and pancreatic cancer in May 2023[40] Clinical Trials and Studies - The objective response rate (ORR) for ATG-008 in previously untreated cervical cancer patients was reported at 46.4%[90] - The ORR for ATG-008 monotherapy in the open-label Phase II TORCH trial for HBV+ unresectable HCC patients was 16.7%, with a median duration of response (DOR) of 4.3 months[107] - In the TORCH-2 study, the ORR for PD-L1 positive subjects was 77.8% (7/9), with a median progression-free survival (PFS) of 5.5 months for all treated patients[107] - The ongoing HATCH trial is evaluating the pharmacokinetics, safety, and efficacy of Eltanexor (ATG-016) in MDS patients after HMA therapy failure[108] Corporate Governance and Strategy - The management team emphasized the importance of maintaining high corporate governance standards to protect shareholder interests[196] - The board is reviewing the separation of the roles of Chairman and CEO to enhance governance practices[198] - The company has adhered to all corporate governance codes, with minor deviations explained in the report[196] Market and Financial Outlook - The company provided guidance for the next quarter, projecting revenue between $B million and $C million, indicating a growth rate of D%[190] - New product launches are expected to contribute an additional $E million in revenue, with anticipated market expansion in regions X and Y[190] - Market expansion efforts include entering new geographical markets, targeting an increase in market share by G% over the next year[190] - The company is considering strategic acquisitions to bolster its portfolio, with potential targets identified in the industry[190]

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 72,016 thousand, an increase of 33.4% compared to RMB 53,956 thousand for the same period in 2022[2] - The loss for the period was RMB (218,694) thousand, compared to RMB (144,451) thousand in the same period last year, reflecting a year-over-year increase in loss of 51.5%[2] - The adjusted loss for the period, excluding foreign exchange gains, was RMB (281,690) thousand, compared to RMB (270,659) thousand in the previous year, indicating a slight increase in adjusted loss[2] - Loss for the period increased from RMB 1,445 million for the six months ended June 30, 2022, to RMB 2,187 million for the six months ended June 30, 2023, an increase of RMB 742 million[12] - The company reported a loss attributable to ordinary shareholders of RMB 218.694 million for the six months ended June 30, 2023, compared to a loss of RMB 144.451 million for the same period in 2022[146] - The company reported a total comprehensive loss of RMB 57,549 thousand for the six months ended June 30, 2023, compared to RMB 49,365 thousand in the same period of 2022, indicating a 16.5% increase in losses[101] Research and Development - Research and development costs increased to RMB (226,093) thousand, up 26.0% from RMB (179,407) thousand in the prior year[2] - R&D expenses increased from RMB 1,794 million for the six months ended June 30, 2022, to RMB 2,261 million for the six months ended June 30, 2023, primarily due to increased licensing fees and R&D personnel costs by RMB 467 million[12] - The company is conducting multiple Phase I trials for new assets, including ATG-017, ATG-101, and ATG-037, targeting various cancers[5][7] - The company received IND approval from the FDA for ATG-031 to initiate a Phase I trial for treating advanced solid tumors or B-NHL patients in May 2023[5] - The company has initiated a Phase I trial for ATG-022 (Claudin 18.2 antibody-drug conjugate) and has observed partial responses prior to the predicted effective dose range[72] - The company is conducting a Phase I trial of ATG-037 (CD73 inhibitor) in combination with pembrolizumab, with 13 patients currently enrolled in the combination therapy[74] Product Pipeline and Approvals - The company submitted a New Drug Application (NDA) for XPOVIO® (Selinexor) in Indonesia in May 2023 for the treatment of relapsed/refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma[3] - The company has received NDA approvals for XPOVIO® (Selinexor) in mainland China, South Korea, Singapore, Australia, Taiwan, and Hong Kong[21] - XPOVIO® (Selinexor) received NDA approval for the treatment of relapsed/refractory multiple myeloma in July 2023, and a supplemental NDA was submitted for its use in combination with bortezomib and dexamethasone[33] - The company has secured exclusive global rights for the development and commercialization of ATG-017, a mTORC1/2 inhibitor, from AstraZeneca[32] - The company announced significant progress in its product pipeline and operations during the reporting period, including the latest results of the I/II phase TORCH-2 study presented at ASCO 2023[14] Financial Position and Assets - Current assets decreased to RMB 1,445,151 thousand as of June 30, 2023, down from RMB 1,896,080 thousand at the end of 2022, reflecting a decline of 23.7%[80] - The total equity attributable to owners of the parent company was RMB 1,466,336 thousand as of June 30, 2023, down from RMB 1,713,322 thousand at the end of 2022, representing a decrease of 14.4%[81] - The company's net assets decreased to RMB 1,466,336,000 from RMB 1,713,322,000 at the end of 2022[113] - As of June 30, 2023, the company's cash and bank balance was RMB 1,322.4 million, down from RMB 1,789.6 million as of December 31, 2022, mainly due to operating expenses and milestone payments[183] Strategic Partnerships and Collaborations - The company has partnered with Karyopharm for the commercialization of XPOVIO® in multiple regions, enhancing its market presence[34] - The company entered into an exclusive collaboration agreement with Jiangsu Hengrui Medicine Co., Ltd. for the commercialization of XPOVIO® in mainland China, with potential upfront payments of up to RMB 200 million[71] - The company is actively expanding its product pipeline and exploring new therapeutic areas through strategic partnerships and collaborations[31] Clinical Trials and Results - The open-label Phase II study of Eltanexor (ATG-016) for high-risk myelodysplastic syndromes is currently ongoing in mainland China[15] - The objective response rate (ORR) for the combination therapy of ATG-008 (onatasertib) and pembrolizumab in recurrent/metastatic cervical cancer patients was 52.4%, based on early data from 21 patients[38] - In the TORCH-2 study, the ORR for PD-L1 positive subjects was 77.8% (7 out of 9 patients) and the median progression-free survival (PFS) for all treated patients was 5.5 months[38] - The ORR for ATG-008 monotherapy in the open-label Phase II TORCH trial for HBV+ unresectable HCC patients was 16.7%, with a median duration of response (DOR) of 4.3 months[38] Governance and Compliance - The audit committee consists of three independent non-executive directors, ensuring compliance with listing rules[196] - The independent auditor, Ernst & Young, conducted a review of the interim financial information for the six months ending June 30, 2023[197] - The company plans to continue reviewing its corporate governance practices, including the separation of the roles of Chairman and CEO[189]

Financial Performance - Total revenue for 2022 reached RMB 160.1 million, a significant increase from RMB 28.8 million in 2021, representing a growth of 457%[10] - The net loss for the year decreased to RMB 601.5 million in 2022, down from RMB 655.5 million in 2021, indicating improved financial performance[14] - Adjusted net loss, excluding the impact of equity-settled share-based payment expenses, was RMB 550.2 million in 2022, a reduction from RMB 613.4 million in 2021[15] - Gross profit for 2022 was RMB 132.0 million, compared to RMB 24.2 million in 2021, indicating a gross margin improvement[142] - Other income and gains rose to RMB 293.9 million in 2022, up from RMB 42.6 million in 2021, primarily due to foreign exchange gains attributed to the appreciation of the US dollar against the RMB[12] Research and Development - Research and development costs increased to RMB 488.5 million in 2022, compared to RMB 405.0 million in 2021, reflecting ongoing investment in product development[10] - R&D expenses rose from RMB 405 million for the year ended December 31, 2021, to RMB 488.5 million for the year ended December 31, 2022, attributed to increased drug development costs and expansion of R&D personnel[34] - The company has a strategic focus on developing a pipeline of 9 clinical-stage assets, including ATG-031, which is approaching the IND submission stage[60] - The company is focusing on optimizing drug development processes to maximize clinical and commercial value of its assets[106] - The company has adopted a differentiated "combination, complementary" R&D strategy to build a pipeline of synergistic assets[106] Product Launches and Approvals - The company launched its first commercialized product, XPOVIO® (Selinexor), in multiple hospitals and pharmacies in mainland China in May 2022, marking a significant market entry[16] - XPOVIO® was included in the Chinese multiple myeloma diagnosis and treatment guidelines in May 2022 for treating first relapse or multiple relapses[41] - The company received NDA approval in Taiwan in October 2022 for XPOVIO® for three indications, including treatment for relapsed/refractory diffuse large B-cell lymphoma[39] - NDA approvals for XPOVIO® have been obtained in mainland China, Australia, Korea, Singapore, and Taiwan, with additional submissions planned for Malaysia and Thailand[60] - The company plans to submit an NDA for XPOVIO® in Indonesia in the first half of 2023, targeting relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma[60] Clinical Trials and Studies - The first patient was dosed in the SWATCH study in May 2022, evaluating the safety and preliminary efficacy of XPOVIO® combined with lenalidomide and rituximab for treating relapsed/refractory diffuse large B-cell lymphoma[20] - The first patient was dosed in the MATCH study in April 2022, assessing the safety and preliminary efficacy of XPOVIO® combined with onatasertib for treating relapsed/refractory diffuse large B-cell lymphoma[18] - The company received IND approval for an open-label Phase II trial of ATG-016 in March 2022, targeting high-risk myelodysplastic syndromes[22] - The company initiated the ERASER trial in Australia in October 2022, using ATG-017 as a monotherapy and in combination with nivolumab for treating advanced solid tumors[43] - The company has completed the first patient dosing in the ATG-022 Phase I trial for advanced or metastatic solid tumors in March 2023[71] Market Expansion and Collaborations - In Australia, XPOVIO® was registered for two indications in March 2022 and included in the Pharmaceutical Benefits Scheme (PBS) for reimbursement in September 2022, expanding its market reach[17] - A clinical trial collaboration with BeiGene was established in June 2022 to evaluate the safety and efficacy of Selinexor in combination with BeiGene's anti-PD-1 inhibitor in lymphoma patients[47] - The company has established a global clinical collaboration with Merck for the STAMINA-001 trial, evaluating ATG-037 in combination with KEYTRUDA® for advanced solid tumors[75] - The company is preparing its commercial team for the launch of XPOVIO® in Greater China and other Asia-Pacific regions to address unmet medical needs[163] - The company has received regulatory approvals for XPOVIO® in five major markets in the Greater China/APAC region, including mainland China, Australia, South Korea, Singapore, and Taiwan[80] Financial Position and Assets - The total current assets decreased to RMB 1.9 billion in 2022 from RMB 2.4 billion in 2021, while total current liabilities increased to RMB 381.8 million from RMB 159.4 million[11] - Cash and bank balances decreased to RMB 1,789.6 million as of December 31, 2022, down from RMB 2,274.8 million at the end of 2021, mainly due to operating expenses[149] - The current ratio as of December 31, 2022, was 496.6%, a decrease from 1,513.9% in 2021, indicating a decline in liquidity[151] - The debt-to-asset ratio was reported at 20.0% as of December 31, 2022, a significant increase from 6.4% in the previous year[172] - The company had no significant investments or acquisitions during the year ending December 31, 2022[173] Employee and Management - The company has a strong management team with extensive experience in the pharmaceutical industry, including leadership roles in major pharmaceutical companies[178][195] - As of December 31, 2022, the company had 346 employees in China and 48 employees overseas[199] - Employee compensation includes salaries, bonuses, social insurance contributions, and other benefits payments[199] - The company contributes to social security funds, including pension plans, medical insurance, work injury insurance, unemployment insurance, and maternity insurance, as well as housing provident funds[199] - The company is focused on business development and commercialization strategies to enhance growth[180]

Financial Performance - Total revenue for the year ended December 31, 2022, was RMB 160.1 million, a significant increase of 458% from RMB 28.8 million in the previous year[3] - The net loss for the year narrowed to RMB 601.5 million, a decrease of 8.2% from RMB 655.5 million in the previous year[6] - Adjusted net loss, excluding equity-settled share-based payment expenses, decreased to RMB 550.2 million, down 10.3% from RMB 613.4 million[7] - The company reported a loss attributable to ordinary shareholders of approximately RMB 617.82 million for the reporting period[43] - The total comprehensive loss for the year was RMB (96,977) thousand, compared to a profit of RMB 16,039 thousand in the previous year[138] - The company reported a pre-tax loss for the year, with basic loss per share calculated at RMB 601,488,000 for 2022, compared to RMB 655,529,000 in 2021[168] Revenue Growth - Other income and gains rose to RMB 293.9 million, up 590% from RMB 42.6 million, primarily due to foreign exchange gains[5] - Revenue increased from RMB 288 million in 2021 to RMB 1,601 million in 2022, primarily due to the commercial launch of the first-in-class XPO1 inhibitor, Selinexor (XPOVIO), in mainland China on May 13, 2022[196] - The revenue from the Greater China region for 2022 was RMB 154,870,000, a significant increase from RMB 28,531,000 in 2021, representing a growth of approximately 442%[146] - Total revenue from customer contracts for 2022 was RMB 160,135 thousand, a significant increase from RMB 28,769 thousand in 2021, representing a growth of 457%[129] Research and Development - Research and development costs increased to RMB 488.5 million, a rise of 20.6% from RMB 405.0 million, attributed to higher drug development expenses and expansion of R&D personnel[5] - The company plans to continue expanding its product pipeline and R&D capabilities to support future growth[9] - The company continues to pursue a "combination, complementary" R&D strategy to discover, develop, and commercialize first-in-class and best-in-class therapies globally[30] - The company has a pipeline of 9 clinical-stage oncology candidates, including ATG-031, which is about to enter the IND submission phase[34] - The company is advancing nine clinical-stage assets, including ATG-031 (CD24 monoclonal antibody), across various therapeutic areas and implementing a dual-engine approach for pipeline development[117] Product Development and Approvals - The lead product, XPOVIO® (Selinexor), was commercially launched in mainland China in May 2022, contributing to revenue growth[5] - XPOVIO® received multiple regulatory approvals in Singapore and Australia for various indications, enhancing market presence[9] - The company received orphan drug designation (ODD) from the FDA for ATG-101, a novel PD-L1/4-1BB bispecific antibody, for the treatment of pancreatic cancer in September 2022[24] - The company has received FDA approval for ATG-031 in the US and South Korea, with NDA submissions completed in Greater China and other regions[35] - XPOVIO® has received NDA approval in mainland China, Australia, South Korea, Singapore, and Taiwan, with plans to submit NDA applications in Malaysia and Thailand for treating relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma[33] Clinical Trials and Collaborations - The company completed the first patient dosing in the single-arm Ib phase study (MATCH study) in April 2022, evaluating the safety, tolerability, and preliminary efficacy of XPOVIO® (selinexor) combined with onatasertib (ATG-008) for relapsed/refractory diffuse large B-cell lymphoma[11] - A clinical trial collaboration was established with BeiGene to evaluate the safety and preliminary efficacy of selinexor combined with BeiGene's anti-PD-1 checkpoint inhibitor in T-cell and NK-cell lymphoma patients[30] - The company is conducting a global clinical collaboration with Merck for the STAMINA-001 trial, exploring ATG-037 as a monotherapy and in combination with pembrolizumab for locally advanced or metastatic solid tumors[30] - The company has entered into a clinical trial collaboration with BeiGene to evaluate the safety and efficacy of XPOVIO® in combination with BeiGene's anti-PD-1 inhibitor[71] Operational Expenses - Sales and distribution expenses surged to RMB 355.4 million, an increase of 523% from RMB 67.9 million, driven by milestone payments related to the commercialization of the lead product[6] - Administrative expenses slightly decreased to RMB 167.1 million from RMB 169.5 million, mainly due to reduced professional fees[6] - Employee benefits expenses, excluding directors and senior management, rose to RMB 289,136 thousand in 2022 from RMB 183,540 thousand in 2021, an increase of 57%[132] - Total expenses for the year reached RMB 488,491 thousand in 2022, compared to RMB 405,029 thousand in 2021, indicating a rise in operational costs[198] Market Strategy and Future Plans - The company plans to build its commercial team in preparation for the launch of Selinexor tablets in Greater China and other Asia-Pacific regions, addressing unmet medical needs[136] - The company anticipates continued growth in revenue driven by the expansion of its product offerings and market presence[196] - The company plans to continue expanding its market presence, particularly in the Greater China region, which has shown substantial revenue growth[146]

Financial Performance - Revenue for the six months ended June 30, 2022, was RMB 53.96 million, a significant increase from RMB 0 for the same period in 2021[6] - Other income and gains rose to RMB 167.82 million, up from RMB 18.14 million in the previous year, primarily due to foreign exchange gains[7] - Loss for the period decreased to RMB 144.45 million from RMB 232.99 million, reflecting improved financial performance[6] - Adjusted loss for the period, excluding equity-settled share option expenses, decreased to RMB 126.26 million from RMB 209.86 million[10] - The company reported a strong financial performance in the latest half-year report, with a notable increase in revenue compared to the previous period, reflecting effective commercialization strategies[100] - The basic and diluted loss per share for the period was RMB 0.23, compared to RMB 0.37 in the same period last year[161] - The total comprehensive loss for the period was RMB 193,816 thousand, compared to RMB 227,685 thousand in the previous year[163] Research and Development - R&D expenses increased to RMB 179.41 million from RMB 135.33 million, attributed to higher drug development costs and expansion of R&D personnel[9] - The adjusted R&D costs for the six months ended June 30, 2022, were approximately RMB 170.0 million, compared to RMB 125.9 million for the same period in 2021[59] - The company has a pipeline of 15 oncology drug assets, including 5 with Asia-Pacific rights and 10 with global rights, and has received NDA approvals in China, Korea, Singapore, and Australia[30] - The company aims to accelerate value creation through internal discovery and strategic partnerships as part of its dual-engine strategy[27] - The company is focused on developing cancer treatment strategies and optimizing the drug development process to maximize clinical and commercial value[57] Product Pipeline and Clinical Trials - The company achieved significant progress with its product pipeline, including the commercial launch of XPOVIO® (ATG-010) in mainland China on May 13, 2022[7] - XPOVIO® received multiple regulatory approvals in Singapore and Australia for treating relapsed/refractory multiple myeloma[12][13] - The company completed the first patient dosing in a Phase Ib study evaluating XPOVIO® in combination with onatasertib for relapsed/refractory diffuse large B-cell lymphoma[13] - The company has initiated five additional registration clinical trials for selinexor in mainland China for various indications[30] - The product pipeline consists of 15 candidates in various stages of clinical development focused on cancer treatment[33] Expenses and Costs - Sales and distribution expenses surged to RMB 90.38 million from RMB 0.13 million, mainly due to increased employee costs and market development expenses[9] - Administrative expenses rose to RMB 85.88 million from RMB 78.51 million, driven by higher professional fees related to operational and administrative activities[9] - Employee benefits expenses surged to RMB 150,350,000 in the first half of 2022, up from RMB 83,735,000 in the same period of 2021, indicating a 79.8% increase[189] Cash Flow and Financial Position - Cash and bank balances as of June 30, 2022, were RMB 2,151.0 million, down from RMB 2,274.8 million as of December 31, 2021, mainly due to operating expenses[82] - The company experienced a net cash outflow from operating activities of RMB 257,985,000 for the six months ended June 30, 2022, compared to RMB 210,292,000 for the same period in 2021[169] - The ending cash and cash equivalents balance as of June 30, 2022, was RMB 937,210,000, down from RMB 993,410,000 at the end of 2021[171] Strategic Focus and Future Plans - The company plans to expand its commercial team to up to 200 full-time employees by the end of 2022 to support market entry in the Asia-Pacific region[27] - The company aims to enter new international markets, targeting a 10% market share in Asia-Pacific within the next three years[104] - The management is committed to maintaining a robust pipeline, with 5 new drug candidates expected to enter clinical trials in the next 12 months[96] Shareholder Information and Corporate Governance - The company has fully complied with the Corporate Governance Code, except for a deviation regarding the separation of the roles of Chairman and CEO[116] - The Chairman and CEO roles are currently held by Dr. Mei Jianming, which the board believes enhances strategic execution and communication[116] - The company repurchased 1,300,000 shares at a total cost of approximately HKD 12.0 million, with the highest price per share at HKD 9.61 and the lowest at HKD 9.07[118]

Financial Performance - The company's revenue increased from RMB 0 in 2020 to RMB 287.69 million in 2021, primarily due to the rise in income from designated patient medication programs[13]. - Other income and gains rose from RMB 268.34 million in 2020 to RMB 425.67 million in 2021, attributed to increased government subsidies and bank interest income[13]. - The company reported a net loss of RMB 655.53 million for 2021, compared to a net loss of RMB 2,928.92 million in 2020[10]. - The annual loss decreased from RMB 2,928.9 million for the year ended December 31, 2020, to RMB 655.5 million for the year ended December 31, 2021, primarily due to the reduction in fair value loss of convertible redeemable preferred shares[16]. - The adjusted net loss for 2021 was RMB 613.4 million, compared to RMB 454.9 million in 2020[108]. - The company reported a pre-tax loss of RMB 655.5 million for the year ended December 31, 2021, compared to a pre-tax loss of RMB 2.9 billion in the previous year[93]. Research and Development - Research and development costs for 2021 amounted to RMB 405.03 million, up from RMB 347.66 million in 2020[10]. - R&D expenses increased from RMB 347.7 million in 2020 to RMB 405.0 million in 2021, a rise of 16.5%[96]. - Employee costs for R&D staff rose from RMB 43.1 million in 2020 to RMB 60.1 million in 2021, an increase of 39.5%[98]. - The management highlighted ongoing research and development efforts aimed at new product innovations and technological advancements[10]. - The company is focusing on innovative therapies, with XPOVIO® (selinexor) being the first and only oral XPO1 inhibitor[53]. - The company is developing a clinical project pipeline with eight projects and 18 clinical studies, including five registration trials, focusing on unmet medical needs[46]. Clinical Trials and Approvals - The company received IND approval for selinexor in combination with rituximab, gemcitabine, dexamethasone, and platinum for the treatment of relapsed/refractory diffuse large B-cell lymphoma in January 2021[20]. - In May 2021, the company obtained approval to conduct a Phase III clinical trial for selinexor as a monotherapy for advanced or relapsed endometrial cancer patients[21]. - The company submitted an NDA for selinexor in Taiwan for three indications in July 2021, marking the sixth NDA submission for ATG-010 after submissions in multiple regions[24]. - In December 2021, the company announced that the total response rate (ORR) for the Ib phase Touch trial of selinexor combined with gemcitabine and oxaliplatin in Chinese patients with relapsed/refractory T-cell and NK-cell lymphoma was 46.2%, with a complete response rate (CRR) of 26.9% and a median progression-free survival (PFS) of 2.7 months[28]. - The company received conditional approval from the National Medical Products Administration (NMPA) in December 2021 for selinexor in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (rrMM) who have previously received at least one treatment including an enzyme inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody[25]. Strategic Initiatives - The company plans to continue expanding its product offerings and market presence in the coming years[10]. - The company is exploring strategic partnerships and potential acquisitions to enhance its market position[10]. - The company plans to expand its commercial organization in China and the Asia-Pacific region to up to 200 full-time employees by the end of 2022, focusing on marketing, field personnel, pricing, and market access[40]. - The company has established partnerships for the development and commercialization of several drug candidates, enhancing its market reach and capabilities[57]. - The company is committed to becoming a fully integrated biopharmaceutical enterprise, focusing on innovative drug development and commercialization strategies[44]. Financial Position - The total assets as of December 31, 2021, were RMB 2,557.61 million, with current assets valued at RMB 2,412.57 million[12]. - Total liabilities as of December 31, 2021, were RMB 163.30 million, with current liabilities at RMB 159.36 million[12]. - The company's total equity as of December 31, 2021, was RMB 2,394.31 million, a decrease from RMB 3,037.81 million in 2020[12]. - As of December 31, 2021, the company's cash and bank balances were RMB 2,274.8 million, down from RMB 3,109.8 million as of December 31, 2020, primarily due to operating expenses and funds used in investment and financing activities[111]. - The current ratio as of December 31, 2021, was 1,513.9%, a decrease from 2,077.0% as of December 31, 2020[114]. Management and Governance - The company has a strong management team with diverse backgrounds in finance, investment, and pharmaceuticals, including Dr. Mei Jian Ming as Chairman and CEO, and Dr. Kevin Patrick Lynch as Chief Medical Officer[142]. - The company has seen significant leadership changes, with several directors resigning as of December 31, 2021, indicating a potential shift in strategic direction[133]. - The company is committed to maintaining a robust governance structure with independent directors overseeing strategic initiatives[140]. - The company has a diverse board composition, which is essential for navigating the complexities of the biopharmaceutical industry[139]. Market and Competitive Landscape - The company faces intense industry competition, and competitors may successfully commercialize drugs before the company does[170]. - The company has limited experience in drug production and commercialization, which may adversely affect its business if issues arise in future drug production processes[173]. - The company continues to collaborate with Karyopharm for the development and commercialization of selinexor across multiple regions[59]. Future Outlook - The company aims to commercialize its innovative therapies to improve patient outcomes and quality of life globally[51]. - The company may require additional financing to support operations, and if such financing is not obtained, it may not be able to complete the development and commercialization of candidate drugs[170]. - The expected timeline for the unutilized net proceeds of RMB 1,518.46 million is to be fully used by December 31, 2024[186].

Financial Performance - Total revenue for the six months ended June 30, 2021, was RMB 18.1 million, a decrease of RMB 1.3 million from RMB 19.4 million for the same period in 2020[7]. - The loss for the period was RMB 233.0 million, a reduction of RMB 304.7 million from RMB 537.7 million in the prior year[10]. - Adjusted loss for the period, excluding certain expenses, was RMB 209.9 million, an increase of RMB 73.4 million from RMB 136.5 million in the prior year[13]. - The company reported a pre-tax loss of RMB 2,329.95 million for the six months ended June 30, 2021, compared to a loss of RMB 5,377.47 million for the same period in 2020, indicating a significant reduction in losses[59]. - The total loss for the period was RMB 2,329.95 million for the six months ended June 30, 2021, compared to RMB 5,377.47 million for the same period in 2020, indicating improved financial performance[59]. - The company reported a net loss of RMB 232,995 thousand for the six months ended June 30, 2021, compared to a net loss of RMB 537,747 thousand for the same period in 2020, representing a 56.7% improvement in losses year-over-year[168]. Research and Development - R&D expenses decreased to RMB 135.3 million for the six months ended June 30, 2021, down RMB 34.6 million from RMB 169.9 million in the prior year[7]. - The company plans to continue focusing on R&D and expanding its clinical trials to enhance its product pipeline[7]. - The company has made steady progress in its preclinical pipeline, including assets such as ATG-101 (PD-L1/4-1BB bispecific antibody) and ATG-037 (CD73 inhibitor)[25]. - The company has a pipeline of 13 oncology drug assets, with 5 having Asia-Pacific rights and 8 having global rights[31]. - The company is advancing several preclinical candidates, including ATG-018 (ATR inhibitor) and ATG-012 (KRAS inhibitor), with IND applications planned for early 2022[46]. Clinical Trials and Approvals - The company received IND approval from the National Medical Products Administration (NMPA) for the global Phase II/III study of Selinexor (ATG-010) in combination with Rituximab, Gemcitabine, Dexamethasone, and Cisplatin for treating relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) on January 25, 2021[15]. - The NMPA accepted the New Drug Application (NDA) for ATG-010 for treating relapsed/refractory multiple myeloma (rrMM) on January 28, 2021, and granted priority review on February 24, 2021[15]. - The company announced a total response rate (ORR) of 26.7% in the Phase II MARCH trial for Selinexor combined with low-dose Dexamethasone in Chinese patients with rrMM, with an ORR of 33.3% in patients previously treated with three drug classes[17]. - The NMPA accepted an IND application for a Phase II study to evaluate the safety and efficacy of Selinexor in treating patients with myelofibrosis on July 6, 2021[20]. - The company submitted an NDA to the Taiwan Food and Drug Administration (TFDA) for Selinexor for three indications on July 14, 2021, marking the sixth NDA submission for ATG-010 in various regions[20]. Financial Position - As of June 30, 2021, the company's cash and bank balances were RMB 2,806.5 million, down from RMB 3,109.8 million as of December 31, 2020, primarily due to R&D costs and administrative expenses[72]. - Current assets totaled RMB 2,876.2 million, with current liabilities of RMB 122.2 million, resulting in a current ratio of 2,352.8% as of June 30, 2021, up from 2,077.0% at the end of 2020[77]. - The company's debt-to-asset ratio was 4.4% as of June 30, 2021, a slight decrease from 4.9% at the end of 2020[78]. - The company reported a foreign exchange gain of RMB 5,310 thousand in other comprehensive income for the first half of 2021[171]. - The company’s total equity attributable to owners increased to RMB 6,385,298,000 as of June 30, 2021, from RMB 6,383,316,000 at the beginning of the year[176]. Management and Governance - Dr. Kevin Patrick Lynch appointed as Chief Medical Officer in April 2021, with nearly 30 years of R&D experience in the pharmaceutical industry[89]. - Mr. Long Zhen Guo appointed as Chief Financial Officer in June 2020, with over 16 years of experience in investment banking and asset management[90]. - The company is focused on overall medical development and strategic planning under the leadership of its executive team[89]. - The board includes members with diverse expertise in finance, investment, and pharmaceutical development, enhancing the company's strategic direction[93]. - The company aims to leverage its leadership's extensive experience to drive growth and innovation in the healthcare sector[94]. Shareholder Information - As of June 30, 2021, the company’s board members and executives hold a total of 179,927,994 shares, representing approximately 26.81% of the total shares outstanding[119]. - The major shareholder, JAY MEI 2020 GRAT, holds 175,927,994 shares, accounting for 26.21% of the total shares[128]. - Boyu Capital Group Holdings Ltd. owns 73,789,650 shares, which is 10.99% of the total shares[128]. - The company has a total of 4,000,000 stock options granted to Dr. Mei Jianming, subject to vesting conditions[123]. - The company’s major shareholders include several investment firms, indicating a diversified ownership structure[128]. Use of Proceeds - The net proceeds from the IPO and the exercise of the over-allotment option amounted to approximately RMB 2,274.70 million[115]. - 41% of the net proceeds is allocated for ongoing and planned clinical trials and milestone payments for two core products, with RMB 62.37 million utilized as of June 30, 2021[116]. - 25% of the net proceeds is designated for ongoing and planned clinical trials and milestone payments for four other clinical-stage candidates, with RMB 33.46 million utilized[116]. - The total unutilized net proceeds as of June 30, 2021, amounted to RMB 1,907.12 million[116]. - The company plans to utilize the remaining proceeds in accordance with the business needs and future developments[115].