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].

Financial Performance - Total revenue for the year 2020 was RMB 26.83 million, a decrease of 49.6% from RMB 52.95 million in 2019[12] - The net loss for the year 2020 was RMB 2.93 billion, compared to RMB 323.79 million in 2019, reflecting increased operational costs[12] - The total comprehensive loss for the year increased from RMB 323.8 million in the year ended December 31, 2019, to RMB 2,928.9 million in the year ended December 31, 2020, primarily due to an increase in R&D costs and administrative expenses by RMB 463.3 million and a fair value loss on convertible redeemable preferred shares by RMB 2,141.8 million[18] - The adjusted total comprehensive loss for the year was RMB 454.96 million in 2020, compared to RMB 109.24 million in 2019, indicating a significant increase in losses[20] - Other income and gains decreased from RMB 52.9 million in 2019 to RMB 26.8 million in 2020, primarily due to foreign exchange losses in 2020 compared to gains in 2019[88] - The total loss and comprehensive loss for the year ended December 31, 2020, was RMB (2,928,921) thousand, compared to RMB (323,787) thousand for the year ended December 31, 2019[99] - Adjusted loss and comprehensive loss for the year ended December 31, 2020, was RMB (454,958) thousand, compared to RMB (109,236) thousand for the year ended December 31, 2019[99] Expenses - R&D expenses increased to RMB 347.66 million in 2020, up 200.5% from RMB 115.79 million in 2019, primarily due to increased payments to licensing partners and clinical-related costs[17] - Administrative expenses rose to RMB 154.22 million in 2020, an increase of 292.5% from RMB 39.35 million in 2019, mainly due to higher employee costs and IPO-related expenses[17] - Other expenses surged from a loss of RMB 220.7 million in 2019 to RMB 2.45 billion in 2020, largely due to non-cash adjustments related to convertible redeemable preferred shares[88] - Employee costs, including salaries and benefits, increased significantly, with total employee costs reaching RMB 43.1 million for R&D personnel in 2020, up from RMB 15.8 million in 2019[90] Cash and Assets - Cash and bank balances increased significantly to RMB 3.11 billion by the end of 2020, up from RMB 746.80 million at the end of 2019, primarily due to Series C financing and the IPO[15] - Total current assets reached RMB 3.13 billion in 2020, compared to RMB 755.60 million in 2019[14] - Total liabilities decreased to RMB 156.59 million in 2020 from RMB 1.32 billion in 2019, indicating improved financial stability[14] - The current ratio as of December 31, 2020, was 2,077.0%, compared to 1,681.3% as of December 31, 2019[104] - The debt-to-asset ratio as of December 31, 2020, was 4.9%, significantly improved from 173.4% as of December 31, 2019[105] Clinical Development and R&D - The company plans to continue expanding its R&D efforts and explore new market opportunities following the IPO[17] - Future guidance indicates a focus on enhancing product pipelines and potential strategic partnerships to drive growth[17] - The company received accelerated approval from the U.S. FDA for XPOVIO® (selinexor) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) in June 2020[22] - The company submitted new drug applications (NDA) for selinexor in multiple Asia-Pacific markets, including Singapore and Australia, for the treatment of relapsed/refractory multiple myeloma and rrDLBCL[22] - The company completed the first patient dosing in a Phase II trial for onatasertib (ATG-008) in HCC patients in 2020 and initiated trials in NSCLC patients[24] - The company has ongoing registration studies for selinexor in China for relapsed/refractory multiple myeloma and rrDLBCL patients[22] - The company is focusing on innovative drug discovery, with internal assets expected to enter clinical stages in 2021[34] - A total of 13 clinical trials are currently underway for various drug candidates, covering hematology, oncology, viral infections, and autoimmune diseases[35] - The company aims to continue advancing six clinical-stage products across various therapeutic areas while implementing a dual-engine approach for external collaborations and internal discoveries[84] Strategic Partnerships and Market Expansion - The company expanded its partnership with Karyopharm Therapeutics Inc. in May 2020 to develop and commercialize selinexor, eltanexor, verdinexor, and ATG-019 in selected Asia-Pacific markets[26] - The company is focusing on a dual-engine strategy to accelerate value creation through internal discovery and strategic partnerships[26] - The company has expanded rights for the development and commercialization of four licensed drugs to 17 Asia-Pacific markets in collaboration with Karyopharm[37] - The company is actively expanding its market presence and exploring new strategies for growth, particularly in the healthcare sector[119] - The company is committed to addressing unmet clinical needs in oncology through innovative therapies and strategic partnerships[43] Management and Governance - The management team has extensive experience in leading clinical development and commercialization processes in hematology and solid tumors[39] - The company appointed John F. Chin as Chief Business Officer in January 2020 to lead global business development and commercialization efforts[26] - Thomas Karalis appointed as head of Asia-Pacific region, bringing over 30 years of experience in multinational biopharmaceutical companies[27] - The company appointed Dr. Kevin Lynch as Chief Medical Officer in March 2021, bringing nearly 30 years of experience in the pharmaceutical industry[81] - The board of directors includes experienced professionals with extensive backgrounds in investment and management, ensuring robust governance and strategic oversight[122] Shareholder Information - The company reported no dividends declared or paid for the year ended December 31, 2020[138] - As of December 31, 2020, the company's reserves available for distribution amounted to approximately RMB 3,450.1 million, compared to zero in 2019[141] - The ownership structure indicates significant control by a few major shareholders, with the top three shareholders holding over 46% of the total shares[192] - The company is subject to the Securities and Futures Ordinance, which requires disclosure of interests in shares and related securities[191] Future Outlook and Risks - The company has recorded significant net losses since its establishment and anticipates continued net losses in the foreseeable future, posing a risk of substantial investment loss for potential investors[157] - The business and financial outlook heavily depend on the success of clinical-stage and preclinical-stage candidate drugs; failure to complete clinical development or obtain regulatory approval could adversely affect business and profitability[159] - The company faces intense industry competition, with competitors potentially achieving commercialization of competing drugs before the company[157]