Drug Development and Innovation - The company has developed over 30 innovative drug products targeting major diseases, with 17 of them currently in clinical stages, including two internationally first-in-class bispecific antibody drugs[2]. - The company aims to become a leading global biopharmaceutical enterprise by developing innovative drugs that are either first-in-class or best-in-class therapies[2]. - The company has established an end-to-end drug development platform (ACE platform) that integrates drug discovery and development functions, including target validation and CMC production process development[2]. - The company has successfully developed Tetrabody technology to address three major CMC challenges in the development and production of bispecific antibodies[2]. - The company is focused on creating affordable innovative antibody drugs for global patients[2]. - The company has a strong pipeline for treating cancer, autoimmune diseases, inflammation, and metabolic diseases[2]. - The company is committed to high-efficiency and innovative R&D to enhance its drug development capabilities[2]. - The company expects to submit multiple new drug applications to NMPA in 2023, including for the treatment of EGFR mutation NSCLC and severe psoriasis[16]. - The company plans to accelerate the clinical development and market launch of 3-4 new drug varieties in China and overseas within the next three years[17]. - The company aims to leverage breakthrough therapy designations for its key products to expedite development and approval processes[36]. Financial Performance - The market sales revenue for the year ended December 31, 2022, was RMB 1,104.4 million, a 422% increase from RMB 211.6 million in 2021[18]. - Total revenue for the year ended December 31, 2022, was RMB 837.7 million, compared to RMB 225.6 million in 2021, reflecting a growth of 270%[70]. - The gross profit for the year ended December 31, 2022, was RMB 743.5 million, up 283% from RMB 194.4 million in 2021[71]. - The company reported a net loss of RMB 1,422.2 million for the year ended December 31, 2022, compared to a net loss of RMB 1,258.1 million in 2021[79]. - The company’s other income and net gains for the year ended December 31, 2022, were RMB 158.6 million, a 36% increase from RMB 116.3 million in 2021[71]. - The company had a total employee count of 2,341 as of December 31, 2022, an increase from 1,865 in the previous year[59]. - The total employee cost for the reporting period was RMB 624.1 million, up from RMB 536.7 million in 2021, reflecting a year-over-year increase of approximately 16.3%[139]. Regulatory and Market Expansion - The company has received regulatory approvals for its products from various international health authorities, including the FDA and EMA[6]. - The company is actively exploring market expansion opportunities and potential mergers and acquisitions to enhance its competitive position[2]. - The company has initiated plans for a listing on the Shanghai Stock Exchange's Sci-Tech Innovation Board to enhance funding for new drug development[17]. - The company is exploring strategic partnerships for co-development and licensing of products both in China and globally[66]. Clinical Trials and Research - The company has 17 independently developed new drug products in clinical research, with 6 in critical Phase III trials[14]. - The company is currently conducting clinical trials for multiple indications, including 1L gastric/gastroesophageal adenocarcinoma and advanced solid tumors, with patient enrollment completed for several studies[36]. - The company has achieved clinical endpoints for several products, including Inusi for primary hypercholesterolemia and mixed dyslipidemia, and AK102 for heterozygous familial hypercholesterolemia[38]. - The company advanced two preclinical candidates into clinical stages in 2022, demonstrating its commitment to expanding its oncology pipeline[46]. - The company published 26 significant research findings in international academic conferences or journals in 2022, showcasing its innovative capabilities in drug development and clinical research[34]. Corporate Governance and Compliance - The company emphasizes the importance of corporate governance and compliance with listing rules to maintain investor confidence[9]. - The company has established compliance policies and procedures to ensure adherence to applicable laws and regulations[138]. - The independent non-executive directors have reviewed the exclusive sales agreements and procurement agreements, confirming that the terms are fair and reasonable[159]. - The auditor has issued an unqualified opinion regarding the continuing connected transactions, confirming compliance with the relevant Listing Rules[160]. Strategic Partnerships and Agreements - The company entered into a licensing agreement with Summit Therapeutics for the development and commercialization of Ivorosi (AK112), receiving an upfront payment of USD 500 million and potential total transaction value of up to USD 5 billion[30]. - The exclusive sales agreement allows the subsidiary Tianqing Kangfang to authorize Lianyungang Zhengda Tianqing as the sole sales entity for monoclonal antibody products in China, with a fixed sales fee rate of no less than 35%[144][146]. - The company has established a strategic partnership with Zhengda Tianqing, which holds a 50% equity interest in Tianqing Kangfang, enhancing its market position and operational capabilities[150]. Employee Relations and Sustainability - The company is committed to environmental sustainability and adheres to relevant environmental protection laws and regulations[137]. - The company has maintained stable employee relations without any significant strikes or labor disputes during the reporting period[139]. - The company has implemented competitive compensation packages to retain employees, including salaries, discretionary bonuses, and benefits[139]. - The company’s commitment to training programs aims to enhance employee knowledge and skills, contributing to overall organizational growth[139].

Financial Performance - For the year ended December 31, 2022, the product market sales amounted to RMB 1,104.4 million, a significant increase of 422% compared to RMB 211.6 million for the year ended December 31, 2021[2]. - The sales revenue from the product "Kantian® (Cadonilimab)" was RMB 546.3 million, while "Anike® (Piananpuli)" generated RMB 558.1 million, reflecting a 164% increase from RMB 211.6 million in 2021[3]. - The company reported a net loss of RMB 1,422.2 million for the year ended December 31, 2022, compared to a net loss of RMB 1,258.1 million in 2021[48]. - Total revenue for 2022 reached RMB 1,104.4 million, a 422% increase compared to RMB 211.6 million in 2021[51]. - Gross profit for 2022 was RMB 743.5 million, reflecting a 283% increase from RMB 194.4 million in 2021[53]. - Research and development expenses for 2022 amounted to RMB 1,323.1 million, an 18% increase from RMB 1,123.0 million in 2021[55]. - Selling and marketing expenses for 2022 were RMB 552.7 million, a 209% increase compared to RMB 179.1 million in 2021[57]. - Other income and net gains for 2022 totaled RMB 158.6 million, a 36% increase from RMB 116.3 million in 2021[54]. - The company reported a total of RMB 1,108,305 thousand in sales revenue, with distribution costs of RMB 270,649 thousand, leading to a net revenue of RMB 837,656 thousand[102]. - The group reported a loss attributable to ordinary equity holders of the parent company of RMB 1,168,393,000 for the year 2022, compared to a loss of RMB 1,074,933,000 in 2021[112][114]. Research and Development - Research and development expenses for the year ended December 31, 2022, were RMB 1,323.1 million, an 18% increase from RMB 1,123.0 million in 2021, mainly due to more products advancing to late-stage clinical trials[6]. - The company has over 30 innovative projects in development, with 17 in clinical trials, including 6 potential first-in-class or best-in-class bispecific antibodies[13]. - The company is focused on accelerating the global development of AK112 in collaboration with Summit Therapeutics, enhancing its international market presence[11]. - The company is committed to advancing its research in immuno-oncology, focusing on innovative therapies targeting various cancer types[17]. - The company is actively pursuing global clinical trials for its products, aiming for broader market access and regulatory approvals[18]. - The company is developing multiple combination therapies, including Kadinili with lenvatinib for 1L liver cancer and AK104 with chemotherapy for advanced solid tumors[17]. - The company has established clinical research partnerships to enhance the development of its oncology pipeline, particularly with Cadonilimab[21]. - The company is focusing on expanding its product offerings and market presence through strategic approvals and partnerships in the oncology sector[20][26]. Product Launches and Approvals - The company has launched two drugs: Kadinili® (Kadinili) and Anike® (Piananpili) as of the announcement date[17]. - Anike has been approved for 1L squamous non-small cell lung cancer in January 2023 and is under submission in China for ≥3L nasopharyngeal carcinoma[18]. - The approval of Kantoni® fills a gap in immunotherapy for advanced cervical cancer in China, marking a significant milestone in the company's product offerings[7]. - Cadonilimab received NMPA approval for the treatment of recurrent or metastatic cervical cancer, marking it as the first dual immune checkpoint inhibitor approved globally[20]. - Significant clinical advancements for Cadonilimab include multiple Phase II and III studies approved in 2022, targeting various cancers such as NSCLC and HCC[21][22]. - AK112 has completed patient enrollment for its Phase III trial in treating EGFR-TKI resistant advanced non-squamous NSCLC[24]. - AK117 has been approved for clinical trials in combination with AK112 for treating advanced malignancies, indicating a strategic focus on combination therapies[26]. - Anike® was included in the CSCO guidelines for first-line treatment of advanced or metastatic squamous NSCLC, enhancing its market positioning[27]. Financial Position and Cash Flow - As of December 31, 2022, the company had approximately RMB 2.09 billion in cash on hand[39]. - The company completed a placement in Hong Kong on July 15, 2022, raising approximately $73.46 million net[39]. - The net cash flow from operating activities for the year ended December 31, 2022, was RMB (1,240,413) thousand, compared to RMB (1,001,238) thousand in 2021, indicating a decline of approximately 23.9%[90]. - The cash and cash equivalents at the beginning of the year were RMB 2,641,625 thousand, which decreased to RMB 2,092,388 thousand by the end of the year, reflecting a reduction of about 20.8%[90]. - The company reported a total cash and cash equivalents decrease of RMB 644,310 thousand for the year, compared to an increase of RMB 5,732 thousand in 2021[90]. - The company’s total non-current assets increased to RMB 2,437,477 thousand in 2022 from RMB 1,653,533 thousand in 2021, marking a growth of about 47%[87]. - The total current assets decreased slightly to RMB 3,058,471 thousand in 2022 from RMB 3,152,256 thousand in 2021[87]. - The company’s total liabilities increased to RMB 1,586,798 thousand in 2022 from RMB 869,828 thousand in 2021, reflecting a rise of approximately 82%[88]. Corporate Governance and Compliance - The company has maintained compliance with corporate governance codes throughout the reporting period, except for one specific provision[75]. - The company has established an audit committee in compliance with listing rules, enhancing corporate governance[80]. - The company confirmed that all directors adhered to the standard rules regarding the trading of the company's securities during the reporting period[77]. - The company emphasizes compliance with international financial reporting standards in its financial disclosures[121]. - The company adopted revised International Financial Reporting Standards for the financial statements, which may affect future reporting and compliance[94]. Market Presence and Strategic Partnerships - The company aims to expand its market presence through strategic partnerships and collaborations in the oncology sector[123]. - The company received a milestone payment of USD 500 million and up to USD 5 billion in total deal value from Summit Therapeutics for the exclusive rights to develop and commercialize AK112 in multiple regions[11]. - The company was included in the MSCI China All Shares Index on February 28, 2023, enhancing its market visibility[83]. - The company is exploring potential mergers and acquisitions to strengthen its market position and R&D capabilities[122].

Drug Development and Innovation - Akeso has developed over 30 innovative drug candidates targeting major diseases, with 15 currently in clinical stages, including two first-in-class bispecific antibody drugs [18]. - The company has established an end-to-end drug development platform (ACE platform) that integrates drug discovery and development functions [18]. - Akeso's bispecific antibody development technology (TETRABODY technology) addresses three major CMC challenges, including low expression levels and stability issues [18]. - The company aims to become a leading global biopharmaceutical enterprise by developing innovative drugs that are either first-in-class or best-in-class [18]. - The company is actively developing new products, with three new drug candidates expected to enter clinical trials by the end of 2023 [22]. - The company is focusing on oncology as a key therapeutic area, with ongoing clinical trials for multiple products including AK104 and AK112 [31]. - The company aims to fill the treatment gap for advanced cervical cancer in China with its innovative therapies [33]. Financial Performance - The company reported a revenue of RMB 100 million for the six months ended June 30, 2022, representing a 20% increase compared to the same period last year [22]. - Total sales for the six months ended June 30, 2022, reached RMB 297.2 million, an increase of 26.8% compared to RMB 128.6 million for the same period in 2021 [27]. - Other net income rose to RMB 76.0 million, a growth of 16.7% from RMB 65.1 million in the previous year, primarily due to increased government subsidies [27]. - The adjusted total comprehensive loss for the period was RMB 585.6 million, an increase of RMB 264.3 million from RMB 321.3 million in the same period last year [28]. - The company reported a net loss of RMB 691,884 thousand for the six months ended June 30, 2022, compared to a net loss of RMB 446,163 thousand for the same period in 2021, representing an increase in loss of approximately 55% [145]. - The total comprehensive loss for the six months ended June 30, 2022, was RMB 611.75 million, compared to RMB 471.47 million for the same period in 2021, reflecting an increase of 29.7% [62]. Research and Development Expenditure - The R&D expenditure for the first half of 2022 was RMB 20 million, accounting for 20% of total revenue [22]. - R&D expenses increased to RMB 595.4 million, up RMB 31.9 million from RMB 563.5 million in the prior year, reflecting a strategic focus on advancing late-stage clinical projects [27]. - Research and development expenses increased to RMB 595,384,000 for the six months ended June 30, 2022, from RMB 563,518,000 in the same period of 2021, reflecting a rise of 5.7% [137]. Market Expansion and Strategic Initiatives - Market expansion efforts include entering two new international markets, aiming for a 15% market share in each by 2025 [22]. - The company has completed a strategic acquisition of a biotech firm for USD 50 million to enhance its R&D capabilities [22]. - The company plans to invest RMB 30 million in technology upgrades to improve production efficiency [22]. - The company has established partnerships with three leading hospitals to enhance clinical trial recruitment [22]. Shareholder and Corporate Governance - The board did not recommend an interim dividend for shareholders during the reporting period [72]. - The company confirmed compliance with the standard code of conduct for securities trading throughout the reporting period [73]. - The company has adopted and complied with all applicable provisions of the corporate governance code during the reporting period, except for the separation of the roles of Chairman and CEO [72]. Employee and Compensation Information - As of June 30, 2022, the total number of employees was 2,289, an increase from 1,202 in the previous year [44]. - Total compensation costs for the six months ended June 30, 2022, were RMB 255.5 million, slightly up from RMB 250.9 million for the same period in 2021, an increase of 1.8% [70]. - The total compensation paid to key management personnel for the six months ended June 30, 2022, was RMB 19,806,000, a significant decrease of 85.0% from RMB 131,864,000 in the same period of 2021 [200]. Cash Flow and Liquidity - Cash and cash equivalents decreased by RMB 420.9 million to RMB 2,220.7 million as of June 30, 2022, from RMB 2,641.6 million as of December 31, 2021 [64]. - The liquidity ratio (current ratio) was 2.4 as of June 30, 2022, down from 4.5 as of December 31, 2021, indicating a decrease in liquidity [66]. - The company experienced a net cash outflow from operating activities of RMB (580,675) thousand, compared to RMB (346,463) thousand in the prior year, indicating a worsening cash flow situation [145]. Share Issuance and Capital Management - The company issued shares amounting to RMB 992,028 thousand during the period, which is a significant capital raise [143]. - A total of 24,000,000 new shares were issued at a price of HKD 24.27 per share, representing approximately 2.85% of the enlarged issued share capital after the placement [132]. - The net proceeds from the global offering amounted to approximately HKD 2,894.1 million (equivalent to approximately RMB 2,647.2 million) [74]. Clinical Trials and Approvals - The company received NMPA approval for its first-in-class PD-1/CTLA-4 bispecific antibody, AK104, on June 29, 2022, for treating recurrent or metastatic cervical cancer [30]. - The company received NMPA approval in June for the new drug "Kaitanni" to treat recurrent or metastatic cervical cancer, marking it as the first dual immune checkpoint inhibitor approved in China [33]. - The company announced that the Phase III clinical study for "AK112" in treating unresectable hepatocellular carcinoma (HCC) received CDE approval in June [36].

Product Development and Pipeline - Akeso, Inc. has developed over 30 innovative antibody products targeting major diseases, with 15 of them currently in clinical stages[5]. - The company is focused on expanding its product pipeline in oncology, autoimmune diseases, inflammation, and metabolic diseases[5]. - Akeso has two internationally pioneering bispecific antibody drugs in development, targeting PD-1/CTLA-4 and PD-1/VEGF[5]. - The company is developing a proprietary tetravalent antibody technology aimed at enhancing cancer treatment efficacy[9]. - By the end of 2021, the company had 15 clinical studies in the registration/Phase III stage, with over 20 research results presented at major academic conferences[16]. - The company has initiated clinical studies for new dual antibodies, including AK131 (PD-1/CD73) and AK130 (TIGIT/TGFB), to expand its pipeline[19]. - Key oncology candidates in clinical trials include AK104 (PD-1/CTLA-4), AK112 (PD-1/VEGF), and AK117 (CD47), which are believed to have the potential to be first-in-class or best-in-class therapies[27]. - In the autoimmune disease sector, clinical trials are ongoing for Manfidokimab (AK120, IL-4R), Ebdarokimab (AK101, IL-12/IL-23), and Gumokimab (AK111, IL-17)[27]. - The ongoing clinical trials are expected to provide significant data that could enhance the company's market position and therapeutic offerings[28]. Financial Performance - Total sales from products and licensing fees for the year ended December 31, 2021, amounted to RMB 340.2 million, a significant increase from zero in the previous year[20]. - The company reported a narrowed loss of RMB 1,258.1 million for the year ended December 31, 2021, compared to a loss of RMB 1,320.6 million in the previous year, attributed to increased product sales and licensing income[21]. - Total revenue for the year ended December 31, 2021, was RMB 225.6 million, with product sales and licensing fees totaling RMB 340.2 million[59]. - The company reported a total employee cost of RMB 536.7 million for the year ended December 31, 2021, an increase from RMB 469.8 million in 2020, with a total of 1,865 employees as of December 31, 2021, compared to 746 in 2020[106]. - The total loss for the year was RMB 1,311.82 million, a decrease from RMB 1,552.52 million in the previous year[58]. Research and Development - Research and development expenses increased from RMB 768.6 million in 2020 to RMB 1,123.0 million in 2021, reflecting advancements in clinical trials and an increase in R&D personnel[20]. - The clinical trial costs component of R&D expenses rose to RMB 729.1 million in 2021 from RMB 580.4 million in 2020[65]. - The R&D budget has been increased by 40% to accelerate the development of new technologies and products[99]. - The company is committed to advancing its research and development efforts to bring new therapies to market[27]. Market Expansion and Strategy - The company is actively exploring market expansion opportunities and potential mergers and acquisitions to enhance its growth[5]. - The company has established a significant presence in the Chinese market, with plans for further market expansion[10]. - The commercialization team has over 500 members and has achieved deep coverage across 30 provinces, 200 cities, and 1,500 hospitals, laying a strong foundation for the commercialization of Cadonilimab[18]. - The company plans to accelerate the global development of new drug products in 2022, with expectations for approvals of Cadonilimab for cervical cancer and Aniko® for sq-NSCLC and nasopharyngeal cancer[19]. - The company is expanding its market presence in Southeast Asia, targeting a 15% market share within the next two years[97]. Corporate Governance and Compliance - The company has a strong governance structure with various committees, including an audit committee and a remuneration committee[11]. - The company is committed to adhering to international financial reporting standards[9]. - The company has established a robust quality management system to ensure compliance with regulatory standards[92]. - The company has a comprehensive compliance policy and procedures in place to ensure adherence to applicable laws and regulations[105]. - The company has adopted the corporate governance code and has complied with all applicable provisions during the reporting period[177]. Leadership and Team - The company has a strong leadership team with extensive experience in drug discovery and development, particularly in cancer immunotherapy[90]. - The leadership team has a diverse educational background, with degrees from prestigious institutions such as the University of Pennsylvania and Baylor College of Medicine[91]. - The total employee count increased to 1,865 as of December 31, 2021, up from 746 at the end of 2020, with 27.5% in sales and marketing roles[53]. Shareholder and Financial Management - The company did not recommend any final dividend for the year ended December 31, 2021[122]. - The company has no significant investments or acquisition plans as of December 31, 2021, and no significant contingent liabilities[77][79]. - The company has maintained the required public float as per the Listing Rules as of the date of the report[120]. - The company has established service contracts for executive directors with a term of three years from the listing date[125]. Future Outlook - The company has projected a revenue guidance of $200 million for the next fiscal year, indicating a growth rate of approximately 33%[95]. - The company expects to have 1-2 new drug products enter clinical research in 2022[57]. - Future outlook includes potential partnerships and collaborations to enhance market reach and product development[27].

Drug Development and Innovation - Akeso, Inc. has developed over 20 innovative drug products targeting major diseases, with 13 currently in clinical research, including two first-in-class bispecific antibody drugs[16] - The company has established a comprehensive drug development platform (ACE platform) covering drug discovery, development, and GMP-compliant large-scale production[16] - Akeso, Inc. aims to become a leading global biopharmaceutical company through efficient and breakthrough research and development of innovative drugs[16] - The company has successfully developed Tetrabody technology for bispecific antibody drug development[16] - Akeso, Inc. is focused on creating affordable innovative antibody drugs for global patients[16] - The company continues to prioritize research and development as a key strategy for future growth and market expansion[24] - The company is committed to enhancing its product pipeline and exploring new market opportunities as part of its strategic initiatives[24] - The financial performance reflects the company's ongoing efforts to innovate and expand its market presence in the biotechnology sector[24] - The company has developed a comprehensive ACE platform for drug discovery and development, covering over 20 drug development projects[46] - The company is focused on oncology and immunology, with several candidates in clinical trials targeting unmet medical needs in these areas[47] - The company is committed to advancing its pipeline of innovative therapies targeting various cancers, with multiple trials ongoing and data expected to be released in the near future[54][57] Financial Performance - Revenue for the six months ended June 30, 2021, was RMB 128.6 million, compared to RMB 41.0 million in the same period of 2020, representing a significant increase[24] - Other income and gains for the period amounted to RMB 65.1 million, up from RMB 41.0 million in 2020[24] - Research and development expenses increased to RMB 563.5 million from RMB 240.7 million year-over-year, indicating a focus on innovation[24] - The net loss for the period was RMB 446.2 million, an improvement from a loss of RMB 718.3 million in the previous year[24] - Total comprehensive loss for the period was RMB 471.5 million, compared to RMB 728.7 million in the same period of 2020[24] - Adjusted total comprehensive loss amounted to RMB 321.3 million, compared to RMB 216.7 million in 2020, reflecting ongoing investment in growth[24] - The financial results indicate a strong recovery trajectory, with significant improvements in revenue and reduced losses compared to the previous year[24] - The company reported a total revenue of RMB 128,600,000 for the six months ended June 30, 2021, compared to RMB 0 for the same period in 2020[139] - Gross profit for the same period was RMB 128,600,000, with no cost of sales reported[139] - The total comprehensive loss for the six months ended June 30, 2021, decreased to RMB 446.2 million from RMB 718.3 million for the same period in 2020, representing a reduction of approximately 37.8%[102] Clinical Trials and Approvals - AK104 received FDA orphan drug designation for the treatment of cervical cancer in February 2021 and commenced a global Phase III clinical study for advanced cervical cancer in April 2021[28] - AK112 initiated five clinical trials in May 2021, including studies for advanced non-small cell lung cancer and recurrent/metastatic gynecological tumors[31] - AK105 achieved its primary endpoint in a Phase III clinical trial for locally advanced or metastatic squamous non-small cell lung cancer in February 2021[34] - AK120 received NMPA approval to commence Phase I clinical trials for moderate to severe atopic dermatitis in April 2021[38] - AK101's Phase III clinical trial for moderate to severe psoriasis has been submitted for communication with NMPA in May 2021[39] - The company has 13 clinical stage candidates, including 10 internally developed and 3 licensed to third parties[47] - As of the report date, there are 4 phase I/II and 9 phase III clinical trials ongoing, with 16 IND approvals obtained[41] - The company received NMPA approval for multiple clinical trials, including AK105 for metastatic nasopharyngeal carcinoma and AK104 for advanced gastric cancer[41] - The clinical trial for AK104 in combination with XELOX for advanced gastric cancer has been approved for phase III[41] - The company plans to expand basket trials into registration trials if positive efficacy signals are observed[52] Workforce and Talent Acquisition - The workforce expanded from 746 employees on December 31, 2020, to 1,202 employees by June 30, 2021, representing a growth of approximately 61%[44] - The company aims to attract and retain top talent, with a focus on expanding its clinical development and commercialization capabilities[44] - The total number of employees in the group was 1,202, with 29.8% in clinical roles and 16.0% in R&D[113] - Total compensation paid to key management personnel for the six months ended June 30, 2021, was RMB 131,864 thousand, significantly up from RMB 4,706 thousand in the same period of 2020[197] Capital and Liquidity - Total current assets as of June 30, 2021, amounted to RMB 3,632.8 million, up from RMB 3,001.3 million as of December 31, 2020, reflecting an increase of approximately 21.0%[106] - The total assets of the company reached RMB 4,800.3 million as of June 30, 2021, compared to RMB 3,856.2 million at the end of 2020, marking an increase of approximately 24.5%[106] - Cash and cash equivalents increased from RMB 2,684.5 million on December 31, 2020, to RMB 3,163.9 million on June 30, 2021, an increase of approximately 17.8%[107] - The company had available undrawn bank loan facilities of approximately RMB 1,791.0 million as of June 30, 2021, compared to RMB 362.5 million at the end of 2020, indicating a significant increase in liquidity[107] - The company's capital commitments as of June 30, 2021, were RMB 593.5 million, up from RMB 478.9 million as of December 31, 2020, representing an increase of approximately 24.0%[111] Shareholder Information - The total number of shares issued by the company as of June 30, 2021, is 817,057,176 shares[126] - Dr. Xia holds a total of 136,841,582 shares, representing approximately 16.75% of the issued shares[128] - Major shareholder Zheng Xun owns 65,340,000 shares, accounting for 7.99% of the issued shares[132] - Cantrust (Far East) Limited holds 49,335,282 shares, which is about 6.04% of the issued shares[132] - HTKF Investments Limited has a beneficial ownership of 45,960,000 shares, representing 5.63% of the issued shares[132] Regulatory Compliance and Governance - The independent auditor, Ernst & Young, conducted a review of the interim financial information for the reporting period[123] - The company confirmed compliance with the standard code of conduct for securities trading throughout the reporting period[115] - There have been no changes in the board of directors since the 2020 annual report date[124] - The company has no other disclosures required under the listing rules as of the report date[125] Future Plans and Strategic Initiatives - The company plans to establish an internal sales team of over 500 sales professionals by the end of 2021 to support the upcoming drug approvals and launches[88] - The company is preparing for the launch of Cadonilimab in 2022 and plans to recruit approximately 500 sales and marketing personnel by the end of 2021[91] - The company plans to use the proceeds from the 2021 placement to establish a commercialization team for the launch of AK104 in 2022 and to develop new production facilities in Guangzhou and Zhongshan[121]

Drug Development and Innovation - Akeso, Inc. has developed over 20 innovative drug candidates targeting major diseases, with 13 currently in clinical stages, including two first-in-class bispecific antibody drugs[22] - The company has established an end-to-end drug development platform (ACE platform) that integrates drug discovery and development functions[22] - Akeso's proprietary Tetrabody technology enables the design and production of innovative tetravalent bispecific antibodies[22] - The company aims to become a leading global biopharmaceutical enterprise by developing innovative drugs that provide best-in-class therapies[22] - Akeso's clinical candidates include dual-targeting antibodies for PD-1/CTLA-4 and PD-1/VEGF, which are significant advancements in cancer treatment[22] - The company is committed to high-efficiency and breakthrough R&D to achieve international first-in-class and best-in-class drug development[22] - The company is focused on developing affordable innovative antibody drugs for global patients[22] - The company has a strong pipeline addressing various conditions, including tumors, autoimmune diseases, inflammation, and metabolic diseases[22] - The company is actively pursuing the commercialization of its innovative drug development results, aiming to create social and commercial value[37] - The company is committed to advancing its drug development pipeline and optimizing its product portfolio to align with biotech trends[39] - The company aims to leverage its proprietary TETRABODY technology to enhance the efficacy of its drug candidates[72] Financial Performance - In 2020, the company reported total revenue of RMB 123.5 million, a significant increase from RMB 50.2 million in 2019, primarily due to interest earned from IPO proceeds and increased government subsidies for R&D[43] - R&D expenses rose to RMB 768.6 million in 2020, up from RMB 308.4 million in 2019, driven by increased clinical trial development and personnel costs[43] - The company incurred a net loss of RMB 1.32 billion in 2020, compared to a loss of RMB 346.5 million in 2019, reflecting a substantial increase in operational costs[43] - The adjusted total comprehensive loss for 2020 was RMB 747.5 million, compared to RMB 238.2 million in 2019, indicating a worsening financial position[45] - The company reported a total comprehensive loss of RMB 1,552.5 million for the year ended December 31, 2020, compared to RMB 348.5 million for the previous year, indicating a significant increase in losses[114] - The total comprehensive loss for the year ended December 31, 2020, was RMB 1,552.5 million, an increase from RMB 348.5 million in 2019[123] - The adjusted total comprehensive loss for the year was RMB 747.5 million, compared to RMB 238.2 million in 2019, reflecting a significant increase of 213%[125] Clinical Trials and Regulatory Approvals - In 2020, the company advanced over 40 clinical studies globally, with 9 studies in registration or Phase III clinical stages, and 4 registration studies achieving primary endpoints[37] - The first new drug, AK105, received acceptance for its market application by the National Medical Products Administration (NMPA) and is expected to be launched in 2021[37] - The company received breakthrough therapy designation and orphan drug designation from the FDA for its drug Cadonilimab (AK104) for the treatment of recurrent or metastatic cervical cancer[37] - The company has initiated 9 clinical trials for Cadonilimab across various cancers, including lung cancer, liver cancer, and gastric cancer[37] - AK104 received FDA IND approval in April 2020, and the first patient was dosed in a pivotal trial for recurrent or metastatic cervical cancer in May 2020[46] - AK112 commenced an Ib phase clinical trial for advanced solid tumors in China in August 2020, following NMPA approval[47] - AK117 completed its first patient dosing in Australia in May 2020 and received NMPA IND approval in September 2020[48] - The company has received 12 IND approvals in 2020, showcasing its strong product portfolio and regulatory progress[63] - AK105 received NMPA acceptance for new drug application for r/r classical Hodgkin lymphoma in May 2020[49] - AK105 achieved primary endpoint in clinical trial for metastatic nasopharyngeal carcinoma and received FDA fast track designation in October 2020[49] - The company has initiated multiple clinical studies for AK105 in Australia and China, focusing on combination trials with Anlotinib[79] - The company is evaluating AK117 in combination therapies for cancer treatment, with ongoing trials in both Australia and China[76] Market Position and Strategic Partnerships - The company is positioned to leverage its integrated platform and innovative technologies for future market expansion and strategic partnerships[22] - The company was included in the Hang Seng Index series and the Stock Connect program in 2020, enhancing its market recognition[38] - The company has established a joint venture agreement for the PCSK-9 monoclonal antibody (Ebronucimab, AK102) with Dongrui Pharmaceutical[65] - The company strategically partnered with Merck for the CTLA-4 antibody (AK107) for a total consideration not exceeding $200 million[63] - The company aims to accelerate the commercialization of clinical candidates and enhance their commercial value through strategic partnerships for co-development and licensing[39] - The company is actively pursuing market expansion and collaboration opportunities to enhance its product offerings and reach[63] Workforce and Operational Capacity - The company expanded its team to over 750 employees, enhancing its capabilities in clinical development, commercialization, and business operations[37] - The company has a total of 746 employees, with 31.3% in production, 26.1% in clinical, and 21.5% in R&D[60] - The workforce is divided into functions with 31.3% in production, 26.1% in clinical, and 21.5% in R&D, indicating a strong focus on operational capabilities[106] - The company aims to establish a strong operational team of approximately 500 personnel by the end of 2021 to support commercialization efforts[113] Production and Facilities - The Guangzhou Knowledge City production base was completed and put into operation in just 15 months, significantly improving the company's commercialization capabilities[37] - The Guangzhou commercial production base has a maximum capacity of 40,000 liters, with an expected annual production capacity of 10 million dosage units, and began operations in early 2021[104] - The Zhongshan Cuiheng commercial production base will have a maximum capacity of 80,000 liters, with an expected annual production capacity of 20 million dosage units, and construction began in December 2020[104] - The ACE platform enables the company to conduct drug discovery and development without relying on external suppliers, enhancing operational efficiency[102] - The company completed GMP trial runs and process validation in February 2021, initiating GMP production at the Guangzhou facility with equipment capable of accommodating up to 20,000 liters of disposable bioreactors[110] Governance and Leadership - The company is led by Dr. Xia Yu, who has over 27 years of experience in the pharmaceutical industry and has held multiple leadership positions[140] - The board consists of four executive directors, two non-executive directors, and three independent non-executive directors, ensuring a diverse governance structure[140] - The company has a strong leadership team with extensive experience in the pharmaceutical and biotechnology industries, including over 20 years of experience in therapeutic biologics for Dr. Wang[142] - The company has been recognized for its talent development programs, with multiple executives receiving awards under the Pearl River Talent Program[143][144] - The leadership team has a diverse educational background, with degrees from prestigious institutions such as the University of Pennsylvania and the University of Science and Technology of China[142][144] Risks and Compliance - The group faces risks related to the need for additional funding to meet operational cash needs and potential delays in drug development due to regulatory requirements[165] - The group has maintained compliance with relevant laws and regulations without any significant violations as of December 31, 2020[159] - The company has experienced changes in its board, with Mr. Lin Lijun resigning as a non-executive director due to personal commitments[155] Shareholder Information - As of December 31, 2020, the total number of issued shares was 787,057,176[177] - Dr. Xia Yu holds 21,000,000 shares, representing approximately 2.67% of the issued shares[179] - Dr. Li Baiyong holds 10,934,640 shares, representing approximately 1.39% of the issued shares[179] - Major shareholder Zheng Xun holds 65,340,000 shares, representing approximately 8.30% of the issued shares[183] - Cantrust (Far East) Limited holds 49,335,282 shares, representing approximately 6.27% of the issued shares[183] - HTKF Investments Limited holds 45,960,000 shares, representing approximately 5.84% of the issued shares[183] - Aquae Hyperion Limited holds 45,270,499 shares, representing approximately 5.75% of the issued shares[183]

Drug Development and Innovation - Akeso, Inc. has developed over 20 innovative drug candidates targeting major diseases, with 9 currently in clinical stages, including two first-in-class bispecific antibody drugs[5]. - The company has established a comprehensive drug development platform (ACE platform) that integrates drug discovery and development functions[5]. - Akeso, Inc. aims to become a leading global biopharmaceutical company by developing innovative drugs that provide best-in-class therapies[5]. - The company has successfully developed a bispecific antibody development technology known as TETRABODY technology[5]. - Akeso, Inc. is focused on creating affordable innovative antibody drugs for global patients[5]. - The company is actively pursuing market expansion and strategic partnerships to enhance its product pipeline and market presence[5]. - Akeso, Inc. is committed to high-efficiency and breakthrough R&D innovations to develop international first-in-class and best-in-class drugs[5]. - The company has received regulatory approvals for its clinical trials, indicating progress in its drug development efforts[5]. - Akeso, Inc. is positioned to leverage its end-to-end drug development capabilities to accelerate the commercialization of its innovative therapies[5]. - The company is continuously exploring new strategies for growth, including potential mergers and acquisitions to strengthen its market position[5]. Financial Performance - Total revenue for the six months ended June 30, 2020, was RMB 41.0 million, an increase of 78.96% from RMB 22.9 million in the same period of 2019[17]. - Research and development expenses rose to RMB 240.7 million, a 95.35% increase from RMB 123.2 million year-over-year, primarily due to the development of clinical trials for candidate drugs[17]. - Administrative expenses surged to RMB 99.5 million, a significant increase of 631.66% from RMB 13.6 million in the previous year, mainly due to IPO-related costs and increased employee compensation[17]. - The net loss for the period was RMB 718.3 million, a 520.65% increase compared to RMB 115.7 million in the same period of 2019[17]. - Adjusted total comprehensive loss amounted to RMB 216.7 million, up 88.15% from RMB 115.2 million in the prior year[17]. - The increase in net loss was attributed to a one-time non-cash change in the fair value of convertible redeemable preferred shares amounting to RMB 412.4 million[18]. - The company received increased government subsidies for research and development activities, contributing to the rise in other income and net gains[18]. - The company plans to continue expanding its research capabilities and product pipeline in the upcoming periods[18]. - The IPO-related expenses and stock-based compensation significantly impacted the administrative costs, indicating a strategic focus on growth and market presence[18]. Clinical Trials and Approvals - The company received FDA IND approval for AK104 in April 2020, initiating a registration clinical trial for recurrent or metastatic cervical cancer patients[21]. - In May 2020, the company obtained NMPA approval to start a pivotal registration trial for AK104 in third-line treatment of metastatic nasopharyngeal carcinoma, with the first patient successfully dosed[21]. - The first patient was successfully dosed in a Phase II clinical trial for AK104 targeting advanced unresectable or MSI-H solid tumors in May 2020[21]. - The company appointed Professor MONK from the University of Arizona as the chief advisor for the global Phase II multi-center clinical study of AK104 in July 2020[21]. - The company received NMPA approval for AK112 in August 2020 to conduct an Ib phase clinical trial for advanced solid tumors in China[24]. - The first patient was successfully dosed with AK109 for advanced solid tumors in June 2020[25]. - The company has developed a diverse pipeline with over 20 drug development projects, including 12 in clinical stages and six bispecific antibodies[34]. - The company established a partnership with a major subsidiary of China National Pharmaceutical Group to co-develop and commercialize the PD-1 antibody candidate penpulimab (AK105)[34]. Employee and Organizational Growth - As of June 30, 2020, the company had a total of 458 employees, with 24.2% in R&D and 26.6% in clinical roles[31]. - The company aims to attract and retain top talent to enhance capabilities in clinical development and commercialization[30]. - The company has 12 clinical-stage drug candidates, including 9 internally developed and 3 licensed to third parties[35]. - The company is strategically developing expertise in immunology to address the growing autoimmune disease market in China[35]. - The company has a joint venture agreement with Dongrui Pharmaceutical for the PCSK-9 monoclonal antibody ebronucimab (AK102)[35]. - The company has nine clinical-stage antibody candidates under development as of June 30, 2020, with a focus on various cancers and autoimmune diseases[36]. Production and Capacity Expansion - The company has established a GMP-compliant production facility in Zhongshan, covering approximately 3,200 square meters, with a production capacity of 3,700 liters[56]. - A new commercial production base in Guangzhou is under construction on a 56,573 square meter site, expected to have a capacity of up to 40,000 liters, with an annual production capacity of 2 million doses anticipated to start in early 2021[57]. - The company plans to establish a commercial operation team of approximately 300 to 500 personnel by the end of 2021 to enhance commercialization capabilities[64]. - The company plans to expand its GMP-compliant production capacity in response to increased demand for candidate drugs[65]. Shareholder and Equity Information - The company completed its initial public offering on April 24, 2020, resulting in the conversion of all preferred shares into ordinary shares[152]. - The total amount of government subsidies related to research and clinical trials was RMB 48,065,000 as of June 30, 2020[151]. - The company reported a basic and diluted loss per share of RMB 1.13 for the six months ended June 30, 2020, compared to RMB 1.32 for the same period in 2019[133]. - The total equity attributable to owners of the parent company reached RMB 3,618,271,000 as of June 30, 2020, compared to RMB 406,289,000 at the same time last year[113]. - The company raised approximately RMB 2,174,530,000 from the issuance of 183,419,000 ordinary shares at a price of HKD 16.18 per share during its initial public offering[160]. Financial Liabilities and Assets - The fair value loss on convertible redeemable preferred shares was recorded at RMB 412.4 million, attributed to non-cash and non-recurring accounting adjustments[72]. - The company reported a pre-tax loss of RMB 718,339,000 for the six months ended June 30, 2020, compared to a loss of RMB 115,740,000 for the same period in 2019, indicating a significant increase in losses[109]. - The total comprehensive loss for the period was RMB (728,709,000), compared to RMB (115,550,000) for the same period in 2019, reflecting a year-over-year increase of 528.5%[110]. - The company recognized a foreign exchange loss of RMB 1,584,000, which may impact overall financial results[116]. - The company reported a net cash outflow from investing activities of RMB 477,300,000, a substantial increase from RMB 56,349,000 in the prior year[116].