Financial Performance - The group's total revenue for 2023 was RMB 780,629 thousand, representing a 77% year-on-year increase[1]. - The net loss for 2023 was RMB 37,757 thousand, a reduction of RMB 12,289 thousand or 25% compared to the net loss of RMB 50,046 thousand in 2022[6]. - Adjusted EBITDA for the year was RMB 40,041 thousand, reflecting a substantial increase of 274% year-on-year[14]. - The total comprehensive loss for the year ended December 31, 2023, was RMB 36,020 thousand, an improvement from RMB 43,732 thousand in 2022[21]. - The company reported total revenue of RMB 780,629 thousand for the year ended December 31, 2023, compared to RMB 442,178 thousand in 2022[31]. - The overall comprehensive loss for the year was RMB 36,020 thousand, a decrease from RMB 43,602 thousand in the previous year[44]. - The company's operating revenue for 2023 was RMB 780,629 thousand, an increase of RMB 338,451 thousand or 77% compared to RMB 442,178 thousand in 2022[66]. - The net loss for 2023 was RMB 37,757 thousand, a reduction of RMB 12,289 thousand or 25% from a net loss of RMB 50,046 thousand in 2022[66]. - The group's financial income for 2023 was RMB 2,974 thousand, an increase of RMB 709 thousand from RMB 2,265 thousand in 2022, primarily due to optimized fund allocation[124]. - The group's financial cost for 2023 was RMB 5,175 thousand, a decrease of RMB 1,427 thousand from RMB 6,602 thousand in 2022, mainly due to the repayment of part of the working capital loans[125]. Revenue Sources - Product sales revenue reached RMB 630,207 thousand, a 107% increase year-on-year, primarily driven by significant sales growth of the core product, Puxinting® (Bevacizumab Injection)[1]. - CDMO/CMO business revenue was RMB 140,898 thousand, up 94% year-on-year, with a total of 39 new projects added, a 44% increase compared to the previous year[7]. - The company achieved a stable cash flow contribution from product commercialization, with total sales revenue reaching RMB 630 million[38]. - The company's CDMO/CMO business revenue for 2023 was RMB 140,898 thousand, an increase of RMB 68,360 thousand from RMB 72,538 thousand in 2022, primarily due to large-scale expansion in the CDMO/CMO sector[91]. Research and Development - R&D expenses increased to RMB 103,890 thousand, up from RMB 71,563 thousand in 2022[42]. - Research and development expenses for 2023 amounted to RMB 103,890 thousand, down from RMB 151,168 thousand in 2022[66]. - The company has established a global R&D service center in October 2023, covering an area of 25,000 square meters, to enhance CDMO business capabilities[16]. - The company has formed strategic collaborations to accelerate the development and commercialization of innovative conjugated drugs[33]. Production and Capacity - The company has optimized its production lines, significantly enhancing flexibility and capacity, with annual production capacity of 300,000 liters for antibody raw materials and 20 million doses for formulations[16]. - The second ADC formulation production line commenced operation in June 2023, with over 10 projects, including 3 pre-BLA projects, already produced on this line[16]. - The company has built a large-scale ADC formulation commercial production line with an annual capacity of 5.3 million bottles, significantly improving production flexibility and capacity[33]. - The company has established a large-scale commercial production line for ADC raw materials and formulations, with an annual production capacity of 300,000 liters for antibody raw materials and over 20 million doses for formulations[144]. Strategic Collaborations - The company has formed multiple long-term strategic collaborations with various biopharmaceutical companies, enhancing its ADC CDMO competitive advantage[15]. - The company has partnered with Sugar Ridge Biologics to co-develop the DisacLinkTM ADC glyco-conjugation technology platform, promoting accelerated development in the ADC industry[161]. - The company established a strategic partnership with Shijian Biotech to support the clinical and commercial development of ADC drugs[164]. - A comprehensive CDMO strategic collaboration was formed with Borui Biotech to provide one-stop CDMO services for multiple ADC development projects[165]. Market Outlook - The core product, Puxinting®, has achieved a market size exceeding RMB 10 billion, with a projected global market size for Bevacizumab expected to reach nearly RMB 49 billion by 2030, growing at a CAGR of 7.6% from 2021 to 2030[179]. - The Chinese market for Bevacizumab is anticipated to grow to RMB 18.4 billion by 2030, with a CAGR of 8.3% from 2021 to 2030[179]. Operational Metrics - The CDMO team has increased by 34% compared to the end of 2022, now comprising 464 members, with a core technical team averaging over 12 years of experience in biopharmaceuticals[18]. - The company added 39 new projects in the CDMO business, a year-on-year increase of 44%, bringing the total to 95 projects, with ADC projects accounting for 30 of the new additions[160]. - The company has successfully secured 4 pre-BLA projects, totaling 6 pre-BLA projects, showcasing its strong capabilities in commercializing CDMO projects[160]. Financial Position - Total assets increased to RMB 1,426,101 thousand, up from RMB 1,262,031 thousand in 2022[46]. - The company's net assets as of December 31, 2023, were RMB 686,686 thousand, a decrease of RMB 28,753 thousand from RMB 715,439 thousand at the end of 2022, primarily due to the net loss incurred during the period[118]. - The total liabilities to total assets ratio increased to 0.5 as of December 31, 2023, compared to 0.4 at the end of 2022, primarily due to increased long-term bank loans for the global R&D service center construction[154]. Compliance and Quality - The company has established a quality management system compliant with commercial production standards, supporting the commercialization of two listed products[170]. - The company has successfully completed 7 regulatory inspections by NMPA and other global regulatory bodies, ensuring compliance with high industry standards[170]. - The company is committed to continuously improving its international quality management system to provide high-quality services to clients[170].

Financial Performance - The net loss for the first half of 2023 decreased to RMB 15,163 thousand from RMB 15,724 thousand in the same period of 2022, reflecting effective cost control, particularly in R&D expenses [15]. - The company achieved a revenue of RMB 328,063 thousand in the first half of 2023, representing an 80% year-on-year growth. Excluding one-time licensing income from the previous year, the revenue growth reached 147% [48]. - Sales revenue amounted to RMB 277,881 thousand, a significant increase of 167% year-on-year, primarily driven by the strong sales performance of the core product, Puxinting (Bevacizumab biosimilar) [48]. - Financial revenue for the first half of 2023 was RMB 1,278 thousand, an increase of RMB 863 thousand compared to RMB 415 thousand in the same period of 2022 [115]. - The company reported a total comprehensive loss attributable to equity holders of RMB 11,746 thousand for the period, compared to a loss of RMB 12,488 thousand in the previous period, indicating a slight improvement [168]. - Total revenue for the six months ended June 30, 2023, was RMB 328,063 thousand, a significant increase from RMB 182,019 thousand for the same period in 2022, representing an increase of approximately 80.4% [200]. Research and Development - R&D expenses were significantly reduced to RMB 49,969 thousand, showcasing the company's strategic adjustments [15]. - Research and development expenses decreased to RMB 49,969 thousand in the first half of 2023 from RMB 70,268 thousand in the same period of 2022, suggesting improved cost management [120]. - The company is focusing on optimizing its product pipeline and enhancing R&D resources to drive future growth [134]. - The company has initiated the construction of a global R&D center with a total planned investment of approximately RMB 180 million [117]. CDMO/CMO Business - The number of CDMO projects in hand reached 45, a 96% increase year-on-year, significantly outpacing industry average growth [24]. - The CDMO/CMO business generated revenue of RMB 46,546 thousand, reflecting a 105% year-on-year growth [48]. - In the first half of 2023, the revenue from CDMO/CMO business reached RMB 46,546 thousand, representing a year-on-year growth of 105% [89]. - The company has established a comprehensive "end-to-end" commercialization production line for ADC, with a total capacity of 20,000L for antibodies and intermediates, meeting the majority of domestic ADC drug capacity needs [90]. - The company has successfully implemented two ADC production lines capable of producing freeze-dried products at a speed of 200 bottles per minute [84]. Market and Product Development - The global ADC drug market is projected to grow from USD 7.9 billion in 2022 to USD 64.7 billion by 2030, with a compound annual growth rate (CAGR) of 30% [34]. - The ADC CDMO market reached USD 1.5 billion in 2022, with a CAGR of 34.5% from 2018 to 2022, and is expected to grow to USD 11 billion by 2030 [39]. - The company has established partnerships for ADC drugs and has successfully obtained 3 pre-BLA ADC projects, demonstrating its capabilities in the ADC CDMO field [24]. - The company has partnered with Sugar Ridge Biotech to develop the DisacLink™ ADC glyco-conjugation technology platform, enhancing ADC innovation [48]. - The core product, Bevacizumab Injection (朴欣汀®), has achieved sales growth of 161% year-on-year in the first half of 2023, driven by a differentiated marketing strategy targeting second and third-tier cities [53]. Financial Position and Risks - As of June 30, 2023, the company's net assets were RMB 708,050 thousand, a decrease of RMB 7,389 thousand from RMB 715,439 thousand at the end of 2022 [115]. - The company's cash and cash equivalents as of June 30, 2023, were RMB 432,975 thousand, an increase of RMB 15,206 thousand from RMB 417,769 thousand at the end of 2022 [116]. - The company's total liabilities to total assets ratio increased to 0.5 as of June 30, 2023, compared to 0.4 as of December 31, 2022, primarily due to increased bank borrowings for the global R&D center construction [117]. - The company has identified various financial risks, including market risk, credit risk, and liquidity risk, and is focused on mitigating potential adverse impacts on financial performance [162]. - The company’s overall risk management plan emphasizes the unpredictability of financial markets to safeguard its financial condition and performance [162]. Workforce and Corporate Culture - The workforce consists of 463 employees, with 67% in production, 16% in R&D, 13% in general and administrative roles, and 5% in sales and marketing [140]. - Employee benefits expenses for the first half of 2023 were RMB 80,899 thousand, up from RMB 60,831 thousand in the same period of 2022, reflecting a significant increase in workforce costs [118]. - The company has restructured its corporate culture to promote long-term sustainable development and improve customer satisfaction [109].

Financial Data and Key Metrics Changes - The company's total revenue for the first half of 2023 reached RMB 328 million, representing an 80% year-on-year increase. Excluding the impact of licensing fees from the previous year, the revenue growth was 147% [11][13][17] - Adjusted EBITDA turned positive for the first time at RMB 13.5 million, compared to a loss of RMB 37.49 million in the same period last year [19][15] - Operating cash flow for the first half of 2023 was RMB 62.41 million, a significant increase of 116% year-on-year [20][11] Business Line Data and Key Metrics Changes - The CDMO revenue was RMB 46.55 million, reflecting a 105% increase compared to the previous year [11][17] - The company has focused on ADC technology, with the number of ADC projects increasing from 8 to 28, a growth of 250% [9][31] - The company has established the largest ADC commercial production line in China, with an annual production capacity of 530,000 units [11][16] Market Data and Key Metrics Changes - The market for ADCs is expected to grow significantly, with the potential for the market size of Bevacizumab in China to reach RMB 18.4 billion [5][9] - The company has initiated registration applications in 20 overseas countries, with 8 applications already accepted [7][9] Company Strategy and Development Direction - The company aims to continue focusing on the ADC CDMO market and expand into XDC and other antibody-based therapies [11][15] - The strategy includes enhancing the production capabilities and maintaining a competitive edge through a fully integrated ADC production platform [12][19] - The company plans to leverage its established relationships and technology to capture a larger share of the ADC market [11][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about maintaining growth momentum in the second half of 2023, expecting at least similar performance to the first half [11][15] - The company acknowledges the challenges in the financing environment for biotech firms but remains confident in the demand for ADCs [11][27] - The management highlighted the importance of strategic partnerships and collaborations to enhance market presence and operational efficiency [12][31] Other Important Information - The company has achieved a project success delivery rate of 100%, indicating strong operational capabilities [12][19] - The workforce in the CDMO segment has increased by 13% since the end of 2020, with a focus on enhancing technical expertise [9][10] Q&A Session Summary Question: What is the current status of the company's orders and future timelines? - The company has a total order backlog of RMB 1.2 billion, with RMB 900 million expected to convert into revenue [20][21] Question: How does the company plan to expand its overseas market presence? - The company is focusing on emerging markets and has initiated collaborations to enhance its international footprint [27][30] Question: What are the key differences in customer structure compared to competitors? - The company has a strong focus on ADC projects, with a higher proportion of late-stage clinical projects compared to competitors [32][33]

Financial Performance - The group's operating revenue reached RMB 328,063 thousand, representing an 80% year-on-year increase, and a 147% increase when excluding one-time licensing income from the first half of 2022[2]. - Revenue for the six months ended June 30, 2023, was RMB 328,063,000, compared to RMB 182,019,000 for the same period in 2022, indicating an increase of about 80%[32]. - Sales revenue amounted to RMB 277,881 thousand, a significant increase of 167%, primarily driven by strong sales performance of the core product, Bevacizumab (Bai Xin Ting) biosimilar[56]. - The company's CDMO/CMO revenue for the first half of 2023 was RMB 46,546 thousand, an increase of RMB 23,889 thousand or 105% compared to RMB 22,657 thousand in the same period of 2022[110]. - The company's net loss for the first half of 2023 was RMB 15,163 thousand, a decrease of RMB 561 thousand or 4% from a net loss of RMB 15,724 thousand in the same period of 2022[134]. Cash Flow and Expenses - Operating cash flow showed a positive trend, with net cash flow from operating activities increasing by 116% to RMB 62,413 thousand[2]. - The financial cost for the first half of 2023 was RMB 2,261 thousand, a decrease of RMB 1,157 thousand from RMB 3,418 thousand in the same period of 2022[140]. - The company reported a significant increase in R&D expenses, totaling RMB 197,376 thousand, compared to RMB 70,268 thousand in the previous year[3]. - Research and development expenses for the first half of 2023 amounted to RMB 49,969 thousand, down from RMB 70,268 thousand in the same period of 2022[134]. Project Development and Collaborations - The group focused on ADC CDMO differentiated competition, with 45 ongoing projects, of which 28 are ADC projects, accounting for 62%[2]. - In the first half of the year, 20 new projects were added, including 15 ADC projects, which included 3 new pre-BLA ADC projects[2]. - The company has established partnerships for ADC projects with several biopharmaceutical companies, showcasing its capabilities in the ADC CDMO field[83]. - The company established multiple strategic collaborations, including with Shijian Biotech for ADC drug development and commercialization[164]. Market Outlook - The market size for Bevacizumab in China is projected to reach RMB 18.4 billion by 2030, with a compound annual growth rate of 8.3% from 2021 to 2030[62]. - The Chinese biopharmaceutical market is expected to grow from RMB 410 billion in 2021 to RMB 710.2 billion by 2025, with a compound annual growth rate of 14.7%[66]. - The ADC drug market is projected to grow from $7.9 billion in 2022 to $64.7 billion by 2030, with a compound annual growth rate (CAGR) of 30%[186]. - By 2030, the ADC CDMO market is projected to grow significantly to $11 billion, with a CAGR of 28.4% from 2022 to 2030[193]. Production Capacity and Infrastructure - The company has established a commercial production line for ADCs, with a total production capacity exceeding 20,000L, equipped with industry-leading facilities[95]. - The company has two ADC production lines with an annual capacity of 5.3 million vials, operating at a speed of 200 vials per minute[181]. - The ADC production workshop has three independent rooms with an annual production capacity of 150 batches and a designed output of 600 kg[149]. - The company has built a quality management system compliant with international standards, supporting the commercialization of two listed products[170]. Corporate Governance and Strategy - The company has adopted the principles and code of conduct outlined in the corporate governance code as a basis for its corporate governance practices[175]. - The company aims to become a leading and trusted partner in the biopharmaceutical industry, focusing on enhancing service quality and technical capabilities[132]. - The company is committed to long-term sustainable development by enhancing team communication and collaboration, aiming to become a trusted partner in the biopharmaceutical industry[106]. - The board has resolved not to declare an interim dividend for the six months ended June 30, 2023[195].

Compliance and Certifications - The company has achieved compliance with GMP standards and possesses commercialization capabilities[1] - The company has received NMPA GMP certification for its self-developed products, ensuring commercial production capabilities[5] - The company has received NMPA GMP certification for its monoclonal antibody production line, ensuring compliance with quality standards[75] Research and Development - The global R&D center, covering an area of 25,000 square meters, is set to be operational in the second half of 2023, marking a significant milestone in the company's global industrial layout[6] - The company has a strong focus on R&D and production of renewable energy solutions, as indicated by the previous roles of its executives in related industries[33] - The company is focused on developing and commercializing innovative oncology drugs, with a pipeline that includes monoclonal antibodies (mAb) and antibody-drug conjugates (ADC)[140] Production and Operational Achievements - The company completed 100% of production project deliveries in 2022, gaining market trust and high recognition from customers despite challenges posed by the pandemic[10] - The company has established a leading "end-to-end" ADC industrialization platform to enhance its CDMO business scale and market competitiveness[11] - The company has successfully completed multiple batches of clinical production and process validation for ADC drugs and CDMO projects[5] - The company has equipped its production lines with advanced technology, including a fully automated filling line for monoclonal antibodies, maximizing production efficiency[5] - The company has achieved a monoclonal antibody production scale of over 20,000L, equipped with commercial, pilot, and small-scale production lines[75] - The ADC (Antibody-Drug Conjugate) production facility has a capacity of up to 500L, with multiple batches of ADC drugs completed for clinical production and process validation, meeting GMP standards[76] - The formulation production capacity exceeds 18,000 bottles per hour for filling, with freeze-dried product capacity exceeding 50,000 bottles per batch[77] Corporate Governance - The company has adopted the corporate governance code as a foundation for its governance practices, ensuring accountability, transparency, fairness, and risk management[38] - The board believes that high standards of corporate governance are essential for protecting shareholder interests and enhancing corporate value[38] - The company has established a clear separation of roles between the Chairman and the CEO to enhance governance[43] - The board consists of seven members, including two executive directors, two non-executive directors, and three independent non-executive directors as of December 31, 2022[41] - The board has maintained compliance with listing rules by having at least three independent non-executive directors, representing one-third of the board members[46] - The board consists of three independent non-executive directors, accounting for 42.9% of the board[55] - The company has implemented strict guidelines for employee trading of securities to prevent insider trading[41] Risk Management and Compliance - The company confirmed its responsibility for the effectiveness of risk management and internal control systems, which are designed to manage, not eliminate, risks to achieving business objectives[105] - The audit and related party transaction committee has assisted the board in overseeing the design, implementation, and monitoring of risk management and internal control systems[108] - The company has established a risk governance framework to identify, assess, resolve, monitor, and communicate key risks, including strategic, financial, operational, and compliance risks[105] - The company has established a whistleblowing procedure to allow employees to confidentially express concerns regarding financial reporting and internal controls[113] - The company has conducted annual self-assessments to ensure compliance with control policies across various departments[111] Leadership and Management - The company appointed Dr. Pan Zhiwei as Vice President of CMC (Chemistry, Manufacturing, and Controls) in March 2023, responsible for process development and project management[33] - Ms. Xiao Ben joined the company in January 2022 and was appointed as Chief Financial Officer in October 2022, overseeing financial management and investment matters[33] - The company has expanded its leadership team with experienced professionals from various sectors, enhancing its strategic capabilities[33] - The leadership team has extensive experience in the biopharmaceutical and biotechnology sectors, which is crucial for the company's growth strategy[33] - The strategic appointments reflect the company's commitment to strengthening its operational and financial management capabilities[33] Environmental, Social, and Governance (ESG) - The company is focused on enhancing its ESG governance standards and integrating ESG concepts into its regular management practices[10] - The strategic and ESG committee consists of five members, including Mr. Fu Shan as the chairman, overseeing the implementation and evaluation of significant changes in ESG projects[21] - The company aims to review its long-term strategic development plans and provide recommendations to the board regarding ESG-related issues[21] - The company is focused on assessing its environmental and social impacts while monitoring international and Chinese ESG trends to identify potential business opportunities and risks[21] - The company has implemented ESG policies to ensure sustainability and compliance with applicable laws and regulations[93] Financial Performance - The company reported a net loss for the year ending December 31, 2022, with specific figures detailed in the comprehensive loss statement on page 82 of the annual report[141] - The company has no plans to pay any cash dividends in the foreseeable future, as it intends to retain all available funds for business development[131] - For the year ended December 31, 2022, revenue from the group's top five customers accounted for less than 30% of total revenue[152] - As of December 31, 2022, purchases from the group's top five suppliers represented 46% of total procurement costs, with the largest supplier accounting for 21%[156] Shareholder and Stakeholder Engagement - The company has maintained regular communication with shareholders through various channels, including annual general meetings and social media platforms[117] - The company emphasizes effective communication with shareholders to strengthen investor relations and understanding of its business performance and strategies[128] Diversity and Inclusion - The board consists of 5 male directors and 2 female directors, achieving a gender diversity ratio of 29% female and 71% male[86] - The senior management team has a gender diversity ratio of 53% female and 47% male, with 9 female and 8 male members[88] - The overall employee gender ratio is 53% female and 47% male, comprising 229 female and 202 male employees[88] - The company has adopted a Board Diversity Policy to enhance diversity at the board level, considering factors such as gender, age, and professional qualifications[85] Compensation and Incentives - The company’s compensation policy for executives is based on skills, knowledge, responsibilities, and company performance, with performance bonuses included[41] - The group has established a compensation committee responsible for developing compensation policies for all directors, senior management, and employees[152] - The group has implemented an employee stock option plan since 2013 to incentivize and reward employees[153] - The group has adopted a restricted share incentive plan in 2020 to further motivate employees[153] Audit and Financial Oversight - The Audit and Related Party Transactions Committee held four meetings during the year ended December 31, 2022, to review and approve interim and annual financial performance and reports[79] - The external auditor's fees for the year ended December 31, 2022, totaled RMB 3,230,000, with RMB 3,200,000 for audit services and RMB 30,000 for non-audit services[114]

Financial Performance - The company's revenue for the year ended December 31, 2022, reached RMB 442,178 thousand, a significant increase of 479% compared to RMB 76,325 thousand in 2021[6] - The net loss was reduced by 81% to RMB 50,046 thousand, and the net cash flow from operating activities turned positive at RMB 59,929 thousand[6] - In 2022, the group's operating revenue increased by 479% year-on-year to RMB 442,178 thousand, driven by a significant rise in self-developed product sales, continuous development of CDMO business, and increased milestone licensing income[16] - The group's net loss narrowed by 81% year-on-year to RMB 50,046 thousand, and net cash flow from operating activities turned positive for the first time, amounting to RMB 59,929 thousand[16] - The company reported a net loss of RMB 50,046 thousand for the year, compared to a net loss of RMB 261,216 thousand in the previous year[44] - The company's cash and cash equivalents increased to RMB 417,769 thousand in 2022, up from RMB 152,805 thousand in 2021[47] - The company's financing activities generated a net cash inflow of RMB 212,082 thousand in 2022[38] - The company's weighted average number of ordinary shares issued increased to 639,307 thousand in 2022 from 573,360 thousand in 2021, indicating a rise of approximately 11.5%[64] - The company's total equity as of December 31, 2022, was RMB 715,439 thousand, compared to RMB 335,091 thousand in 2021[47] Revenue Breakdown - Product sales revenue amounted to RMB 304,361 thousand, while CDMO/CMO business revenue was RMB 72,538 thousand, and licensing income was RMB 54,151 thousand[6] - The total revenue from sales in 2022 was RMB 304,361 thousand, driven by steady growth in sales of the core product, Bevacizumab Injection (朴欣汀®)[108] - The CDMO/CMO business generated revenue of RMB 72,538 thousand in 2022, representing a 35% year-over-year growth[41] - The group's revenue from royalties in 2022 was RMB 54,151 thousand, an increase of RMB 48,208 thousand from RMB 5,943 thousand in 2021[91] Market Expansion and Strategy - In 2023, the company aims to accelerate international expansion and enhance brand influence while continuing to implement its CDMO strategic objectives[11] - The company has successfully completed multiple market launch applications in various countries to meet overseas market demand[21] - The company is actively expanding its market presence in second and third-tier cities through strategic partnerships and marketing initiatives[163] - The company has established a new sales promotion agreement with a third party, indicating a strategy for market expansion[104] Production Capacity and Development - The company has established a production scale of 20,000L for monoclonal antibodies, with an annual capacity design exceeding 300,000 liters[10] - The ADC commercialization production capacity has been enhanced, with a fully integrated ADC formulation workshop and antibody liquid production workshop achieving zero defects in EU Qualified Person audits[10] - The company completed 45 CDMO projects in 2022, including 18 ADC projects, 23 antibody projects, and 2 chemical drug projects, with 25 projects successfully delivered[182] - The company has established a comprehensive ADC industrialization platform with end-to-end capabilities, enhancing its market competitiveness[155] - The company has completed multiple clinical production batches of ADC drugs, meeting GMP standards and commercial requirements[193] Research and Development - Research and development expenses for the year were RMB 151,168 thousand, compared to RMB 214,699 thousand in the previous year[44] - The company has initiated the construction of a global R&D center with a total investment of approximately RMB 180 million, with expenditures of RMB 49,778 thousand incurred by December 31, 2022[137] - The company is advancing the clinical development of ADC candidate drug TAE020 and collaborating with Hengrui Medicine Co., Ltd. on the co-development of innovative antibody drug TAC020[168] Financial Obligations and Assets - The total liabilities increased to RMB 546,592 thousand in 2022 from RMB 375,172 thousand in 2021, indicating a significant rise in financial obligations[29] - The total equity and liabilities reached RMB 1,262,031 thousand in 2022, up from RMB 710,263 thousand in 2021, reflecting the company's growth trajectory[29] - Total assets as of December 31, 2022, amounted to RMB 1,262,031 thousand, an increase from RMB 710,263 thousand in 2021[47] Compliance and Quality Management - The company achieved a significant milestone by passing the EU QP audit in October 2022, enhancing its international quality management capabilities[125] - The company's antibody and ADC commercial production base in Suzhou passed the EU QP audit with zero defects, confirming compliance with EU GMP standards[170] - The company has established a commercial production quality management system compliant with international standards, passing GMP compliance checks for its antibody and ADC production facilities[169] ESG and Governance - The company has enhanced its ESG governance standards through various initiatives, integrating ESG concepts into routine management[197] - The company has implemented a series of pandemic prevention and control policies to ensure stable production capacity during challenging times[197] Future Market Projections - The Chinese biopharmaceutical market is projected to grow from RMB 410 billion in 2021 to RMB 710.2 billion by 2025, with a compound annual growth rate (CAGR) of 14.7%[141] - The ADC drug market in China is expected to grow rapidly, with a compound annual growth rate (CAGR) of 116.0% from 2021 to 2025, reaching a market size of 7.8 billion RMB by 2025[153] - The global biopharmaceutical CDMO market is projected to reach 35.3 billion USD by 2025 and 67.9 billion USD by 2030, while China's biopharmaceutical CDMO market is expected to reach 37.3 billion RMB by 2025 and 85.3 billion RMB by 2030[159]

Financial Performance - In the first half of 2022, TOT Biopharm reported revenue of RMB 182 million, a year-on-year increase of 687%, primarily driven by sales growth from its product Puxinting® and a 94% increase in CDMO business revenue to RMB 22.66 million[6]. - The company's net loss for the first half of 2022 was RMB 15,724 thousand, a reduction of RMB 99,281 thousand or 86% from a net loss of RMB 115,005 thousand in the same period of 2021[62]. - The group reported total revenue of RMB 182,019 thousand for the first half of 2022, a significant increase from RMB 23,132 thousand in the same period of 2021, reflecting a growth of 687%[79]. - Revenue from product sales reached RMB 104,170 thousand, up from RMB 13 thousand in the previous year, indicating a substantial increase[115]. - The company reported a loss attributable to equity holders of RMB 15,724 thousand for the six months ended June 30, 2022, a decrease from a loss of RMB 115,005 thousand in the same period of 2021, showing an improvement in financial performance[125]. Research and Development - Research and development expenses for the first half of 2022 amounted to RMB 70,268 thousand, a decrease of RMB 18,481 thousand or 21% from RMB 88,749 thousand in the same period of 2021[62]. - The company aims to enhance its CDMO business scale and strengthen its self-sustaining capabilities through deep collaboration with partners[60]. - The company has completed multiple clinical production projects and process validation for ADC drugs, ensuring compliance with GMP standards[36]. - The company has developed over 10 different ADC technologies, accumulating rich practical experience in clinical production projects[28]. - The company’s research and development expenses for the six months ended June 30, 2022, were RMB 8,431 thousand, down from RMB 13,104 thousand in the same period of 2021, indicating a reduction in R&D spending[124]. Market Opportunities - The market for anti-tumor drugs in China is projected to reach RMB 416.2 billion by 2025, with a compound annual growth rate (CAGR) of approximately 16.1% from 2020 to 2025[5]. - The global ADC drug market exceeded USD 5 billion in 2021, with an expected CAGR of 53.0% from 2021 to 2025[5]. - The market size for wAMD drugs in China is expected to reach USD 3.5 billion by 2030[10]. - The global ADC market is projected to reach USD 16.4 billion by 2026, indicating a strong growth opportunity for the company's ADC pipeline[24]. Product Development and Clinical Trials - The ADC drug TAA013 has completed patient enrollment for its Phase III clinical trial, with ongoing follow-up for participants[8]. - TAB014, the first recombinant humanized anti-VEGF monoclonal antibody for treating wAMD in China, has completed the first patient enrollment for its Phase III clinical trial[10]. - The ADC drug TAA013 is currently in Phase III clinical trials and is gaining significant market attention due to its promising clinical data[24]. - The company plans to accelerate the analysis of Phase III clinical data for TAA013 and expedite the market layout for its products, including Puxintin® and Tezacaftor®[60]. Strategic Partnerships and Collaborations - The company is actively seeking partners for the market collaboration of TAA013 and plans to submit consultation documents to the EMA[9]. - The company signed an exclusive promotion agreement for TAB008 with Jiangxi Jimin Kexin Pharmaceutical, enhancing its market penetration across all provinces in China[17]. - The company has established a collaboration with Sinovac Biotech to commercialize TAB008 in international markets, with preliminary cooperation intentions reached with over ten countries[19]. - The company has partnered with Frontline Bio to promote its product Meishiya (Medroxyprogesterone Acetate Oral Suspension) in the AIDS treatment sector, leveraging Frontline's extensive marketing network[23]. Financial Position and Cash Flow - As of June 30, 2022, the group's cash and cash equivalents amounted to RMB 154,876 thousand, an increase of RMB 2,071 thousand from RMB 152,805 thousand at the end of 2021[68]. - The group's operating cash flow for the first half of 2022 was a net inflow of RMB 24,241 thousand, compared to a net outflow of RMB 93,624 thousand in the same period of 2021, primarily due to a significant increase in sales revenue[68]. - The total liabilities to total assets ratio as of June 30, 2022, was 0.6, up from 0.5 at the end of 2021, mainly due to an increase in advance payments from product sales and CDMO business expansion[75]. - The company reported a net cash inflow from operating activities of RMB 24,241 thousand for the first half of 2022, a recovery from a net outflow of RMB 93,624 thousand in the same period of 2021[86]. Shareholder Information - Major shareholder Shengde Pharmaceutical Co., Ltd. holds approximately 29.19% of the company's shares, totaling 179,561,700 shares[181]. - Vivo Capital LLC and its affiliates collectively hold 16.78% of the company's shares, amounting to 103,245,000 shares[181]. - The total number of issued shares as of June 30, 2022, is 615,229,497 shares[182]. - The company has implemented a pre-IPO share option plan to attract and retain talent, enhancing productivity and creating value for shareholders[186]. Corporate Governance - The company has adopted the principles and code provisions of the Corporate Governance Code as its corporate governance practices[197]. - The audit committee reviewed the financial reporting process and internal control systems, confirming compliance with applicable accounting standards and legal requirements[200]. - The company confirmed that all directors complied with the standard code of conduct during the reporting period[198].

Financial Performance - In 2021, the company achieved a revenue of RMB 76,325 thousand, a 239.36% increase from RMB 22,491 thousand in 2020, with RMB 53,690 thousand coming from CDMO/CMO business[9] - The operating loss for 2021 was RMB 259,700 thousand, a 10% improvement from the operating loss of RMB 288,672 thousand in 2020[17] - The net loss for 2021 was RMB 261,216 thousand, which is a 9% decrease from the net loss of RMB 288,498 thousand in 2020[17] - The adjusted net loss for 2021 was RMB 255,920 thousand, a decrease of RMB 16,746 thousand compared to the adjusted net loss of RMB 272,666 thousand in 2020[22] - The adjusted EBITDA for 2021 was RMB 219,215 thousand, down RMB 19,663 thousand from RMB 238,878 thousand in 2020[22] - CDMO and CMO service revenue for 2021 reached RMB 53,690 thousand, up RMB 47,267 thousand from RMB 6,423 thousand in 2020[23][26] - The company's general and administrative expenses increased to RMB 56,336 thousand in 2021 from RMB 46,855 thousand in 2020, an increase of RMB 9,481 thousand[30] - The total assets as of December 31, 2021, were RMB 710,263 thousand, compared to RMB 641,183 thousand as of December 31, 2020[39] - The net assets decreased to RMB 335,091 thousand as of December 31, 2021, down RMB 247,266 thousand from RMB 582,357 thousand in 2020[38] - The total liabilities increased significantly to RMB 375,172 thousand in 2021 from RMB 58,826 thousand in 2020[39] Research and Development - Research and development expenses for 2021 were RMB 214,699 thousand, a decrease of 8.72% from RMB 235,196 thousand in 2020, primarily due to the completion of Phase III clinical trials for TAB008[9] - R&D expenses for 2021 were RMB 214,699 thousand, a 9% decrease from RMB 235,196 thousand in 2020[17] - The global R&D center, with a total construction area of 25,000 square meters, was initiated on November 9, 2021, to enhance innovative drug development capabilities[12] - The company has accelerated the development of its one-stop innovative drug CDMO business, providing effective solutions for new drug development[12] - The company is focusing on antibody drug development, with several products in various stages of clinical trials, including TAA013 for HER2-positive breast cancer[59] Product Development and Launches - The company’s first self-developed biopharmaceutical, TAB008 (Bevacizumab Injection), was approved for market launch, establishing exclusive promotion partnerships in China and commercialization agreements in emerging overseas markets[9] - The company successfully launched TOZ309 (Temozolomide Capsules) and TOM218 (Medroxyprogesterone Acetate Oral Suspension), with promotional collaborations established for both products in the Chinese market[10] - Three products were successfully approved for market launch in 2021: TAB008 (Bevacizumab injection) on November 30, TOZ309 (Temozolomide capsules) in May, and TOM218 (Medroxyprogesterone acetate oral suspension) in May[57][63][65] - TAB008, a biosimilar to Avastin, targets multiple high-incidence cancers and had global sales of $6.09 billion in 2020, with an expected market size in China nearing RMB 10 billion by 2030[62] - TOZ309 is a generic version of Temodar, used as a first-line treatment for newly diagnosed and recurrent glioblastoma, offering stronger efficacy and fewer side effects compared to conventional chemotherapy[63] - TOM218 is the first high-concentration oral suspension of Medroxyprogesterone acetate approved in China, aimed at improving the condition of patients with cancer and AIDS-related cachexia[65] Strategic Partnerships and Collaborations - The company has formed a strategic partnership with Borui Biopharmaceuticals to strengthen its one-stop CDMO service platform[12] - The company has established a global strategic cooperation with HAPLOMED for the joint development of innovative antibody drugs targeting tumor diseases[58] - The company signed an exclusive promotion agreement with Jiangxi Jixin Pharmaceutical to enhance market penetration for TOZ309 and TAB008, achieving 90% provincial coverage for national procurement[70] - The company is collaborating with Sinovac Biotech to commercialize the product Puxintin in overseas markets, aligning with the Belt and Road Initiative[71] Market Outlook and Growth - The Chinese oncology drug market was valued at USD 28.6 billion in 2020 and is projected to grow to USD 60.3 billion by 2025, with a CAGR of 16.1%[55] - The CDMO/CMO market in China is projected to grow at a compound annual growth rate (CAGR) of 30.0% from 2021 to 2025, with expected revenue of CNY 123.5 billion by 2025[74] - The ADC drug market is anticipated to reach USD 16.4 billion globally by 2026, with TAA013 being one of the three HER2-positive breast cancer drugs in Phase III trials[74] Corporate Governance - The board consists of nine members, including two executive directors, four non-executive directors, and three independent non-executive directors as of December 31, 2021[133] - The company has adopted the corporate governance code as a basis for its governance practices, ensuring compliance with all applicable provisions[133] - The company has established a strict set of guidelines for employees regarding the handling of unpublished price-sensitive information[133] - The board believes that high standards of corporate governance are essential for protecting shareholder interests and enhancing corporate value[133] - The company has implemented internal and external training for senior management and employees to ensure compliance with governance policies[133] Risk Management - The company faces significant risks, including substantial net losses and cash flow issues, as well as potential impacts from infectious disease outbreaks on business operations and clinical research[195] - The company has established a risk governance framework to identify, assess, and monitor key risks, including strategic and financial risks[174] - The company has implemented multiple risk management procedures and guidelines to address potential risks in key business processes[177] Sustainability and ESG - The establishment of a strategic and ESG committee by the board aims to integrate environmental, social, and governance factors with the company's strategy for sustainable development[94] - The company recognizes the importance of environmental policies for sustainable growth and has established a strategic and ESG committee to enhance corporate governance[196] - The company emphasizes the importance of evaluating its environmental and social impacts, aligning with international and local ESG trends[158]

Market Growth - The global cancer drug market reached $150.3 billion in 2020 and is projected to grow to $304.8 billion by 2025, with a CAGR of 15.2%[6] - The Chinese cancer drug market was valued at $28.6 billion in 2020 and is expected to increase to $60.3 billion by 2025, with a CAGR of 16.1%[6] Revenue and Financial Performance - Total revenue for the first half of 2021 was RMB 23.132 million, reflecting a year-on-year increase of 77.5%[8] - The company reported operating revenue of RMB 23,132 thousand for the six months ended June 30, 2021, compared to RMB 13,030 thousand for the same period in 2020, representing an increase of 77.6%[63] - The net loss for the first half of 2021 was RMB 115,005 thousand, a decrease from RMB 129,183 thousand in the same period of 2020, reflecting a reduction of 11%[49] - The company reported a loss attributable to equity holders of RMB (115,005,000) for the six months ended June 30, 2021, an improvement from a loss of RMB (129,183,000) in the same period of 2020[111] - The total comprehensive loss for the period was RMB 114,980 thousand, compared to RMB 124,962 thousand in the first half of 2020, indicating a decrease in comprehensive losses[68] Product Development and Pipeline - The company has 12 products in its pipeline, including monoclonal antibodies and ADCs targeting various cancers[11] - The first self-developed chemical drug, Temozolomide capsules (TOZ309), was approved for market in May 2021[11] - The company has a robust pipeline with multiple drugs in various stages of development, including TAA013 for HER2-positive breast cancer and TAY018 for non-Hodgkin lymphoma, among others[13] - TAA013, an ADC drug for HER2-positive breast cancer, is in Phase III clinical trials, with the market size expected to grow from $2.6 million in 2020 to $228.9 million by 2024, representing a CAGR of 207.4%[23] - TAB014, an anti-VEGF monoclonal antibody for wet age-related macular degeneration, has received FDA approval for Phase III clinical trials, with the market projected to increase from $240 million in 2019 to $3.5 billion by 2030, reflecting a CAGR of 27.5%[24] Research and Development - The company has developed three comprehensive technology platforms to support innovative drug development and collaboration[10] - The company has developed a gene engineering-based therapeutic technology platform that integrates anti-tumor immunotherapy, gene therapy, and viral therapy, focusing on early detection and collaboration with innovative tumor drug companies[12] - The company is focused on ongoing and planned clinical trials, facility expansions, and potential commercial launches for its drug candidates[189] Strategic Partnerships and Collaborations - The company is actively promoting the commercialization of self-developed products through partnerships with major pharmaceutical companies[7] - The company has formed strategic partnerships to enhance its ADC CDMO service platform, facilitating the development and commercialization of innovative drugs[32] - The company is actively collaborating with domestic pharmaceutical companies to enhance market access and product distribution[19] Production and Manufacturing - The company has established a GMP-standard ADC commercial production facility, enhancing its competitive edge in the ADC sector[10] - The company has established a GMP-compliant production facility for ADC commercial production, enhancing its capabilities in antibody drug and ADC commercialization[37] - The company plans to expand its ADC production capacity, with a target of 1,000 to 3,000 grams per batch for ADC bulk production and 10,000 to 15,000 vials per batch for ADC formulation[39] Financial Management and Liquidity - The company’s cash and cash equivalents as of June 30, 2021, were RMB 156,243 thousand, down from RMB 225,533 thousand at the end of 2020, a decrease of 30.7%[49] - The total liabilities to total assets ratio as of June 30, 2021, was 0.2, up from 0.1 at the end of 2020, indicating an increase in leverage due to higher bank borrowings[49] - The company raised RMB 72,175 thousand from bank borrowings during the first half of 2021, which was not present in the same period of 2020[70] - The group maintains sufficient cash and cash equivalents to meet liquidity requirements, with a focus on monitoring cash flow risks[88] Employee and Management - As of June 30, 2021, the company had a total of 354 employees, with 32.8% in R&D, 15.2% in sales and marketing, 11.6% in general and administrative, and 40.4% in manufacturing[56] - Employee benefits expenses for the first half of 2021 amounted to RMB 65,213 thousand, an increase of 18.5% from RMB 54,927 thousand in the first half of 2020[56] - Dr. Liu Jun's salary as CEO is RMB 70,000 per month, effective from April 2021, with additional bonuses as applicable[190] Corporate Governance and Compliance - The company has complied with all applicable corporate governance code provisions during the reporting period[184] - The financial statements for the six months ended June 30, 2021, were reviewed and deemed compliant with applicable accounting standards and regulations[185] Market Trends and Opportunities - The aging population in China is driving the market for wet age-related macular degeneration treatments, indicating a growing opportunity for the company's products[24] - ADC drugs are gaining significant attention in the market, with 12 products approved globally and four in China, highlighting the competitive advantage of the company's ADC drug development[26] Future Outlook - The company provided a forward guidance of 20% revenue growth for the next quarter, projecting $1.44 billion[198] - The company is exploring acquisition opportunities to enhance its product portfolio, targeting a deal valued at $200 million[198] - A new strategic partnership was announced, expected to drive an additional $100 million in revenue over the next year[198]

R&D and Product Development - TOT Biopharm has established a comprehensive R&D and industrialization platform for monoclonal antibodies (mAb) and ADC drugs, enhancing production capacity to meet both domestic and international clinical and commercial needs[6]. - The company has a diverse product pipeline, including monoclonal antibodies, ADCs, oncolytic viruses, and small molecule drugs, indicating a robust R&D capability[7]. - The company is committed to international standards in the commercialization of biopharmaceuticals, particularly ADCs, to enhance its market position[7]. - The company has developed an innovative cell expansion technology that allows scaling from a 25L WAVE reactor to a 2,000L biopharmaceutical reactor, successfully producing clinical trial drugs[14]. - The company aims to enhance its ADC research and commercialization platform, with plans to equip facilities for both pilot and commercial production[54]. - The company has established three comprehensive technology platforms for monoclonal antibodies and ADCs, enhancing its commercial production capabilities and international quality management systems[38]. - The company has initiated lipid-based drug delivery system research and technology development for nucleic acid drugs[41]. - The company has developed the tumor drug TVP211 based on vaccinia virus and continues to validate this drug on its platform[43]. Clinical Trials and Regulatory Approvals - The TAA013 drug for treating HER2-positive advanced breast cancer has successfully entered Phase III clinical trials, showcasing the company's strength in the ADC field[8]. - TAB008, the fastest progressing biological drug, reached the primary endpoint of Phase III clinical trials in April 2020 and has submitted for market approval, expected to be granted in 2021[9]. - TAA013, an anti-HER2 ADC for HER2-positive breast cancer, initiated Phase III clinical trials in June 2020, with patient recruitment ongoing[29]. - The Phase I clinical results of TAA013 were presented at the SABCS, showing good safety and preliminary efficacy in HER2-positive breast cancer patients previously treated with anti-HER2 therapies[39]. - The clinical trial for TOM312 has been approved by the ethics committee, indicating progress in its development[33]. - The company reported that the Phase III clinical results for TAB008 have reached endpoints, with findings presented at the ESMO ASIA conference in November 2020[28]. Financial Performance - The company reported a revenue of RMB 22,491 thousand for the year ended December 31, 2020, a decrease of 50% compared to RMB 45,308 thousand in 2019[56]. - The company experienced a net loss of RMB 288,498 thousand, which is a 4% decrease from the net loss of RMB 299,300 thousand in 2019[56]. - Research and development expenses increased by 23% to RMB 235,196 thousand from RMB 191,078 thousand in the previous year[56]. - The company's revenue for 2020 was RMB 22,491 thousand, a decrease of 50.4% from RMB 45,308 thousand in 2019[62]. - The net loss for 2020 was RMB 288,498 thousand, a reduction of 3.6% compared to a net loss of RMB 299,300 thousand in 2019[62][76]. - Adjusted net loss for 2020 was RMB 272,666 thousand, an increase of RMB 65,927 thousand from RMB 206,739 thousand in 2019[62]. - Adjusted EBITDA for 2020 was RMB 238,878 thousand, an increase of RMB 61,781 thousand from RMB 177,097 thousand in 2019[62]. Market and Strategic Development - The company has accelerated its strategic development, achieving multiple goals in a competitive market, with a focus on advancing the clinical progress of its drug candidates[8]. - The company is expanding its CDMO/CMO business to create new growth momentum, aligning with the increasing demand for innovative drugs[6]. - The company aims to enhance its CDMO/CMO business, expanding production capacity and business volume to create new revenue growth points[13]. - The company plans to expand its commercial production capacity to tens of thousands of liters over the next three years, enhancing its CDMO/CMO business[28]. - The company aims to establish long-term partnerships with multiple suppliers to support the rapid growth of its CDMO/CMO business[54]. - The company is actively seeking strategic collaborations both domestically and internationally to enhance its market competitiveness[54]. - The company aims to strengthen its competitive advantage by accelerating international strategic collaborations and expanding its ADC leadership in China[26]. Corporate Governance and Leadership - Huang Chunying has been appointed as Executive Director and Vice Chairman of the Board since October 2020, previously serving as General Manager from July 2010 to October 2020[106]. - Fu Shan has been the Chairman of the Board since September 2018 and is also the Managing Partner of Vivo Capital LLC, focusing on biotechnology and healthcare investments[107]. - The company has a strong leadership team with extensive experience in investment management and pharmaceutical development, enhancing its strategic direction[109]. - The board consists of nine members, including two executive directors, four non-executive directors, and three independent non-executive directors[127]. - The company has adopted the corporate governance code principles and provisions as the basis for its governance practices[127]. - The board believes that high standards of corporate governance are essential for protecting shareholder interests and enhancing corporate value[127]. Risk Management - The company has established a risk governance framework to identify, assess, and monitor key risks, including strategic, financial, operational, and compliance risks[168]. - The board is responsible for risk management and internal control systems, which aim to manage risks rather than eliminate them[168]. - The company recognizes the importance of risk management for effective operations and reliable financial reporting[194]. - The company has implemented internal control mechanisms to address any deficiencies in financial risk management[193]. Market Trends and Projections - The global ADC market is projected to reach $12.9 billion by 2024, with a compound annual growth rate (CAGR) of approximately 35% from 2018 to 2024, indicating substantial market potential[9]. - The Chinese oncology drug market is projected to grow from $16.9 billion in 2015 to $28.1 billion in 2019, with a CAGR of 13.5%, and is expected to reach $56.5 billion by 2024 and $101.8 billion by 2030, averaging a CAGR of approximately 15.0%[19]. - The ADC market for HER2-positive breast cancer in China is projected to grow from $2.6 million in 2020 to $228.9 million by 2024, with a CAGR of 207.4%[37]. Employee and Operational Insights - The company maintained a total of 366 employees as of December 31, 2020, with 55.2% in R&D and 16.9% in sales and marketing[88]. - Employee benefits expenses increased to RMB 106,382 thousand in 2020 from RMB 101,067 thousand in 2019, reflecting costs related to salaries, bonuses, and social security contributions[88]. - The company has implemented a restricted share incentive plan in 2020 to further motivate and reward employees[196]. - The company did not experience any significant impact from the COVID-19 pandemic on its R&D, clinical trials, or production as of the report date[89].