Financial Performance - The net cash used in operating activities for the year ended December 31, 2023, was RMB 144.4 million, compared to RMB 278.8 million for 2022[1]. - The company reported a basic and diluted loss per share of RMB (2.30) for 2023, compared to RMB (22.52) for 2022[28]. - The total comprehensive loss for the year decreased by 46.5% to RMB 562.5 million in 2023 from RMB 1,052.0 million in 2022, indicating improved financial performance[87]. - Adjusted total comprehensive loss for the year was RMB 263.6 million, a 4.1% increase compared to RMB 253.2 million in 2022[92]. - The total comprehensive loss for the year decreased by 46.5% from RMB 1,052.0 million in 2022 to RMB 562.5 million in 2023[92]. Revenue Growth - Revenue from the mainland China market for the year 2023 was RMB 634.9 million, an increase from RMB 567.4 million in 2022, representing a growth of approximately 11.3%[20]. - The company's revenue for the year ended December 31, 2023, increased by 11.9% to RMB 634.9 million from RMB 567.4 million in 2022, reflecting strong sales growth of the product Envidat (Envafolimab) since its launch in 2021[88]. - Envidat® achieved sales revenue of RMB 634.9 million in China for the year ended December 31, 2023, representing an 11.9% increase year-over-year[93]. - The main drivers for revenue and gross profit growth for the year ended December 31, 2023, were the significant increase in sales volume and gross margin of Envida®[76]. Research and Development - Research and development expenses increased by 21.3% to RMB 425.5 million, up from RMB 350.9 million in the same period of 2022[70]. - The company is focusing on developing next-generation tumor immune checkpoint inhibitors and researching mRNA candidates based on its extensive clinical development experience[76]. - The company is committed to enhancing its internal discovery capabilities and conducting critical clinical trials to address unmet clinical needs in cancer patients[76]. - The company is advancing its pipeline with next-generation tumor immunotherapy candidates, including peptide and mRNA tumor vaccines[79]. - The ongoing Phase I clinical study of 3D189, a peptide cancer vaccine targeting WT1 protein, has shown satisfactory progress in safety and immunogenicity among Chinese hematological cancer patients[124]. Clinical Trials and Approvals - The company received IND approval for a Phase III clinical trial of Envidat in combination with platinum-based chemotherapy for resectable stage III non-small cell lung cancer (NSCLC) patients[84]. - The FDA approved a Phase III clinical study for Envidat® in combination with Lenvatinib for the treatment of advanced or recurrent endometrial cancer on October 28, 2023[105]. - The recruitment for the Phase II clinical study of ENVOVIL monoclonal antibody combined with BD0801 for the treatment of advanced solid tumors was completed on March 9, 2023[107]. - The clinical study for the treatment of advanced solid tumors with Envidat® in combination with BD0801 has completed patient recruitment[133]. Strategic Initiatives - The company plans to utilize approximately 50% of the net proceeds from the 2023 placement for clinical trials of the Envorili monoclonal therapy, amounting to RMB 103.7 million[9]. - The construction of the production facility in Xuzhou, China, is expected to utilize 40% of the net proceeds, which is approximately RMB 82.9 million[9]. - The company raised approximately HKD 226.8 million through a placement of new shares in July 2023 to strengthen its financial position and accelerate the development of multiple clinical projects[94]. - The company has established a sales and marketing department focused on the commercialization of pipeline products, covering 1,300 hospitals and 1,100 pharmacies across 30 provinces[163]. Employee and Operational Expenses - The total employee benefits expenses for the year ended December 31, 2023, amounted to approximately RMB 403.7 million[3]. - Administrative expenses increased significantly by RMB 74.3 million to RMB 217.1 million, primarily due to an increase in share-based payment expenses of RMB 85.4 million[200]. - Sales and marketing expenses increased by 5.9% from RMB 357.7 million in 2022 to RMB 378.8 million in 2023, driven by a sales growth rate of 11.9% for Envidat®[91]. Market Position and Product Development - The company has established a pipeline consisting of 12 drugs or candidates, with Envida® being commercialized in mainland China in November 2021 and in Macau in January 2024[76]. - Envidat® has been included in three NCCN clinical practice guidelines and nine Chinese clinical treatment guidelines as of the performance announcement date[94]. - Envidat® has accumulated sales exceeding RMB 1 billion, marking its first commercialized product[152]. - The company holds a broad patent portfolio, including 13 granted patents in China and 18 in other jurisdictions, along with 21 pending patent applications[165].

Financial Performance - Revenue for the six months ended June 30, 2023, increased by 70.3% to RMB 352,553,000 compared to RMB 207,028,000 in the same period of 2022[3]. - Gross profit for the same period rose by 69.6% to RMB 325,252,000, up from RMB 191,824,000 in 2022[3]. - Total comprehensive loss for the period improved by 41.2% to RMB 190,204,000 from RMB 323,553,000 in 2022[3]. - Adjusted total comprehensive loss decreased by 29.9% to RMB 81,454,000 from RMB 116,131,000 year-over-year[3]. - The company reported a significant increase in revenue, achieving $150 million for the first half of 2023, representing a 25% year-over-year growth[10]. - The company provided an optimistic outlook, projecting a revenue growth of 20% for the full year 2023, targeting $300 million[10]. - Total comprehensive loss for the period decreased to RMB (190,204) thousand in 2023 from RMB (323,553) thousand in 2022, representing a reduction of approximately 41%[148]. - Adjusted total comprehensive loss for the period improved to RMB (81,454) thousand in 2023 compared to RMB (116,131) thousand in 2022, indicating a 30% decrease[148]. Research and Development - Research and development expenses decreased by 12.4% to RMB 151,606,000 from RMB 173,135,000 year-over-year[3]. - Future outlook includes continued investment in R&D to drive innovation and potential new product launches[3]. - The company is committed to strict compliance with drug production quality management regulations to ensure product quality and control risks[103]. - The company has a total of 12 drug candidates in its pipeline, with seven in various stages of clinical development[67]. - The company is developing a new generation of tumor vaccines aimed at treating various types of blood and solid tumors, with a global Phase III pivotal MRCT for AML currently ongoing[110]. - The company has developed four drug candidates in the IND-enabling stage, including 3D062, a KRAS mutation inhibitor, with PCT applications submitted on January 17 and March 8, 2023[156][157]. - The company is enhancing rights related to the ILB-2109 project in Mainland China through collaboration with Innolake Biopharm[159]. - The R&D platform includes large and small molecule platforms, cell line screening, and compound screening, aimed at increasing the success rate of drug development[159]. Market Expansion and Strategy - The company is focusing on expanding its market presence and enhancing its product pipeline through ongoing research and development efforts[3]. - The company is exploring strategic partnerships and potential acquisitions to bolster its market position[3]. - The company is expanding its market presence in Southeast Asia, with plans to enter three new countries by the end of 2023[10]. - A strategic acquisition of a local biotech firm was announced, valued at $20 million, aimed at enhancing R&D capabilities[10]. - The company plans to increase its workforce by 10% to support growth initiatives and enhance customer service[10]. - The company continues to focus on expanding its product availability in pharmacies and hospitals to enhance sales growth[57]. - The company is gradually carrying out pre-market preparations for products that are close to commercialization[162]. Sales and Marketing - Selling and marketing expenses increased by 62.8% to RMB 220,969,000 compared to RMB 135,751,000 in the previous year[3]. - The increase in revenue was attributed to the differentiation advantages of 恩維達 ®, broader coverage of pharmacies and hospitals, and strong recognition from doctors and patients[166]. - Sales of 恩維達 ® have covered more than 1,150 hospitals and pharmacies in over 200 cities across 30 provinces in China[162]. - The company has established a dedicated sales and marketing department for the commercialization of its pipeline products[162]. - The strong sales performance of Envafolimab in the first half of 2023 is attributed to its differentiated advantages recognized by doctors, good patient compliance, and strategic collaborations[90]. Clinical Trials and Product Development - The phase Ib/II trial for Envafolimab in combination with Lenvatinib has completed patient enrollment, with preliminary results accepted for presentation at the ESMO Annual Meeting in October 2023[67]. - A phase II clinical trial for Envafolimab monotherapy in subjects with dMMR advanced solid tumors has been approved by the FDA, with preparations underway for patient enrollment in multiple regions[67]. - The ongoing ENVASARC study is currently enrolling patients for a 600mg every three weeks monotherapy with Envolimab, with plans for an interim analysis in Q3 2023[102]. - The objective response rate (ORR) in the clinical trial for 3D229 combined with SOX treatment was 50%, with a disease control rate (DCR) of 87.5%[151]. - The company is awaiting final results from a Phase III trial of 3D229 in combination with paclitaxel for platinum-resistant recurrent ovarian cancer, with ongoing studies in RCC and pancreatic cancer[128]. Financial Position and Cash Flow - Cash and bank balances decreased by 8.3% to RMB 864,236,000 from RMB 942,028,000[6]. - Current liabilities totaled RMB 424.1 million as of June 30, 2023, which includes trade payables of RMB 43.2 million and interest-bearing bank loans of RMB 151.6 million[150]. - As of June 30, 2023, total assets amounted to RMB 1,346.3 million, with total liabilities at RMB 523.7 million[195]. - The Group did not have any material contingent liabilities as of June 30, 2023, indicating a stable financial position[175]. - The net cash used in operating activities was RMB 168.1 million, compared to RMB 85.6 million for the same period in 2022, indicating a significant increase in cash outflow[173]. - The net cash flows from financing activities for the six months ended June 30, 2023, were RMB 76.3 million, primarily from new interest-bearing bank borrowings of RMB 127.6 million, partially offset by repayments of RMB 52.5 million[173].

Financial Performance - For the six months ended June 30, 2023, the company's revenue increased by 70.3% to RMB 352.6 million, compared to RMB 207.0 million for the same period in 2022[14]. - The gross profit for the same period rose by 69.6% to RMB 325.3 million, with a gross margin of 92.3%, slightly down from 92.7% in the previous year[16]. - The total comprehensive loss for the period was RMB 190.2 million, a 41.2% improvement compared to RMB 323.6 million in the same period last year[14]. - The adjusted total comprehensive loss, as per non-IFRS measures, was RMB 81.5 million, down 29.9% from RMB 116.1 million in the previous year[14]. - Revenue for the six months ended June 30, 2023, was RMB 352,553 thousand, representing an increase of 70.4% compared to RMB 207,028 thousand for the same period in 2022[111]. - The company reported a loss before tax of RMB 190,204 thousand, a significant improvement from a loss of RMB 323,553 thousand in the previous year, reflecting a reduction of 41.2%[111]. - Basic and diluted loss per share for the six months ended June 30, 2023, was RMB 0.79, compared to RMB 8.41 for the same period in 2022, showing a substantial decrease in loss per share[128]. Research and Development - The company is developing a next-generation tumor vaccine, with a global Phase III pivotal MRCT for treating AML currently ongoing[11]. - The company has advanced its product pipeline with 12 candidate drugs, including the commercialized Envita® (Envafolimab) and 7 products in various clinical stages, with 3D189 currently in Phase III MRCT[21]. - The company is conducting a Phase III study for 3D189, comparing it with the best available treatment in AML patients, with recruitment ongoing at approximately 105 centers globally[36]. - The company plans to submit an IND application for a Phase III clinical trial comparing Envida® combined with platinum-based chemotherapy against placebo in resectable stage III non-small cell lung cancer patients[55]. - The company is advancing its 3D185 capsule in a Phase I clinical trial, with initial doses showing good safety and tolerability[64]. - The company is conducting a Phase III clinical trial of 3D229 combined with paclitaxel for platinum-resistant recurrent ovarian cancer, with the primary endpoint being progression-free survival (PFS) based on RECIST v1.1 criteria[70]. - The company plans to initiate a pivotal clinical trial in North America for soft tissue sarcoma, with progress reported as smooth[33]. Sales and Marketing - Sales and marketing expenses increased by 62.8% to RMB 221.0 million, driven by a significant increase in sales volume of the product Envidat®[6]. - Envidat® sales in China reached RMB 352.6 million for the six months ended June 30, 2023, marking a 70.3% year-on-year growth[9]. - The marketing strategy focuses on patient needs and emphasizes the differentiated features of Envidat® to enhance the quality of life for cancer patients, which has led to recognition from third-party payers[191]. - The average monthly sales growth of innovative drugs has decreased by 19% post-COVID-19, highlighting the strong performance of Envida® in a challenging market[48]. Financial Position - The company raised approximately HKD 226.8 million through a placement of new shares in July 2023 to strengthen its financial position and accelerate the development of multiple clinical projects[11]. - The total liabilities to total assets ratio increased to 39% as of June 30, 2023, compared to 33% as of December 31, 2022[131]. - The total equity as of June 30, 2023, was RMB 822,600,000, down from RMB 895,414,000 as of December 31, 2022[172]. - The company did not declare any interim dividend for the six months ended June 30, 2023[105]. Regulatory and Compliance - Envafolimab has passed a routine quality supervision inspection with zero defects by the Sichuan Provincial Drug Administration, marking a significant regulatory milestone[31]. - The FDA granted orphan drug designation for the treatment of gastric cancer and gastroesophageal junction cancer, with ongoing development of four IND-stage candidate drugs[38]. - 3D185 has received orphan drug designation from the FDA for the treatment of gastric cancer and gastroesophageal junction cancer, marking its second orphan drug designation[74]. - The company is committed to strict compliance with quality management standards to ensure product quality and safety[57]. Strategic Initiatives - The company was included in the Hong Kong Stock Connect list and selected as a constituent stock of the Hang Seng Composite Index effective March 13, 2023[11]. - The strategic partnership with InnoLake Pharmaceuticals has been strengthened for the ILB-2109 project, focusing on clinical development and medical strategy[77]. - The company has established a robust R&D platform in Shanghai and Beijing to enhance the success rate of molecules advancing from preclinical research to market[78]. - The company is preparing for the commercialization of upcoming products, with pre-launch preparations gradually underway[82]. Customer and Revenue Insights - Major customer A contributed RMB 147,848 thousand in revenue, up from RMB 87,816 thousand in the previous year, while major customer B's revenue increased to RMB 39,065 thousand from RMB 28,245 thousand[118]. - All revenue during the reporting period was derived from customers in mainland China, with nearly all non-current assets located there[173]. - The group reported a revenue of RMB 352,553,000 from customer contracts during the reporting period[142].

Financial Performance - The company reported a total revenue of $150 million for the fiscal year 2022, representing a 25% increase compared to the previous year[1]. - The company provided a forward guidance of $180 million in revenue for the next fiscal year, indicating a projected growth of 20%[1]. - The company reported a net profit margin of 12% for 2022, an improvement from 10% in 2021[1]. - The board announced a dividend payout of $0.05 per share, reflecting a 25% increase from the previous year[1]. - Revenues generated in 2022 amounted to RMB 567.4 million, representing an 841.6% increase from 2021[31]. - Revenue for 2022 reached RMB 567.4 million, a significant increase of 841.6% compared to RMB 60.3 million in 2021, primarily driven by the sales of Envafolimab[154]. - Gross profit rose by 838.1% from RMB 56.0 million in 2021 to RMB 525.2 million in 2022, with a stable gross profit margin of approximately 92.6%[156]. - The total comprehensive loss for the year was RMB 1,052.0 million, a decrease from RMB 1,461.8 million in 2021[150]. User Growth and Market Expansion - User data showed a growth in active users to 1.2 million, up from 900,000 in 2021, marking a 33% increase[1]. - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by the end of 2024[1]. - The company plans to expand its market presence in Southeast Asia, targeting a XX% increase in market share by the end of 2023[11]. - The company is exploring partnerships with international firms to enhance its global distribution network, potentially increasing sales by XX%[11]. Research and Development - Research and development efforts focused on advancing three new drug candidates, with clinical trials expected to commence in Q2 2023[11]. - The company advanced a pipeline of 12 innovative drugs or drug candidates into the next phase of development[30]. - The company aims to discover, develop, and commercialize innovative drugs for cancer patients requiring long-term treatment[32]. - The R&D platform includes strong molecule screening and design capabilities, enhancing the success rate of moving molecules from pre-clinical studies to market[117]. - The company has filed multiple patent applications for its in-house developed drug candidates, including 3D062, which targets KRAS mutations[110]. Clinical Trials and Approvals - The company is conducting 10 clinical trials, with one pivotal trial approved by the US FDA[26]. - The company is currently conducting 10 clinical trials, with two new INDs approved by NMPA and the US FDA[64]. - A Phase II study for envafolimab in combination with lenvatinib for late-stage non-MSI-H/non-dMMR endometrial cancer has enrolled its first patient and is ongoing as expected[68]. - The company has received IND approval for 3D229 (Batiraxcept) and completed Phase I clinical trials in healthy volunteers[56]. Product Development and Commercialization - New product launches included two innovative therapies, expected to contribute an additional $30 million in revenue in 2023[1]. - The commercialization strategy for Envafolimab includes targeted marketing efforts to improve the quality of life for cancer patients and gain recognition from third-party payers[126]. - The company is building a dedicated sales and marketing department with experience in oncology treatment commercialization to handle product positioning and market strategy[127]. - The company aims to maximize the commercial value of Envafolimab by conducting clinical trials independently and in collaboration with partners outside of China[142]. Financial Position and Cash Flow - Cash and cash equivalents as of December 31, 2022, were RMB 696.7 million, sufficient to fund operations for at least the next two years[31]. - Total current assets as of December 31, 2022, were RMB 1,143.1 million, up from RMB 919.2 million in 2021[190]. - Net cash used in operating activities decreased from RMB 377.1 million in 2021 to RMB 278.8 million in 2022[193]. - The net cash flow from financing activities for the fiscal year ended December 31, 2022, was RMB 408.4 million, primarily due to proceeds from the issuance of common stock amounting to RMB 313.5 million[198]. Strategic Acquisitions and Investments - A strategic acquisition of a biotech firm was completed for $50 million, aimed at enhancing R&D capabilities[1]. - The company invested $10 million in new technology development, focusing on improving production efficiency by 30%[1]. - The company has established in-house production facilities in Xuzhou, Jiangsu province, with a GMP-compliant manufacturing system to support the entire drug development process[124]. Sustainability and Corporate Responsibility - The management highlighted a commitment to sustainability, with plans to reduce carbon emissions by 40% by 2025[1]. - Other expenses rose from RMB 8.9 million in 2021 to RMB 53.4 million in 2022, primarily due to donations worth RMB 51.9 million to a charity supporting cancer patients[179].

Financial Performance - The company reported a significant revenue increase from product sales, with sales of Envafolimab reaching RMB 567.4 million in 2022, up 841.6% from RMB 60.3 million in 2021[17]. - Revenue for 2022 reached RMB 567,392,000, a significant increase of 841.6% compared to RMB 60,260,000 in 2021[34]. - The company reported a total comprehensive loss of RMB 1,052.0 million for the year, a 28.0% improvement from a loss of RMB 1,461.8 million in 2021[21]. - The adjusted total comprehensive loss was RMB 253.2 million, down 26.1% from RMB 342.4 million in 2021[21]. - The group reported a total loss of RMB 1,052,030 thousand for the year ended December 31, 2022, compared to a loss of RMB 1,461,825 thousand in 2021[153]. - The basic and diluted loss per share for the year was RMB (22.52), compared to RMB (36.72) in 2021, reflecting an improvement in loss per share[153]. Cost and Expenses - The cost of sales for the company was RMB 42.2 million in 2022, an increase of 887.0% compared to RMB 4.3 million in 2021, primarily due to the increased product costs associated with Envafolimab[17]. - Sales and marketing expenses rose to RMB 357.7 million in 2022, a 735.0% increase from RMB 42.8 million in 2021, driven by marketing activities for Envafolimab[17]. - Research and development expenses decreased by 5.5% to RMB 350.9 million in 2022 from RMB 371.2 million in 2021, attributed to reduced milestone payments and increased outsourcing costs[17]. - Financial costs rose from RMB 1.5 million in 2021 to RMB 3.1 million in 2022, primarily due to increased interest on lease liabilities and bank loans[108]. - The total employee benefits expenses for the group amounted to approximately RMB 277.9 million, which includes salaries, social security, and stock-based compensation[166]. Product Development and Clinical Trials - The company has submitted five clinical applications, including one FDA-approved global registration clinical study[22]. - The company is actively pursuing new product development, with ongoing clinical trials for its tumor vaccine Galinpepimut-S and five patent applications submitted[22]. - The company is conducting a Phase III trial comparing chemotherapy with and without chemotherapy for advanced biliary tract cancer[30]. - The company is conducting a Phase III pivotal trial for 3D229 in the US and Europe, with enrollment completed[54]. - The company is conducting a Phase III pivotal trial for 3D189 in the treatment of AML in the U.S. and Europe[82]. - The company has received IND approval for multiple clinical trials, including those for NSCLC, RCC, and UC patients[42]. Market Presence and Product Acceptance - Envafolimab has been included in seven clinical treatment guidelines in China, indicating its growing acceptance in the medical community[22]. - Envafolimab generated sales revenue exceeding HKD 500 million in its first full fiscal year post-commercialization[38]. - Envafolimab (PD-L1) sales covered over 1,000 hospitals and more than 1,000 pharmacies across 200 cities in China by the end of 2022[70]. - Six CSCO guidelines and one Chinese Anti-Cancer Association guideline have adopted Envafolimab since its launch[32]. - The company has received recommendations from professional clinical guidelines to support the commercialization of Envafolimab[69]. Financial Position and Assets - Cash and cash equivalents as of December 31, 2022, were RMB 942,028,000, a 14.3% increase from RMB 824,484,000 in 2021[34]. - As of December 31, 2022, total assets amounted to RMB 1,332,063 thousand, an increase from RMB 1,060,293 thousand in 2021[134]. - The total liabilities to total assets ratio decreased to 33% as of December 31, 2022, from 314% as of December 31, 2021, primarily due to a reduction in preferred stock liabilities post-IPO[136]. - The net cash flow from financing activities was RMB 408.4 million in 2022, primarily from issuing ordinary shares (RMB 313.5 million) and new bank loans (RMB 149.0 million)[112]. Corporate Governance and Future Plans - The company is committed to maintaining high standards of corporate governance to enhance shareholder value and accountability[171]. - The company does not recommend the payment of a final dividend for the year ended December 31, 2022, as it plans to retain all future earnings for business operations and expansion[170]. - The company aims to enhance its market position by discovering, developing, and commercializing innovative drugs for cancer patients[120]. - The company plans to expand the indications for Envafolimab through additional clinical studies, including non-small cell lung cancer and renal cancer[119]. - The company is actively exploring financing channels to strengthen its capital reserves for ongoing R&D efforts[87].