Financial Performance - Revenue increased from RMB 502 million for the year ended December 31, 2021, to RMB 1,019 million for the year ended December 31, 2022, primarily due to increased CDMO service revenue[3] - Other income rose from RMB 329 million for the year ended December 31, 2021, to RMB 464 million for the year ended December 31, 2022, mainly due to interest income and government grants recognized[3] - Administrative and selling expenses decreased from RMB 1,452 million for the year ended December 31, 2021, to RMB 1,124 million for the year ended December 31, 2022, mainly due to reduced labor costs and professional services[4] - The total loss and comprehensive expenses for the year decreased from RMB 17,138 million for the year ended December 31, 2021, to RMB 4,177 million for the year ended December 31, 2022, primarily due to increased CDMO service revenue[4] - The company reported a net loss attributable to shareholders of RMB 406,745,000 for the year ended December 31, 2022, compared to a loss of RMB 1,715,543,000 in 2021[87] - Total comprehensive expenses for the year ended December 31, 2022, amounted to RMB 417.7 million, a decrease from RMB 1,713.8 million in 2021[99] - Adjusted loss and comprehensive expenses for the year ended December 31, 2022, were RMB 400.9 million, compared to RMB 485.0 million in 2021[99] - As of December 31, 2022, cash and cash equivalents totaled RMB 993.4 million, down from RMB 1,222.0 million as of December 31, 2021, primarily due to operating cash outflows[103] - Trade receivables as of December 31, 2022, amounted to RMB 34,012,000, significantly up from RMB 2,565,000 in 2021[90] - Trade payables as of December 31, 2022, totaled RMB 48,154,000, an increase from RMB 31,430,000 in 2021[92] - Total assets decreased from RMB 2,544.96 million in 2021 to RMB 2,134.55 million in 2022, while total liabilities increased from RMB 579.39 million to RMB 660.65 million[174] Research and Development - R&D expenses increased from RMB 3,444 million for the year ended December 31, 2021, to RMB 3,498 million for the year ended December 31, 2022, attributed to pipeline progress and resource optimization[4] - The proprietary antibody discovery platform, IMTB, enables the company to expand its product pipeline from monoclonal antibodies to bispecific antibodies and antibody-drug conjugates, supporting precision medicine strategies[12] - The company has developed three best-in-class molecules and two first-in-class molecules to address urgent patient needs, supported by a strong clinical development and regulatory team[32] - The company is focusing on developing ADC candidates, with TST013 showing high affinity and strong cytotoxicity in preclinical studies[193] - The company is developing a first-in-class multifunctional antibody for systemic lupus erythematosus (SLE), addressing a large patient population with limited treatment options[194] - The company is expanding its non-oncology pipeline to address significant medical needs in bone and kidney diseases, including TST002 and TST004[194] Clinical Development and Milestones - In 2022, the company achieved significant clinical and regulatory milestones, expanding its product portfolio and advancing its pipeline[18] - The primary asset, osemitamab (TST001), demonstrated encouraging clinical efficacy and good safety in ongoing trials for advanced gastric cancer, with key materials produced for a global pivotal III trial[18] - The company completed evaluations of four dose cohorts for TST005 and initiated recruitment for the highest dose level in a global I trial[18] - In 2022, 11 out of 15 evaluable patients with Claudin18.2 expressing advanced gastric cancer achieved partial response in a mid-term efficacy data presentation[19] - The company established a global clinical collaboration with BMS to evaluate osemitamab (TST001) in combination with Opdivo® for treating Claudin18.2 expressing gastric cancer[21] - TST002 showed promising bone mineral density (BMD) increases in early dose cohorts, with the third dose cohort evaluation completed in December 2022[20] - TST003 received IND approval from the FDA in September 2022, with preclinical data presented at the TEMTIA conference in November[20] - The company is advancing multiple exploratory trials for Osemitamab (TST001) across various indications, including a successful Phase IIa study for advanced or metastatic cholangiocarcinoma[39] - The company plans to submit an IND application for TST004 in China[154] - TST004 received IND approval from the FDA in October 2022, marking a significant milestone for the product[200] CDMO Services and Business Expansion - The company expanded its CDMO services in 2022, adding new service categories in analytical testing and formulation production, resulting in over 80% increase in external contract value compared to 2021[10] - The company reported a significant increase in CDMO business revenue, enhancing continuous flow production capabilities[18] - CDMO services generated revenue of RMB 87,949,000 for the year ended December 31, 2022, up from RMB 44,200,000 in 2021, reflecting a 98.5% increase[144] - The company has improved its integrated continuous flow bioprocessing (ICB) platform and expanded its CMC capabilities, enabling support for internal project development and generating revenue through CDMO services for external clients and partners[23] - The company aims to enhance its CDMO services by improving operational efficiency and reducing costs, particularly for mRNA therapies and ADC process development[167] Strategic Partnerships and Collaborations - A partnership was established with a prominent U.S. research university in December 2022 to further evaluate the potential of Gremlin1 antibody for treating castration-resistant prostate cancer[22] - The company is executing a globalization strategy by partnering with global and local biopharmaceutical companies and academic research institutions[54] - The company is establishing collaborations to accelerate product development in its promising non-oncology pipeline[194] Corporate Governance and Financial Management - The company has adopted corporate governance principles and complies with all applicable codes during the reporting period[120] - The audit committee was established to oversee the financial reporting process and internal controls, consisting of three members[132] - The board believes that the change in the use of net proceeds will not adversely affect the company's operations and aligns with its vision[130] - The company has maintained compliance with the standard code for securities trading by all directors during the reporting period[121] - No dividends were paid or declared to ordinary shareholders in 2022, consistent with 2021[93] - The board has recommended not to distribute a final dividend for the year ended December 31, 2022[134] Future Outlook and Plans - The company plans to continue expanding its pipeline by developing one new drug candidate for clinical trials each year[138] - The company plans to allocate 10% of the net proceeds, approximately HKD 55.3 million, for clinical trials and commercialization of TST002 by December 31, 2025[127] - A total of 12% of the net proceeds, approximately HKD 66.5 million, is designated for preclinical trials of other pipeline products by December 31, 2025[127] - The company plans to expand its perfusion capacity from 300L to 1,000L while enhancing downstream platforms to significantly reduce product costs[165] - A second 2,000L single-use bioreactor will be installed to increase production capacity[166] - The company is shifting resources from MSB2311 to osemitamab (TST001) due to competitive advantages and commercial potential[161]

Financial Performance - Revenue decreased from RMB 267 million for the six months ended June 30, 2021, to RMB 218 million for the six months ended June 30, 2022, primarily due to a reduction in CDMO revenue offset by an increase in contract R&D service income[18]. - Other income increased from RMB 112 million for the six months ended June 30, 2021, to RMB 239 million for the six months ended June 30, 2022, mainly due to an increase in government grants recognized during the period[18]. - Other income and losses improved from a loss of RMB 762.5 million for the six months ended June 30, 2021, to a gain of RMB 10.2 million for the six months ended June 30, 2022, primarily due to the impact of preferred shares issued in 2021[18]. - Adjusted total loss and comprehensive expenses decreased from RMB 216.6 million to RMB 204.1 million, mainly due to reduced listing expenses and increased government subsidies[20]. - The company incurred a total loss of RMB 204.1 million for the six months ended June 30, 2022, significantly reduced from a loss of RMB 994.9 million in the same period of 2021[114]. - The gross profit for the six months ended June 30, 2022, was RMB 3.1 million, down from RMB 4.5 million in the previous year[115]. - The total comprehensive expenses amounted to RMB (210,064) thousand, a significant decrease from RMB (994,284) thousand for the same period in 2021, reflecting a reduction of approximately 78.8%[131]. - The adjusted loss and total comprehensive expenses for the period were RMB (204,088) thousand, compared to RMB (216,634) thousand in the previous year, indicating a decrease of about 5.8%[131]. Research and Development - R&D expenses increased from RMB 1,669 million for the six months ended June 30, 2021, to RMB 1,703 million for the six months ended June 30, 2022, driven by progress in the pipeline[18]. - R&D expenses (excluding share-based payment expenses) increased slightly from RMB 165.4 million to RMB 165.8 million, attributed to progress in the pipeline[20]. - The company has developed a unique antibody discovery platform, the Immune Tolerance Breakthrough (IMTB) technology platform, enabling the discovery of antibodies with superior drug-like properties[5]. - The company is focusing on establishing partnerships for TST001, TST002, TST003, and TST004 to maximize asset value and cash flow[110]. - The company aims to enhance its antibody discovery capabilities through the evaluation and establishment of new technology platforms[112]. - The company is developing a comprehensive translational research strategy to maximize the clinical and commercial potential of its molecules[43]. Clinical Trials and Pipeline Progress - TST001, a key project targeting Claudin18.2, is preparing for global pivotal trials pending favorable data review by regulatory authorities[5]. - TST005 and TST002 are advancing in Phase I clinical trials, with TST005 showing strong anti-tumor activity and good safety profile[22]. - TST001's clinical data was presented at the ASCO annual meeting, showing good tolerability and encouraging preliminary anti-tumor activity in patients with advanced gastric cancer[25]. - TST002 successfully completed the first patient dosing in a Phase I study for osteoporosis in China[26]. - TST003's IND application was submitted in August 2022, following the completion of its IND preparation studies[30]. - TST004, a humanized MASP-2 monoclonal antibody candidate for kidney diseases, demonstrated effective in vitro/in vivo inhibition of the MASP2 complement pathway and excellent safety in non-human primates as of June 2022[33]. - The company has made significant progress in its oncology pipeline, including the completion of the first patient dosing in a Phase IIa study for TST001 in China for advanced or metastatic biliary tract cancer[51]. - TST005's dose escalation phase is anticipated to be completed in the first quarter of 2023[109]. - The global clinical trial for TST003, a potential new cancer therapy, is set to be initiated[109]. Collaborations and Partnerships - The company is actively engaging in discussions with potential partners to leverage its differentiated products and advanced technology platforms for market expansion[6]. - The company established a global clinical collaboration with BMS to evaluate TST001 in combination with Opdivo® for treating unresectable locally advanced or metastatic Claudin18.2 expressing gastric cancer patients[37]. - The company has formed a joint venture with Shanghai Lianbang Pharmaceutical to conduct preclinical and clinical trials for TST004 in the Greater China region[84]. - The company continues to expand strategic collaborations with global and local biopharmaceutical companies and academic research institutions[44]. - The company has established multiple research collaborations with prestigious academic institutions, including Harvard Medical School and Peking University Cancer Hospital[86]. Production and Technology Advancements - The integrated continuous flow bioprocessing (ICB) platform has demonstrated industry-leading productivity of over 6 g/L per day, improving production rates by over 10 times compared to traditional methods[6]. - The company achieved a production milestone by converting flow processing into enhanced perfusion processing, which is expected to increase production capacity by over eight times[22]. - The company has developed a high-yield perfusion technology and is collaborating with Merck to enhance downstream production processes, aiming to eliminate GMP manufacturing bottlenecks[87]. - The company has achieved an eightfold increase in production capacity by transitioning TST001's process from batch to enhanced perfusion technology, approved by both the National Medical Products Administration and the FDA[89]. - The automated single-use purification technology is expected to be operational in GMP by September 2022, ahead of the TST001 PPQ in 2023[90]. - A new 2000L single-use bioreactor will be added to the Hangzhou facility by the end of 2022 to enhance manufacturing capacity[93]. Financial Position and Assets - Non-current assets decreased to RMB 1,106.9 million as of June 30, 2022, from RMB 1,149.4 million as of December 31, 2021[117]. - Total assets decreased to RMB 2,427.1 million as of June 30, 2022, from RMB 2,544.9 million as of December 31, 2021[117]. - The company reported a cash and bank balance of RMB 1,091.4 million as of June 30, 2022, down from RMB 1,222.0 million as of December 31, 2021, a decrease of about 10.7%[134]. - The company maintained a net cash position, making the debt-to-equity ratio not applicable as of June 30, 2022[135]. - The company had no significant investments or acquisitions during the six months ended June 30, 2022, maintaining a conservative approach to capital allocation[136]. Shareholder Information - As of June 30, 2022, the total number of shares outstanding is 445,331,917[149]. - The company has various partnerships and trusts that collectively hold significant shares, indicating a diversified ownership structure[156]. - The total number of shares involved in the pre-IPO equity incentive plan is capped at 69,325,254 shares, representing 15.57% of the company's issued shares as of the last practicable date[160]. - The company has established a trust for certain participants, with 2,670,445 shares issued to a third party trust as part of the incentive plan[175]. - The board has the authority to set the terms and conditions for the exercise of stock options and restricted share units, which must be approved by the board[162]. Governance and Compliance - The company has established an audit committee to oversee financial reporting and internal controls, consisting of three members[188]. - The company has complied with the corporate governance code and will continue to review its practices to align with the latest standards[194]. - There are no significant future investment or capital asset plans beyond what has been disclosed in the interim report[190]. - The company has confirmed that there were no violations of the securities trading standard code by its employees during the reporting period[195].

Pipeline Development - Transcenta achieved significant progress in advancing its pipeline and business operations in 2021, accelerating the development of TST001 for multiple indications, including gastric and pancreatic cancers[10]. - The company is advancing three clinical stage programs, including MSB0254, TST005, and TST002, targeting various cancers and osteoporosis[10]. - TST001 is advancing in multiple indications, with a Phase IIa trial for advanced gastric cancer initiated in August 2021 and for advanced pancreatic cancer in September 2021[20][21]. - The company plans to initiate clinical studies for TST002 in patients with low bone density, accelerating its development in China[12]. - TST005's phase Ia dose escalation trial is expected to be completed by the end of the year in both the US and China[124]. - The company aims to submit IND applications for TST003 in the US and China and plans to initiate clinical studies[126]. - TST003 is a first-in-class humanized antibody targeting cancer-associated stromal cells, currently in the IND preparation stage[65]. - TST004 is currently in the IND preparation stage, undergoing GLP-compliant toxicology and CMC studies[92]. - TST010, a newly selected preclinical candidate targeting regulatory T cells, is entering IND preparation to enhance T cell-mediated tumor killing[65]. - The company has initiated two IND preparation projects in 2021, including TST003 in oncology and TST004 for kidney disease, and advanced TST010 to IND preparation research[96]. Clinical Collaborations - The company announced a global clinical collaboration with Bristol-Myers Squibb (BMS) to evaluate the combination of TST001 with BMS's anti-PD-1 therapy, Opdivo, for treating advanced gastric cancer[11]. - The company is expanding strategic collaborations with global and local biopharmaceutical companies and academic institutions[59]. - The company has established collaborations with leading academic institutions, including Harvard Medical School and Peking University Cancer Hospital, to enhance research capabilities[101]. Financial Performance - Revenue decreased from RMB 81.0 million for the year ended December 31, 2020, to RMB 50.2 million for the year ended December 31, 2021, primarily due to reduced CDMO services to support internal CMC needs[16]. - R&D expenses increased from RMB 200.3 million for the year ended December 31, 2020, to RMB 344.4 million for the year ended December 31, 2021, reflecting significant pipeline progress[17]. - The total comprehensive loss for the year increased from RMB 319.5 million for the year ended December 31, 2020, to RMB 1,713.8 million for the year ended December 31, 2021, primarily due to fair value losses from preferred shares[17]. - The company reported a net loss of RMB 1,715,543 thousand for the year ended December 31, 2021, compared to a net loss of RMB 322,900 thousand in 2020[137]. - The company’s revenue for the year ended December 31, 2021, was RMB 50,242 thousand, a decrease of 38% from RMB 80,980 thousand in 2020[137]. - The CDMO business generated revenue of RMB 44,200 thousand in 2021, down from RMB 80,980 thousand in 2020[140]. - Other income increased to RMB 32,906 thousand in 2021 from RMB 11,944 thousand in 2020, primarily due to increased government subsidies[141]. Research and Development - Transcenta's proprietary continuous flow bioprocessing platform has achieved breakthroughs, increasing production yield by over 10 times compared to conventional processes, providing flexibility in scaling up capacity and reducing product costs[10]. - The company has developed a comprehensive translational research strategy to maximize clinical and commercial potential of its molecules[59]. - The company has established a pipeline of ten innovative molecules for the treatment of tumors, bone lesions, and kidney diseases, with most molecules discovered and developed in-house[61]. - The company employs a global multi-regional development strategy to enhance operational efficiency and expedite clinical trials in areas with significant medical needs[63]. - The company retains core clinical development functions internally while utilizing Contract Research Organizations (CROs) for trial execution[63]. Manufacturing and Production - The company completed the upgrade of its Hangzhou factory to expand manufacturing capacity for commercialization[32]. - The new integrated continuous flow bioprocessing platform (ICB) has achieved an industry-leading daily volumetric productivity of over 6 g/L, which is more than 15 times higher than conventional methods using the same cell line[107]. - The modular GMP facilities have been expanded to meet recent production demand, achieving over a 10-fold increase in production rates compared to conventional flow processing methods[103]. - The company has localized the procurement of key materials and major equipment, resulting in significant cost savings[110]. Strategic Outlook - The company is optimistic about its business outlook, leveraging its experienced team and integrated capabilities to drive innovation[14]. - The company plans to establish significant global partnerships for its innovative pipeline molecules, including TST001, TST003, and TST004[12]. - The company aims to maximize productivity and reduce costs through the development and application of advanced technologies[134]. - The company is focused on establishing partnerships to enhance the global development and commercialization of its candidate products[135]. Regulatory and Compliance - The company received orphan drug designation from the FDA for TST001 for the treatment of gastric cancer, with global registration trial preparations underway[23]. - The company is preparing for BLA submission work for TST001, anticipating positive feedback from the National Medical Products Administration of China and the FDA[123]. - The company has complied with all relevant laws and regulations without any significant violations during the reporting period[187]. Risk Management - The company has faced several major risks, including the ability to identify new drug candidates and complete clinical development[184]. - The management team is based in China and the United States, focusing on clinical development, regulatory access, and business development[178].

Drug Development and Pipeline - The company has developed a proprietary antibody discovery platform, the Immune Tolerance Breakthrough (IMTB) technology platform, enabling the generation of antibodies against challenging proteins, resulting in lead candidates with enhanced drug-like properties [5]. - As of the last practicable date, the company has independently discovered and developed eight out of nine candidate drugs, including one core product, MSB2311, a humanized PD-L1 monoclonal antibody candidate targeting TMB-H solid tumors [7]. - The company is developing TST003, a novel therapeutic antibody candidate targeting immune regulatory proteins produced by tumor-associated fibroblasts, and TST008, a triple-function antibody with potential for treating autoimmune diseases [8]. - The company has a diverse pipeline addressing significant medical needs in oncology, kidney disease, and bone disorders, with four major candidate drugs including TST001 and TST005 [7]. - TST001, a key product targeting Claudin 18.2, ranks among the top two global candidates and is the first Claudin 18.2 candidate to enter Phase II clinical trials in China [28]. - The company initiated Phase I trials for TST001 in April 2021 as a first-line treatment for gastric cancer and in May 2021 for second-line treatment, with multiple patients already dosed [29][30]. - TST005, a dual-function antibody targeting TGF-β and PD-L1, entered clinical development in 2021, with an IND application submitted to the FDA in March 2021 and approval received in April 2021 [31]. - MSB2311, a second-generation PD-L1 inhibitor, received approval for a Phase II trial for TMB-H solid tumor patients after a successful Phase I analysis submitted in January 2021 [34]. - The company has established an innovative pipeline covering nine drug candidates for tumors, bone lesions, and kidney diseases, with most developed in-house and one acquired through licensing [24]. Financial Performance - The company reported a loss of RMB 994,895,000 for the six months ended June 30, 2021, compared to a loss of RMB 114,325,000 for the same period in 2020 [56][57]. - Revenue for the six months ended June 30, 2021, was RMB 26,685,000, a decrease from RMB 28,309,000 in the same period of 2020, representing a decline of approximately 5.7% [149]. - Gross profit decreased to RMB 4,520,000 in 2021 from RMB 11,139,000 in 2020, reflecting a decline of approximately 59.5% [149]. - Research and development expenses surged to RMB 166,901,000 for the six months ended June 30, 2021, up from RMB 77,148,000 in the same period of 2020 [169]. - The company reported a basic and diluted loss per share of RMB 10.19 for the six months ended June 30, 2021, compared to RMB 1.73 for the same period in 2020 [149]. - The company incurred a cumulative loss of RMB (1,919,156,000) as of June 30, 2021 [154]. - The company’s total comprehensive loss attributable to owners was RMB 994,284,000 for the six months ended June 30, 2021, compared to RMB 112,900,000 in 2020 [149]. Research and Development - R&D expenses increased from RMB 77.1 million for the six months ended June 30, 2020, to RMB 166.9 million for the six months ended June 30, 2021, primarily due to preclinical testing, clinical trial expenses, and increased personnel costs [14]. - The company has formed a translational research team to analyze drug target protein expression and evaluate in vivo disease intervention activity, guiding clinical research design [6]. - The company is focused on developing innovative biotherapeutics, with ongoing research into multiple early-stage candidates [8]. - The company has made significant progress in multiple clinical stages and IND phases for its pipeline assets during the first half of 2021 [28]. Production and Manufacturing - The company has established a modular GMP facility in Hangzhou with a total annual production capacity exceeding 1,000 kg, utilizing advanced perfusion production processes that have shown over 100% yield improvement compared to conventional methods [9]. - The company is one of only three in China implementing continuous perfusion processes for GMP clinical supply, enhancing product quality control and enabling the production of both stable and unstable antibodies [9]. - The company expanded its production facilities by establishing a GMP filling production line in Hangzhou, which is now operational for drug production [21]. - The company has implemented an integrated continuous biomanufacturing platform to enhance process robustness and minimize operational risks, achieving industry-leading production rates [9]. Cash Flow and Financing - As of June 30, 2021, the group's bank balances and cash increased from RMB 813.6 million as of December 31, 2020, to RMB 957.6 million, primarily due to cash inflows from Series C financing and bank loans [14]. - The net cash generated from financing activities for the six months ended June 30, 2021, was RMB 342,018,000, compared to RMB 169,926,000 in the same period of 2020, showing a substantial increase [156]. - The company raised approximately HKD 645 million from the issuance of 40,330,000 new shares at HKD 16.0 per share upon listing on the Hong Kong Stock Exchange on September 29, 2021 [53]. - The company has not utilized any of the net proceeds from the offering as of the date of the interim report [127]. Shareholder Information - Major shareholders include Qian Xueming with 57,177,906 shares (12.84%) and HSBC Trust Company with 45,653,530 shares (10.25%) [103]. - Yi Shi holds 67,233,203 shares, representing 15.10% of the company [103]. - The total number of shares granted under the pre-IPO equity incentive plan amounts to 22,661,106 [114]. - The company has a significant portion of shares held by various investment funds, indicating strong institutional interest [107]. Strategic Collaborations and Partnerships - The company is actively exploring strategic collaboration opportunities globally to maximize the commercial value of its pipeline assets [49]. - The company is collaborating with LAV Group and Shanghai Liyang Pharmaceutical Technology Co., Ltd. for the development of TST004 in the Greater China region [26]. - The company has established a joint venture with Shanghai Libang Pharmaceutical Technology Co., Ltd. to develop pipeline product TST004, with an initial investment of RMB 500,000 [175].