Financial Performance - The company reported a loss of RMB 237,647 thousand for the six months ended June 30, 2023, compared to a loss of RMB 204,073 thousand for the same period in 2022[22]. - Revenue from CDMO services was RMB 36,084 thousand, an increase from RMB 21,758 thousand in the previous year, representing a growth of approximately 65.8%[24]. - Gross profit for the period was RMB 10,112 thousand, significantly up from RMB 3,072 thousand in the prior year, indicating a gross margin improvement[24]. - Other income decreased from RMB 239 million to RMB 233.7 million, primarily due to a reduction in government subsidies recognized during the six months ended June 30, 2023[27]. - The company reported a net income of 5,761,160 for the first half of 2023, compared to 6,816,185 in the same period last year, indicating a decrease of approximately 15.5%[171]. Research and Development - Research and development expenses increased to RMB 207,940 thousand from RMB 170,315 thousand year-over-year, reflecting ongoing investment in pipeline development[24]. - Research and development expenses for the six months ended June 30, 2023, amounted to RMB 88,507,000, an increase from RMB 51,202,000 in the same period of 2022[75]. - Clinical expenses for the same period were RMB 88,507,000, up 73% year-over-year from RMB 51,202,000[75]. - The company plans to showcase clinical data for TST002 at medical conferences in the second half of 2023[10]. - The company completed a dose escalation study for TST002 in China with 32 patients successfully enrolled as of January 2023[32]. - The company has obtained IND approval from the US FDA and is collaborating with a partner to advance IND in China[41]. - The company is exploring several solid tumors expressing Claudin18.2 beyond gastric cancer or gastroesophageal junction cancer[47]. - The company has established partnerships with BMS for osemitamab (TST001) clinical trials and with Eli Lilly for TST002 licensing in Greater China[36]. - The company has completed the establishment of an ADC development laboratory to support internal and external ADC projects[44]. Business Strategy and Expansion - The company aims to expand its CDMO business and increase revenue through enhanced operational efficiency and cost reduction strategies[19]. - The company is actively pursuing collaborations for clinical assets, including TST003 and other pipeline molecules, to maximize asset value[13]. - The company is in discussions with several multinational companies regarding potential collaborations[42]. - The company plans to achieve several milestone results related to clinical development and partnerships by 2025[156]. - The company plans to expand its market presence through new product development and strategic partnerships[156]. - The company anticipates a revenue growth of 10% for the upcoming fiscal year, driven by new product launches and market expansion strategies[162]. - The company has allocated a budget of 1 million HKD for research and development in the next quarter to enhance its product offerings[162]. - The company is exploring potential mergers and acquisitions to strengthen its market position and diversify its product portfolio[162]. - The company has implemented a new strategy to improve operational efficiency, aiming for a 15% reduction in costs by the end of 2024[162]. Shareholder and Equity Information - As of June 30, 2023, the total number of issued shares was 425,481,390[66]. - The total number of restricted stock units available for grant under the pre-IPO equity incentive plan was 8,753,179 as of January 1, 2023[71]. - No restricted stock units were granted during the reporting period, and the pre-IPO equity incentive plan was terminated on May 31, 2023[71]. - The company has a significant shareholder, Yi Shi, holding 70,536,703 shares, representing 16.58% of total shares[95]. - The maximum number of shares involved in the pre-IPO equity incentive plan is capped at 69,325,254 shares, representing 16.04% of the company's issued shares as of the last practicable date[99]. - As of June 30, 2023, there were 8,273,043 shares or options available for future grants under the equity incentive plan limit[112]. - The exercise price for the pre-IPO options exercised during the reporting period ranged from $0.1 to $0.4688 per share[124]. - A total of 6,816,185 shares and 8,644,205 options were granted to eligible participants under the equity incentive plan during the reporting period[112]. - The pre-IPO equity incentive plan was terminated on May 31, 2023, and no further grants will be made under this plan[120]. - The fair value of restricted share units is calculated based on accounting standards and policies, using a binomial pricing model[108]. - 25,704,680 shares were cancelled as part of a settlement agreement with certain participants due to their inability to pay related debts[125]. - The company has an existing unpaid share plan and an existing share plan, namely the pre-IPO equity incentive plan and the share incentive plan[119]. - As of January 1, 2023, there were 23,411,593 reward shares or options available for future grants under the share incentive plan limit[112]. - The company has granted a total of 2,670,445 shares under the pre-IPO equity incentive plan, which were transferred to a trust[102]. - The company granted a total of 44,551,933 shares under the share incentive plan, which is the maximum limit set for the plan[134]. - As of June 30, 2023, there were 4,905,000 restricted share units granted, with 4,562,500 units vested[129]. - The exercise price for the restricted share units ranged from $0.00 to $0.001 per share during the reporting period[132]. - A total of 32,840,878 shares were granted to participants under the pre-IPO equity incentive plan, with 25,704,680 shares cancelled as part of a settlement agreement[133]. - The company reported a total of 7,305,180 shares granted to other participants, excluding directors and major shareholders[144]. - The fair value of the options granted was calculated using a binomial pricing model, considering factors such as risk-free interest rates and expected volatility[158]. - The exercise period for the options granted is set for 10 years from the grant date, subject to the terms of the share incentive plan[158]. - The company reported a total of 2,971,727 options purchased at an exercise price of HKD 3.02 during the reporting period[138]. Governance and Compliance - The company has established an audit committee in accordance with Listing Rule 3.21 and the Corporate Governance Code, consisting of three members, with Mr. Tang as the chairman[197]. - The expected timeline for the use of net proceeds from the fundraising is subject to change based on future developments and unforeseen circumstances[196].

Financial Performance - Revenue increased from RMB 218 million for the six months ended June 30, 2022, to RMB 361 million for the six months ended June 30, 2023, primarily due to increased CDMO services[11]. - Other income decreased from RMB 239 million for the six months ended June 30, 2022, to RMB 176 million for the six months ended June 30, 2023, mainly due to a reduction in government grants recognized[11]. - Adjusted loss and total comprehensive expenses increased by RMB 27.9 million to RMB 232 million for the six months ended June 30, 2023, compared to RMB 204.1 million for the same period in 2022, primarily due to increased R&D expenses offset by higher CDMO revenue[11]. - The company reported a gross profit of RMB 10,112 thousand for the six months ended June 30, 2023, compared to RMB 3,072 thousand for the same period in 2022[150]. - The total assets of the company decreased to RMB 1,930,032 thousand as of June 30, 2023, from RMB 2,134,545 thousand as of December 31, 2022[151]. - The company reported a basic and diluted loss per share of RMB (0.58) for the six months ended June 30, 2023, compared to RMB (0.47) for the same period in 2022[187]. - Total comprehensive expenses for the period amounted to RMB (245,305,000), up from RMB (210,064,000) in the previous year[187]. Research and Development - R&D expenses increased by RMB 38.1 million to RMB 203.9 million for the six months ended June 30, 2023, compared to RMB 165.8 million for the same period in 2022, driven by pipeline progress and resource optimization[11]. - The company has developed a diverse pipeline of 13 molecules targeting tumors, bone lesions, and kidney diseases, with most candidates developed internally[28]. - The company continues to expand its proprietary antibody discovery platform to support precision medicine strategies and enhance its integrated CMC capabilities[41]. - The oncology pipeline includes multiple innovative and differentiated biotherapeutics targeting major cancer pathways, with several candidates addressing significant unmet medical needs[45]. - The company is expanding its discovery pipeline with two new IND-approved projects and advancing early-stage projects aimed at developing enhanced ADCC antibodies[111]. Clinical Trials and Approvals - The company received regulatory approval from the China National Medical Products Administration and Korea MFDS to initiate the global Phase III trial of osemitamab (TST001) in combination with chemotherapy for HER2-negative gastric cancer patients[1]. - The company completed the first dose escalation cohort of TST003 in July 2023 and initiated the first China pilot of the global FIH study in August 2023[2][3]. - In March 2023, the company received orphan drug designation from the US FDA for osemitamab (TST001) for the treatment of pancreatic cancer[18]. - The global pivotal Phase III trial (TranStar301) for Osemitamab (TST001) in combination with Nivolumab and chemotherapy has been approved by regulatory authorities in China and South Korea[57]. - The Phase I/II study in China for osemitamab (TST001) has completed patient recruitment, with data supporting a global pivotal Phase III trial set to start in the second half of 2023[68]. CDMO Services - The CDMO business unit added over 12 new customers in China and the U.S. during the first half of 2023, expanding services in various areas including media development and ADC development[5]. - The company expanded its CDMO services in 2023, adding over 12 new clients compared to the first half of 2022, enhancing capabilities in cell culture development and ADC development[25]. - The company plans to enhance its CDMO business by increasing marketing efforts overseas and improving operational efficiency to reduce costs[141]. Product Development and Pipeline - Osemitamab (TST001) demonstrated a 9.5-month PFS in a Phase I/II study for Claudin18.2 positive advanced gastric cancer, indicating that over 55% of patients may benefit from this treatment[33]. - TST002 (Blosozumab) showed a significant increase in lumbar bone density of 3.52% to 5.94% and total hip bone density increase of 1.30% to 2.24% after treatment, exceeding the minimum significant difference of 2.77%[34]. - TST005, a dual-function fusion protein targeting TGF-β and PD-L1, completed its global Phase I study with encouraging preliminary results reported at ASCO 2023[72]. - The company is developing TST010, a preclinical candidate antibody aimed at enhancing T cell-mediated tumor killing[169]. - TST006, a bispecific Claudin18.2-PD-L1 antibody, is currently in preclinical stage[63]. Strategic Partnerships and Collaborations - The company continues to execute a globalization strategy by forming partnerships with global and local biopharmaceutical companies and academic institutions[27]. - The company has established collaborations with multiple multinational companies for the development of TST002 and TST004, indicating strong interest in its pipeline[103]. - The company is actively exploring partnerships for the development and commercialization of TST002 in the Greater China region[128].

(以存續方式於開曼群島註冊的有限公司) 股票代號: 6628 董事會 授權代表 審計委員會 提名委員會 德勤‧關黃陳方會計師行 執業會計師 香港 金鐘 金鐘道88號 太古廣場1期35層 Walkers Corporate Limited 190 Elgin Avenue, George Town Grand Cayman KY1-9008 Cayman Islands 中國 蘇州 星湖街218號生物納米園B6-501室 郵政編碼215123 香港九龍 觀塘道348號 宏利廣場5樓 法律顧問 中環康樂廣場8號 交易廣場2期40樓 創勝集團醫藥有限公司 2022 年年度報告 4 2022年是創勝成立的第十年，年內實現優異的營運和財務表現。儘管2022年對全球生物技術行業而言是充滿挑戰的一 年，但我們在多個方面取得關鍵進展。首先，我們在推進管線分子方面取得重大進展，特別是主要項目TST001、TST002 及TST003。其次，我們繼續強化我們的臨床和商業供應能力、於2022年在提供CDMO服務方面實現強勁收益增長及削減 營運開支。最後，我們招募多名核心人才，以增強我們的全球開發能力及合作策略。我們正在按計劃執行我 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 截至2022年12月31日止年度的 全年業績公告 及更改所得款項用途 於本公告內，「我們」及「我們的」指本公司（定義見上文）及倘文義另有所指，則 指本集團（定義見上文）。本公告所載若干金額及百分比已經約整，或約整至小數 點後一位或兩位。本公告所列任何表格、圖表或其他地方的總數與金額總和如有 任何差異，皆因約整所致。 | --- | --- | |-------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | 國際財務報告準則（ ...

Transcenta Holding Limited 創勝集團醫藥有限公司 （以存續方式於開曼群島註冊的有限公司） 股份代號 : 6628 2022 中期報告 公司簡介 2 公司資料 3 財務摘要 5 業務摘要 6 管理層討論及分析 10 其他資料 32 簡明綜合財務報表審閱報告 44 簡明綜合損益及其他全面開支表 45 簡明綜合財務狀況表 46 簡明綜合權益變動表 48 簡明綜合現金流量表 49 簡明綜合財務報表附註 50 釋義 67 目 錄 2022 年中期報告 創勝集團醫藥有限公司 2 公司簡介 概覽 我們是一家具備發現、研究、開發及製造用於存在巨大醫療需求缺口的治療領域（包括腫瘤、腎病及骨骼疾病）的差異化 抗體藥物綜合能力的臨床階段生物製藥公司。我們的管理團隊及主要業務（包括臨床開發、監管准入及業務拓展）位於美 國及中國，而我們的發現、研發、工藝開發及生產團隊均位於中國。自成立以來，我們一直致力於全球戰略及願景。我們 努力開發我們擁有全球知識產權的分子，並設計及開展多地區臨床試驗以滿足國內和國際監管要求，這將有助於為我們的 產品打造全球化的商業通道。 我們已開發功能獨有的抗體發現平台，即免疫耐受突破( ...

创胜集团 TRANSCENTA Transcenta Holding Limited 創勝集團醫藥有限公司 (以存續方式於開曼群島註冊的有限公司) 股票代號: 6628 2021 年度報告 | --- | --- | |--------------------------|-------| | | | | 目 錄 | | | 公司資料 2 | | | 首席執行官致辭 4 | | | 財務摘要 6 | | | 業務摘要 7 | | | 管理層討論及分析 11 | | | 董事報告 33 | | | 董事及高級管理層 48 | | | 企業管治報告 54 | | | 獨立核數師報告 70 | | | 綜合損益及其他全面收益表 | 74 | | 綜合財務狀況表 75 | | | 綜合權益變動表 77 | | | 綜合現金流量表 78 | | | 綜合財務報表附註 80 | | | 三年財務概要 156 | | | 釋義 157 | | 創勝集團醫藥有限公司 2021 年年度報告 2 公司資料 董事會 執行董事 錢雪明博士（首席執行官） 石明博士（首席醫學官） 朱達先生 翁曉路先生（首席財務官） 非執行董事 趙奕寧博 ...

Transcenta Holding Limited 創勝集團醫藥有限公司 INTERIM REPORT 2021 中期報告 Transcenta Holding Limited 創勝集團醫藥有限公司 （以存續方式於開曼群島註冊的有限公司） 股份代號 : 6628 2021 中期報告 | --- | --- | |------------------------------|-------| | | | | 目 錄 | | | 公司簡介 2 | | | 公司資料 4 | | | 財務摘要 6 | | | 業務摘要 7 | | | 管理層討論及分析 8 | | | 其他資料 20 | | | 簡明綜合財務報表審閱報告 28 | | | 簡明綜合損益及其他全面開支表 | 29 | | 簡明綜合財務狀況表 30 | | | 簡明綜合權益變動表 32 | | | 簡明綜合現金流量表 33 | | | 簡明綜合財務報表附註 34 | | | 釋義 50 | | 創勝集團醫藥有限公司 2021 年中期報告 2 公司簡介 概覽 我們是一家集發現、研究、開發、製造及業務拓展能力為一體的臨床階段生物製藥公司。我們的管理團隊及主 ...