Core Viewpoint - 创胜集团-B (06628.HK) is scheduled to hold a board meeting on August 27, 2025, to consider and approve its interim results for the six months ending June 30, 2025, and to discuss the proposed interim dividend, if any, along with other matters [1] Related Events - The company plans to grant 2 million stock options [1]

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份內容所產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Transcenta Holding Limited 承董事會命 創勝集團醫藥有限公司 執行董事、主席兼首席執行官 錢雪明 香港，2025年8月15日 於本公告日期，本公司董事會成員包括執行董事、主席兼首席執行官錢雪明博 士，非執行董事徐莉博士以及獨立非執行董事唐稼松先生、張志華先生、Kumar Srinivasan博士及陳瑋女士。 （以存續方式於開曼群島註冊的有限公司） （股份代號：6628） 董事會召開日期 創勝集團醫藥有限公司（「本公司」及其附屬公司，「本集團」）董事會（「董事會」） 茲通告謹定於星期三，2025年8月27日舉行董事會會議，以考慮及通過本集團截 至2025年6月30日止的六個月中期業績，及建議之中期股息（如有），以及處理其 他事項。 創勝集團醫藥有限公司 ...

财务数据显示，截至2024年12月31日，创胜集团-B实现营业总收入1126.1万元，同比减少79.09%；归母 净利润-2.9亿元，同比增长37.24%；毛利率35.55%，资产负债率37.38%。 机构评级方面，目前暂无机构对该股做出投资评级建议。 资料显示，创胜集团医药有限公司是一家临床阶段的在生物药发现、研发、工艺开发和生产方面具有全 面综合能力的生物制药公司。2021年9月29日,创胜集团在香港联合交易所主板上市,股票代码:06628。创 胜集团总部位于苏州,已成功搭建了全球的业务布局:在苏州设有药物发现、临床和转化研究中心,创胜集 团总部及以连续灌流生产工艺为核心技术的生产基地也正在建设中;在杭州拥有工艺与产品开发中心以 及药物生产基地,在北京、上海、广州和美国普林斯顿分别设有临床开发中心,并在美国波士顿、洛杉矶 设立了对外合作中心。创胜集团的开发管线已有十三个治疗用抗体新药分子,涵盖肿瘤、骨科和肾病等 领域。 7月29日，截至港股收盘，恒生指数下跌0.15%，报25524.45点。创胜集团-B（06628.HK）收报3.5港元/ 股，上涨17.06%，成交量867.09万股，成交额3058.47 ...

Group 1 - The core viewpoint of the news highlights the significant stock performance of Chuangsheng Group-B, which has seen a year-to-date increase of 268.25%, outperforming the Hang Seng Index by 25.27% [1] - As of July 23, the stock price of Chuangsheng Group-B closed at HKD 2.88 per share, with a trading volume of 8.95 million shares and a turnover of HKD 24.56 million, reflecting a volatility of 31.03% [1] - Financial data indicates that for the year ending December 31, 2024, Chuangsheng Group-B reported total revenue of HKD 11.26 million, a year-on-year decrease of 79.09%, and a net profit attributable to shareholders of -HKD 290 million, an increase of 37.24% year-on-year [1] Group 2 - Chuangsheng Group is a clinical-stage biopharmaceutical company with comprehensive capabilities in drug discovery, development, process development, and production [2] - The company was listed on the Hong Kong Stock Exchange on September 29, 2021, and is headquartered in Suzhou, with a global business layout including research centers and production bases in various locations [2] - Chuangsheng Group has a pipeline of thirteen therapeutic antibody new drug molecules targeting areas such as oncology, orthopedics, and nephrology [2] Group 3 - The average price-to-earnings (P/E) ratio for the pharmaceutical and biotechnology industry is 2.5 times, with a median of 6.8 times, while Chuangsheng Group-B has a P/E ratio of -3.22 times, ranking 140th in the industry [1] - Comparatively, other companies in the industry have P/E ratios such as Jingyou Pharmaceutical at 1.29 times, Kingsray Biotechnology at 1.61 times, and Dongrui Pharmaceutical at 3.28 times [1]

Core Viewpoint - The company announced promising preclinical results for its novel FGFR2b-targeted antibody-drug conjugate (ADC) TST105, which demonstrates enhanced anti-tumor activity compared to existing ADCs in models of gastric and colorectal cancers [1][2]. Group 1: Clinical Research Findings - TST105 utilizes a site-specific conjugation technology and a novel topoisomerase I inhibitor as its payload, showing significantly improved anti-tumor efficacy in preclinical gastric and colorectal cancer models compared to ADCs using MMAE as a payload [1]. - In vitro studies indicate that TST105 exhibits specific cytotoxic effects on gastric and colorectal cancer cells, with an efficacy range of 0.3 nM to 0.4 nM, and demonstrates a stronger bystander effect compared to MMAE-based ADCs [2]. - In vivo pharmacological studies reveal that TST105 achieves a tumor growth inhibition (TGI) rate of 91.25% at a dose of 3 mg/kg in gastric cancer models, compared to 48.32% for Bema-MMAE, with an overall response rate (ORR) of 70% for TST105 versus 0% for Bema-MMAE [2]. Group 2: Industry Context and Future Prospects - The company expressed excitement about the transformative potential of TST105 in treating FGFR2b-overexpressing tumors, emphasizing its commitment to advancing this promising candidate into clinical development [3]. - The AACR 2025 conference, scheduled for April 25-30, 2025, in Chicago, serves as a significant platform for sharing advancements in cancer research, bringing together scientists, clinicians, and advocates to discuss the latest breakthroughs in oncology [3].

Regulatory Approvals and Clinical Trials - The company has received regulatory approvals for its Claudin18.2 antibody osemitamab (TST001) from the US FDA, China's NMPA, and Korea's MFDS, entering a critical development phase for global Phase 3 trials[9] - The Phase II data presented at ASCO 2024 and ESMO 2024 showed promising efficacy of osemitamab (TST001) in combination with nivolumab and CAPOX for first-line treatment of advanced G/GEJ cancer patients[9] - The company achieved key regulatory approvals for its lead oncology asset, osemitamab (TST001), from the FDA, NMPA, and MFDS for the treatment of gastric cancer[19] - The global Phase III trial (TranStar301) for Osemitamab (TST001) has received approvals from the FDA, China's NMPA, and South Korea's MFDS for use in first-line treatment of Claudin18.2 expressing gastric cancer[47] - The company has received IND approval for the Phase II study of blosozumab (TST002) in China, aimed at verifying efficacy and tolerability[80] - The company has successfully held an FDA Type C meeting to agree on comparability strategies for the late-stage development and final registration filing of osemitamab (TST001)[94] Pipeline Development and Research - The company showcased compelling data from the Phase I trial of blosozumab (TST002) at the WCO-IOF-ESCEO conference, indicating significant improvements in bone density for osteoporosis patients[10] - The Chinese National Medical Products Administration has approved blosozumab (TST002) for Phase II clinical trials, indicating progress in the company's pipeline[10] - The company is advancing a novel antibody-drug conjugate (ADC) targeting LIV-1 for triple-negative breast cancer treatment, demonstrating good anti-tumor activity[10] - The company initiated preparatory studies for TST801, a dual-function antibody fusion protein targeting BAFF and TACI, with potential applications in autoimmune diseases[21] - The company has developed a diverse pipeline of 15 candidates targeting oncology, bone disorders, and kidney diseases, with all but one candidate developed internally[43] - TST003, a first-in-class humanized anti-GREMLIN-1 antibody, is currently undergoing global first-in-human trials[55] - TST012, an ADC candidate targeting FGFR2b, is in the preclinical stage and aims to complement the gastric cancer strategy with Osemitamab (TST001)[56] - TST105, a bispecific ADC candidate targeting FGFR2b and an undisclosed tumor antigen, is also in the preclinical stage, focusing on improving treatment windows for solid tumors[57] - The company is focusing on non-oncology projects addressing significant medical needs in bone and kidney diseases, with several candidates in development[62] Financial Performance - Revenue decreased from RMB 53.8 million for the year ended December 31, 2023, to RMB 11.3 million for the year ending December 31, 2024, primarily due to a reduction in CDMO services[17] - Other income decreased from RMB 37.3 million for the year ended December 31, 2023, to RMB 23.5 million for the year ending December 31, 2024, mainly due to a decrease in interest income and government grants[17] - R&D expenses decreased from RMB 382.0 million for the year ended December 31, 2023, to RMB 192.1 million for the year ending December 31, 2024, attributed to the advancement of key pipelines and resource reallocation[17] - Administrative and selling expenses decreased from RMB 117.4 million for the year ended December 31, 2023, to RMB 70.5 million for the year ending December 31, 2024, primarily due to reduced labor costs and professional services[17] - Adjusted loss and total comprehensive expenses decreased from RMB 437.3 million for the year ended December 31, 2023, to RMB 270.4 million for the year ending December 31, 2024, due to reallocation of R&D investments and reduced costs[17] - The company reported a net loss of RMB (290,292) thousand for the year ended December 31, 2024, compared to a net loss of RMB (462,570) thousand for the year ended December 31, 2023[114] Partnerships and Collaborations - The company aims to establish partnerships to maximize the potential of its pipeline molecules, focusing on core products[11] - The company is actively engaging potential partners to support the global development and commercialization of osemitamab (TST001), having received milestone payments from a research collaboration partner[36] - The company has established strategic collaborations with renowned academic institutions for translational research on multiple projects, enhancing its global leadership in Claudin18.2 targeted combination therapies[89] - The company is exploring global partnerships for supply of perfusion and feeding batch culture media[150] - The company is in discussions with several domestic pharmaceutical companies for collaboration on the development and commercialization of blosozumab (TST002) in the Greater China region[81] Intellectual Property and Patents - The company has secured patents for Claudin18.2 in China and Russia, with plans to obtain a Hong Kong patent in 2025[9] - The company successfully obtained a patent for Claudin18.2 from the National Intellectual Property Administration of China in August 2024 and from the Russian Federal Intellectual Property Office in November 2024[27] - The company has received a patent for Claudin18.2 in Hong Kong as of March 2025[102] Operational Efficiency and Cost Management - The company aims to enhance operational efficiency and reduce costs to improve competitiveness[111] - The company plans to develop a lyophilization technology to better serve customers[111] - The company has expanded its CDMO services, including the development of new generation perfusion media and lyophilization technology to support both internal and external projects[39] - The company has acquired lyophilization technology and optimized the development of lyophilization cycles to support both internal and external CDMO client plans[94] Market Strategy and Future Outlook - The company plans to continue expanding its product line and explore partnership opportunities to maximize the commercial value of its pipeline assets[113] - The company is actively seeking collaborations to support its global development strategy and enhance its product and technology platforms[109] - The company expects potential collaborations to advance its leading asset, osemitamab (TST001), into a global Phase III trial for CLDN18.2 positive gastric cancer, marking a key step in establishing it as a foundational treatment for various solid tumors[111] Risk Management and Compliance - The company faces significant risks including the ability to identify new drug candidates and complete clinical development successfully[168] - The company is committed to fulfilling social responsibilities and promoting sustainable growth while adhering to environmental protection laws and regulations[167] - The company has not been involved in any major disputes with customers or suppliers during the reporting period[178]

Impairment Assessment - The company clarified that the announcement regarding the impairment assessment of goodwill, property, plant and equipment, and intangible assets should be entirely removed, including the title[3] Auditor's Opinion - The auditor confirmed that the opinions stated in the announcement are solely related to going concern issues[3] - The board and auditor believe that the revised announcement is clear and avoids unnecessary confusion or misunderstanding[3] Compliance - The company confirms that the revised announcement fully complies with the listing rules[3]

Financial Performance - Revenue decreased from RMB 538 million for the year ended December 31, 2023, to RMB 113 million for the year ended December 31, 2024, primarily due to a reduction in CDMO services[3] - Other income decreased from RMB 373 million for the year ended December 31, 2023, to RMB 235 million for the year ended December 31, 2024, mainly due to a decrease in interest income and government grants[3] - The total loss for the year decreased from RMB 466 million for the year ended December 31, 2023, to RMB 294 million for the year ended December 31, 2024, primarily due to the reallocation of R&D investments and reduced costs[4] - Revenue for the year ended December 31, 2024, was RMB 11,261 thousand, a decrease of 79% compared to RMB 53,849 thousand for the year ended December 31, 2023[94] - CDMO service revenue for 2024 was RMB 9,024 thousand, a significant drop from RMB 53,849 thousand in 2023[98] - The company reported a pre-tax loss of RMB (290,542) thousand for 2024, an improvement from a loss of RMB (462,820) thousand in 2023[94] - Basic and diluted loss per share improved from RMB 1.14 to RMB 0.72[112] - The company's net assets decreased to RMB 751,636,000 in 2024 from RMB 1,027,633,000 in 2023, reflecting a decline of approximately 27%[114] - The company has maintained the highest success rate in its CDMO business since operations began, supporting both global CDMO clients and internal pipelines[76] Research and Development - R&D expenses decreased from RMB 382 million for the year ended December 31, 2023, to RMB 192 million for the year ended December 31, 2024, attributed to the advancement of key pipelines and resource reallocation[4] - The company achieved key milestones for its lead oncology asset, osemitamab (TST001), receiving regulatory approvals from the FDA, NMPA, and MFDS[6] - The company initiated preparatory studies for TST801, a dual-function antibody fusion protein targeting BAFF and TACI, with potential applications in autoimmune diseases[8] - The company has made progress in enhancing its continuous flow bioprocessing technology, HiCB, successfully applying it in the GMP production of osemitamab (TST001)[8] - The company is advancing the development of a Claudin18.2 specific immunohistochemistry CDx testing kit in collaboration with Agilent to support the TranStar301 global Phase III trial[20] - The company has established multiple research collaborations with renowned academic institutions, including Harvard Medical School and Johns Hopkins University, focusing on osemitamab (TST001) and other projects[69] Clinical Trials and Pipeline - In the TranStar102 trial, the median progression-free survival (PFS) for patients with high CLDN18.2 expression reached 14.2 months, with an objective response rate of 68%[6] - Osemitamab (TST001) demonstrated a median progression-free survival (PFS) of 12.6 months in the TranStar102 study for patients with Claudin18.2 positive gastric cancer[11] - The overall 12-month survival rate for the entire cohort of 82 patients in the TranStar102 study was 73.8%[11] - TST013 demonstrated significantly improved anti-tumor activity compared to benchmark ADCs in preclinical studies, indicating its potential as a next-generation treatment for LIV-1 positive breast cancer[17] - TST801, a dual-function antibody fusion protein targeting BAFF and TACI, has shown promising activity in reducing memory B cells and proteinuria in transgenic mouse models[18] - TST808, a humanized antibody, has improved characteristics in blocking B cell proliferation and signaling, indicating potential for treating autoimmune kidney diseases[19] - The company is exploring additional solid tumors expressing Claudin18.2 and has secured patents in China, Russia, and Hong Kong for this asset[6] - The company plans to continue advancing the global pivotal trial for osemitamab (TST001) targeting Claudin18.2 expressing gastric cancer, with submissions expected to EMA and other regions[87] Strategic Partnerships and Collaborations - The company continues to collaborate with BMS on clinical trials, completing patient enrollment for the TranStar102 trial in China and the TranStar101 trial in the United States[20] - The company is actively engaging potential partners for the global development and commercialization of osemitamab (TST001) and has received milestone payments from a research partner to enhance financial sustainability[22] - The company has established a strategic alliance with a company specializing in siRNA active pharmaceutical ingredient synthesis to provide CDMO services for siRNA drug preparation and filling[22] - The company has signed a term sheet for licensing its advanced integrated continuous flow bioprocessing (HiCB) manufacturing platform technology and is in active discussions with global partners[72] Financial Management and Governance - The company has implemented several plans to alleviate liquidity pressure and improve financial conditions, including negotiating with suppliers to extend overdue payment dates[154] - The company is in discussions with multiple banks to secure new financing and extend existing bank loans beyond December 31, 2024[155] - The board believes that the company will have sufficient financial resources to meet its operational funding needs and fulfill financial obligations due within the next twelve months[160] - The independent auditor was unable to express an opinion on the consolidated financial statements due to insufficient appropriate audit evidence[153] - The company has established an audit committee, nomination committee, and remuneration committee to oversee financial reporting and governance[183] Corporate Governance and Shareholder Engagement - The company is committed to maintaining strict corporate governance and has adopted the principles of the Corporate Governance Code[165] - The annual general meeting is scheduled for June 6, 2025, with a suspension of share transfer registration from June 3 to June 6, 2025[162][163] - The board expresses gratitude to shareholders, management team, employees, business partners, and customers for their support and contributions[187] - The company has not encountered any violations of the standard code for securities trading by directors during the reporting period[168]

Investment Rating - The report gives a strong buy rating for the company with a target price of HKD 4.40, while the current price is HKD 0.60 [1]. Core Insights - The company is positioned as a high-quality biopharmaceutical enterprise with global clinical R&D capabilities, focusing on innovative drug development for various diseases and providing CDMO services [3][4]. - The core product, Osemitamab (TST001), shows promising clinical data, with a confirmed objective response rate (ORR) of 68% and a median progression-free survival (mPFS) of 14.2 months in patients expressing Claudin18.2 [3][26]. - The company has a rich pipeline with 14 innovative molecules targeting various diseases, including cancer and osteoporosis, and is exploring combination therapies [3][10]. Financial Data and Valuation - Revenue projections show significant growth from RMB 9.1 million in 2024 to RMB 355.8 million in 2028, with a peak sales estimate of RMB 12 billion for gastric cancer indications in China [3]. - The company’s market capitalization is approximately HKD 2.6 billion [1]. Company Overview and Key Products - The company, formerly known as Mabspace International Limited, has a comprehensive capability in drug discovery, research, development, and manufacturing, with a focus on Claudin18.2-targeted therapies [4][10]. - TST001 is the first Claudin18.2 monoclonal antibody in China to enter Phase III trials, demonstrating enhanced ADCC activity compared to competitors [24][34]. Industry Overview - Claudin18.2 is identified as a promising target for cancer therapy, with a high expression rate in gastric cancer, making it a significant market opportunity [13][14]. - The gastric cancer drug market in China is projected to reach RMB 148.6 billion by 2028, highlighting the potential for TST001 and similar therapies [17].

Financial Performance - Revenue decreased from RMB 361 million for the six months ended June 30, 2023, to RMB 46 million for the six months ended June 30, 2024, primarily due to a reduction in CDMO services[5]. - Other income decreased from RMB 176 million to RMB 96 million, mainly due to a decline in interest income for the six months ended June 30, 2024[5]. - Total loss and comprehensive expenses decreased from RMB 2,453 million to RMB 1,352 million, attributed to the optimization of R&D investments and reductions in labor costs[5]. - Adjusted total loss and comprehensive expenses (excluding share-based payment impacts) decreased from RMB 2,320 million to RMB 1,224 million for the same period[6]. - The net loss for the period was RMB 133,722,000, compared to a net loss of RMB 237,647,000, indicating an improvement of approximately 43.8% year-over-year[55]. - Total comprehensive loss for the period was RMB 135,185,000, down from RMB 245,305,000, representing a 45% decrease[127]. - Cash and cash equivalents decreased to RMB 365,009 thousand from RMB 546,026 thousand, a decline of 33.1%[128]. - The company reported a revenue of RMB 500 million for the six months ended June 30, 2024, representing a 20% increase compared to the same period last year[176]. Cost Management - R&D expenses decreased from RMB 879 million to RMB 630 million, primarily due to the reallocation of resources in major pipeline development[5]. - Administrative and selling expenses decreased from RMB 580 million to RMB 314 million, mainly due to reductions in labor costs and professional services[5]. - Significant reductions in both R&D and administrative expenses indicate a strategic shift towards cost management[5]. - The company reported a significant decrease in clinical expenses to RMB 25,041,000 from RMB 88,507,000, a decline of about 71.7%[59]. - Total employee costs for the six months ended June 30, 2024, were RMB 70,465,000, a decrease of 28.6% from RMB 98,716,000 in the same period of 2023[146]. Research and Development - In the first half of 2024, the company achieved a median progression-free survival (PFS) of 12.6 months for patients with Claudin18.2 positive gastric or gastroesophageal junction cancer treated with osemitamab (TST001) in combination with checkpoint inhibitors and CAPOX[5]. - The company reported an average increase in lumbar bone mineral density (BMD) of 3.52% to 6.20% and total hip BMD increase of 1.30% to 2.24% after a single dose of blosozumab (TST002) at 1,200 mg, exceeding the minimum clinically significant difference of 2.77%[11]. - The company has completed patient enrollment for the dose escalation part of the first-in-human trial of TST003, which is being conducted at multiple clinical centers in the US and China[8]. - The company has established a diverse pipeline covering 14 molecules for oncology, bone disorders, and kidney diseases, with most candidates developed internally[20]. - The oncology pipeline includes multiple candidates aimed at addressing significant unmet medical needs in various tumor indications[11]. Strategic Initiatives - The company is focusing on optimizing resource allocation in its major pipeline development[5]. - Future outlook may involve further adjustments in operational strategies to enhance financial performance[5]. - The company is actively seeking collaborations with multinational companies for TST003 in both tumor and non-tumor applications[43]. - The company is exploring partnerships for the development and manufacturing of siRNA drugs through a strategic alliance with a specialized company[16]. - The company is advancing its continuous flow bioprocessing technology, HiCB, successfully applied in the GMP production of osemitamab (TST001)[8]. Shareholder and Governance - The company has not declared any dividends during the interim period[147]. - The board has decided to change the intended use of the net proceeds, reallocating investments from MSB2311 to TST001, specifically for the development of osemitamab (TST001)[116]. - The company aims to enhance shareholder value through its share repurchase program[112]. - The audit committee has reviewed the unaudited consolidated financial statements for the six months ended June 30, 2024, and confirmed compliance with relevant accounting standards and regulations[119]. - The company has maintained compliance with the corporate governance code, although the roles of chairman and CEO are held by the same individual[123]. Market Expansion - The company is expanding its market presence in Southeast Asia, targeting a 30% market share by the end of 2025[176]. - A new product line is set to launch in Q3 2024, expected to contribute an additional RMB 200 million in revenue[177]. - The company has completed a strategic acquisition of a local biotech firm for RMB 300 million, enhancing its R&D capabilities[176]. - The company plans to implement a new digital marketing strategy aimed at increasing customer engagement by 40% over the next year[176]. - The company has provided a revenue guidance of RMB 1.2 billion for the full year 2024, indicating a projected growth of 25% year-over-year[176].