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盛禾生物(02898) - 截至二零二五年十月三十一日止月份之股份发行人的证券变动月报表
2025-11-03 08:38
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 盛禾生物控股有限公司 呈交日期: 2025年11月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02898 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 200,000,000 | USD | | 0.0005 | USD | | 100,000 | | 增加 / 減少 (-) | | | 0 | | | | USD | | 0 | | 本月底結存 | | | 200,000,000 | USD | | 0.0005 | USD | | 100,000 | 本月底法定/註冊股本 ...
部分港股医药股走强
Mei Ri Jing Ji Xin Wen· 2025-10-22 02:38
Core Viewpoint - Some Hong Kong pharmaceutical stocks have shown strong performance, with notable increases in share prices for specific companies [1] Group 1: Stock Performance - Yaojie Ankang-B (02617.HK) experienced a significant increase, rising over 25% at one point and closing up 14.13% [1] - Shenghe Biotechnology-B (02898.HK) saw a rise of 4.31% [1] - Beikang Medical-B (02170.HK) increased by 3.65% [1]
盛禾生物(02898) - 截至二零二五年九月三十日止月份之股份发行人的证券变动月报表
2025-09-30 08:37
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 致:香港交易及結算所有限公司 公司名稱: 盛禾生物控股有限公司 呈交日期: 2025年9月30日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02898 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 200,000,000 | USD | | 0.0005 | USD | | 100,000 | | 增加 / 減少 (-) | | | 0 | | | | USD | | 0 | | 本月底結存 | | | 200,000,000 | USD | | 0.0005 | USD | | 100,000 | 本月底法定/註冊股本總額: USD 100,000 第 1 頁 共 10 ...
盛禾生物(02898) - 2025 - 中期财报
2025-09-26 13:14
Product Development - Sunho Biologics has three core products: IAH0968, IAP0971, and IAE0972, all of which are self-developed and currently in clinical trials[6] - IAH0968, an ADCC-enhanced monoclonal antibody, has initiated Phase II clinical trials for colorectal cancer and gastric cancer[6] - IAP0971 and IAE0972 have completed Phase I clinical trials for advanced solid tumors, including non-small cell lung cancer and colorectal cancer[6] - IAH0968 demonstrated an objective response rate (ORR) of 40% and a disease control rate (DCR) of 80% in patients with metastatic colorectal cancer and biliary tract cancer who had previously failed multiple lines of therapy[10] - The company has developed an antibody-cytokine fusion protein platform (AICTM platform) to enhance anti-tumor effects and overcome limitations of traditional cytokine therapies[8] - IAH0968 is the first clinical-stage anti-HER2 antibody with 100% fucose removal, significantly enhancing its binding affinity to FcγRIIIa[9] - The company aims to expand its research capabilities to include bispecific antibodies and fusion proteins for indications beyond oncology[7] - The Phase I clinical trial of IAH0968 showed good tolerability with only one dose-limiting toxicity reported at a dosage of 10 mg/kg[10] - IAP0971 showed good safety profile with up to 200μg/kg in Phase I trial, achieving stable disease in all five patients treated[13] - IAE0972 completed Phase I clinical trial in July 2023, with preliminary efficacy observed in patients with advanced solid tumors[16] - IAE0972 received IND approval for Phase II and III trials in recurrent or metastatic HNSCC and NPC in September 2024[17] - IBB0979 is in Phase I clinical trial, with first patient dosed in July 2023, targeting B7H3 for immune activation[18] - IAH0968 is set to enter Phase IIb/III trials for CRC in January 2024 and for GC in August 2024[11] - IAP0971 received IND approval for Phase I and II trials in advanced malignancies from both NMPA and FDA in late 2021 and early 2022[14] - IAE0972 observed no dose-limiting toxicities (DLT) or maximum tolerated dose (MTD) in its Phase I trial[16] - Company has multiple candidates in clinical and IND stages, with exclusive rights for IBC0966 in Greater China[18] - IAH0968 IND approved for combination chemotherapy in late-stage or metastatic GC and HER2-expressing solid tumors in April 2024[11] - IBC0966, a clinical-stage anti-PD-L1 antibody-SIRPα bispecific fusion protein, completed Phase I clinical trials for advanced malignancies in December 2023, with exclusive rights for development and commercialization in Greater China obtained from Yiming Oncology[19] - IBD0333, a clinical-stage 4-1BB and CD24 bispecific antibody, received IND approvals from the FDA and NMPA in June and July 2023, respectively, and initiated Phase I clinical trials for locally advanced/metastatic solid tumors in March 2024[19] - ISH0613, a dual-function antibody fusion protein developed for treating systemic lupus erythematosus, has an IND application submitted to the FDA for Phase I clinical trials scheduled for June 2025[19] - IAN0982, a multispecific innate effector activator, is being developed as a monotherapy or in combination with other therapies for advanced solid tumors[19] - The company has developed multiple candidates based on its proprietary platforms, including IAP0971, IAE0972, IBB0979, and ISH0613 from the AICTM platform, and IAH0968 from the AEATM platform[25] - The AICTM platform focuses on antibody-cytokine fusion protein development, showcasing strengths in antibody selection, structural design, and customized cell line production[26] - The AEATM platform produces antibodies with 0% fucose content, enhancing ADCC activity by up to 100 times due to increased binding affinity to FcγRIIIa receptors[29] - The AICTM platform enables high expression levels of 4g/L and 86% purity in antibody production through customized cell lines and advanced protein engineering[30] Financial Performance - Other income increased by 178% from approximately RMB 1.8 million to about RMB 5.0 million, primarily due to a rise in interest income from financial institutions[37] - The company recorded a net other loss of approximately RMB 1.0 million during the reporting period, attributed mainly to foreign exchange losses[38] - The company's net loss increased from approximately RMB 36.1 million in the first half of 2024 to about RMB 38.2 million in the reporting period[46] - As of June 30, 2025, the total cash and cash equivalents amounted to approximately RMB 171 million, representing an increase of about 116% compared to RMB 79 million as of December 31, 2024[47] - The company's total current assets were approximately RMB 488.1 million, while current liabilities were about RMB 74.1 million, including interest-bearing bank loans of approximately RMB 61.3 million[47] - The debt-to-asset ratio increased to approximately 13.73% as of June 30, 2025, compared to about 8.7% as of December 31, 2024[49] - As of June 30, 2025, the company's capital commitments amounted to RMB 19.1 million, primarily related to contracts for equipment purchases and land use rights[51] - The total payroll cost for the reporting period was approximately RMB 18.1 million, down from about RMB 28.5 million in the first half of 2024[57] - The company had no significant investments, acquisitions, or disposals of subsidiaries, associates, or joint ventures during the reporting period[50] - The net proceeds from the global offering amount to approximately HKD 391.6 million, with 28.2% allocated for clinical trials of IAH0968, 35.8% for IAP0971, and 36.0% for IAE0972, all expected to be fully utilized by the end of 2028[60] - The total amount allocated for clinical trials is distributed as follows: IAH0968 (HKD 110.4 million), IAP0971 (HKD 140.1 million), and IAE0972 (HKD 141.1 million)[60] - The company reported a net cash outflow from operating activities of RMB 36,115,000 for the six months ended June 30, 2025, compared to RMB 120,198,000 in the same period of 2024, indicating a significant improvement in cash flow management[83] - The company’s total liabilities increased to RMB 74,075,000 as of June 30, 2025, from RMB 44,146,000 as of December 31, 2024, marking an increase of approximately 67.8%[80] - The company raised new bank loans amounting to RMB 41,800,000 during the six months ended June 30, 2025, compared to RMB 22,980,000 in the same period of 2024, indicating a 81.9% increase in financing activities[83] - The company's bank loans as of June 30, 2025, stood at RMB 41,300,000, significantly up from RMB 9,500,000 as of December 31, 2024[106] - The company confirmed expenses related to the restricted share unit plan amounting to RMB 7,527,000 for the six months ended June 30, 2025, down from RMB 19,483,000 for the same period in 2024[114] - The company reported RMB 2,287,000 in accounts payable for R&D costs as of June 30, 2025, compared to RMB 1,022,000 as of December 31, 2024, indicating a significant increase[105] - The company has a fixed market interest rate on bank loans ranging from 3.22% to 3.44% as of June 30, 2025, compared to 3.35% to 3.80% as of December 31, 2024[106] Corporate Governance - The company has appointed a new auditor, Zhonghui Anda CPA, effective September 16, 2025, following the resignation of Deloitte[61] - No significant events have occurred that would materially impact the company's operations since the reporting period[62] - The company has not reported any changes in the board of directors or executive officers since the last annual report[63] - The company has complied with all applicable provisions of the Corporate Governance Code during the reporting period[73] - The company has established an Audit Committee consisting of three independent non-executive directors[76] - The company confirmed compliance with the standard code for securities trading by all directors during the reporting period[74] Shareholder Information - As of June 30, 2025, Mr. Zhang Feng holds 100 million shares, representing 63.83% of the issued share capital[64] - Major shareholders include Sunho Wisdom and Sunho Fortune, each holding 88 million shares, accounting for 56.17% of the issued share capital[66] - The total issued shares as of June 30, 2025, is 156,666,800[69] - The company has a total of 156,666,800 shares issued as of June 30, 2025, which is the basis for calculating the percentage ownership of shareholders[64] - The company’s total number of shares increased to 200,000,000 as of June 30, 2025, from 177,485,000 as of January 1, 2024[108] - The company adopted a Restricted Share Unit Plan on August 2, 2023, allowing for a maximum of 6,000,000 shares to be granted under the plan[68] - As of June 30, 2025, the number of unexercised Restricted Share Units granted under the plan is 4,800,000, with a weighted average closing price of HKD 5.28[70] - The plan includes performance targets and vesting conditions, with 20% of the granted units vesting on the first five anniversaries of the listing date[71] - The company did not recommend the payment of an interim dividend for the reporting period ending June 30, 2024[78] - The company did not declare or propose any dividends during the interim period, consistent with the previous year[97] Research and Development - The company emphasizes addressing technical challenges and resistance issues in immunotherapy development through its innovative platforms[25] - The company emphasizes the importance of R&D investment for long-term growth and aims to diversify its product pipeline through internal development and external collaborations[32] - A collaboration agreement was established with Yiming Oncology for the technology transfer and commercialization of IBC0966, including patent rights and technical data[33] - R&D expenses decreased from approximately RMB 37.7 million in the first half of 2024 to about RMB 28.8 million in the reporting period, primarily due to a reduction in share-based compensation[41] - Total administrative expenses for the reporting period were approximately RMB 12.7 million, down from about RMB 15.3 million in the first half of 2024, mainly due to a decrease in administrative costs related to the company's listing[42] Revenue and Loss - Total revenue for the six months ended June 30, 2025, was RMB 5,035,000, compared to RMB 1,782,000 for the same period in 2024, representing a significant increase[79] - The net loss for the six months ended June 30, 2025, was RMB 38,199,000, compared to a net loss of RMB 36,077,000 in 2024, reflecting an increase in losses of about 5.9%[79] - Basic and diluted loss per share improved to RMB 0.25 in 2025 from RMB 0.34 in 2024, showing a reduction in loss per share of approximately 26.5%[79] - Cash and cash equivalents at the end of June 30, 2025, totaled RMB 171,166,000, a decrease from RMB 493,882,000 at the end of June 30, 2024[83] - The company raised new bank loans amounting to RMB 41,800,000 during the six months ended June 30, 2025, compared to RMB 22,980,000 in the same period of 2024, indicating a 81.9% increase in financing activities[83] - The company reported a net cash outflow from operating activities of RMB 36,115,000 for the six months ended June 30, 2025, compared to RMB 120,198,000 in the same period of 2024, indicating a significant improvement in cash flow management[83]
盛禾生物-B委任中汇安达为新核数师
Zhi Tong Cai Jing· 2025-09-16 10:12
Core Viewpoint - Shenghe Biotechnology-B (02898) has announced the appointment of Zhonghui Anda CPA Limited as the new auditor starting from September 16, 2025, to fill the temporary vacancy left by Deloitte's resignation, with the term lasting until the conclusion of the next annual general meeting [1] Group 1 - The decision was made following a recommendation from the audit committee [1] - The new auditor will serve until the next annual general meeting of the company [1] - This appointment addresses the immediate need for an auditor after Deloitte's resignation [1]
盛禾生物-B(02898.HK):德勤·关黄陈方辞任核数师
Ge Long Hui· 2025-09-16 10:11
Group 1 - The core point of the article is that Shenghe Biotech-B (02898.HK) announced the resignation of its auditor, Deloitte Touche Tohmatsu [1] Group 2 - The resignation of the auditor may impact the company's financial reporting and investor confidence [1] - The announcement was made on September 16, indicating a recent development in the company's governance [1]
盛禾生物-B(02898)委任中汇安达为新核数师
智通财经网· 2025-09-16 10:09
Group 1 - The company, Shenghe Biotech-B (02898), announced the appointment of Zhonghui Anda Certified Public Accountants as the new auditor starting from September 16, 2025 [1] - This decision follows the resignation of Deloitte, filling the temporary vacancy left by their departure [1] - The term of the new auditor will last until the conclusion of the company's next annual general meeting [1]
盛禾生物(02898) - 委任核数师
2025-09-16 10:03
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。 Sunho Biologics, Inc. 盛 禾 生 物 控 股 有 限 公 司 (於開曼群島註冊成立的有限公司) (股份代號:2898) 委任核數師 本公告乃由盛禾生物控股有限公司(「本公司」)董事(「董事」)會(「董事會」)根據香 港聯合交易所有限公司證券上市規則(「上市規則」)第13.51 (4)條作出。 董事會謹此熱烈歡迎中匯安達獲委任為新核數師。 承董事會命 盛禾生物控股有限公司 主席兼執行董事 茲 提述 本公 司 日期 為2025 年 9 月 15 日 的公 告, 內容 有 關德 勤‧ 關 黃陳 方會 計 師行 (「德勤」)辭任本公司核數師(「該公告」)。除另有界定者外,本公告所用詞彙與該 公告所界定者具有相同涵義。 在德勤辭任核數師前,審核委員會已取得並審閱德勤及其他專業會計師事務所提 供的審核建議,並已考慮多項因素,包括 ...
盛禾生物-B:德勤辞任公司核数师
Zhi Tong Cai Jing· 2025-09-15 11:25
Group 1 - The company Shenghe Biotechnology-B (02898) announced the resignation of its auditor, Deloitte, effective immediately [1] - The reason for Deloitte's resignation is the failure to reach an agreement on the audit fees for the company's consolidated financial statements for the year ending December 31, 2025 [1]
盛禾生物-B(02898.HK):德勤辞任核数师一职
Ge Long Hui· 2025-09-15 11:22
Group 1 - The company announced the resignation of its auditor, Deloitte, effective September 9, 2025 [1]