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加科思(01167) - 翌日披露报表
2025-04-16 13:33
FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別: 股票 狀態: 新提交 公司名稱: 加科思藥業集團有限公司 呈交日期: 2025年4月16日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 01167 | 說明 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | 庫存股份變動 | | | | | 事件 | 已發行股份(不包括庫存股份)數 目 | 佔有關事件前的現有已發 行股份(不包括庫 ...
加科思20250320
2025-03-20 05:39
Summary of the Conference Call for 加科思 (Gakos) Company Overview - 加科思 is focused on the KS (Kirsten rat sarcoma viral oncogene homolog) and tumor immunology fields, with 13 projects in development, 10 of which are in clinical stages, and 9 ranked among the top three globally. The company anticipates 3-4 new biotechnology products to be launched within the next five years [3][4][38]. Key Achievements and Financials - 2024 is a milestone year for 加科思, having formed a strong R&D partnership with 艾力斯 (Elysium) and completed the first patient enrollment for 邦特 (Bont) [3]. - The company has a robust financial position with a reserve of 1.4 billion RMB, sufficient to cover expenses for the next four years even in the worst-case scenario. Expected cash inflow for 2024 is 320 million RMB [3][4][18]. - Sales of 格来昔布 (Grail) are expected to begin in 2025, contributing to a stable financial outlook over the next 5-6 years [3][4]. Research and Development Highlights - The KRG12C drug for advanced non-small cell lung cancer has submitted an NDA application, with three key clinical studies approved [3][4]. - 加科思 is leading in the KS signaling pathway, with the KSG12C inhibitor's NDA submitted and SHP2 inhibitor in phase III clinical trials for first-line pneumonia [5]. - In tumor immunology, 加科思 is focusing on PD-1 antibody research, targeting the 70% of cold tumors that do not respond to existing therapies. A new approach in the steam X field aims to convert cold tumors into hot tumors, with an NDA submission planned for 2026 [6]. Clinical Trial Results - The clinical trial for 普拉雷塞加 CT two 移植剂 3,312 in first-line non-small cell lung cancer has shown an optimal response rate (ORR) of 77%, with 54% of tumors shrinking by over 50% [9]. - For PD-L1 low-expressing patients, 加科思's new oral drug combination has achieved a progression-free survival (PFS) of 12.2 months and an OR of 65%, outperforming standard therapies [10]. Strategic Partnerships and Collaborations - 加科思 signed a licensing agreement with 艾力斯 for SHP2 and 格莱雷塞 in China, receiving 200 million RMB upfront and 700 million RMB in milestone payments, along with sales royalties [12]. - The company has a history of collaboration with 艾力斯, which previously included an 850 million USD agreement, resulting in 120 million USD in payments after termination [12]. Future Outlook - In 2025, 加科思 expects the NDA for 格利尔 to be approved, triggering early milestone payments. The company plans to publish transformative research articles based on first-line data with 3,312 [19]. - The company is also preparing for IND submissions for various projects, including the second-generation KS-targeted KRSG12b ADC clinical candidate [19]. Market Position and Competitive Landscape - 加科思 holds a significant advantage in the Chinese market, particularly in gastrointestinal safety and second-line monotherapy for lung cancer. It is the only company in China conducting first-line lung cancer trials and has received broad clinical trial approvals [31][32]. - The potential market size for 格莱雷赛 in China is estimated at 5 billion RMB, based on the incidence of multiple indications [26]. Conclusion - 加科思 has demonstrated resilience and innovation in its R&D efforts, with a strong pipeline and strategic partnerships positioning it for future growth. The company is optimistic about its prospects in both the KS and tumor immunology sectors, aiming to launch new products and expand its market presence [38].
加科思(01167) - 董事名单及其角色和职能
2025-03-19 13:00
( 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ) (股份代號:1167) 董事名單及其角色和職能 加科思藥業集團有限公司的董事會(「董事會」)成員載列如下。 執行董事 王印祥博士 JACOBIO PHARMACEUTICALS GROUP CO., LTD. 加 科 思 藥 業 集 團 有 限 公 司 獨立非執行董事 宋瑞霖博士 吳革博士 魯白博士 — 1 — 附註: C 相關董事委員會主席 M 相關董事委員會成員 香港 王曉潔女士 胡雲雁女士 非執行董事 陳德禮博士 2025年3月19日 — 2 — 董事會設有三個委員會。下表載列各董事會成員任職的委員會的成員資料。 委員會 董事 審核委員會 薪酬委員會 提名委員會 王印祥博士 C 王曉潔女士 M 胡雲雁女士 M 陳德禮博士 M M 宋瑞霖博士 C M 吳革博士 M M M 魯白博士 C M M ...
加科思(01167) - 2024 - 年度业绩
2025-03-19 12:58
Financial Performance - Revenue increased from RMB 63.5 million for the year ended December 31, 2023, to RMB 155.7 million for the year ended December 31, 2024, representing a growth of 145.2% attributed to licensing agreements[16]. - Gross profit increased from RMB 3.2 million for the year ended December 31, 2023, to RMB 155.7 million for the year ended December 31, 2024, a rise of 4,765.6%[96]. - Total revenue for the year ended December 31, 2024, was RMB 155.708 million, a significant increase from RMB 63.520 million in 2023, representing a growth of approximately 144.5%[160]. - Total expenses for the year ended December 31, 2024, amounted to RMB 373,228,000, a decrease from RMB 479,252,000 in 2023, reflecting a reduction in outsourcing service fees and employee benefits[188]. - The adjusted loss for 2024 was RMB 145.7 million compared to RMB 337.0 million in 2023, showing an improvement[111]. - Net loss attributable to shareholders for 2024 was RMB 155.709 million, down from RMB 359.119 million in 2023, marking a decrease of about 56.7%[160]. - Operating loss decreased to RMB 188.173 million in 2024 from RMB 397.878 million in 2023, reflecting a reduction of approximately 52.8%[160]. Research and Development - R&D expenses decreased by RMB 42.1 million or 11.3% from RMB 372.3 million for the year ended December 31, 2023, to RMB 330.2 million for the year ended December 31, 2024, mainly due to reduced material costs and employee expenses[17]. - The company has made significant progress in clinical development, with glecirasib (JAB-21822) being the leading asset, having submitted an NDA review to CDE in May 2024 for KRAS G12C mutation NSCLC patients, receiving priority review[26]. - The company is developing innovative therapies targeting "undruggable" targets, particularly focusing on the RAS signaling pathway, addressing a medical gap for 23%-25% of potential patients globally[20]. - The product pipeline includes six clinical-stage assets, three assets in IND approval stage, and several others in IND initiation stage, all targeting undruggable targets with broad applicability across various tumor types[22]. - The company is also developing innovative candidates, including small molecules and monoclonal antibodies, to address various cancer types and enhance combination therapy potential[22]. Clinical Trials and Approvals - The company completed its first NDA submission for Glecirasib in China for second-line NSCLC and initiated a pivotal Phase III trial for Glecirasib combined with SHP2 inhibitor Sitneprotafib[4]. - Glecirasib's NDA application for second-line NSCLC was submitted in May 2024 and is expected to receive approval in the first half of 2025[5]. - The company has initiated two first-in-human trials for JAB-30355 and JAB-23E73 in the US and China[4]. - The company received breakthrough therapy designation for PDAC and expanded its pivotal trial to include multiple cancer types[6]. - JAB-23E73 and JAB-30355 are in dose escalation phases, with completion expected in the second half of 2025[9][10]. Strategic Partnerships and Licensing - The company entered into an exclusive licensing agreement with Elysium for Glecirasib and Sitneprotafib in Greater China, with a transaction value of RMB 900 million[15]. - The company plans to actively seek strategic partnerships with leading multinational companies to enhance the success rate of its candidates and maximize their clinical and commercial value globally[21]. - The company has entered into licensing agreements with Elysium for Glecirasib and Sitneprotafib, indicating strategic partnerships for development[47]. Market Position and Competitive Advantage - The company has established a strong patent portfolio in the KRAS inhibitor field, with over 80 patents compared to competitors' 10+, providing a significant competitive barrier[85]. - The strategic accumulation of patents in the KRAS inhibitor field is expected to solidify the company's market position and support future growth and innovation[85]. - The company emphasizes the potential of its innovative strategies in cancer treatment, particularly in KRAS-targeted therapies, while cautioning investors about the uncertainties in drug development[66]. Financial Position and Cash Flow - As of December 31, 2024, the company's cash and cash equivalents amounted to RMB 1,174.5 million, a decrease from RMB 1,197.9 million as of December 31, 2023[118]. - The net cash used in operating activities decreased from RMB 364.2 million in 2023 to RMB 74.1 million in 2024, a decrease of RMB 290.1 million[114]. - The net cash generated from investing activities increased from RMB 47.4 million in 2023 to RMB 256.2 million in 2024, an increase of RMB 303.6 million[114]. - The total bank borrowings as of December 31, 2024, were RMB 721 million, slightly down from RMB 736 million as of December 31, 2023[118]. - The company had unused bank loan facilities of RMB 280 million and no significant equity financing plans[118]. Employee and Operational Metrics - The total employee count as of December 31, 2024, was 257, down from 301 employees in 2023, with total salary costs of RMB 153.5 million compared to RMB 174.1 million in 2023[127]. - The company's lease liabilities as of December 31, 2024, were RMB 80 million[120]. - The company confirmed no income tax expense for the years ended December 31, 2024, and 2023[107]. Future Outlook and Plans - The company plans to establish a sales and marketing team in China with an allocation of RMB 47.3 million (4%) for commercialization activities[143]. - The company intends to utilize all unutilized net proceeds by the end of 2025[142]. - The company is focusing on developing and commercializing its pipeline in promising areas such as KRAS-targeted therapies, with multiple innovative therapies targeting different forms of KRAS[84].
加科思(01167) - 董事会召开日期
2025-03-07 08:35
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之內容概不負責,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之任何損失承擔任何責任。 JACOBIO PHARMACEUTICALS GROUP CO., LTD. 加 科 思 藥 業 集 團 有 限 公 司 ( 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ) (股份代號:1167) 董事會召開日期 加科思藥業集團有限公司(「本公司」)董事會(「董事會」)茲通告謹定於2025年3月19日(星 期三)舉行董事會會議,以審議及批准(其中包括)本公司及其附屬公司截至2024年12月31 日止年度之全年業績及其發佈,以及處理其他事項。 承董事會命 加科思藥業集團有限公司 董事長 王印祥 香港,2025年3月7日 於本公告日期,董事會成員包括董事長兼執行董事王印祥博士;執行董事王曉潔女士及 胡雲雁女士;非執行董事陳德禮博士;及獨立非執行董事宋瑞霖博士、魯白博士及吳革 博士。 ...
加科思(01167) - 自愿公告 KRAS抑制剂戈来雷塞註册性临床数据见刊医学期刊《自然医学》(N...
2025-01-06 22:13
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之內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就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。 JACOBIO PHARMACEUTICALS GROUP CO., LTD. 加科思藥業集團有限公司 (股份代號:1167) 自願公告 KRAS抑制劑戈來雷塞註冊性臨床數據見刊醫學期刊 《自然醫學》(Nature Medicine) 本公告由加科思藥業集團有限公司(「本公司」或「加科思」,連同其附屬公司,統 稱「本集團」)自願刊發,以告知本公司股東及潛在投資者有關本集團最新業務發 展的資料。 本公司董事(「董事」)會(「董事會」)欣然宣佈,本公司自主研發的KRAS抑制劑戈 來雷塞註冊性臨床試驗數據在醫學期刊《自然醫學》(Nature Medicine)發佈。在文 章中,加科思首次完整公開戈來雷塞治療KRAS G12C突變的二線或以上肺癌患者 的完整數據。 關鍵性二期臨床試驗數據顯示,在單藥二線非小細胞肺癌患者中,戈來雷塞確認 客觀緩解率為47.9%(56/117),中位無進展生存期為8.2個月,中位總 ...
加科思(01167) - 自愿公告加科思在2024年第66届美国血液学年会上展示了BET抑制剂JAB...
2024-12-08 23:50
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之內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就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。 JACOBIO PHARMACEUTICALS GROUP CO., LTD. 加科思藥業集團有限公司 (於開曼群島註冊成立的有限公司) (股份代號:1167) 自願公告 加科思在2024年第66屆美國血液學年會上展示了 BET抑制劑JAB-8263治療骨髓纖維化的初步臨床數據 本公告由加科思藥業集團有限公司(「本公司」或「加科思」,連同其附屬公司,統 稱「本集團」)自願刊發,以告知本公司股東及潛在投資者有關本集團最新業務發 展的資料。 本公司董事(「董事」)會(「董事會」)欣然宣佈,本公司在加利福尼亞州聖地牙哥 舉行的2024年第66屆美國血液學會(「ASH」)年會上展示了BET抑制劑JAB-8263 治療骨髓纖維化(MF)臨床一期的初步數據。 資料顯示,JAB-8263具有良好的耐受性,二期推薦劑量為0.3毫克(每日給藥)。 JAB-8263單藥治療骨髓纖維化適應症的初步療效資料是令人鼓舞的。大多數 ...
加科思(01167) - 自愿公告 加科思完成泛KRAS抑制剂JAB-23E73 I/IIa期临牀...
2024-11-25 00:07
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之內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就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。 本公告由加科思藥業集團有限公司(「本公司」或「加科思」,連同其附屬公司,統 稱「本集團」)自願刊發,以告知本公司股東及潛在投資者有關本集團最新業務發 展的資料。 JACOBIO PHARMACEUTICALS GROUP CO., LTD. 加科思藥業集團有限公司 (於開曼群島註冊成立的有限公司) (股份代號:1167) 本公司董事(「董事」)會(「董事會」)欣然宣佈,本公司自主研發的泛KRAS抑制劑 JAB-23E73在中國完成I/IIa期臨床試驗首例患者給藥。 KRAS廣泛存在於多種腫瘤突變,約23%-25%的癌症患者帶有KRAS突變,全球 每年新增約270萬帶有KRAS相關突變的腫瘤患者有望從泛KRAS抑制劑中獲益。 自願公告 加科思完成泛KRAS抑制劑JAB-23E73 I/IIa期 臨牀試驗在中國的首例患者給藥 承董事會命 加科思藥業集團有限公司 董事長 王印祥 香港,2024年11月25日 ...
加科思(01167) - 翌日披露报表
2024-10-25 09:13
FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別: 股票 狀態: 新提交 公司名稱: 加科思藥業集團有限公司 呈交日期: 2024年10月25日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 01167 | 說明 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份(不包括庫存股份)數 目 | 佔有關事件前的現有已發 行股份(不包括 ...
加科思(01167) - 2024 - 中期财报
2024-09-27 08:36
Financial Performance - Loss for the reporting period increased from RMB 166.3 million for the six months ended June 30, 2023, to RMB 169.1 million for the same period in 2024[20]. - The company reported a loss of RMB 169,053 thousand for the six months ended June 30, 2024, compared to a loss of RMB 166,281 thousand for the same period in 2023, indicating a slight increase in losses of approximately 1.1%[152]. - Adjusted loss for the six months ended June 30, 2024, was RMB 163.5 million, compared to RMB 158.3 million for the same period in 2023[86]. - The company reported a basic loss per share of RMB 0.22 for both the six months ended June 30, 2024, and 2023, with a weighted average number of shares outstanding of 776,652,000 and 769,773,000 respectively[179]. - The company incurred a loss of RMB 169,053,000 attributable to owners for the six months ended June 30, 2024, compared to a loss of RMB 166,281,000 in the same period of 2023[179]. Research and Development - R&D expenses decreased by RMB 22.0 million or 11.1% to RMB 176.8 million for the six months ended June 30, 2024, compared to RMB 198.8 million for the same period in 2023[18]. - The company is committed to enhancing its R&D platform to maintain competitiveness in the biopharmaceutical industry[73]. - The company aims to strengthen its drug discovery platform and advance its pipeline to achieve global market leadership in innovative cancer therapies[69]. - The product pipeline includes nine clinical-stage assets and several others in the IND stage, showcasing broad applicability across various tumor types[35]. - The company plans to seek significant opportunities in targeted therapies and tumor immunology to expand its pipeline[69]. Clinical Trials and Drug Development - NDA for Glecirasib monotherapy in ≥2L NSCLC submitted in May 2024 and received priority review qualification[24]. - Glecirasib combined with JAB-3312 showed good efficacy and safety in 1L NSCLC, with the III phase trial initiated on August 7, 2024[24]. - Glecirasib is the first KRAS G12C inhibitor to enter the registration trial for ≥2L PDAC, with the first patient enrolled in October 2023[25]. - Glecirasib received orphan drug designation from the FDA for pancreatic cancer indication in April 2024[25]. - Phase II single-arm trial for Glecirasib in various cancers approved in August 2024, with impressive clinical results reported[26]. Financial Position and Cash Flow - As of June 30, 2024, the company's cash and bank balances amounted to RMB 1,060.2 million, down from RMB 1,147.8 million as of December 31, 2023[92]. - The net cash used in operating activities was RMB 180.4 million, a decrease of RMB 39.4 million compared to RMB 219.8 million for the same period in 2023[91]. - The net cash generated from investing activities for the six months ended June 30, 2024, was RMB 43.7 million, down RMB 126.9 million from RMB 170.6 million in the prior year[91]. - The net cash generated from financing activities for the six months ended June 30, 2024, was RMB 25.8 million, a decrease of RMB 163.5 million compared to RMB 189.3 million for the same period in 2023[91]. - The company recorded a net current asset value of RMB 899.5 million as of June 30, 2024, a decrease of RMB 63.8 million from RMB 963.3 million as of December 31, 2023[97]. Shareholder and Corporate Governance - The board of directors consists of three executive directors, one non-executive director, and three independent non-executive directors, ensuring a strong independent element[101]. - The company has adopted the Corporate Governance Code and confirmed compliance with its provisions, except for a deviation regarding the separation of the roles of Chairman and CEO[101]. - Deloitte has been appointed as the new auditor effective June 7, 2024, following the resignation of PwC, with no disagreements reported[105]. - The company has established an audit committee in compliance with the Listing Rules, consisting of qualified independent directors[101]. - The company advises caution to shareholders and potential investors regarding the successful development and commercialization of its products[54][56][57][58][59]. Income and Revenue - Other income increased from RMB 0.8 million for the six months ended June 30, 2023, to RMB 7.5 million for the six months ended June 30, 2024, primarily due to increased government subsidies related to R&D projects[77]. - Revenue from licensing and collaboration agreements was RMB 40.3 million for the six months ended June 30, 2023, with no revenue recognized for the same period in 2024 due to the termination of the agreement with AbbVie[74]. - The gross profit from licensing and collaboration agreements decreased from RMB 2.4 million for the six months ended June 30, 2023, to zero for the same period in 2024[76]. - The company recognized revenue of RMB 40,335,000 from agreements during the reporting period[164]. - The company generated revenue of RMB 40,335,000 from a single customer for the six months ended June 30, 2023, with no revenue reported for the same period in 2024[167]. Share Repurchase and Equity - During the reporting period, the company repurchased a total of 2,335,200 shares at a total cost of HKD 3,849,042, with a maximum price of HKD 1.86 and a minimum price of HKD 1.51 per share[102][103]. - As of June 30, 2024, the total number of issued shares was 791,755,080, including the repurchased shares[108]. - The company aims to utilize repurchased shares for resale at market price to raise additional funds, among other purposes, depending on market conditions[102]. - The total number of issued and fully paid ordinary shares remained at 791,755,080 as of June 30, 2024, unchanged from January 1, 2024[191]. - The total equity as of June 30, 2024, was RMB 906,544,000, a decrease from RMB 1,262,727,000 as of June 30, 2023[156].