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 ...

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 ...

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 ...

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].

Drug Development and Clinical Trials - Glecirasib (JAB-21822) NDA submitted for ≥2L NSCLC treatment, received priority review qualification in May 2024[2] - JAB-3312 (SHP2 inhibitor) entered Phase III registration trial, marking it as the first SHP2 inhibitor to do so globally[3] - JAB-8263 (BET inhibitor) II phase trial expected to start in H2 2024, showing promising safety and efficacy signals in myelofibrosis patients[4] - JAB-30355 (p53 Y220C activator) IND approved by FDA and CDE, with patient recruitment actively ongoing in China and the US[4] - JAB-2485 (Aurora A kinase inhibitor) global trial initiated, with encouraging clinical efficacy signals observed[4] - IND approvals received for JAB-BX300 (anti-LIF monoclonal antibody), JAB-26766 (PARP7 inhibitor), and JAB-24114 (glutamine-related metabolic enzyme inhibitor)[5] - Glecirasib's clinical activity and safety results in pancreatic cancer patients presented at ASCO GI 2024[3] - Glecirasib's breakthrough therapy designation for ≥2L PDAC granted by the FDA in April 2024[3] - JAB-8263 showed a 56.5% spleen volume reduction in myelofibrosis patients after over a year of treatment[4] - JAB-3312 demonstrated good efficacy and safety in patients, with the first patient initiated in the Phase III trial in China[3] - JAB-23E73, a novel oral pan-KRAS inhibitor, is expected to complete IND applications with CDE and the US FDA in June and August 2024, respectively[6] - The clinical candidate JAB-BX400 is anticipated to be nominated in the second half of 2024 after showing effectiveness in preclinical studies[6] - The company aims to initiate Phase II POC trials for JAB-8263 in the second half of 2024 targeting specific biomarker-positive tumors[10] - IND approval for JAB-30355 was received from the US FDA in March 2024, with further approvals from CDE in June 2024[10] - Glecirasib (JAB-21822) has shown a clinical overall response rate (cORR) of 47.9% in patients with KRAS G12C mutation NSCLC, with a disease control rate (DCR) of 86.3% and a median progression-free survival (mPFS) of 8.2 months[14] - The NDA for Glecirasib as a monotherapy for ≥2L NSCLC was submitted to CDE in May 2024 and received priority review designation[14] - The combination therapy of Glecirasib and JAB-3312 for 1L NSCLC has shown an overall response rate (ORR) of 64.7% and a DCR of 93.1%, with a mPFS of 12.2 months[15] - The first patient in the Phase III trial for Glecirasib combined with JAB-3312 was enrolled in August 2024, marking it as the first SHP2 inhibitor to enter Phase III registration trials globally[15] - Glecirasib is the first KRAS G12C inhibitor to enter ≥2L pancreatic cancer registration trials, with the first patient enrolled in October 2023[17] - The clinical results for Glecirasib in ≥2L NSCLC were first reported at the 2024 ASCO annual meeting, highlighting its efficacy compared to FDA-approved KRAS G12C inhibitors[14] - Glecirasib has been granted orphan drug designation by the FDA for pancreatic cancer in April 2024, indicating its potential in treating this indication[17] - The combination of Glecirasib and cetuximab for treating ≥3L CRC patients has received CDE approval for a Phase III trial design in May 2024[17] - The company has initiated a Phase II pivotal study for Glecirasib in China for patients with KRAS G12C mutation in PDAC, with significant progress reported in patient recruitment[17] - The safety and efficacy data for Glecirasib combined with JAB-3312 were presented at the 2024 ASCO oral abstract session, demonstrating controllable safety and good efficacy[15] - Glecirasib demonstrated an overall response rate (ORR) of 52.6% (10/19) and a disease control rate (DCR) of 84.2% (16/19) in a study involving patients with KRAS G12C mutations across various cancer types[18] - In a clinical trial for advanced colorectal cancer (CRC) in China, glecirasib as a monotherapy showed an ORR of 33.3% (11/33) and a DCR of 90.9% (30/33) with a median progression-free survival (mPFS) of 6.9 months[19] - The combination of glecirasib with cetuximab in advanced CRC patients resulted in an ORR of 62.8% (27/43) and a DCR of 93% (40/43), although mPFS data is still pending[19] - Glecirasib is the most advanced KRAS G12C inhibitor in terms of patient recruitment and data publication among all clinical-stage KRAS G12C inhibitors globally[18] - JAB-3312, a second-generation SHP2 inhibitor, has shown promising preclinical results with an IC50 value of 0.7-3.0 nM and has received orphan drug designation for esophageal cancer treatment in the U.S.[22] - JAB-8263, a potent BET family protein inhibitor, demonstrated significant efficacy signals in solid tumors and hematological malignancies, with a total symptom score improvement and a spleen volume reduction of 56.5% in one patient[24] - JAB-2485, an Aurora kinase A inhibitor, is currently in I/IIa global trials, showing encouraging clinical efficacy signals, including disease stabilization in a patient treated for over a year[25] - JAB-30355 is a potent oral small molecule p53 activator targeting p53 Y220C mutations, showing 2-3 times the efficacy of registered drugs in preclinical studies[26] - JAB-30355's IND application was approved by the FDA in March 2024, with the first patient dosed in China in July 2024[26] - JAB-BX102, a humanized monoclonal antibody targeting CD73, has completed dose escalation in a Phase I/IIa trial for advanced solid tumors[27] - JAB-BX300's IND application was approved in June 2023, targeting KRAS-driven tumors by reducing M2 macrophages and activating NK and cytotoxic T cells[28] - JAB-26766, an oral PARP7 inhibitor, received IND approval for a Phase I/IIa trial in June 2023, showing significant tumor suppression in various models[28] - JAB-24114, a prodrug of DON, has IND approval for a Phase I/IIa trial, enhancing T cell function while blocking tumor nutrition[29] - JAB-23E73, a novel oral pan-KRAS inhibitor, has shown significant anti-tumor effects in preclinical studies and IND applications submitted in June and August 2024[30] - JAB-22000, a selective KRAS G12D inhibitor, is in preclinical development with multiple patent applications filed[31] - The iADC project utilizes STING agonists as payloads, aiming to enhance anti-tumor immunity and convert "cold" tumors into "hot" tumors[32] - JAB-BX400, an iADC candidate, shows less than 1% release of free payload in plasma after 48 hours, indicating improved plasma stability compared to competitors[34] - The clinical candidate JAB-BX400 is expected to be nominated in the second half of 2024, with ongoing development of additional iADC candidates targeting TAA[34] Financial Performance - R&D expenses decreased by RMB 22.0 million or 11.1% to RMB 176.8 million for the six months ending June 30, 2024, primarily due to reduced costs of raw materials and employee expenses[7] - Administrative expenses decreased by RMB 2.5 million or 10.5% to RMB 21.2 million for the six months ending June 30, 2024, mainly due to lower administrative staff costs and professional service fees[7] - Loss for the reporting period increased to RMB 169.1 million for the six months ending June 30, 2024, compared to the loss for the same period in 2023[7] - For the six months ended June 30, 2024, the company reported no revenue, compared to RMB 40.3 million for the same period in 2023, which was related to a terminated collaboration agreement with AbbVie[43] - The cost of revenue for the six months ended June 30, 2024, was zero, while it was RMB 37.9 million for the same period in 2023, associated with the SHP2 inhibitor under the same terminated agreement[44] - Gross profit decreased from RMB 2.4 million for the six months ended June 30, 2023, to zero for the same period in 2024[45] - Other income increased significantly from RMB 0.8 million in the first half of 2023 to RMB 7.5 million in the first half of 2024, primarily due to increased government grants related to R&D projects[46] - Net other income decreased from RMB 34.7 million for the six months ended June 30, 2023, to RMB 4.7 million for the same period in 2024, mainly due to a reduction in foreign exchange gains[47] - The adjusted loss for the six months ended June 30, 2024, was RMB (163,459) thousand, compared to RMB (158,338) thousand for the same period in 2023, reflecting an increase in loss of approximately 3.4%[53] - The net cash used in operating activities for the six months ended June 30, 2024, was RMB 180.4 million, a decrease of RMB 39.4 million compared to RMB 219.8 million for the same period in 2023[56] - The net cash generated from investing activities for the six months ended June 30, 2024, was RMB 43.7 million, a significant decrease of RMB 126.9 million from RMB 170.6 million in the same period of 2023[57] - The net cash generated from financing activities for the six months ended June 30, 2024, was RMB 25.8 million, down RMB 163.5 million from RMB 189.3 million in the same period of 2023[58] - As of June 30, 2024, the company's cash and bank balances were RMB 1,060.2 million, a decrease from RMB 1,147.8 million as of December 31, 2023, primarily due to cash used in operating activities[58] - The company had no significant investments, acquisitions, or disposals of subsidiaries, associates, or joint ventures during the six months ended June 30, 2024[58] - The company recorded a net current asset value of RMB 899.5 million as of June 30, 2024, a decrease from RMB 963.3 million as of December 31, 2023, indicating a reduction of RMB 63.8 million[61] - The total number of employees as of June 30, 2024, was 298, with total salary costs amounting to RMB 79.7 million, down from RMB 92.0 million for the same period in 2023[62] - The company did not recommend an interim dividend for the six months ending June 30, 2024, consistent with the previous period[63] - The company repurchased a total of 2,335,200 shares at a total cost of HKD 3,849,042 during the reporting period[66] - The net proceeds from the global offering amounted to approximately HKD 1,421.8 million, with RMB 121.8 million utilized as of June 30, 2024[67] - 25% of the net proceeds, amounting to RMB 300.6 million, is allocated for clinical trials and registration preparations for JAB-3068[68] - 18% of the net proceeds, totaling RMB 213.0 million, is designated for the registration clinical trials of JAB-3312 and JAB-21822[68] - 10% of the net proceeds, equivalent to RMB 118.3 million, is allocated for ongoing and planned clinical trials[68] - 22% of the net proceeds, amounting to RMB 254.6 million, is for the clinical development of JAB-21822, including registration trials[68] - 9% of the net proceeds, totaling RMB 107.3 million, is designated for the discovery and development of new candidate drugs[68] - The company plans to utilize the remaining unutilized proceeds by the end of 2025[67] - The audit committee reviewed the interim results and confirmed compliance with applicable accounting principles and standards[65] - The net proceeds from the fundraising activities amounted to approximately RMB 139.1 million, with an expected utilization by the end of 2025[70] - The proportion of net proceeds allocated for the clinical development of glecirasib increased from RMB 254.6 million to RMB 454.6 million, primarily for registration clinical trials and NDA preparation[69] - The net proceeds for ongoing and planned early drug discovery and development increased from RMB 107.3 million to RMB 207.9 million, focusing on projects like JAB-23E73, JAB-30355, JAB-26766, and iADC[69] - The company reported a total revenue of RMB 40.3 million for the six months ended June 30, 2024, compared to RMB 37.9 million for the same period in 2023[76] - The operating loss for the six months ended June 30, 2024, was RMB 185.9 million, slightly higher than the loss of RMB 184.6 million in the same period of 2023[76] - The net loss attributable to the company's owners for the period was RMB 169.1 million, consistent with the loss of RMB 166.3 million in the previous year[76] - The company reported a net financial income of RMB 16.8 million for the six months ended June 30, 2024, compared to RMB 18.3 million in the previous year[76] - The total comprehensive loss for the period was RMB 169.3 million, compared to 166.2 million in the same period of 2023[77] - Total assets decreased from RMB 1,460,481 thousand as of December 31, 2023, to RMB 1,312,762 thousand as of June 30, 2024, representing a decline of approximately 10.1%[78] - Non-current assets totaled RMB 233,496 thousand as of June 30, 2024, down from RMB 292,071 thousand as of December 31, 2023, a decrease of about 20.0%[78] - Current assets decreased from RMB 1,168,410 thousand to RMB 1,079,266 thousand, reflecting a decline of approximately 7.6%[78] - The total equity attributable to owners decreased from RMB 1,073,371 thousand to RMB 906,544 thousand, a reduction of about 15.5%[78] - The total liabilities increased from RMB 387,110 thousand to RMB 406,218 thousand, an increase of approximately 4.0%[80] - Revenue for the six months ended June 30, 2024, was RMB 0, compared to RMB 40,335 thousand for the same period in 2023, indicating a significant decline in income[88] - Employee benefit expenses decreased from RMB 92,033 thousand in the first half of 2023 to RMB 79,702 thousand in the first half of 2024, a reduction of approximately 17.0%[91] - Testing expenses decreased from RMB 97,776 thousand to RMB 77,291 thousand, reflecting a decline of about 21.0%[91] - The company reported a cumulative loss of RMB (3,362,852) thousand as of June 30, 2024, compared to RMB (3,193,799) thousand as of December 31, 2023, indicating an increase in losses[78] - Long-term bank deposits were reduced to zero as of June 30, 2024, from RMB 50,013 thousand as of December 31, 2023, indicating a complete withdrawal of long-term deposits[78] - The company reported a basic loss per share of RMB 0.22 for the six months ended June 30, 2024, consistent with the loss per share for the same period in 2023[96] - The total loss attributable to the company's owners for the six months ended June 30, 2024, was RMB 169,053 thousand, compared to RMB 166,281 thousand for the same period in 2023[96] - The company has not declared or recommended any dividends for the six months ended June 30, 2024, remaining at zero as in the previous year[98] - As of June 30, 2024, the company's cash and cash equivalents amounted to RMB 361,808 thousand, down from RMB 469,155 thousand as of December 31, 2023[100] - The company has a redeemable liability of RMB 105,592 thousand as of June 30, 2024, an increase from RMB 58,817 thousand as of December 31, 2023[101] - The company’s non-current assets include investments in preferred shares of associates totaling RMB 11,053 thousand as of June 30, 2024, slightly down from RMB 11,339 thousand at the end of 2023[99] - The company has no estimated taxable profits for federal and state corporate income taxes in the U.S. for the six months ended June 30, 2024[94] - The company’s subsidiaries in mainland China benefit from a reduced corporate income tax rate of 15% due to their qualification as high-tech enterprises[95] - The company’s cash and bank balances decreased from RMB 1,147,847 thousand as of December 31, 2023, to RMB 1,060,201 thousand as of June 30, 2024[100] - The company has short-term bank loans of RMB 63,806 thousand as of June 30, 2024, down from RMB 73,616 thousand as of December 31, 2023[103] Strategic Initiatives and Partnerships

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） 2023中期報告及2023年度報告的補充公告 茲提述(i)加科思藥業集團有限公司（「本公司」，連同其附屬公司統稱為「本集團」） 於2023年3月22日刊發的截至2022年12月31日止年度的年度業績公告及所得款項 用途變動（「2022年度業績公告」）；(ii)本公司於2023年9月28日刊發的截至2023年 6月30日止六個月的中期報告（「2023中期報告」）；及(iii)本公司於2024年4月24日 刊發的截至2023年12月31日止年度的年度報告（「2023年度報告」）。除另有界定 者外，本公告所用詞彙與及2022年度業績公告、2023中期報告及2023年度報告所 載者具有相同涵義。 全球發售所得款項用途變動 本公告乃為2023中期報告及2 ...

Financial Performance - For the fiscal year ending December 31, 2023, the company's revenue was RMB 635 million, primarily due to reimbursement from a collaboration agreement with AbbVie for the development, manufacturing, and commercialization of SHP2 inhibitors[11]. - The net loss for the fiscal year ending December 31, 2023, decreased to RMB 359.1 million from RMB 371.9 million in the previous year[14]. - The company recorded revenue of RMB 63.5 million for the year ended December 31, 2023, a decrease from RMB 95.7 million in 2022, primarily due to the collaboration agreement with AbbVie for the development of SHP2 inhibitors[71]. - Gross profit decreased to RMB 3.2 million for the year ended December 31, 2023, compared to RMB 12.6 million in 2022[73]. - The company reported a significant increase in revenue, achieving a total of $500 million for the fiscal year, representing a 25% year-over-year growth[34]. - The company provided guidance for the next fiscal year, projecting revenue growth of 20% to $600 million[34]. Research and Development - Research and development expenses decreased by RMB 73.3 million or 16.4% to RMB 372.3 million for the fiscal year ending December 31, 2023, compared to RMB 445.6 million for the previous year[12]. - The company is advancing multiple drug candidates, including BET inhibitors and p53 activators, which are expected to show greater potential as research and clinical discoveries progress[8]. - The company is focused on enhancing research and development efficiency and transitioning from a startup to a more mature organization[8]. - The company is actively involved in the development of innovative drugs for neurological diseases, with Dr. Lu Bai as a prominent figure in this research area[116]. - The company is focused on developing a pipeline targeting p53 mutations, with specific projects aimed at correcting p53 Y220C mutations[68]. - The company is advancing a diverse pipeline targeting key cancer signaling pathways, with potential first-in-class and/or best-in-class candidates expected to enter the market[58]. Clinical Trials and Drug Development - JAB-3312 became the first SHP2 inhibitor to enter Phase III clinical trials globally, marking a significant milestone for the company[8]. - The objective response rate for the combination treatment of JAB-3312 and the KRAS G12C inhibitor reached 86.7% (13/15) in the optimal dosing group for non-small cell lung cancer[8]. - The key trial for glecirasib monotherapy in ≥2L NSCLC patients with KRAS G12C mutations completed patient recruitment in September 2023, with safety and efficacy data expected to be announced in the second half of 2024[17]. - Glecirasib combined with JAB-3312 for 1L NSCLC has shown better safety and efficacy compared to the current standard treatment, with approximately 100 out of 200 patients treated being 1L NSCLC patients[17]. - JAB-8263, a BET inhibitor, is set to initiate a Phase II trial in H2 2024, showing promising safety and tolerability in previous studies[22]. - The combination of Glecirasib and JAB-3312 is expected to start a Phase III trial for 1L NSCLC in Q3 2024, following CDE approval in February 2024[37]. Strategic Partnerships and Collaborations - The company aims to establish strategic partnerships with leading multinational corporations to enhance the success rate of its drug candidates[27]. - Collaboration with Merck for cetuximab in combination trials is ongoing in China and Europe[41]. - The company has established a global strategic partnership with AbbVie for the SHP2 inhibitor project[178]. Governance and Management - The management team includes CEO Wang Yinxiang, who has been with the company since July 2015, and CFO Wang Xiaojie, who joined in September 2015, indicating stability in leadership[117]. - The board consists of three executive directors, two non-executive directors, and three independent non-executive directors as of December 31, 2023[123]. - The company has adhered to all applicable provisions of the Corporate Governance Code as of December 31, 2023, except for a deviation regarding the separation of roles between the Chairman and CEO[121]. - The company emphasizes a culture of openness and inclusivity in research, focusing on innovation and growth in the life sciences sector[122]. - The board is responsible for overseeing all major affairs of the company, including policy formulation, overall strategy, and risk management systems[126]. Environmental, Social, and Governance (ESG) Initiatives - The report covers the company's environmental, social, and governance (ESG) performance for the year 2023, adhering to the ESG reporting guidelines[171]. - The company has established a three-tier ESG governance structure, with the board overseeing overall ESG strategy and performance, supported by an ESG working group and functional departments for execution[189]. - The company was recognized as one of the top 20 ESG competitive pharmaceutical companies in China in 2023[183]. - High-priority ESG issues include clinical trial safety, product quality and safety, and intellectual property protection, which are critical for the company's operations[199]. - The company emphasizes the importance of effective communication with stakeholders, including government, investors, employees, and customers, to address their expectations and concerns[191].

Clinical Development - Glecirasib monotherapy for ≥2L NSCLC has completed patient recruitment from approximately 60 centers in China, with safety and efficacy data expected to be announced in the second half of 2024[2]. - The NDA application for Glecirasib monotherapy in ≥2L NSCLC is anticipated to be submitted to CDE in the second quarter of 2024[2]. - The combination treatment of Glecirasib and JAB-3312 for 1L NSCLC has shown better safety and efficacy compared to the current standard treatment, with a Phase III trial design approved by CDE[3]. - Glecirasib has been granted breakthrough therapy designation for KRAS G12C mutation pancreatic cancer patients after progression on first-line standard treatment[3]. - JAB-8263, a BET inhibitor, is set to initiate Phase II trials in the second half of 2024, showing promising safety and tolerability signals[4]. - JAB-2485, an Aurora A kinase inhibitor, has commenced global Phase I/IIa trials in the US and China, with encouraging clinical efficacy signals observed[4]. - JAB-30355, a potent oral P53 activator, has received IND approval from the FDA, with trials expected to start in the second half of 2024[4]. - The company is conducting a Phase I/IIa dose escalation trial for JAB-BX102 (anti-CD73 humanized monoclonal antibody) in China, with the RP2D expected to be determined in Q2 2024[5]. - IND applications for JAB-26766 (PARP7 inhibitor), JAB-24114 (glutamine-utilizing enzyme inhibitor), and JAB-BX300 (anti-LIF humanized monoclonal antibody) have been approved, with clinical development strategies being optimized[5]. - The company plans to submit an IND application for JAB-23E73 (KRAS multi-inhibitor) in Q2 2024, which is a first-in-class oral small molecule targeting multiple KRAS mutations[5]. - The iADC platform is being developed, with JAB-BX400 (HER2-STING iADC) showing effectiveness in preclinical studies, and clinical candidates expected to be nominated in H2 2024[5]. - The Phase III pivotal trial for JAB-3312 combined with Glecirasib in 1L NSCLC patients received approval from China's CDE in February 2024, with plans to initiate in Q3 2024[10]. - Glecirasib is undergoing a single-arm Phase II pivotal study for PDAC in China, with trial design submitted to CDE, expected approval in Q2 2024[11]. - The clinical development of JAB-3312 and Glecirasib shows significant synergistic anti-tumor effects in preclinical studies, prioritizing their combination therapy[10]. - Glecirasib has demonstrated favorable pharmacokinetic properties and tolerability compared to competitors' KRAS G12C inhibitors in internal studies[12]. - Short-term safety and efficacy results for JAB-3312 combined with Glecirasib were reported at the 2023 ESMO conference in October 2023[10]. - Long-term safety and efficacy data for the combination therapy will be presented at the 2024 ASCO annual meeting in June 2024[10]. - Glecirasib is a highly active, selective, and orally available small molecule targeting the KRAS G12C mutation, showing promising preclinical anti-tumor effects[12]. - Glecirasib monotherapy for ≥2L NSCLC showed a confirmed overall response rate (cORR) of 42.5% (17/40) and a disease control rate (DCR) of 95% (38/40) with a median progression-free survival (mPFS) of 9.6 months[13]. - In the combination treatment of Glecirasib with JAB-3312 for 1L NSCLC, the overall response rate (ORR) was 65.5% (38/58) and the DCR was 100%[14]. - Glecirasib monotherapy for ≥2L PDAC demonstrated a confirmed overall response rate (cORR) of 41.9% (13/31) and a DCR of 93.5% (29/31) with an mPFS of 5.6 months[16]. - In the ongoing trial for Glecirasib in advanced colorectal cancer (CRC), the monotherapy showed an overall response rate (ORR) of 33.3% (11/33) and a DCR of 90.9% (30/33)[18]. - The combination of Glecirasib with cetuximab in CRC patients resulted in an ORR of 62.8% (27/43) and a DCR of 93% (40/43)[18]. - Glecirasib has been granted breakthrough therapy designation for KRAS G12C mutation in advanced or metastatic NSCLC, allowing for expedited review by CDE[13]. - The clinical activity of Glecirasib in various solid tumors has been presented at major oncology conferences, indicating ongoing development and interest in its efficacy[19]. - The company is in discussions with regulatory authorities for a Phase II pivotal trial for Glecirasib in patients with KRAS G12C and STK 11 co-mutations[20]. - Glecirasib is the first KRAS G12C inhibitor to enter registration trials for ≥2L pancreatic cancer globally, highlighting its innovative position in the market[16]. - Glecirasib's Phase I dose escalation global study completed in August 2022, with Phase II initiated in September 2022, showing similar clinical responses in Chinese patients[21]. - JAB-3312, a clinical-stage oral SHP2 inhibitor, has an IC50 value of 0.7-3.0 nM in preclinical studies, with FDA orphan drug designation for esophageal cancer treatment[22]. - JAB-8263, a selective BET family protein inhibitor, shows 80-90% c-Myc suppression for over 48 hours at low doses, with plans for Phase II trials in late 2024[25]. - JAB-2485, a selective Aurora kinase A inhibitor, has shown promising clinical efficacy signals, with dose escalation ongoing and RP2D expected in Q2 2024[26]. - JAB-30355, a p53 activator for tumors with p53 Y220C mutation, has received FDA IND approval, with Phase I trials expected to start in late 2024[27]. - JAB-BX102, a humanized monoclonal antibody targeting CD73, began I/IIa trials in September 2022, with RP2D anticipated in Q2 2024[29]. - JAB-3312 is being evaluated in combination with KRAS G12C inhibitors and anti-PD-1 antibodies, with early clinical responses observed[24]. Financial Performance - The company's revenue for the year ended December 31, 2023, was RMB 635 million, primarily due to reimbursement from a collaboration agreement with AbbVie for the development, manufacturing, and commercialization of SHP2 inhibitors[6]. - Research and development expenses decreased by RMB 73.3 million or 16.4% to RMB 372.3 million for the year ended December 31, 2023, compared to RMB 445.6 million for the year ended December 31, 2022[6]. - Administrative expenses increased by RMB 4.0 million or 9.4% to RMB 46.6 million for the year ended December 31, 2023, mainly due to increased depreciation and amortization related to the new Beijing headquarters[6]. - The net loss for the year ended December 31, 2023, was RMB 359.1 million, a decrease from RMB 371.9 million for the year ended December 31, 2022[6]. - Revenue for the year ended December 31, 2023, was RMB 63.5 million, a decrease of 33.5% from RMB 95.7 million in 2022, primarily due to the reimbursement of R&D costs related to the SHP2 inhibitor collaboration with AbbVie[47]. - Cost of revenue for the same period was RMB 60.3 million, down from RMB 83.1 million in 2022, reflecting reduced clinical trial expenses for the SHP2 inhibitor[47]. - Gross profit decreased to RMB 3.2 million in 2023 from RMB 12.6 million in 2022, indicating a significant decline in profitability[47]. - Other income increased significantly to RMB 7.5 million in 2023 from RMB 1.9 million in 2022, mainly due to increased government subsidies related to R&D projects[48]. - R&D expenses decreased to RMB 372.3 million in 2023 from RMB 445.6 million in 2022, primarily due to a reduction in materials used and an increase in employee benefits[50]. - Administrative expenses rose to RMB 46.6 million in 2023 from RMB 42.6 million in 2022, largely due to increased depreciation and amortization related to a new lease for the Beijing headquarters[51]. - Financial income increased to RMB 47.1 million in 2023 from RMB 24.6 million in 2022, attributed to higher average interest rates on time deposits[52]. - Financial expenses increased to RMB 8.3 million in 2023 from RMB 2.3 million in 2022, due to higher interest costs on lease liabilities and borrowings[52]. - The company did not incur any income tax expenses for the years ended December 31, 2023, and 2022, as no taxable profits were generated[53]. - The net loss for the year ended December 31, 2023, was RMB 359.1 million, a decrease from RMB 371.9 million in 2022, representing a 3.7% improvement[54]. - Adjusted net loss for the same period was RMB 337.0 million, compared to RMB 356.2 million in 2022, indicating a 5.4% reduction[54]. - Cash used in operating activities increased to RMB 364.2 million in 2023 from RMB 292.4 million in 2022, an increase of RMB 71.8 million[56]. - Cash flow from investing activities decreased significantly to RMB 48.0 million in 2023 from RMB 686.3 million in 2022, a reduction of RMB 638.3 million[56]. - Cash flow from financing activities increased to RMB 246.3 million in 2023, up from RMB 9.9 million in 2022, marking a substantial increase of RMB 256.2 million[56]. - As of December 31, 2023, the company had cash and cash equivalents totaling RMB 1,197.9 million, down from RMB 1,298.7 million in 2022[58]. - The company has no significant contingent liabilities as of December 31, 2023, compared to zero in 2022[61]. - The company has a total bank credit facility of RMB 270.0 million and has no major equity financing plans[58]. - The company’s lease liabilities as of December 31, 2023, amounted to RMB 136.3 million[59]. - The company reported a significant increase in revenue, reaching $150 million for the fiscal year ending December 31, 2023, representing a 25% year-over-year growth[113]. - The company provided guidance for the next fiscal year, projecting revenue growth of 20% to $180 million[113]. - Research and development expenses increased by 30%, totaling $45 million, reflecting the company's commitment to advancing its pipeline[113]. - The company reported a net profit margin of 10%, up from 8% in the previous year, indicating improved operational efficiency[113]. Corporate Governance - The company is committed to high standards of corporate governance and has adopted the Corporate Governance Code as its own governance framework, ensuring compliance with applicable provisions[67]. - The audit committee reviewed the annual performance for the year ending December 31, 2023, confirming compliance with all applicable accounting principles and standards[71]. - The board of directors consists of three executive directors, two non-executive directors, and three independent non-executive directors, ensuring a balanced distribution of power and authority[68]. - The company continues to provide various incentives and benefits to employees, including competitive salaries, bonuses, and share-based compensation, to attract and retain qualified personnel[64]. - The company has implemented ongoing training programs for employees to enhance their skills and ensure compliance with policies and procedures[64]. - There have been no significant events affecting the company since the end of the reporting period on December 31, 2023[65]. - The company did not recommend the payment of a final dividend for the year ending December 31, 2023, consistent with the previous year where no dividend was declared[65]. - The company completed a placement and subscription agreement on February 10, 2023, selling 22,100,100 shares at HKD 7.26 per share, raising approximately HKD 158.9 million net of expenses, aimed at developing its product pipeline and strengthening its financial position[72]. - During the reporting period, the company repurchased a total of 1,807,200 shares at a total cost of HKD 6,121,110, with all repurchased shares being cancelled[73]. Market Strategy - The company aims to establish strategic partnerships with leading multinational companies to enhance the success rate of its drug candidates and maximize their clinical and commercial value globally[7]. - The pipeline includes several clinical-stage assets and one asset in the NDA pre-filing stage, showcasing broad applicability across various tumor types[8]. - The company is developing a diverse combination targeting the RAS signaling pathway, including KRAS G12C inhibitor JAB-21822 and other KRAS multi-inhibitors, addressing significant unmet medical needs in tumors with KRAS mutations[40]. - The company is advancing a pipeline targeting the MYC signaling pathway with a potent BET inhibitor JAB-8263 and a selective Aurora A kinase inhibitor JAB-2485[41]. - The company is developing a pipeline targeting P53 mutations, specifically JAB-30355 for P53 Y220C, aiming to provide more effective treatment options[42]. - The company is enhancing its drug discovery platform and aims to achieve global market leadership through innovative therapies in cancer treatment[39]. - The company is focusing on expanding its pipeline in targeted therapies and tumor immunology, with a commitment to developing and commercializing promising signaling pathways[39]. - The company is pursuing collaborations to expand its global development and commercialization footprint, particularly in unmet medical needs[45]. - The company is applying for Marketing Authorization Holder (MAH) status in China and plans to collaborate with a reputable CDMO for production[46]. - The company warns that it cannot guarantee the successful development or commercialization of its core products, advising shareholders and potential investors to exercise caution[46].

智通财经APP获悉，加科思-B(01167)盘中一度涨超18%，截至发稿，涨12.29%，报2.65港元，成交额 2126.16万港元。 消息面上，加科思公布，其自主研发的P53 Y220C激活剂JAB-30300的新药临床试验申请(IND)，已获得 美国食品药监局(FDA)批准。公司将在美国开展I/IIa期晚期实体瘤临床试验，以评估JAB30300的安全性 及有效性。 公告显示，公司同时计划在中国向国家药监局药品审评中心提交新药临床申请，获批后将在中美两国同 步开展临床试验。目前P53 Y220C激活剂在全球只有一个同类项目处于临床一期。JAB-30300有望成为 首批上市的产品之一。 ...

智通财经APP讯，加科思-B(01167)发布公告，该公司自主研发的SHP2抑制剂JAB-3312与KRAS G12C抑 制剂戈来雷塞联合用药获国家药品监督管理局(NMPA)药品审评中心(CDE)批准注册性三期临床试验。 JAB-3312成为全球首个与KRAS G12C抑制剂联合用药获进入三期注册性临床研究的SHP2抑制剂。 此次在中国获批的研究是一项随机阳性药对照的三期临床试验，旨在评估JAB-3312与戈来雷塞联合用 于KRAS G12C突变的一线非小细胞肺癌(NSCLC)患者的疗效及安全性，试验的对照组是目前一线非小 细胞肺癌的标準疗法，即PD-1抗体和化疗联合治疗。 加科思于2018年启动SHP2抑制剂的临床试验。由加科思在 2023年欧洲肿瘤内科学会年会(ESMO 2023) 发布的数据显示，在129位非小细胞肺癌患者中，其中有58位一线治疗的患者(包括7个剂量组)， ORR(客观缓解率)为65.5%(38/58)，DCR(疾病控制率)为100%。其中在800毫克戈来雷塞(每日一次)及2毫 克JAB-3312(每日一次，给药一周停药一周)联用的剂量组中，ORR为86.7%(13/15)，该临床研究在 ...