Core Insights - Candid Therapeutics, Inc. has made progress in clinical evaluation of GB261, a novel T cell engager for autoimmune diseases, with the first patients receiving treatment and showing good tolerance [1] - The subcutaneous formulation of GB261 has been established, which is a bispecific antibody targeting CD20 on B cells and CD3 on T cells, designed to mediate T cell cytotoxicity against CD20-expressing B cells [1] - GB261 has a low affinity for CD3, reducing the risk of T cell overactivation while maintaining effective and selective B cell clearance [1] Company Overview - Candid Therapeutics, Inc. is a clinical-stage biotechnology company focused on transforming treatment methods for autoimmune and inflammatory diseases through its novel T cell engager platform [2] - The company has granted a global exclusive license to TRC 2004, Inc. for the development and commercialization of GB261, excluding mainland China, Hong Kong, Macau, and Taiwan [2] - Following the merger of Candid Therapeutics, Inc. and TRC 2004, Inc. in August 2024, the rights will be transferred to Candid Therapeutics, which is led by an experienced management team including CEO Dr. Ken Song [2]

Mergers and Collaborations - The company signed a merger agreement with Eton Pharmaceuticals on September 13, 2024, where Eton's shareholders will hold approximately 77% of the enlarged issued shares post-merger, while the company's shareholders will hold about 23%[8]. - The merger agreement with Yiteng Pharmaceutical was established on September 13, 2024, with Yiteng's shareholders expected to hold approximately 77% of the enlarged issued shares post-merger, while the company will retain about 23%[23]. - The merger is expected to significantly enhance the commercialization success of the CDK4/6i product due to Yiteng's established sales and distribution network[25]. - The merger will be settled entirely through the issuance of consideration shares, ensuring the company has sufficient cash resources for business development post-merger[28]. - The collaboration with TRC 2004, Inc. includes granting global exclusive rights for the development and commercialization of GB261, with potential milestone payments reaching up to USD 443 million[28]. - The company signed an outsourcing management agreement with Yiteng Pharmaceutical for CDK4/6i management on September 13, 2024[34]. - A collaboration agreement was signed with Yiteng Pharmaceutical for the development of two trispecific antibodies, GBD218 and GBD220, both in the early discovery phase[76]. Drug Development and Clinical Trials - The company submitted a New Drug Application (NDA) for Lerociclib (GB491) in combination with letrozole for the treatment of HR+/HER2- advanced breast cancer to the National Medical Products Administration (NMPA) on February 28, 2024, which was officially accepted on March 13, 2024[10]. - The company achieved significant progress with the NDA for Lerociclib in combination with fulvestrant for advanced second-line breast cancer, completing the submission of supplementary materials in March 2024 and passing inspections in September and October 2024[11]. - GB268, a tri-specific antibody targeting PD-1, VEGF, and CTLA-4, entered the preclinical development stage in 2024, with promising safety and efficacy results observed in preclinical studies[12]. - The company’s candidate drug GB263T, a tri-specific antibody, showed promising efficacy and safety in treatment doses of 1,260-1,680 mg, with updated clinical trial results accepted for presentation at the ESMO conference in September 2024[13]. - GB491 (Lerociclib) has completed patient enrollment for a Phase III clinical trial in advanced first-line breast cancer, achieving the primary endpoint in interim analysis with a p-value of 0.0004[31]. - The independent data monitoring committee (IDMC) recommended that the trial met the statistical significance requirements for efficacy and safety[31]. - GB261, a bispecific antibody, is undergoing Phase I/II clinical trials in Australia and China, with good safety and pharmacokinetic profiles reported[33]. - The initial results of GB261's I/II clinical trial showed a favorable safety and efficacy balance, with low incidence of cytokine release syndrome (CRS)[62]. - The company has paused the internal development of GB226 PD-1 and GB221 for further evaluation of development strategies and resource allocation[15]. - The company is focusing on optimizing CMC quality and efficiency, significantly reducing production costs while maintaining product quality[40]. - The company is advancing GB268 (anti-PD-1/VEGF/CTLA-4 trispecific antibody) into pre-IND development and conducting CMC process development and GLP toxicology studies[51]. Financial Performance - Total revenue for the reporting period was approximately RMB 206.2 million, compared to zero for the year ended December 31, 2023, primarily due to income from a licensing and equity agreement with TRC 2004, Inc.[21]. - Research and development expenses for the reporting period were approximately RMB 202.8 million, down from RMB 564.3 million for the year ended December 31, 2023, mainly due to new drug development costs and ongoing clinical trial expenses[21]. - Total comprehensive loss for the reporting period was approximately RMB 51.5 million, a decrease from RMB 676.0 million for the year ended December 31, 2023, attributed to increased revenue and reduced expenses[21]. - Adjusted loss for the reporting period was approximately RMB 41.3 million, compared to RMB 614.3 million for the year ended December 31, 2023, calculated by excluding share-based payment expenses[21]. - The company's loss for the reporting period decreased from RMB 675.2 million in 2023 to RMB 53.0 million in 2024, indicating improved financial performance[96]. - Cash and bank balances decreased from RMB 1,165.5 million as of December 31, 2023, to RMB 1,058.8 million as of December 31, 2024, primarily due to operating losses during the reporting period[98]. - The current ratio improved from 5.41 in 2023 to 8.74 in 2024, and the debt ratio decreased from 0.18 to 0.11, indicating a stronger liquidity position and lower leverage[102]. Pipeline and Product Candidates - The company has several promising drug candidates in its pipeline, including GB491 for HR+/HER2- breast cancer and GB261 for non-Hodgkin lymphoma, currently in various clinical stages[15]. - The company is actively pursuing business development collaborations for its pipeline, focusing on new drug applications and approvals[22]. - The company has optimized its structure and successfully implemented a light-asset model to reduce operational costs while actively pursuing strategic collaborations and signing merger agreements[22]. - The company is focusing on advancing core pipeline development and new drug approvals through multiple flexible external cooperation forms[22]. - The company is actively pursuing clinical pipeline development with efficient project management and patient recruitment strategies[46]. - The company is focusing on global oncology and autoimmune disease FIC and BIC innovative pipelines, aiming to address unmet medical needs[83]. Corporate Governance and Compliance - The board of directors has confirmed compliance with relevant laws and regulations without any serious violations during the reporting period[126]. - The company has complied with all applicable social security fund obligations as per Chinese law as of December 31, 2024[111]. - There were no significant acquisitions or disposals of subsidiaries or associated companies during the reporting period, consistent with the previous year[104]. - The company has no significant contingent liabilities as of December 31, 2024, consistent with the previous year[107]. - The company does not face significant foreign exchange risks, with a potential RMB 102.9 million impact on pre-tax losses if the RMB appreciates or depreciates by 10% against the USD[109]. - The company has no major events affecting its operations reported after the fiscal year-end[121]. Employee and Shareholder Information - As of December 31, 2024, the total employee count is 24, with 25% in R&D, 46% in clinical development, and 29% in general and administration[110]. - The interests of directors and senior executives in the company's shares as of December 31, 2024, included 1,522,500 shares (0.29%) held by Mr. Ong and 21,158,108 shares (4.07%) held by Dr. Guo[152]. - The company has adopted several stock option plans to incentivize qualified participants, including pre-IPO and post-IPO stock option plans[112]. - The company aims to incentivize key employees through the pre-IPO share option plan to promote growth and development[156]. - The total number of shares available for issuance under the pre-IPO share option plan is capped at 58,573,872 shares, which is about 11.26% of the total issued shares[160]. - The maximum number of shares that can be received by Dr. Guo under various share option plans is 5,579,054 shares[157]. - The total number of issued shares is 520,358,899[153]. - The company has no controlling shareholder following the completion of the global offering, and no significant contracts were established with any controlling shareholder during the reporting period[149].

智通财经APP获悉，据港交所4月15日披露，嘉和生物-B(06998)向港交所递交上市申请书。亿腾医药通过换股方式反向收购嘉和生物，合并后公司更名为"亿 腾嘉和医药集团有限公司"。摩根士丹利和浦银国际为新上市申请联席保荐人。 | 治療領域 | 候還產品 | 檀應症 | 作用機制 | 分類 | 來源 | 搜量 | 產品權利 | IND | I/II期 | 川期 | 新疆 新疆 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 原研產品 | | | | | | | | | | | | | 抗感染 | 穩可信 | JIRSA | 糖肽 | 原研樂 | 收購藥品 | 禮來 | 中國、意大利 | | | | | | | 希刻勞 | 草蘭氏 陽性／陰性 頭孢菌素 細菌感染! | | | 原研藥 收購藥品 | 禮來 | 中國 | | | | | | 呼吸系統 | 億瑞平 | 哮喘 | ICS | | 原研藥 收購藥品 | GSK | 中國、荷蘭 | | | | | | 創新產品 | | | | | | | | | | ...

Financial Performance - Total revenue for the reporting period was approximately RMB 206.2 million, compared to zero for the year ended December 31, 2023, primarily due to income from a licensing and equity agreement with TRC 2004, Inc.[6] - Total comprehensive loss for the reporting period was approximately RMB 51.5 million, a significant decrease from RMB 676.0 million for the year ended December 31, 2023, attributed to increased revenue and reduced expenses[6] - Adjusted loss for the reporting period was approximately RMB 41.3 million, compared to RMB 614.3 million for the year ended December 31, 2023, reflecting a substantial improvement[6] - The company reported a net loss of RMB 52.974 million for the year, a substantial improvement compared to a net loss of RMB 675.216 million in 2023[111] - The operating loss decreased significantly from RMB 711.2 million in 2023 to RMB 72.6 million in 2024, reflecting improved operational efficiency[66] - The company reported a pre-tax loss of RMB 35,132 thousand in 2024, a significant improvement compared to a loss of RMB 677,496 thousand in 2023[126] Research and Development - Research and development expenses for the reporting period were approximately RMB 202.8 million, down from RMB 564.3 million for the year ended December 31, 2023, mainly due to new drug development costs and ongoing clinical trial expenses[6] - The company has committed RMB 1,329.2 million for R&D activities related to GB491, GB261, and GB263, including ongoing and planned clinical trials[106] - The company is focusing on core pipeline development and new drug approvals, with multiple pipeline BD collaborations in progress[23] - GB491 (Lerociclib) has completed patient enrollment for a Phase III clinical trial, achieving significant statistical differences in efficacy with a p-value of 0.0004[15] - The independent data monitoring committee recommended that the Phase III trial of Lerociclib has met the predefined efficacy statistical significance requirements[15] - GB268, a trispecific antibody targeting PD-1, CTLA-4, and VEGF, has shown promising preclinical results and is entering the pre-IND enabling development stage[16] Mergers and Acquisitions - The company entered into a merger agreement with Eton Pharmaceuticals on September 13, 2024, where the shareholders of Eton will hold approximately 77% of the enlarged issued shares post-merger[10] - The proposed merger with Yiteng Pharmaceuticals is a key step towards becoming a mature and fully integrated biopharmaceutical company, expected to bring complementary and synergistic effects, laying a solid foundation for sustainable development[14] - The merger consideration will be settled entirely through the issuance of consideration shares, ensuring no cash outflow for the company[11] - The company signed a merger agreement with Yiteng Pharmaceutical Group on September 13, 2024, where Yiteng's shareholders will hold approximately 77% of the enlarged issued shares post-merger[24] Clinical Trials and Drug Development - The company has achieved significant progress in the NDA submission for Lerociclib (GB491) in combination with Letrozole for HR+/HER2- advanced breast cancer, with the NDA officially accepted on March 13, 2024[26] - The new drug application for Lerociclib (GB491) in combination with letrozole for HR+/HER2- locally advanced or metastatic breast cancer was accepted in March 2024, with clinical site inspection completed in September 2024[38] - GB261, the first T-cell engager with low-affinity binding to CD3, is undergoing Phase I/II clinical trials, with promising safety and pharmacokinetic profiles[17] - The clinical trial results for GB263T (EGFR/cMET tri-specific antibody) were accepted for presentation at the ESMO conference in September 2024[38] Financial Position and Liquidity - Cash and bank balances decreased from RMB 1,165.5 million at the end of 2023 to RMB 1,058.8 million at the end of 2024, primarily due to operating losses during the reporting period[74] - Current ratio increased to 8.74 in 2024 from 5.41 in 2023, indicating improved liquidity[76] - Quick ratio rose to 8.72 in 2024 compared to 5.25 in 2023, reflecting better short-term financial health[77] - Debt ratio decreased to 0.11 in 2024 from 0.18 in 2023, showing reduced leverage[81] Corporate Governance and Compliance - The audit committee has reviewed the consolidated financial statements for the reporting period and confirmed they were prepared in accordance with applicable accounting standards[99] - The company has complied with all provisions of the corporate governance code, except for a temporary deviation regarding the roles of Chairman and CEO[95] - The company has not engaged in any major litigation or arbitration during the reporting period[102] Employee and Compensation - Total employee compensation costs for 2024 amounted to RMB 81.4 million, down from RMB 225.4 million in 2023[85] - Administrative expenses decreased by 42.7% to RMB 71.7 million from RMB 125.2 million, mainly due to reduced employee welfare costs[69] Taxation and Financial Reporting - The effective tax expense for 2024 was RMB 17,842 thousand, compared to a tax benefit of RMB 2,280 thousand in 2023[126] - The company has not recognized any Hong Kong profits tax liabilities for the years ended December 31, 2024, and 2023, due to no estimated taxable profits[129] - The company has recognized deferred tax assets of RMB 8,915,000 based on the carryforward of operating losses[134]

Product Development and Clinical Trials - The core product Lerociclib (GB491) completed patient enrollment for Phase III clinical trials, with interim analysis achieving primary endpoints[5]. - The company submitted a New Drug Application (NDA) to the National Medical Products Administration (NMPA) on February 28, 2024, which was officially accepted on March 13, 2024[5]. - The company established a rich pipeline of innovative drug candidates, accelerating clinical trial applications and processes focused on China and the Asia-Pacific region[6]. - The company entered into a licensing and equity purchase agreement on August 2, 2024, to jointly develop and commercialize the bispecific antibody GB261 (CD20/CD3) for autoimmune diseases[4]. - The company’s self-developed tri-specific antibody GB263T showed promising efficacy and good safety characteristics in treatment doses of 1,260-1,680 mg, with updated clinical data accepted by ESMO in 2024[5]. - The company has five projects of globally first-in-class or best-in-class bispecific/multispecific antibodies that have completed PCC molecular development[5]. - The company’s innovative tri-specific antibody GB268, targeting PD-1, CTLA-4, and VEGF, has the potential to become an upgraded immune checkpoint inhibitor[5]. - The company is focused on the rapid advancement of its core pipeline while ensuring efficient operations and creating opportunities in a challenging economic environment[4]. - Clinical trials for GB226 and GB221 have been paused for further strategic evaluation and resource allocation[8]. - Lerociclib (GB491) has shown significant efficacy in treating HR+/HER2- advanced breast cancer, with a median progression-free survival (mPFS) of 11.07 months compared to 5.49 months for letrozole alone, demonstrating a hazard ratio (HR) of 0.451[19]. - The interim analysis of the LEONARDA-1 clinical trial indicated a statistically significant difference in efficacy, with a p-value of 0.0004 based on investigator assessment and 0.0011 based on independent review committee assessment[19]. - GB261 (CD20/CD3 bispecific antibody) has shown promising safety and efficacy in clinical trials, with a low incidence of cytokine release syndrome (CRS) and significant tumor suppression in patients previously treated with multiple regimens[21]. - GB263T demonstrated effective dual inhibition of EGFR and cMET signaling pathways, showing significant dose-dependent tumor suppression in various tumor models[22]. Financial Performance - Total revenue for the reporting period was approximately RMB 145 million, primarily due to research and manufacturing services provided under paid service contracts, compared to zero for the six months ended June 30, 2023[11]. - R&D expenses for the reporting period were approximately RMB 1,097 million, a decrease from RMB 2,248 million for the six months ended June 30, 2023, mainly due to reduced employee benefits and lower new drug development and clinical trial expenses[11]. - Total comprehensive loss for the reporting period was approximately RMB 1,323 million, down from RMB 2,764 million for the six months ended June 30, 2023, primarily due to reduced expenses[11]. - Adjusted loss for the reporting period was approximately RMB 1,214 million, compared to RMB 2,379 million for the six months ended June 30, 2023, calculated by excluding share-based payment expenses from the reported loss[11]. - The financial summary indicates a significant reduction in losses, reflecting improved cost management and operational efficiency[11]. - The company reported revenue of approximately RMB 14.47 million for the six months ended June 30, 2024, compared to zero revenue for the same period in 2023[36]. - Gross profit for the same period was RMB 14.12 million, with a significant reduction in administrative expenses to RMB 38.55 million from RMB 72.64 million year-over-year[35]. - R&D expenses decreased to RMB 109.68 million from RMB 224.78 million, indicating a focus on cost optimization[35]. - The company reported a net loss of RMB 126.29 million for the six months ended June 30, 2024, compared to a loss of RMB 275.04 million in the same period of the previous year[35]. - The total comprehensive loss for the six months was RMB 132,268,000, compared to RMB 276,407,000 in the same period last year, indicating a significant reduction in overall losses[142]. Corporate Governance and Management - The company’s management team has an average of over 20 years of industry experience, providing a solid foundation for achieving development goals[5]. - The company continues to optimize its structure and implement a light-asset model through flexible external collaborations[4]. - The board of directors did not recommend the payment of an interim dividend for the reporting period[53]. - The company is actively seeking suitable candidates to fill the vacancy in the audit committee to ensure compliance with listing rules[138]. - The company has adopted corporate governance principles and has complied with all applicable codes, except for a deviation regarding the roles of the Chairman and CEO[136]. - The company plans to continue regular reviews and monitoring of corporate governance practices to ensure compliance and maintain high standards[136]. - The company’s CEO, Dr. Guo, will continue to serve as CEO despite resigning from the board chairman and executive director roles effective September 12, 2024[70]. Market Expansion and Strategic Initiatives - The company is focused on expanding its market presence in the Asia-Pacific region, excluding Japan, for several of its new drug candidates[7]. - The company is engaged in both internal development and collaborative partnerships for its drug candidates, enhancing its research capabilities and market reach[7]. - The company is exploring partnerships with leading research institutions to accelerate innovation[200]. - The company plans to invest $10 million in new technology to improve production efficiency over the next year[200]. - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2025[200]. - A strategic acquisition of a biotech firm was announced, valued at $50 million, aimed at enhancing R&D capabilities[200]. Employee and Shareholder Information - As of June 30, 2024, a total of 28 employees, a decrease from 104 employees as of December 31, 2023[52]. - The total salary cost incurred during the reporting period was approximately RMB 53.0 million, compared to RMB 128.3 million for the six months ended June 30, 2023[52]. - Major shareholders include HHJH Holdings Limited with 126,239,103 shares (24.56%) and Hillhouse Management, Ltd. with 127,989,103 shares (24.90%) as of June 30, 2024[57]. - The company has adopted various stock option plans to incentivize eligible participants, including plans prior to and after the IPO[53]. - The company aims to incentivize key employees through the share options plan to contribute to its growth and development[60]. Future Outlook - The company provided a positive outlook for the next fiscal year, projecting revenue growth of 20% to $180 million[200]. - Future guidance includes maintaining a gross margin of approximately 70% for the upcoming fiscal year[200]. - The company aims to address unmet medical needs globally by focusing on innovative drug development for oncology and autoimmune diseases[34].

Financial Performance - Total revenue for the reporting period was approximately RMB 145 million, primarily due to providing research and manufacturing services under paid service contracts, compared to zero for the same period in 2023[3]. - Total comprehensive loss for the reporting period was approximately RMB 1,323 million, down from RMB 2,764 million for the same period in 2023, primarily due to reduced expenses[3]. - Adjusted loss for the reporting period was approximately RMB 1,214 million, compared to RMB 2,379 million for the same period in 2023[3]. - The company's loss decreased from approximately RMB 275.0 million for the six months ended June 30, 2023, to approximately RMB 126.3 million in the reporting period[43]. - The net loss attributable to the company for the six months ended June 30, 2024, was RMB 126,285 thousand, compared to RMB 275,043 thousand in the same period of 2023[67]. - The operating loss for the six months ended June 30, 2024, was RMB 130,077 thousand, a decrease from RMB 295,784 thousand in the same period of 2023[67]. - Basic loss per share improved to RMB 0.25 for the six months ended June 30, 2024, compared to RMB 0.54 for the same period in 2023[76]. Research and Development - R&D expenses for the reporting period were approximately RMB 1,097 million, a decrease from RMB 2,248 million for the same period in 2023, mainly due to reduced employee benefits and lower new drug development and clinical trial costs[3]. - The late-stage Phase III clinical trial for Lerociclib (GB491) completed patient enrollment, achieving primary endpoints, with NDA submission to NMPA on February 28, 2024[4]. - The independent data monitoring committee recommended that the clinical trial for Lerociclib met the statistical significance requirements for efficacy during the interim analysis[4]. - GB263T showed a promising objective response rate (ORR) of approximately 30% in patients with EGFR-sensitive mutations who were resistant to third-generation TKIs[5]. - The company has five projects in development that are potential first-in-class (FIC) or best-in-class (BIC) bispecific/multispecific antibodies, with two trispecific antibody candidates accepted for presentation at the 2024 AACR[12]. - The company is advancing the clinical pipeline with the GB263T (EGFR/c-Met/c-Met) I/II trial results accepted for presentation at the 2024 ESMO conference[16]. - Lerociclib is a novel oral CDK4/6 inhibitor designed to provide better safety and efficacy for breast cancer patients, with a unique pharmacokinetic profile allowing continuous dosing without treatment breaks[17][18]. Collaborations and Licensing - A strategic collaboration agreement was signed with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. for the transfer of an antibody drug and related IP rights[6]. - The company has established a global exclusive license agreement for GB261 (CD20/CD3 bispecific antibody) with TRC 2004, Inc., excluding mainland China, Hong Kong, Macau, and Taiwan, focusing on its potential in autoimmune diseases[8]. - The company expects to receive significant compensation from the licensing agreement, including a substantial equity stake, tens of millions of dollars in upfront payments, up to $443 million in milestone payments, and tiered royalties based on net sales ranging from single to double digits percentage[8]. - The collaboration with the licensee will primarily explore the potential of GB261 in autoimmune diseases[35]. Clinical Trial Progress - The company has successfully completed patient enrollment for the phase III clinical trial of its core product Lerociclib (GB491), achieving primary endpoint in interim analysis, and submitted a new drug application (NDA) to the NMPA on February 28, 2024[11]. - The NDA submission for Lerociclib (GB491) in combination with letrozole for HR+/HER2- breast cancer was accepted by NMPA in March 2024[16]. - The interim analysis of the phase III clinical trial for Lerociclib showed a progression-free survival (PFS) risk ratio of 0.464 (95% CI: 0.293, 0.733) with a p-value of 0.0004[17]. - The LEONARDA-1 clinical study demonstrated that Lerociclib combined with letrozole significantly reduced the risk of disease progression and death, with a hazard ratio (HR) of 0.451 and a median progression-free survival (mPFS) of 11.07 months compared to 5.49 months for letrozole alone[19]. - The study also showed a 19.7% lower incidence of diarrhea and a low incidence of grade 3/4 bone marrow suppression, with only 5.1% experiencing grade 4 neutropenia, indicating superior safety and tolerability of Lerociclib[19]. Financial Position and Assets - Cash and bank balances decreased from approximately RMB 1,165.5 million as of December 31, 2023, to approximately RMB 1,026.6 million as of June 30, 2024, mainly due to operating losses during the reporting period[43]. - As of June 30, 2024, total assets amounted to RMB 1,274,321 thousand, a decrease of 11.9% from RMB 1,446,877 thousand as of December 31, 2023[68]. - Non-current assets decreased to RMB 182,120 thousand from RMB 205,754 thousand, representing a decline of 11.5%[68]. - Current assets decreased to RMB 1,092,201 thousand from RMB 1,241,123 thousand, a reduction of 12.0%[68]. - Total equity as of June 30, 2024, was RMB 1,063,342 thousand, down from RMB 1,190,700 thousand, a decrease of 10.7%[69]. Employee and Governance - As of June 30, 2024, the company has a total of 28 employees, a decrease from 104 employees as of December 31, 2023[51]. - The total salary cost incurred by the company during the reporting period is approximately RMB 53.0 million, compared to RMB 128.3 million for the six months ended June 30, 2023[51]. - The company has complied with all provisions of the corporate governance code, except for the separation of the roles of Chairman and CEO, which are held by the same individual[55]. - There were no significant labor disputes or difficulties in recruiting employees during the reporting period[53]. Stock Options and Restricted Stock Units - The company has adopted various stock option plans to incentivize and reward eligible participants, including pre-IPO and post-IPO stock option plans[52]. - The company reported a total of 11,095,725 unexercised stock options as of June 30, 2023, with 6,130,000 options remaining unexercised during the reporting period[83]. - The total number of restricted stock units that have not yet vested as of December 31, 2023, is 10,508,093[94]. - The company granted 4,739,893 restricted stock units on August 31, 2023, with a vesting period extending to September 2, 2027[94]. - The company plans to revise the interim and annual reports to correct the errors identified in the stock option and RSU disclosures[81].

Stock Option and Share Plans - The 2023 stock option plan was adopted on October 27, 2023, with a total of 15,870,754 stock options available for grant as of December 31, 2023[3]. - The total number of shares available for issuance under the pre-IPO stock option plan is capped at 58,573,872 shares, representing approximately 11.53% of the total issued shares as of the report date[21]. - The company aims to incentivize eligible participants to contribute to its growth and development through the restricted share unit plan adopted on October 27, 2023[4]. - The company granted a total of 20,314,067 stock options under the 2023 stock option plan, with 6,130,000 options remaining unexercised as of the reporting date[77]. - The company has a cap of 14,730,911 restricted share units under the 2021 restricted share unit plan, representing approximately 2.90% of the total issued shares as of March 27, 2024[82]. - The total number of shares available for issuance under the 2023 restricted share unit plan is capped at 5,964,556 shares, representing approximately 1.17% of the total issued shares as of March 27, 2024, which is 507,856,625 shares[117]. - The stock options granted under the pre-IPO stock option plan do not require any payment from the participants for acceptance[55]. - The company aims to recruit, motivate, and retain key employees through the stock option plan[70]. - The vesting period for stock options must be no less than 12 months, but may be shorter under certain circumstances[73]. - The fair value of stock options under the 2023 stock option plan ranges from RMB 0.4074 to RMB 0.4573 per share, determined by an independent qualified valuer using a binomial option pricing model[114]. - Performance-based stock options will vest based on the employee's performance evaluation, with a minimum rating of "B" required for 60% vesting[113]. - The vesting period for the granted rewards is not less than 12 months, with certain exceptions[107]. - The stock options and restricted share units are tied to performance milestones and will vest upon achieving specific clinical development or market status[85]. Financial Performance - Total revenue for the reporting period was zero, compared to approximately RMB 159 million for the year ended December 31, 2022[138]. - Total comprehensive loss amounted to approximately RMB 6.76 billion, a decrease from approximately RMB 7.32 billion for the year ended December 31, 2022, primarily due to reduced expenses[139]. - R&D expenses for the reporting period were approximately RMB 564.3 million, compared to RMB 583.9 million for the year ended December 31, 2022, primarily due to new drug development costs and ongoing clinical trial expenses[163]. - The adjusted loss for the reporting period was RMB 614.3 million, down from RMB 682.2 million for the year ended December 31, 2022[164]. Clinical Development and Research - The company has completed the development of 5 PCC molecules, all of which are globally innovative or best-in-class bispecific/multispecific antibody projects[130]. - The late-stage Phase III clinical study of Lerociclib (GB491) achieved its predefined endpoints, with the NDA submitted to NMPA on February 28, 2024, and officially accepted on March 13, 2024[129]. - The core product Lerociclib (GB491) received formal acceptance from the NMPA on March 28, 2023, for a new drug application to treat HR+/HER2- locally advanced or metastatic breast cancer[141]. - The GB261 (CD20/CD3 bispecific antibody) I/II clinical trial has shown promising efficacy and good safety after completing dose escalation[178]. - The initial clinical data for GB261 indicates better safety tolerance, with all CRS cases being grade 1 (8.5%) or grade 2 (4.3%), and no grade 3 CRS reported[145]. - The GB263T (EGFR/cMET/cMET) I/II clinical trial has shown promising efficacy at therapeutic doses (1,260-1,680 mg) with good safety[148]. - The company has established multiple clinical research centers for GB261 in Australia and China, with initial clinical proof of concept data showing good safety and pharmacokinetic characteristics[167]. - The company is actively expanding global innovation and external collaborations in early research and commercialization[156]. - The company continues to push for rapid clinical trial applications and approvals in China and Australia, benefiting from high professionalism and cross-departmental collaboration[177]. - The company plans to submit the NDA for Lerociclib to the NMPA on February 28, 2024, following the analysis of efficacy data from the late-stage III clinical study[175]. Shareholder Information - The company has a total of 507,520,025 shares issued as of December 31, 2023[18]. - The company’s major shareholders include HHJH Holdings Limited and Hillhouse Fund IV, L.P., each holding approximately 24.87% of the shares[17]. - The company is indirectly wholly owned by Watson (Shenzhen Stock Exchange listed company, stock code: 300142) through Shanghai Woga Biotechnology Co., Ltd.[40]. Management and Strategy - The management team has an average of over 20 years of industry experience, with a strong track record in biopharmaceutical development[131]. - The strategic focus remains on optimizing operations and seeking growth opportunities in a challenging economic environment[121]. - The company has signed a technology transfer agreement with East China Pharmaceutical, transferring an antibody drug and related IP rights[156]. - The company signed an agreement with China Medical East for the transfer of an antibody drug and related IP rights on January 19, 2024[196].

Financial Overview - The company reported a total revenue of RMB 15,932 thousand for the year ended December 31, 2023, compared to RMB 14,949 thousand for the previous year, indicating a slight increase [28]. - Operating loss for the year ended December 31, 2023, was RMB 711,196 thousand, a decrease from RMB 782,719 thousand in the previous year [28]. - The company recorded a net loss of RMB 675.22 million for the period, down from RMB 730.40 million in the previous year [137]. - Adjusted annual loss for the year ended December 31, 2023, was RMB 614.3 million, compared to RMB 682.2 million for the year ended December 31, 2022, reflecting a decrease of 10% [140]. - The company reported zero revenue for the period, compared to RMB 159.32 million for the year ended December 31, 2022 [127]. - Research and development expenses for the reporting period were approximately RMB 564.3 million, down from RMB 583.9 million for the year ended December 31, 2022 [41]. - Administrative expenses decreased by 6.6% to RMB 125.24 million from RMB 134.13 million in the previous year [131]. - Financial income decreased to RMB 34.74 million from RMB 53.31 million in the previous year, primarily due to foreign exchange fluctuations [136]. Capital Allocation and Utilization - The company raised approximately HKD 2,923 million through the global offering, with 129,683,500 shares issued [4]. - As of December 31, 2023, the unutilized net proceeds amount to approximately RMB 864.8 million, which will be allocated according to the purposes disclosed in the 2023 interim results announcement [5]. - Total net proceeds allocated for core product R&D activities is RMB 1,065.1 million, with RMB 591.1 million utilized and RMB 474.0 million remaining [10]. - The total allocation of net proceeds amounts to RMB 2,536.0 million, with RMB 1,671.2 million utilized and RMB 864.8 million remaining [10]. - The expected timeline for utilizing the remaining unutilized net proceeds is subject to changes based on market conditions [11]. - The company plans to extend the expected timeline for utilizing the remaining unutilized net proceeds by one to two years due to a strategic shift towards high-differentiation product pipelines [26]. - The total amount allocated for general corporate purposes is RMB 253.6 million, with RMB 77.7 million utilized and RMB 25.9 million remaining unutilized as of December 31, 2023 [18]. Research and Development Progress - The company has prioritized R&D investments in GB491, GB261, and GB263 to address significant medical needs and enhance its product pipeline [26]. - Total net proceeds allocated to R&D activities for GB491, GB261, and GB263 amounted to RMB 1,329.2 million, with RMB 827.2 million utilized and RMB 235.7 million remaining unutilized as of December 31, 2023 [18]. - The company plans to invest in products based on current and future development conditions and market competition [16]. - The company is focusing on developing innovative drug candidates and optimizing its existing product portfolio to meet unmet medical needs globally [124]. - The company aims to accelerate the clinical trial applications for innovative drug candidates, focusing on products in China and the Asia-Pacific region [65]. Clinical Trials and Product Development - The National Medical Products Administration (NMPA) accepted the new drug application for Lerociclib on March 28, 2023, for the treatment of HR+/HER2- breast cancer [43]. - The Phase III clinical trial for Lerociclib in first-line treatment of advanced breast cancer has completed patient enrollment, achieving predefined endpoints [44]. - GB261 (CD20/CD3 bispecific antibody) has shown promising efficacy and good safety in I/II clinical trials, with a dose escalation completed by October 2023 [46]. - Initial clinical data for GB261 indicates a low incidence of cytokine release syndrome (CRS), with 8.5% at grade 1 and 4.3% at grade 2, and no grade 3 CRS reported [46]. - GB263T (EGFR/cMET/cMET trispecific antibody) has completed a dose escalation of 1,680 mg, showing promising efficacy in imaging remission as of August 2023 [48]. - The company has completed five PCC molecular developments, all being first-in-class or best-in-class bispecific/multispecific antibody projects by December 31, 2023 [53]. - The company plans to submit a new drug application (NDA) for Lerociclib (GB491) to the NMPA by February 28, 2024, after achieving predefined endpoints in a Phase III trial [54]. Financial Position and Equity - The company’s total assets decreased from RMB 2,115,091 thousand in 2022 to RMB 1,446,877 thousand in 2023, reflecting a significant reduction [30]. - Cash and bank balances decreased from RMB 1,588,705 thousand in 2022 to RMB 1,165,481 thousand in 2023, indicating a decline in liquidity [30]. - The total liabilities decreased from RMB 309,873 thousand in 2022 to RMB 256,177 thousand in 2023, representing a reduction of approximately 17.3% [57]. - The company’s total equity as of the reporting period is RMB 1,190,700,000, compared to RMB 1,805,218,000 in the previous period [172]. - The current ratio as of December 31, 2023, was 5.41, down from 6.61 as of December 31, 2022 [142]. - The quick ratio as of December 31, 2023, was 5.25, compared to 6.24 as of December 31, 2022 [143]. - The debt ratio increased to 0.18 as of December 31, 2023, from 0.15 as of December 31, 2022 [144]. Corporate Governance and Future Plans - The company has complied with all provisions of the corporate governance code, except for the separation of roles between the chairman and CEO, which has been held by Dr. Guo since November 2, 2021 [167]. - The board believes that having Dr. Guo serve as both chairman and CEO is in the best interest of the company, enhancing operational efficiency and business strategy execution [168]. - The company does not plan to declare a final dividend for the reporting period [161]. - The annual general meeting is scheduled for June 27, 2024 [162]. - The company proposes to adopt the eighth revised and restated articles of association to align with the updated listing rules, allowing electronic communication with shareholders starting December 31, 2023 [163].

Financial Performance - The total comprehensive loss for the reporting period was approximately RMB 276.4 million, compared to RMB 407.5 million for the six months ended June 30, 2022[9]. - For the six months ended June 30, 2023, the company reported a loss of RMB 275,043 thousand, a decrease from a loss of RMB 406,618 thousand for the same period in 2022, representing a 32.3% improvement[48][78]. - Revenue for the six months ended June 30, 2023, was RMB 0, while the revenue for the same period in 2022 was RMB 2,956,000, indicating a significant decline[195]. - The company reported net financial income of RMB 19,624,000 for the first half of 2023, down from RMB 26,247,000 in the same period of 2022, a decrease of 25.3%[195]. - Research and development expenses for the six months ended June 30, 2023, were RMB 224,776 thousand, down from RMB 295,140 thousand in the previous year, indicating a reduction of 23.8%[48][74]. - The company's total assets as of June 30, 2023, were RMB 1,834,499,000, down from RMB 2,115,091,000 as of December 31, 2022, reflecting a decrease of 13.2%[198]. - The total equity attributable to the company's ordinary equity holders decreased to RMB 1,565,952,000 as of June 30, 2023, from RMB 1,805,218,000 as of December 31, 2022, a decline of 13.3%[198]. - Total liabilities as of June 30, 2023, were RMB 268,547,000, a decrease from RMB 309,873,000 as of December 31, 2022, representing a reduction of 13.3%[199]. - The company had cash and bank balances of RMB 1,361,971,000 as of June 30, 2023, down from RMB 1,588,705,000 as of December 31, 2022, a decrease of 14.3%[198]. - Basic loss per share for the six months ended June 30, 2023, was RMB 0.54, compared to RMB 0.81 for the same period in 2022, indicating an improvement in loss per share[196]. Research and Development - As of June 30, 2023, nearly 10 innovative early-stage research projects focusing on oncology are in development, with one potential FIC candidate molecule having entered the IND enabling stage[16]. - The clinical trial data for Lerociclib (GB491) was selected for ASCO Daily News, highlighting its ability to reduce disease progression risk in advanced HR+/HER2- breast cancer patients[11]. - Initial data for GB261 (CD20/CD3 bispecific antibody) shows promising efficacy in patients who previously failed CAR-T and CD3/CD19 treatments[13]. - The dose escalation for GB261 is expected to be completed by October, with the recommended phase 2 dose anticipated by the end of 2023[14]. - The company has established a global FIC/differentiated T-cell engager platform, focusing on molecules with potential clinical efficacy and commercial viability[24]. - The company is focused on advancing its innovative drug development pipeline, with GB268 entering the IND enabling stage and plans to complete clinical POC data verification within 2023[63][66]. - The company plans to accelerate clinical trials for its bispecific and trispecific antibody candidates, with GB261 expected to complete Phase I/II trials within the next 6 to 12 months[72]. - GB263T (EGFR/cMET/cMET, tri-specific antibody) has shown preliminary clinical efficacy, with a response rate exceeding 24 weeks in EGFR-sensitive mutation NSCLC patients who failed multiple lines of treatment[39]. - The LEONARDA-1 study demonstrated excellent efficacy and safety data for Lerociclib in HR+/HER2- advanced breast cancer patients, providing a reliable clinical option[32]. - The company is actively advancing the commercialization cooperation for Lerociclib (GB491), with multiple companies having completed Phase III clinical data communication as of June 30, 2023[35]. Corporate Governance - The board believes that having Dr. Guo serve as both Chairman and CEO is appropriate for the company's best interests, despite a deviation from corporate governance code C.2.1[171]. - The company has complied with all corporate governance code provisions during the reporting period, except for code provision C.2.1[185]. - The company established an audit committee in compliance with listing rules, consisting of three directors, with Mr. Feng Guanhao serving as the chairman[188]. Share Options and Incentives - The total number of shares available for issuance under the pre-IPO share option plan is capped at 58,573,872 shares, representing approximately 11.57% of the issued shares as of August 30, 2023, which amounts to 506,337,036 shares[88]. - The exercise price for the pre-IPO share option plan is set at HKD 0.0002 and USD 2, with various milestones affecting the options granted[93]. - The remaining term for the pre-IPO share option plan is approximately 6.0 years from August 30, 2023, expiring on August 19, 2029[90]. - The company has adopted both pre-IPO and post-IPO share option plans to incentivize qualified participants for their contributions[110]. - The company has established a restricted share unit plan in 2021 to further incentivize contributions from qualified participants[110]. - The options granted under the plan are subject to vesting based on performance or milestone achievements[121]. - The company aims to recruit, motivate, and retain key employees through the share option plan[115]. Utilization of Proceeds - As of June 30, 2023, the company utilized net proceeds of approximately RMB 1,538.0 million according to the disclosed plans in the prospectus[140]. - The company has approximately RMB 998.0 million of unutilized net proceeds as of June 30, 2023, due to changes in the intended use of proceeds[141]. - The net proceeds raised from the global offering amounted to approximately RMB 2,536 million[161]. - During the reporting period, the company utilized net proceeds of approximately RMB 181.4 million[162]. - The company allocated a total of RMB 2,536.0 million for various R&D activities, with RMB 1,179.4 million already utilized and RMB 1,538.0 million remaining as unutilized funds[174]. - The expected timeline for the utilization of remaining unutilized funds has been extended by one to two years due to significant cost reductions and a reallocation of resources[183]. Strategic Focus - The company is exploring strategic collaborations to advance innovative technologies, focusing on differentiated early-stage research projects[47]. - The company is prioritizing the development of highly differentiated product pipelines to address significant treatment gaps in the market[183]. - The company has confirmed that there are no significant changes to its business nature as stated in the prospectus[183]. - The company has no major investment or capital asset plans beyond what has been disclosed in the interim report[168].

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，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 aa aa aa aa aa aa aa aa GENOR BIOPHARMA HOLDINGS LIMITED 嘉和生物藥業（開曼）控股有限公司 （於開曼群島註冊成立的有限公司） （股份代號：6998） 截至2023年6月30日止六個月中期業績公告、 全球發售所得款項淨額用途變更 及有關2022年年報之補充資料 嘉和生物藥業（開曼）控股有限公司（「本公司」，連同其附屬公司，統稱「本集 團」）董事（「董事」）會（「董事會」）欣然宣佈本集團截至2023年6月30日止六個月 （「報告期」）之未經審核中期業績，連同2022年同期之比較數字。該等中期業績已 由本公司審核委員會及本公司核數師審閱。 於本公告內，「我們」指本公司，如文義另有所指，則指本集團。 財務摘要 • 於報告期內，總收益為零，而截至2022年6月30日止六個月則約為人民幣 3.0百萬元。 ...