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].
嘉和生物-B(06998) - 2023 - 年度财报