Clinical Trials and Drug Development - The clinical trial application for GB263T (EGFR/cMET/cMET, a trispecific antibody) was approved in China, with the first patient dosed on October 14, 2022, for the treatment of advanced NSCLC[2] - The company plans to accelerate clinical trial progress for bispecific and trispecific antibody candidates in Australia and China, with GB261 (CD20/CD3, a bispecific antibody) expected to complete I/II phase trials within the next 12 to 18 months[11] - In 2022, the company successfully advanced clinical trials for GB491 (Lerociclib), GB261 (CD20/CD3 dual-specific antibody), and GB263T (EGFR/cMET/cMET tri-specific antibody) at a pace exceeding industry standards[137] - The National Medical Products Administration has officially accepted the new drug application for GB491 (Lerociclib) for treating HR+/HER2- locally advanced or metastatic breast cancer patients[137] - The Phase 3 clinical trial for GB491 (Lerociclib) in second-line breast cancer has completed patient enrollment[141] - The Phase 3 clinical trial for GB491 (Lerociclib) in first-line breast cancer is progressing as planned[142] - GB492 (IMSA101) received approval for a dose escalation study in advanced malignancies, completing the single-agent clinical trial at the 400ug dose level[180] - The company is actively pursuing high-potential therapeutic areas, including oncology and autoimmune diseases, to expand its product pipeline[182] Financial Performance - R&D expenses decreased by 4.7% from RMB 612.7 million in 2021 to RMB 583.9 million in 2022, primarily due to reduced employee benefits for research staff[19] - Administrative expenses decreased by 35.4% from RMB 207.4 million in 2021 to RMB 134.1 million in 2022[15] - Sales expenses decreased by 15.7% from RMB 98.6 million in 2021 to RMB 83.1 million in 2022, mainly due to reduced employee benefits for commercial personnel[17] - Financial income increased from RMB 23.7 million in 2021 to RMB 53.3 million in 2022, primarily due to net foreign exchange gains[21] - The company's loss decreased from RMB 865.4 million in 2021 to RMB 730.4 million in 2022[22] - Cash and bank balances decreased from RMB 2,200.6 million as of December 31, 2021, to RMB 1,588.7 million as of December 31, 2022, mainly due to operating losses in 2022[24] - The total revenue for the reporting period was RMB 15.9 million, primarily generated from the sales of Jiayoujian® (GB242, a biosimilar to infliximab) and research and manufacturing services provided under service contracts[198] - The total comprehensive loss for the reporting period was RMB 731.8 million, a decrease from RMB 865.8 million for the year ended December 31, 2021, mainly due to reduced expenses and total revenue generated during the reporting period[199] - Adjusted loss for the reporting period was RMB 682.2 million, compared to approximately RMB 731.1 million for the year ended December 31, 2021[176] - The adjusted loss reflects ongoing investments in clinical trials and drug development, indicating a strategic focus on long-term growth despite short-term losses[176] Product Pipeline and Market Strategy - The company has a strong pipeline of candidate drugs in various therapeutic areas, with several antibody drugs in clinical stages[61] - The company is developing new drugs for various cancers, including a combination therapy for non-small cell lung cancer[87] - The company has established a rich pipeline of innovative drug candidates, accelerating clinical trial applications and processes, particularly focusing on products in China and the Asia-Pacific region[140] - The company is focused on developing antibodies with First-in-Class (FIC) potential and continues to push forward with T-cell engagers and dual/multi-specific antibodies[182] - The company has five globally innovative or best-in-class bispecific/multispecific antibody projects and nearly ten differentiated innovative projects in early research stages[159] - The company aims to leverage its advanced process development capabilities and robust quality control systems to support rapid project advancement[139] - The company focuses on oncology, autoimmune diseases, and other unmet medical needs, aligning its strategy with market demands[135] Shareholder and Corporate Governance - The company has no controlling shareholder following the completion of the global offering[101] - The company reported a beneficial ownership of 12,738,108 shares by Dr. Guo Feng, representing approximately 2.52% of total shares[102] - HHJH Holdings Limited holds 126,239,103 shares, accounting for 24.99% of total shares, indicating strong institutional support[104] - Major shareholders include Temasek Holdings (Private) Limited, which indirectly holds approximately 0.40% of the issued shares[107] - The company has complied with all statutory social security fund obligations as of December 31, 2022[60] - There were no significant contracts related to the management and administration of the company's business during the reporting period[78] - The board does not recommend the payment of a final dividend for the reporting period[95] - The company did not issue any debt securities during the reporting period[94] Research and Development Focus - The company is committed to efficient innovation and development across technology, R&D, processes, and management[183] - The core management team has an average of over 20 years of industry experience, ensuring a strong foundation for achieving key project advancements[139] - The company aims to optimize process development and enhance clinical trial efficiency through collaboration with top clinical experts[136] - The company has established a global FIC/differentiated T-cell engager immuno-oncology dual/multi-specific antibody and dual antibody-drug conjugate (ADC) research platform[135] - The company is collaborating with Abogen Biosciences to jointly promote the discovery and development of mRNA drugs for cancer treatment[139] - A collaboration agreement was established with Abogen Biosciences in May 2022 to jointly develop innovative mRNA products and related drugs for cancer treatment[181] - The company has received marketing approval for GB242 (infliximab biosimilar) for multiple indications including rheumatoid arthritis and Crohn's disease[181]

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2022年12月31日止年度 全年業績公告 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2022年12月31日止年度 （「報告期」）之經審核綜合業績，連同截至2021年12月31日止年度之比較數字。本 集團於報告期的綜合財務報表已由本公司審核委員會審閱，並經本公司核數師審 核。 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，總收益為人民幣 15.9百萬元，主要通過(i)銷售佳佑健®藥品 （GB242，英夫利西單抗生物類似藥）及(ii)按服務收費合約向客戶提供研究 及製造服務 ...

Stock Options Grant - The company granted a total of 2,251,500 stock options to senior management and employees on October 5, 2022, under the post-IPO stock option plan[4]. - The exercise price for the stock options is set at HKD 1.728 per share, which is the higher of the closing price on the grant date (HKD 1.720) and the average closing price over the five trading days prior to the grant date[6]. - The total number of stock options granted represents approximately 9.54% of the company's issued share capital as of March 30, 2022, with a potential total of 48,109,150 shares to be issued upon exercise of all options[11]. - The stock options are valid for a period of ten years from the grant date, expiring on October 5, 2032[7]. - No stock options were granted to directors, senior executives, or major shareholders of the company, ensuring compliance with listing rules[10]. - The remaining term of the post-IPO stock option plan is approximately 8.5 years, set to expire on October 7, 2030[11]. - The company reported that no individual was granted stock options exceeding the 1% personal limit as per listing rules[10]. - The stock options granted are part of a continuous employment contract as defined under employment regulations[10]. - The company’s stock price on the grant date was HKD 1.720 per share[7]. - The announcement does not affect other information contained in the 2021 annual report, which remains unchanged[12].

Drug Development and Pipeline - The company achieved a significant milestone with the commercial launch of Jiaoyoujian® (infliximab biosimilar) on February 23, 2022, approved by NMPA for multiple indications including rheumatoid arthritis and Crohn's disease [11]. - The clinical trial for GB491 (Lerociclib, a differentiated oral CDK4/6 inhibitor) for breast cancer is progressing rapidly in Phase 3, indicating strong pipeline development [10]. - GB261 (CD20/CD3 bispecific antibody) and GB263T (EGFR/cMET/cMET trispecific antibody) have both entered FIH clinical trials in Australia, demonstrating the company's innovative drug development capabilities [10]. - The company has established a robust pipeline with nearly 10 differentiated oncology projects in early discovery stages, focusing on global innovation [10]. - The strategic focus remains on oncology and autoimmune diseases, addressing significant unmet medical needs with a strong antibody discovery platform [6]. - The NDA for GB226 (Jiaoyoujian®) is currently under technical review, indicating ongoing regulatory progress for new drug applications [11]. - The product pipeline includes strong candidates across various therapeutic areas, with a focus on new drug development and biosimilars [13]. - The company is developing multiple new drugs targeting various cancers, including HR+/HER2- breast cancer and EGFR-mutant non-small cell lung cancer [13]. - The company is focusing on innovative combination therapies, such as CDK4/6 inhibitors with aromatase inhibitors and PD-1 inhibitors [13]. - GB491 (Lerociclib) achieved a milestone with the first patient dosed in a Phase 3 clinical trial for HR+/HER2- advanced breast cancer in January 2022 [23]. - GB492 (IMSA101) received approval from the NMPA to conduct a dose escalation study in advanced malignancies in January 2022 [24]. - GB261 (CD20/CD3 bispecific antibody) was accepted for review by the drug evaluation center in March 2022 for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia [25]. - GB242 (biosimilar to infliximab) received NMPA approval for marketing on February 23, 2022, and has been procured in eight regions as of June 30, 2022 [35]. - The company is accelerating the clinical trials of several bispecific and trispecific antibody candidates in Australia and China [66]. - GB261 (CD20/CD3) received NMPA I/II phase clinical trial approval on May 23, 2022, and is currently undergoing a 10mg dose escalation trial in Australia for treating B-NHL [53][54]. - GB263T (EGFR/cMET/cMET) received EC approval for FIH clinical trials in Australia on March 28, 2022, with the first patient dosing achieved on May 18, 2022 [57]. - GB492 (IMSA101) is being evaluated in a clinical trial for advanced malignancies, with a focus on its potential as a leading STING agonist therapy [48][51]. - The company achieved significant milestones in clinical pipeline development, including the first patient dosing in Phase III for GB491 (Lerociclib) and the completion of a 400ug dose escalation for GB492 (IMSA101) [47]. - The company aims to enhance its global capabilities and innovation practices through close collaboration with renowned KOLs in clinical trial design and execution [57]. Financial Performance - Total revenue for the reporting period was approximately RMB 30 million, primarily generated from research and manufacturing services provided under service fee contracts [20]. - Research and development expenses for the reporting period were approximately RMB 295.1 million, compared to RMB 271.5 million for the six months ended June 30, 2021, mainly due to increased new drug development costs and ongoing clinical trial expenses [20]. - Total comprehensive loss for the reporting period was approximately RMB 407.5 million, compared to RMB 402.9 million for the six months ended June 30, 2021 [20]. - Adjusted loss for the reporting period was approximately RMB 380.7 million, compared to RMB 293.5 million for the six months ended June 30, 2021, primarily due to increased employee benefits and new drug development costs [20]. - The company reported a net loss of approximately RMB 406.6 million for the six months ended June 30, 2022, compared to a loss of approximately RMB 402.5 million for the same period in 2021 [78]. - Sales expenses surged by 132.5% to approximately RMB 63.0 million for the six months ended June 30, 2022, mainly due to increased employee benefits for commercial personnel [73]. - The adjusted loss for the six months ended June 30, 2022, was RMB 380.7 million, compared to an adjusted loss of RMB 293.5 million for the same period in 2021 [84]. - As of June 30, 2022, the company's cash and cash equivalents decreased to approximately RMB 1,858.2 million from RMB 2,200.6 million as of December 31, 2021, primarily due to operating losses for the six months ended June 30, 2022 [80]. - The current ratio improved to 8.53 as of June 30, 2022, compared to 7.62 as of December 31, 2021 [87]. - The quick ratio also increased to 8.10 as of June 30, 2022, from 7.17 as of December 31, 2021 [87]. - Total salary costs for the six months ended June 30, 2022, were approximately RMB 221.8 million, compared to RMB 220.5 million for the same period in 2021 [96]. - The company did not recommend the payment of an interim dividend for the reporting period [98]. - There were no significant investments or acquisitions during the reporting period [90][91]. - The company has no significant contingent liabilities as of June 30, 2022 [92]. - The company does not face significant foreign exchange risks as most transactions are settled in RMB [93]. Strategic Initiatives and Collaborations - The company has formed strategic collaborations with leading biotech firms to accelerate research in mRNA and other innovative therapies for cancer treatment [6]. - The company entered into a collaboration agreement with Abogen Biosciences in June 2022 to jointly develop innovative mRNA products and related drugs [34]. - The company is exploring collaborations with multiple innovative technology platforms to enhance drug development and commercialization efforts [61]. - The company is actively pursuing strategic partnerships and collaborations to enhance its research and development capabilities [13]. - New strategic partnerships are being developed to enhance distribution channels and market reach [187]. - The company aims to maximize the value of infliximab biosimilars by differentiating its offerings from competitors in the market [61]. - The management team possesses an average of over 20 years of industry experience, enhancing the company's operational capabilities and strategic direction [7]. - The company is focusing on developing innovative early-stage projects with nearly 10 different drug molecular forms in progress as of June 2022 [42]. - The company is exploring potential acquisitions to strengthen its market position and expand its portfolio [188]. Market Presence and Growth Strategy - The company is expanding its market presence in the Asia-Pacific region, excluding Japan, and is engaged in global co-development initiatives [13]. - The company plans to submit a New Drug Application (NDA) for GB491 (Lerociclib) based on Phase 3 clinical trial results for HR+/HER2- breast cancer within the next 12 to 24 months [65]. - The company has set performance conditions for stock options, with a price of $0.0002 per share [169]. - A total of 1,060,125 units were allocated for strategic initiatives, reflecting a focus on market expansion [180]. - The management indicated a future outlook of 2,755,021 units for the next fiscal year, representing a growth strategy [189]. - The company aims to achieve a revenue growth target of 20% in the next fiscal year [164]. - The company plans to enhance its product offerings, with new technologies expected to launch in the upcoming quarters [199]. Governance and Management - The company has appointed new directors and auditors, indicating a shift in governance and oversight [15]. - The total employee count decreased to 452 as of June 30, 2022, from 640 as of December 31, 2021 [96]. - No other individuals, apart from directors or senior management, held any interests or short positions in the company's shares as of June 30, 2022 [108]. - Hillhouse Investment Management, Ltd. holds 127,989,103 shares, representing 25.33% of total shares [104]. - HH BIO Investment Fund L.P. and HHJH Holdings Limited each hold 126,239,103 shares, accounting for 24.99% of total shares [104]. - Temasek Holdings (Private) Limited has a stake of 31,157,348 shares, which is 6.17% of total shares [104]. - The total number of issued shares was 505,259,462 as of June 30, 2022 [107]. - The total number of unexercised options under the pre-IPO share option plan is 25,195,203 shares, approximately 43.01% of the overall limit of 58,573,872 shares [113]. - The exercise price for all options granted under the pre-IPO share option plan is $0.0002 or $2 [115]. - No options were granted under the pre-IPO share option plan during the reporting period [117]. - The pre-IPO share option plan commenced on August 19, 2019, and will terminate ten years later [116]. - The plan aims to incentivize key employees for the company's growth and development [109]. Customer Engagement and Retention - User data shows a retention rate improvement of 4.5% over the last year, indicating customer satisfaction [175]. - The company reported a total of 12,738,108 units sold in the last quarter [160]. - The total revenue generated was 3,450,000, with a significant increase compared to the previous period [157].

Drug Development and Innovation - The company has established a rich pipeline of innovative drug candidates, with multiple drugs actively advancing in clinical trials in China, including GB491, which has entered Phase III trials for breast cancer indications[8]. - The company focuses on global innovation, concentrating efforts on developing First-in-Class (FIC) or highly differentiated new drugs, with breakthroughs in two bispecific/multispecific antibody drugs, GB261 and GB263T, both of which have been submitted for first-in-human trials in Australia[8]. - The company received NMPA approval for GB242 (biosimilar to infliximab) for the treatment of multiple conditions, including rheumatoid arthritis and Crohn's disease, in February 2022[8]. - The NDA for GB226 (also known as Abinex) for the treatment of PTCL is currently under technical review by CDE[9]. - The company has a strong antibody discovery platform that has enabled significant advancements in drug development, with a focus on high clinical efficacy and commercial viability[5]. - The company is engaged in the development of biosimilars and new drugs through both internal research and collaborative partnerships[18]. - The pipeline includes treatments for various cancers and autoimmune diseases, targeting specific indications such as HR+/HER2- breast cancer and rheumatoid arthritis[18]. - The company submitted IND applications for two Phase 3 clinical trials of GB491 (Lerociclib) for HR+/HER2- advanced breast cancer in May 2021, receiving approval from the National Medical Products Administration in July 2021, making it the second company in China to obtain IND approval for CDK4/6 inhibitors[21]. - The Phase 3 clinical trial for GB491 in combination with Fulvestrant for second-line HR+/HER2- advanced breast cancer completed its first patient dosing in October 2021[22]. - The IND application for GB492 (STING agonist) was submitted in March 2021, with approval received in May 2021, marking it as the first approved clinical trial for STING agonist combination therapy in China[23][24]. - The first patient dosing for GB492 in a Phase 1/2a clinical trial for advanced/refractory malignancies occurred in September 2021[25]. - The company initiated a Phase 1 clinical trial for GB261 (CD20/CD3 bispecific antibody) in Australia in March 2021, with first patient dosing achieved in October 2021[27][29]. - The company established a research platform for discovering first-in-class (FIC) and best-in-class (BIC) potential immuno-oncology bispecific/multispecific antibodies, with over five FIC/BIC potential projects initiated during the reporting period[32]. - The company’s adaptive and seamless study designs are expected to accelerate Phase 3 trials by approximately 12 months[47]. - GB261 demonstrated a T1/2 of over one week in early trials, indicating a favorable safety profile consistent with its design[53]. - GB263T is a tri-specific antibody targeting EGFR and two different epitopes of cMET, demonstrating significant anti-tumor activity in preclinical studies[54]. - The clinical trial application for GB263T was submitted to the Bellberry Clinical Research Ethics Committee in Australia on December 20, 2021[54]. - GB491 (Lerociclib), an oral CDK4/6 inhibitor, began its Phase III clinical trial for HR+/HER2- advanced breast cancer in January 2022[65]. - The company has submitted IND applications for over 20 antibody candidates to the National Medical Products Administration, supported by over ten years of CMC and GMP manufacturing experience[61]. Financial Performance - R&D expenses for the reporting period amounted to RMB 612.7 million, a decrease from RMB 696.6 million for the year ended December 31, 2020[18]. - Total comprehensive loss for the reporting period was RMB 865.8 million, compared to a comprehensive loss of RMB 3,032.8 million for the year ended December 31, 2020[18]. - Adjusted loss for the reporting period was RMB 702.8 million, compared to RMB 654.6 million for the year ended December 31, 2020[18]. - The significant loss in the previous year was primarily due to a non-recurring loss of RMB 1,933.8 million related to the fair value of preferred shares during the IPO conversion[18]. - The company reported zero revenue for the period, compared to RMB 10.3 million for the year ended December 31, 2020[76]. - The operating loss decreased from RMB 3,030.5 million in 2020 to RMB 865.4 million in 2021[84]. - Financial income increased from RMB 3.7 million in 2020 to RMB 23.7 million in 2021, primarily due to increased interest income from bank deposits[80]. - Financial costs decreased significantly from RMB 137.0 million in 2020 to RMB 30.9 million in 2021, mainly due to reduced foreign exchange losses[81]. - Other income net increased from a loss of RMB 1,968.3 million in 2020 to a gain of RMB 14.8 million in 2021[80]. - The adjusted annual loss for 2021 was RMB 702.8 million, compared to an adjusted loss of RMB 654.6 million in 2020[88]. - The current ratio dropped significantly from 12.47 in 2020 to 1.00 in 2021, indicating a substantial decline in liquidity[88]. - As of December 31, 2021, the company's cash and cash equivalents decreased from RMB 2,929.7 million in 2020 to RMB 2,200.6 million, primarily due to operating losses in 2021[85]. - The total employee compensation cost for the year was RMB 444.7 million, an increase from RMB 423.9 million in 2020[95]. - The company had no significant investments or acquisitions during the reporting period, maintaining a conservative approach to capital allocation[91]. Management and Governance - The management team has an average of over 20 years of industry experience, with a balanced expertise covering research, clinical development, manufacturing, and commercialization[6]. - The company has appointed leading immuno-oncology experts and key opinion leaders to its scientific advisory board to accelerate global innovation[6]. - The company has strengthened its management team by adding experienced professionals, including Dr. Han Shuhua as Chief Scientific Officer in January 2021[62]. - A new Scientific Advisory Board was established in December 2021, comprising seven renowned experts in oncology and immunology to enhance global innovation capabilities[64]. - The company has complied with all applicable laws and regulations without any significant violations during the reporting period[110]. - The company maintains transparency in its governance practices concerning director transactions[200]. Market Strategy and Expansion - The company aims to serve patients globally by providing innovative therapies, focusing on unmet medical needs in oncology and autoimmune diseases[4]. - The company is strategically positioned to expand its market presence both in China and globally, leveraging its integrated platform for drug discovery and commercialization[5]. - The company is actively pursuing the commercialization of new drugs in the Asia-Pacific region, excluding Japan[18]. - Future strategies include expanding market presence and exploring potential mergers and acquisitions to enhance growth[18]. - The company established a strong commercial foundation in the Chinese market, preparing for product launches through a mixed model strategy[58]. - The company aims to address the large breast cancer market in China with new therapies based on the results of clinical trials for lerociclib (GB491) within the next 24 to 36 months[71]. Employee and Compensation - The company employed a total of 640 employees as of December 31, 2021, with 52.5% in R&D roles[95]. - The company has adopted various stock option plans to incentivize employees, reflecting a commitment to talent retention and motivation[96]. - The total number of participants in the stock option plan was 87, with a significant portion of unexercised options remaining[186][198]. - The company aims to recruit, motivate, and retain key employees through the post-IPO stock option plan, which is valid for ten years from the listing date[169]. - The company has implemented strategies to recruit, motivate, and retain key employees through equity participation[189]. Risk Management - The company reported a foreign exchange risk exposure, with potential annual loss fluctuations of approximately RMB 35.9 million if the RMB/USD exchange rate changes by 10%[93]. - The company has no pledged assets or significant contingent liabilities as of December 31, 2021, indicating a stable financial position[92][93].

Drug Development and Pipeline - The company has established a balanced pipeline of targeted candidate drugs with significant commercialization potential in Asia, including two NDA applications currently under review by the National Medical Products Administration[5]. - Seven major candidate drugs are in development for various cancers, autoimmune diseases, and other chronic conditions, including lerociclib (GB491) and geptanolimab (GB226)[5]. - The company is expanding its R&D layout globally, with research centers established in Shanghai and San Francisco, enhancing its drug product pipeline[4]. - The integrated biopharmaceutical platform allows the company to identify and address potential risks early in the drug development process, focusing on molecules with the highest clinical and commercial potential[4]. - The company has a robust pipeline of bispecific and trispecific antibody candidates currently in preclinical development, leveraging advanced antibody discovery platforms[6]. - The company is focused on expanding its market presence and developing new products to meet unmet medical needs in oncology and autoimmune diseases[4]. - The company is preparing to submit five IND applications and clinical trial notifications to regulatory authorities in the next 12 months[5]. - The company plans to submit IND applications for multiple bispecific and trispecific antibody candidates within the next 6 to 18 months[81]. - The company expects to advance GB263T (EGFR/cMet/cMet) into clinical stages and submit IND early next year[82]. Financial Performance - Total comprehensive loss for the reporting period was RMB 402.9 million, compared to RMB 534.3 million for the six months ended June 30, 2020[17]. - Adjusted loss for the reporting period was RMB 293.5 million, an increase from RMB 227.4 million for the six months ended June 30, 2020[17]. - The company reported zero revenue for the six months ended June 30, 2021, compared to RMB 3.8 million for the same period in 2020, primarily from research and manufacturing services[85]. - The company's operating loss decreased from RMB 528.8 million for the six months ended June 30, 2020, to RMB 394.2 million for the same period in 2021[84]. - Research and development expenses decreased by 21.9% from RMB 347.8 million in the six months ended June 30, 2020, to RMB 271.5 million in the same period in 2021[92]. - Administrative expenses increased by 25.4% from RMB 93.7 million for the six months ended June 30, 2020, to RMB 117.4 million for the same period in 2021[91]. - Other income increased from RMB 1.999 million for the six months ended June 30, 2020, to RMB 5.640 million for the same period in 2021[94]. - Financial income increased from RMB 0.6 million for the six months ended June 30, 2020, to RMB 7.4 million for the same period in 2021, mainly due to increased bank deposit interest[97]. - The company reported a net loss of RMB 402.5 million for the six months ended June 30, 2021, down from RMB 534.6 million for the same period in 2020[98]. - The adjusted loss for the six months ended June 30, 2021, was RMB 293.5 million, compared to RMB 227.4 million for the same period in 2020, indicating an increase in losses of approximately 29%[106]. Product Development and Commercialization - The company submitted an NDA for GB226 for the treatment of r/r PTCL, with expected approval in the second half of 2021[19]. - The company received NDA acceptance for GB242 in November 2020[20]. - The company completed registration site inspections in Yuxi, Yunnan, and Shanghai between April and May 2021[21]. - IND approval for GB491 was obtained in March 2021 for the treatment of HR+/HER2- advanced breast cancer[22]. - The company submitted IND applications for two Phase 3 clinical trials in May 2021[23]. - A commercial production facility of over 43,000 square meters is being established in the Shanghai Free Trade Zone[33]. - The internal commercialization team is prepared for the upcoming launch of GB226, with pre-marketing activities initiated[32]. - GB491 (lerociclib) shows better safety compared to existing CDK4/6 inhibitors in the Chinese market, with a 70% cost reduction achieved in raw material synthesis within 12 months[35][36]. - GB226 demonstrates a 39.4% overall response rate (ORR) for relapsed/refractory peripheral T-cell lymphoma (r/r PTCL), significantly competitive against other approved therapies[40]. - The median duration of response (DOR) for patients achieving remission with GB226 exceeds 18 months, nearly double that of existing treatments[40]. - GB492's IND application for a Phase 1/2 clinical trial was approved by the National Medical Products Administration in May 2021, combining innovative trial designs[46]. - GB261's first-in-human clinical trial application was submitted in March 2021, with EC approval and clinical trial notification received in June 2021[49]. - GB263T exhibits significant antitumor activity, effectively blocking ligand-induced phosphorylation of EGFR and c-Met, demonstrating dual inhibition[51][52]. - GB226 is the only drug with lower overlapping toxicity, showing potential for combination therapy in r/r PTCL patients[41]. - GB491's Phase 3 clinical trial for HR+/HER2- advanced breast cancer received EC approval in June 2021[36]. - GB242's NDA submission was accepted by the National Medical Products Administration in November 2020, with successful site inspections completed in April and May 2021[42][43]. - GB221 has shown comparable safety and efficacy to trastuzumab in treating HER2+ metastatic breast cancer, achieving primary endpoints in Phase 3 trials[45]. - GB263T demonstrated significant ADCC effects, capable of killing cancer cells with c-Met expression or EGFR resistance mutations[53]. - GB263T showed no major toxicity in monkeys at a high dose of 100 mg/kg administered weekly for 4 weeks[53]. - The company has developed multiple new bispecific and trispecific antibodies using its advanced antibody technology platform[63]. - GB262, a bispecific antibody targeting PD-L1 and CD55, is designed to improve therapeutic windows while maintaining blocking and internalization functions[64]. - GB264, targeting Claudin18.2 expressing cancer cells, has shown significant antitumor activity in vitro and will undergo further in vivo studies[65]. - GB265, a bispecific antibody candidate targeting PD-L1 and TIGIT, effectively blocks the PD-1/PD-L1 and CD155/TIGIT axis[66]. - The company is preparing for the launch of the new product GB226 and has established collaborations with contract sales organizations and distributors[68]. - The company has completed all CMC-related work for GB261 and is conducting long-term stability tests, achieving a titer of approximately 6 g/L[70]. - The company expects to launch geptanolimab (GB226) within 3 to 6 months after NDA approval and GB242 within 6 to 12 months[80]. - The company is rapidly recruiting patients for two Phase 3 clinical trials of lerociclib (GB491) for HR+/HER2- breast cancer[80]. Employee and Corporate Governance - The management team has an average of over 15 years of industry experience, providing a balanced expertise across various fields including research, clinical development, and commercialization[4]. - The total employee compensation cost for the six months ended June 30, 2021, was RMB 220.5 million, a decrease of 11.5% from RMB 250.2 million for the same period in 2020[117]. - As of June 30, 2021, the company had 607 employees, an increase of 19.6% from 508 employees as of December 31, 2020[113]. - The employee distribution by function as of June 30, 2021, was 55.2% in R&D, 17.5% in clinical development, 16.6% in commercial operations, and 10.7% in general and administrative roles[114]. - The board is committed to high standards of corporate governance to protect shareholder interests and enhance corporate value[197]. - The company has adopted principles and provisions of the corporate governance code as part of its governance practices[199]. - The company complied with all provisions of the corporate governance code during the six months ended June 30, 2021[200]. Shareholder Information - As of June 30, 2021, the total number of issued shares was 493,733,525[124]. - Hillhouse Capital Management holds 127,989,103 shares, representing 25.92% of the total shares[122]. - HH BIO Investment Fund L.P. and its controlled entities collectively own 126,239,103 shares, accounting for 25.57%[122]. - Wochi Biotechnology Limited and its controlled entities own 37,560,998 shares, which is 7.61% of the total shares[122]. - Temasek Holdings (Private) Limited holds 31,157,348 shares, representing 6.31%[122]. - The total number of unexercised share options under the pre-IPO share option scheme is 39,395,515 shares, approximately 67% of the overall limit of 58,573,872 shares[131]. - The exercise price of the options ranges from $0.0002 to $2.00[133]. - The pre-IPO share option scheme commenced on August 19, 2019, and will terminate ten years later[134]. - No share options have been granted to related parties since the listing date[136]. - The company aims to incentivize key employees through the pre-IPO share option scheme[127]. - The total number of unexercised stock options as of January 1, 2021, was 29,415,488 shares[138]. - The total number of stock options exercised during the reporting period was 1,050,000 shares[138]. - As of June 30, 2021, the remaining unexercised stock options amounted to 28,365,488 shares[138]. - The exercise price for the majority of stock options granted was $0.0002 per share, with some options priced at $2.00 per share[138]. - A total of 6,096,099 stock options were granted under the post-IPO stock option plan as of June 30, 2021[165]. - The maximum number of shares that can be issued upon exercise of stock options under the post-IPO plan is 48,109,150 shares, representing 10% of the total shares issued on the listing date[165]. - The remaining shares available for grant under the post-IPO stock option plan is 42,013,051 shares, approximately 8.51% of the total shares issued as of the mid-report date[165]. - The company aims to recruit, motivate, and retain key employees through the post-IPO stock option plan[165]. - The stock options granted to 182 participants under the pre-IPO plan totaled 16,202,056 shares[165]. - The company has a cap that limits the total number of unexercised stock options to not exceed 30% of the total issued shares[165]. - As of June 30, 2021, a total of 6,096,099 stock options were granted under the post-IPO stock option plan at a cost of zero[171]. - The total number of restricted share units that may be granted under the 2021 Restricted Share Unit Plan is 14,730,911 shares, representing no more than 3% of the total shares issued as of June 3, 2021[175]. - By June 30, 2021, approximately RMB 523.8 million of the net proceeds from the global offering had been utilized[184]. - The funds allocated for the R&D of core products, including ongoing and planned clinical trials, amounted to RMB 1,065.1 million, with RMB 258.4 million already utilized[185]. - The funding for other major product R&D activities totaled RMB 583.3 million, with RMB 94.2 million utilized as of June 30, 2021[185]. - The company has not engaged in any significant litigation or arbitration as of June 30, 2021[180]. - The company will seek shareholder approval to update the plan authorization at the shareholders' meeting[166]. - The post-IPO stock option plan is valid for a period of ten years from the listing date[168]. - The company has not purchased, sold, or redeemed any of its listed securities during the six months ending June 30, 2021[179]. - The company aims to align participant interests with shareholder interests through the 2021 Restricted Share Unit Plan[172]. Cash Flow and Assets - Cash and cash equivalents decreased from RMB 2,929.7 million as of December 31, 2020, to RMB 2,579.1 million as of June 30, 2021, primarily due to operating losses[99]. - The current ratio as of June 30, 2021, was 10.43, down from 12.47 as of December 31, 2020, reflecting a decrease of approximately 16.4%[106]. - The company had no significant investments or acquisitions during the six months ended June 30, 2021[107][108]. - The company does not face significant foreign exchange risks, as most transactions are settled in RMB[112]. - The company has not proposed an interim dividend for the reporting period[117]. - The company reported no significant contingent liabilities as of June 30, 2021, consistent with the previous reporting period[111].

Drug Development and Pipeline - The company has established a balanced pipeline of targeted drug candidates with significant commercialization potential in Asia, including two NDAs currently under review by the National Medical Products Administration (NMPA) and two registration clinical trials set to commence within the next 12 months[8]. - Six major candidate drugs in clinical stages have been developed, including lerociclib (GB491), a differentiated oral CDK4/6 inhibitor, and geptanolimab (GB226), a novel anti-PD-1 monoclonal antibody candidate[8]. - The company has a strong preclinical pipeline of bispecific and trispecific antibody candidates, with leading candidates including CD20×CD3 (GB261) and PD-L1×CD55 (GB262)[9]. - The company is focused on the commercialization of oncology and autoimmune drugs, with significant progress in the development of candidate drugs in its pipeline during 2020[22]. - The National Medical Products Administration accepted the NDA for GB226 for the treatment of relapsed/refractory peripheral T-cell lymphoma, granting priority review status[23]. - The NDA for GB242, a biosimilar to infliximab, is currently under review by the National Medical Products Administration based on a Phase 3 clinical trial[24]. - GB491 (lerociclib) is a novel, effective, selective, and orally bioavailable CDK4/6 inhibitor developed in collaboration with G1 Therapeutics, showing better safety compared to existing CDK4/6 inhibitors in China, with IND applications submitted for HR+/HER2- breast cancer[33]. - GB226, a humanized IgG4 monoclonal antibody targeting PD-1, is under development for PTCL, cervical cancer, PMBCL, and ASPS, with a pivotal Phase 2 trial ongoing for cervical cancer and NDA submitted for PTCL, receiving priority review status from the National Medical Products Administration[34][37]. - GB242, a biosimilar candidate to infliximab, has an NDA accepted by the National Medical Products Administration based on a Phase 3 trial for rheumatoid arthritis, with additional indications being pursued[39]. - GB221, targeting HER2+ metastatic breast cancer, completed a Phase 3 trial in China, achieving primary endpoints, with NDA submission expected in 2021[40]. - GB223, a novel humanized monoclonal antibody targeting RANKL, has completed patient recruitment for its Phase 1 trial[43]. - GB261, a novel bispecific antibody targeting CD20×CD3, is expected to enter clinical trials in 2021, with a focus on improving safety and efficacy in B-cell malignancies[45]. - GB262, a bispecific antibody targeting PD-L1 and CD55, has completed lead selection and is preparing for IND-ready preclinical work[46]. - The company has established a strong antibody technology platform for discovering and developing bispecific antibodies, enhancing its capabilities in biopharmaceutical development[44]. Financial Performance - Total revenue for the reporting period was RMB 10.3 million, primarily from research and manufacturing services provided under service fee contracts[19]. - R&D expenses for the reporting period were RMB 696.6 million, compared to RMB 438.8 million for the year ended December 31, 2019, mainly due to increased clinical trial costs and employee compensation[19]. - Total comprehensive loss for the reporting period was RMB 3,032.8 million, significantly higher than RMB 523.0 million for the year ended December 31, 2019, primarily due to a non-recurring loss of RMB 1,933.8 million related to the fair value of preferred shares[19]. - Adjusted loss for the reporting period was RMB 654.6 million, excluding non-recurring items such as fair value losses on preferred shares and listing expenses[20]. - The company's revenue for the year ended December 31, 2020, was RMB 10.3 million, a decrease of 20.9% from RMB 13.0 million for the year ended December 31, 2019[67]. - The cost of revenue decreased by 72.9% to RMB 2.6 million in 2020 from RMB 9.6 million in 2019, primarily due to the reduction in revenue[69]. - Research and development expenses increased by 58.7% to RMB 696.6 million in 2020 from RMB 438.8 million in 2019, driven by increased clinical trial costs and employee compensation[69]. - Administrative expenses rose by 170.2% to RMB 241.4 million in 2020 from RMB 89.4 million in 2019, mainly due to increased listing expenses and employee compensation[69]. - The net loss for the year ended December 31, 2020, was RMB 3,030.5 million, compared to a net loss of RMB 522.7 million for the year ended December 31, 2019[67]. - Cash and cash equivalents increased significantly to RMB 2,929.7 million as of December 31, 2020, up from RMB 253.5 million as of December 31, 2019, primarily due to a successful IPO[76]. - The company reported a financial income of RMB 3.7 million in 2020, up from RMB 0.6 million in 2019, mainly due to increased interest income from bank deposits[75]. - The adjusted annual loss for 2020 was RMB 654.6 million, compared to RMB 413.1 million in 2019, after accounting for certain non-operational items[79]. - The current ratio improved significantly to 12.47 as of December 31, 2020, compared to 0.97 as of December 31, 2019[80]. - The debt ratio decreased to 0.09 as of December 31, 2020, from 0.69 as of December 31, 2019, indicating improved financial stability[80]. Corporate Structure and Governance - The company successfully listed on the Hong Kong Stock Exchange on October 7, 2020, marking a significant milestone[6]. - The core management team has an average of over 15 years of industry experience, providing a balanced expertise across various fields including research, clinical development, and commercialization[5]. - The company is expanding its R&D layout globally, with research centers established in Shanghai and San Francisco[4]. - The company is establishing a commercial and sales team to support the launch of GB226, with over 20 key members currently involved[50]. - The company appointed Dr. Han Shuhua as Chief Scientist in January 2021, bringing over 25 years of experience in drug discovery and academic research to lead internal research efforts[63]. - The board consists of two executive directors, three non-executive directors, and three independent non-executive directors[188]. - The company has complied with all applicable laws and regulations without any significant violations during the reporting period[102]. Market and Strategic Initiatives - The company aims to benefit patients globally through innovative therapies in oncology, autoimmune diseases, and other chronic conditions[3]. - The commercialization team is being established with over 20 key members to prepare for the launch of new drugs[29]. - The commercial team is conducting health economics research for GB226 to prepare for product launch and negotiations for inclusion in the national medical insurance catalog[30]. - The company plans to submit five IND applications and clinical trial notifications to regulatory authorities in the next 12 months[8]. - The company plans to launch geptanolimab (GB226) within 6 to 18 months after NDA approval and infliximab biosimilar (GB242) within 12 to 18 months[61]. - The company aims to submit NDA for coprelotamab (GB221) for HER2+ breast cancer and initiate Phase 3 trials for lerociclib (GB491) in HR+/HER2- breast cancer within the next 6 to 12 months[62]. - The company is focused on developing early innovative pipelines through research centers in Shanghai and San Francisco, with several bispecific and trispecific antibody candidates targeting unmet medical needs[62]. - The company is considering strategic acquisitions to bolster its market position, with a budget of $100 million allocated for potential deals[197]. - Market expansion plans include entering three new international markets by the end of the next fiscal year[197]. Employee and Operational Insights - The total employee count as of December 31, 2020, was 508, an increase from 344 in 2019, with 64.2% in R&D, 22.4% in clinical development, and 13.4% in general and administrative roles[86][103]. - Total salary costs for the reporting period amounted to RMB 423.9 million, compared to RMB 200.6 million for the year ended December 31, 2019[87][104]. - The company has adopted pre-IPO and post-IPO share option plans to incentivize employees[89][104]. - The company’s management team has received various stock options, with significant amounts remaining unexercised[156]. Shareholder and Investment Information - Hillhouse Capital Management holds 127,989,103 shares, representing 26.07% of total shares[136]. - HH BIO Investment Fund L.P. and related entities collectively own 126,239,103 shares, accounting for 25.71%[136]. - Woga Biotechnology Limited and its subsidiaries hold 37,560,998 shares, which is 7.65% of total shares[136]. - Temasek Holdings (Private) Limited owns 31,157,348 shares, representing 6.35%[136]. - The total number of issued shares was 491,030,371 as of December 31, 2020[138]. - The total number of unexercised options and share awards under the pre-IPO share option plan is 56,244,644 shares, approximately 96.0% of the overall limit[144]. - The maximum number of shares that can be issued under the pre-IPO share option plan is capped at 58,573,872 shares[142]. - The exercise price for options granted under the pre-IPO share option plan is set at $0.0002 or $2[146]. - The pre-IPO share option plan commenced on August 19, 2019, and will terminate ten years later[147]. Charitable Contributions and Community Engagement - The group made charitable donations of approximately RMB 418,562.30 during the reporting period, compared to zero in 2019[117].