Financial Performance - The company reported a revenue of RMB 1,540,493 thousand for the year ended December 31, 2023, representing a 91.6% increase compared to RMB 803,933 thousand in 2022[4]. - Gross profit for the same period was RMB 759,185 thousand, up 44.0% from RMB 527,105 thousand in the previous year[4]. - The adjusted annual loss decreased by 24.4% to RMB 450,788 thousand from RMB 596,288 thousand year-over-year[4]. - The company incurred a total operating loss of RMB 383,383 thousand in 2023, compared to an operating loss of RMB 418,550 thousand in 2022, indicating an improvement in operational efficiency[18]. - The company’s basic and diluted loss per share improved to RMB 2.84 in 2023 from RMB 5.74 in 2022[18]. - The company reported a net increase in cash and cash equivalents of RMB 1,416,423 thousand for the year, compared to an increase of RMB 10,455 thousand in the previous year[26]. - The company reported a foreign exchange gain of RMB 16,085 thousand in 2023, a recovery from a loss of RMB 31,944 thousand in 2022[35]. - The company reported a total of RMB 67,449 thousand in notes payable as of December 31, 2023, compared to RMB 27,777 thousand in 2022, an increase of 143.5%[45]. - The annual loss decreased by 6.8% to RMB 574.1 million for the year ended December 31, 2023, from RMB 616.1 million for the year ended December 31, 2022[134]. - The company reported a significant increase in user data, with a 25% growth in patient enrollment for clinical trials compared to the previous year[181]. Research and Development - Research and development expenses increased by 21.9% to RMB 1,030,966 thousand from RMB 845,984 thousand[4]. - The company plans to continue investing in research and development, with a focus on innovative drug development and commercialization[32]. - The company is developing at least 10 non-core clinical stage assets in its pipeline as of the announcement date[52]. - The company has advanced over ten candidate drugs into clinical development, enhancing its technical knowledge and streamlining its drug discovery workflows[100]. - The company is focusing on chronic diseases related to aging, aiming to provide solutions for autoimmune and metabolic diseases through innovative drug candidates[153]. - The company is exploring PROTAC technology to induce target protein degradation, aiming to enhance the therapeutic value of generated PROTAC molecules[155]. - The company has allocated $50 million for research and development of its new PROTAC technology aimed at targeted protein degradation[181]. Clinical Trials and Product Development - SKB264 (MK-2870) received breakthrough therapy designation for treating unresectable locally advanced, recurrent, or metastatic TNBC, with a reported overall response rate (ORR) of 42.4% in a recent study[5][6]. - The company initiated a pivotal Phase 3 trial for SKB264 (MK-2870) in first-line treatment of unresectable locally advanced, recurrent, or metastatic PD-L1 negative TNBC[6]. - A166 achieved its primary endpoint in a pivotal Phase 2 trial for 3L+ advanced HER2+ breast cancer, with an NDA submitted to the National Medical Products Administration in May 2023[8]. - The company is conducting a Phase 1 clinical trial for SKB315 targeting advanced solid tumors, with global Phase 1/2 studies ongoing[8]. - A400, a second-generation selective RET inhibitor, demonstrated an ORR of 80.8% in first-line and 69.7% in second-line advanced RET+ NSCLC, receiving orphan drug designation from the FDA[9]. - The company completed patient enrollment for the Phase 2 trial of A223 in moderate to severe RA patients and is conducting a Phase 2 trial for severe AA patients in China[11]. - The company plans to submit IND applications for several preclinical assets in 2024, primarily focusing on ADC and ADC-derived assets[61]. - The company is advancing multiple clinical development strategies for SKB264, exploring its use as monotherapy and in combination with other therapies for various advanced solid tumors[65]. - A223's target indications have expanded to include AA, with ongoing Phase 2 trials in China[88]. - A400's NDA for RET+NSCLC is planned for submission in 2024 following successful clinical consultations[83]. Financial Position and Assets - The company achieved a cash and financial assets balance of RMB 2,528,342 thousand as of December 31, 2023, a significant increase from RMB 119,221 thousand in 2022[4]. - Total assets increased to RMB 2,399,751 thousand in 2023 from a negative RMB 3,174,216 thousand in 2022, showing a significant recovery[22]. - Cash and cash equivalents rose dramatically to RMB 1,528,774 thousand in 2023 from RMB 92,960 thousand in 2022, indicating improved liquidity[26]. - Total liabilities decreased significantly, with current liabilities dropping to RMB 1,110,004 thousand in 2023 from RMB 4,167,361 thousand in 2022[22]. - The company’s equity total reached RMB 2,329,497 thousand in 2023, recovering from a deficit of RMB 3,226,186 thousand in 2022[23]. - The company has no significant investments, acquisitions, or disposals as of December 31, 2023[142]. - The company has no contingent liabilities or asset pledges as of December 31, 2023[145][144]. Strategic Partnerships and Collaborations - The company received a non-refundable upfront payment of $175 million (approximately RMB 1,205.5 million) from Merck for exclusive licensing and collaboration agreements related to multiple ADC assets[12]. - Merck triggered milestone payments totaling $75 million (approximately RMB 532.9 million) for clinical milestones achieved in the development of SKB264 (MK-2870) and other assets[13]. - The company has entered into a licensing agreement with Public Discovery for the first targeted ADC, with milestone payments and royalties expected upon commercialization[106]. - The strategic partnerships with global companies validate the company's R&D and business development capabilities, driving continuous innovation and long-term growth[60]. - The company is actively seeking new collaboration opportunities globally to maximize the commercial value of its pipeline and strengthen its technology platform[157]. Market Presence and Future Plans - The company successfully listed on the Hong Kong Stock Exchange, raising net proceeds of approximately HKD 1,258.9 million (approximately RMB 1,155.7 million)[16]. - The company plans to expand its market presence by entering two new international markets by the end of 2024[181]. - The company aims to enhance its end-to-end drug development capabilities and expand its global footprint while deepening strategic partnerships to maximize the value of its product pipeline[149]. - The commercialization team is projected to expand to approximately 500 members by the end of 2024, focusing on oncology and preparing for product launches[156]. - The company is exploring potential mergers and acquisitions to enhance its product pipeline and market reach[181]. Regulatory and Compliance - The company received a high-tech enterprise certificate on October 16, 2023, allowing it to enjoy a preferential income tax rate of 15% from 2020 to 2025[36]. - The company’s ADC development facility passed the GMP compliance inspection in October 2023, marking a significant milestone in its regulatory compliance efforts[38]. - The audit committee, consisting of three independent non-executive directors, reviewed the annual financial performance for the year ending December 31, 2023, and confirmed compliance with applicable accounting standards and regulations[166]. - The company has adopted corporate governance codes and has been compliant since its listing on July 11, 2023, with a commitment to maintaining high standards of governance[159].

Financial Performance - Revenue for the six months ended June 30, 2023, reached RMB 1,046,226 thousand, a 203.3% increase compared to RMB 344,988 thousand in the same period of 2022[4] - Gross profit for the same period was RMB 675,660 thousand, reflecting a 199.1% increase from RMB 225,889 thousand year-over-year[4] - The company reported a net loss of RMB 31,130 thousand, significantly reduced by 88.5% from a loss of RMB 270,864 thousand in the prior year[4] - The company's cost of sales for the six months ended June 30, 2023, was RMB 370.57 million, an increase of 211.1% from RMB 119.10 million for the same period in 2022[61] - Gross profit increased by 199.1% to RMB 675.66 million for the six months ended June 30, 2023, compared to RMB 225.89 million for the same period in 2022[62] - The gross margin slightly decreased to 64.6% for the six months ended June 30, 2023, from 65.5% for the same period in 2022[62] - Other net income for the six months ended June 30, 2023, was RMB 24.12 million, an increase of RMB 37.38 million compared to a net expense of RMB 13.26 million for the same period in 2022[64] - Administrative expenses for the six months ended June 30, 2023, were RMB 89.42 million, a 109.88% increase from RMB 42.61 million for the same period in 2022[67] - The company reported a loss of RMB 31.13 million for the six months ended June 30, 2023, a decrease of 88.5% from a loss of RMB 270.86 million for the same period in 2022[73] - Cash and cash equivalents increased to RMB 587.26 million as of June 30, 2023, from RMB 93.0 million at the end of 2022, primarily due to B-round financing and payments from Merck[75] Research and Development - Research and development expenses increased to RMB 490,347 thousand, up 42.6% from RMB 343,787 thousand in the previous year[4] - The company has established a strong pipeline of 14 clinical-stage candidates, with 5 in pivotal trials or NDA registration stages as of June 30, 2023[16] - The company is developing over 10 preclinical ADC assets targeting various solid tumors[18] - The company is recognized as a pioneer in developing ADCs, with over ten years of experience and a proprietary ADC platform, OptiDC[14] - The company aims to optimize patient treatment outcomes through a diversified pipeline offering combination therapy options[9] - The company is actively pursuing a multi-strategy clinical development plan for SKB264 as both monotherapy and in combination therapies for various advanced solid tumors[21] - The company is advancing multiple clinical development plans for A166 in various indications, including ongoing Phase 1b trials and a confirmatory Phase 3 trial for advanced HER2+ BC[27] - The company is exploring combination therapies for its immunotherapy assets and ADCs to expand clinical applications across various cancer types[38] Product Development and Clinical Trials - SKB264 received breakthrough therapy designation from the National Medical Products Administration for treating EGFR-TKI resistant NSCLC in January 2023, with the first patient enrolled in a pivotal Phase 3 trial in July 2023[5] - A166 achieved its primary endpoint in a pivotal Phase 2 trial for advanced HER2+ breast cancer, with a New Drug Application submitted in May 2023[7] - The company has initiated a confirmatory Phase 3 trial for A166 as a second-line treatment for advanced HER2+ BC patients in June 2023[13] - A400's Phase 1 clinical trial data was presented at the ASCO annual meeting in June 2023, with a key trial for advanced RET+ NSCLC starting in July 2023[8] - A223 demonstrated a significant ACR20 difference of 35.1% (63.6% vs. 28.6%) and an ACR50 difference of 33.7% (39.4% vs. 5.7%) in moderate to severe RA patients after 12 weeks of treatment[40] - A400, a second-generation selective RET inhibitor, shows promising preliminary results with an overall response rate (ORR) of 74% in first-line and 66.7% in second-line advanced RET+ NSCLC patients[36] Strategic Partnerships and Collaborations - Merck has entered into an exclusive licensing and collaboration agreement with the company to develop up to seven preclinical ADC assets for cancer treatment, with an upfront payment of $175 million received in March 2023[9] - The company signed nine licensing agreements, including three with Merck Sharp & Dohme LLC, with upfront and milestone payments totaling up to $11.8 billion[15] - The company has retained rights to develop and commercialize SKB264 and other TROP2 ADCs in Greater China, while granting Merck exclusive rights outside this region[24] - The company is pursuing flexible strategies to create collaborative licensing and partnership opportunities globally to enhance commercial value[9] Market Presence and Commercialization - The company successfully listed on the Hong Kong Stock Exchange on July 11, 2023, raising approximately HKD 1,258.9 million (about RMB 1,155.7 million) in net proceeds[10] - The company plans to establish a commercial team of approximately 100 people by the end of 2023 to prepare for the marketing and commercialization of strategic products[56] - The company aims to expand its brand influence through collaborations with major hospitals and experts in the oncology field[56] - The company plans to continue expanding its market presence and investing in new product development to enhance its competitive edge[158] Corporate Governance and Compliance - The company is committed to maintaining high standards of corporate governance and has adopted relevant codes and practices[96] - The audit committee has reviewed the unaudited interim financial information for the six months ended June 30, 2023, ensuring compliance with applicable accounting standards[99] - The independent review of the interim financial report concluded that there were no significant issues regarding compliance with International Accounting Standard 34[141] Employee Incentives and Management - The employee incentive plan has granted significant equity stakes to key personnel, indicating a commitment to aligning interests with shareholders[10] - The employee incentive plan was approved in 2016 and revised in 2020 and 2023, focusing on aligning employee interests with the company's long-term development[122] - The employee incentive management committee determines the allocation of incentive shares based on factors such as tenure and performance[129]

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而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：6990） 截至2023年6月30日止六個月的中期業績公告 董事會欣然宣佈本集團截至2023年6月30日止六個月的未經審計簡明綜合中期業 績，連同截至2022年6月30日止六個月的比較數字。本公司獨立核數師已根據香 港審閱工作準則第2410號「實體獨立核數師審閱中期財務資料」對中期財務資料進 行審閱。除本公告另有界定外，本公告所用詞彙與本公司日期為2023年6月29日 的招股章程所界定者具有相同涵義。 財務摘要 截至6月30日止六個月 2023年 2022年 同比變動 人民幣千元 人民幣千元 （未經審計）（未經審計） 收入 1,046,226 344,988 203.3% ...