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。 期內其他全面收益（開支） 其後可重新分類至損益的項目： 換算海外業務產生之匯兌差額 282 (572) 期內全面開支總額 (44,614) (40,434) 1 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 截至2024年6月30日止六個月中期業績公告 康寧傑瑞生物製藥（「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2024年6月30日止六個月（「報告期間」）的未經審 核簡明綜合業績，連同截至2023年同期的比較數字。 於本公告內，「我們」及「我們的」指本公司，並在文義另有所指時指本集團。本公 告所載若干數額及百分比數字已經四捨五入調整或以四捨五入取至小數點後一位 或兩位數。任何表格、圖表或其他地方所示總額與所列數額總和的任何差異乃因 四捨五入所致。 財務摘要 | --- | --- | | ...

Pipeline and Product Development - The company has a diverse pipeline including monoclonal antibodies, bispecific antibodies, and ADCs, with one product approved and three in late-stage clinical trials[5]. - KN046, a bispecific antibody targeting PD-L1 and CTLA-4, is undergoing approximately 20 clinical trials across more than 10 tumor types, showing promising safety and efficacy results[5]. - KN026, a next-generation anti-HER2 bispecific antibody, has received IND approval for a Phase III trial in HER2-positive breast cancer and has shown good preliminary efficacy in heavily treated patients[6]. - KN035, an innovative anti-tumor immunotherapy, is the first subcutaneously administered PD-L1 inhibitor globally and has received breakthrough therapy designation for certain cancer treatments[7]. - The company is actively seeking collaboration opportunities for clinical trials to enhance the efficacy of KN046[5]. - Recent clinical trial results for KN046 were presented at the 2023 ESMO conference, demonstrating its effectiveness in various cancer types[5]. - The company is advancing its late-stage clinical trials for dual antibody products, including KN046 for advanced squamous non-small cell lung cancer and pancreatic cancer, and KN026 for HER2-positive breast and gastric cancers[14]. - The JSKN003 product, a HER2-targeted bispecific antibody-drug conjugate, has shown preliminary efficacy and good tolerability in Phase I clinical trials in Australia[15]. - The company has received breakthrough therapy designation for the HER2-positive gastric cancer indication of KN026 in combination with chemotherapy[14]. - The clinical trial for JSKN033, a subcutaneous ADC combination product, has been approved in Australia and is set to begin patient dosing by March 26, 2024[15]. - The company is focusing on expanding indications and combination therapies for KN046, KN026, JSKN003, and exploring new products like JSKN033 and JSKN016[15]. - The company achieved significant progress in its drug pipeline, particularly with KN046, which showed promising results in multiple clinical trials[31]. - In 2023, the independent data monitoring committee recommended the continuation of the Phase III trial for KN046 in combination with platinum-based chemotherapy for advanced NSCLC patients[31]. - The company plans to further explore the efficacy of KN046 in various cancer types, with results presented at the 2023 ESMO conference[32]. - In May 2023, KN026 combined with docetaxel received IND approval for a Phase III clinical trial as a first-line treatment for HER2-positive recurrent or metastatic breast cancer (BC) from the National Medical Products Administration (NMPA)[33]. - As of September 15, 2023, the clinical trial of KN026 combined with docetaxel showed a median progression-free survival (PFS) of 27.7 months and a 24-month overall survival (OS) rate of 84.1%, with no new safety signals observed[33]. - In June 2023, positive results were reported from the ongoing ENVASARC Phase II trial of KN035, showing double-digit objective response rates and good tolerability[34]. - In August 2023, IND approval was granted for a Phase III trial of KN035 in resectable non-small cell lung cancer (NSCLC) patients, with the first patient dosed in December 2023[34]. - In November 2023, KN019's subcutaneous formulation received IND approval from the NMPA for clinical development[35]. - Encouraging PFS and OS benefits were reported in the Phase II clinical trial of KN046 combined with albumin-bound paclitaxel for first-line treatment of advanced TNBC, with results published in Nature Communications in February 2024[41]. - The clinical trial for JSKN016, targeting advanced malignant solid tumors, received implied approval from the National Medical Products Administration (NMPA) for clinical research in March 2024[41]. - Results from the Phase II clinical trial of KN046 combined with chemotherapy for first-line treatment of metastatic NSCLC were published in Cell Reports Medicine in March 2024[41]. - The latest results from the Phase I clinical trial of JSKN003 for HER2-expressing advanced solid tumors showed good tolerability and safety, with low incidence of hematologic toxicity and interstitial lung disease (ILD), presented at the AACR Annual Meeting in April 2024[41]. Financial Performance - Total revenue for 2023 increased by 31.12% compared to 2022, reaching 195.55 million RMB from the product KN035, a subcutaneous PD-L1 inhibitor, which grew by 32.54%[14]. - The total loss for 2023 decreased by 35.35% compared to the previous year, indicating improved financial health[14]. - The company reported a revenue of approximately $206.3 million for the year, reflecting a significant increase compared to the previous year[20]. - The company reported a significant increase in revenue, achieving a total of $150 million for the fiscal year, representing a 25% year-over-year growth[23]. - The company anticipates a revenue growth of 15% in the next fiscal year, driven by new product launches and increased market penetration[20]. - The company provided guidance for the next fiscal year, projecting revenue growth of 30% to $195 million[25]. - The company reported a user base growth of 25% year-over-year, indicating strong demand for its products[20]. - The company reported a pre-tax loss of RMB 210,593,000 for 2023, an improvement from a loss of RMB 325,722,000 in 2022[28]. - The company reported a total comprehensive expenses for the year ended December 31, 2023, were RMB 211.4 million, down from RMB 326.2 million in the previous year, indicating a reduction of approximately 35.1%[50]. - The company recorded pharmaceutical sales and licensing revenue of RMB 195.6 million for the year ended December 31, 2023, compared to RMB 147.5 million in the previous year, marking an increase of about 32.5%[51]. - The company reported a total compensation cost incurred for the year ended December 31, 2023, was RMB 189.3 million, compared to RMB 192.0 million for the year ended December 31, 2022[146]. Research and Development - The company has a strong R&D track record supported by proprietary technologies and expertise[4]. - The company has allocated a budget of $50 million for research and development in the upcoming fiscal year, focusing on innovative cancer therapies[19]. - The company plans to optimize manufacturing processes and technologies to enhance product quality and reduce costs[49]. - The company has developed proprietary platforms for various forms of protein constructs, enhancing its R&D and manufacturing capabilities, with a new facility expected to exceed a production capacity of 40,000L[46]. - The company emphasizes the importance of AI and new drug development engineering trends for future growth[14]. - The company is focusing on partnerships with leading research institutions to accelerate innovation in cancer therapies[23]. - The company has established strategic partnerships with leading research institutions to accelerate the development of new therapies[19]. - The company is committed to maintaining compliance with international regulatory standards, ensuring the safety and efficacy of its products[19]. Market Expansion and Strategy - The company continues to expand its market presence through innovative product development and strategic partnerships[4]. - The company is actively pursuing market expansion strategies, particularly in the Asia-Pacific region, to increase its market share[19]. - The company plans to launch new products in 2024, including KN035, which is expected to enhance its competitive position in the oncology market[22]. - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2025[23]. - The company plans to expand its commercialization team to cover major provinces and cities in China, particularly those with higher disposable income levels, as more products and indications are expected to be approved[47]. Corporate Governance and Compliance - The company has adopted the principles and code provisions of the Corporate Governance Code as a benchmark for its governance practices[93]. - As of December 31, 2023, the company has complied with all applicable code provisions of the Corporate Governance Code, except for the separation of the roles of Chairman and CEO[93]. - The board consists of two executive directors and three independent non-executive directors as of December 31, 2023[95]. - The company has established an insider information policy to comply with its obligations under the Securities and Futures Ordinance and Listing Rules[94]. - The board believes that having the same individual serve as both Chairman and CEO enhances the consistency of leadership and strategic planning[96]. - The company will continue to review and monitor its corporate governance practices to ensure compliance with the Corporate Governance Code[93]. - Independent non-executive directors have confirmed their independence in accordance with the Listing Rules[99]. - The nomination committee is responsible for reviewing the composition of the board and recommending suitable candidates for directorship[101]. - The board of directors is responsible for major decisions, including approving and overseeing key policies and overall strategies, internal controls, and risk management systems[102]. - The audit committee consists of three independent non-executive directors, ensuring compliance with the listing rules and overseeing the group's financial information[104]. Employee and Corporate Culture - The company emphasizes employee-centricity, continuous innovation, and aims to solve the pain of cancer patients[92]. - The company continues to strengthen its cultural framework, promoting corporate culture and requiring all employees to consolidate it[92]. - New employees are required to participate in onboarding training to better understand the corporate culture, structure, and policies[92]. - The company invites external experts to train management personnel to enhance their knowledge and management skills[92]. - The company has a zero-tolerance policy for discrimination based on gender, age, race, nationality, and disability, ensuring equal employment opportunities[116]. - The company aims to enhance employee diversity in 2024, aiming for a more balanced representation[116]. - The board believes that corporate culture aligns with the company's mission, values, and strategies[92]. - The company has implemented various stock option plans and restricted share award plans to incentivize employees, aligning compensation with qualifications, industry experience, position, and performance[81]. Shareholder Relations - The company has adopted a shareholder communication policy to enhance effective communication with shareholders and facilitate their participation in the company's operations[133]. - Shareholders can submit inquiries to the board via written communication, with specific contact details provided for the joint company secretaries[132]. - Shareholders can convene special meetings if the board does not respond to requests within 21 days, with the company covering reasonable costs incurred by the requesters[130]. - There are no provisions allowing shareholders to propose new resolutions at general meetings, but they can call special meetings to achieve this[131]. Risk Management - The board is responsible for risk management and internal control systems, ensuring their effectiveness to manage risks associated with achieving business objectives[124]. - The company encourages employees to adopt proactive risk management approaches, enhancing the risk awareness culture within the organization[125]. - The anti-corruption policy is part of the corporate governance framework, ensuring compliance with applicable anti-corruption laws and regulations[127]. - The internal control system has been reviewed by internal consultants and auditors, with no major deficiencies identified, confirming its effectiveness during the reporting period[125]. Environmental and Social Responsibility - The company is committed to sustainable and environmentally friendly development, complying with relevant environmental laws and regulations in China[143]. - The company recognizes the importance of stakeholder relationships for its success and is committed to sustainable practices[149].

Financial Performance - The total comprehensive expenses for the year amounted to RMB 211,387,000, a decrease from RMB 326,162,000 in the previous year, reflecting a reduction of approximately 35%[2] - The company reported a pre-tax loss of RMB 210,593,000 for the year, compared to a pre-tax loss of RMB 325,722,000 in the previous year, indicating an improvement of about 35%[2] - Total revenue for the year ended December 31, 2023, was RMB 218.8 million, an increase of 30.9% from RMB 166.8 million for the year ended December 31, 2022[21] - The company reported a net loss of RMB 210,593 million for the year ended December 31, 2023, an improvement from a net loss of RMB 325,722 million in 2022[51] - The company reported a loss attributable to shareholders of RMB 210,593,000 for 2023, compared to a loss of RMB 325,722,000 in 2022, representing a 35.3% improvement year-over-year[77] Assets and Liabilities - Non-current assets totaled RMB 578,583,000, while current assets were RMB 1,558,530,000, showing an increase in current assets from RMB 1,494,530,000 in the previous year[3] - The net asset value increased to RMB 1,672,112,000 from RMB 1,557,672,000, representing a growth of approximately 7.3%[3] - Total assets as of December 31, 2023, were RMB 3,428.113 million, compared to RMB 3,226.530 million in 2022, showing an increase of 6.2%[52] - Total liabilities decreased to RMB 119,888,000 in 2023 from RMB 135,361,000 in 2022, reflecting a reduction of approximately 11.4%[87] - The company had bank borrowings of RMB 250 million as of December 31, 2023, down from RMB 325 million in 2022, with interest rates ranging from 2.70% to 2.87%[44] Research and Development - The company achieved significant progress in its drug pipeline, including positive results from multiple clinical trials for KN046 and KN026, with promising efficacy and safety signals reported[4][6] - The company reported a significant increase in research and development (R&D) expenses, reflecting its commitment to advancing its drug development pipeline[2] - Research and development expenses decreased to RMB 407.5 million, down 12.9% from RMB 468.2 million in 2022, due to some existing projects nearing completion[29] - The company is committed to ongoing research and development in oncology biopharmaceuticals, with plans to expand its product pipeline in the coming years[60] Clinical Trials and Drug Development - In the KN046 clinical trials, encouraging overall survival (OS) benefits were observed in patients with advanced non-small cell lung cancer (NSCLC) who previously failed epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors[5] - The independent data monitoring committee recommended the continuation of the KN046 trial for advanced pancreatic ductal adenocarcinoma, indicating ongoing positive developments[5] - The company plans to expand its clinical trials for KN026, with new drug clinical trial approvals received from the National Medical Products Administration of China[6] - In November 2023, KN026 received breakthrough therapy designation from the National Medical Products Administration (NMPA) for treating HER2-positive GC/GEJ patients who failed first-line standard treatment[7] - In June 2023, TRACON Pharmaceuticals reported positive results from the ongoing KN035 ENVASARC Phase II trial, demonstrating double-digit objective response rates and good tolerability[7] Revenue and Sales - Pharmaceutical sales and licensing income amounted to RMB 195.6 million, up 32.5% from RMB 147.5 million in the previous year, primarily driven by sales of the KN035 product[23] - Revenue from drug sales and licensing fees was RMB 195,551 thousand in 2023, compared to RMB 147,544 thousand in 2022, reflecting a year-over-year increase of about 32.5%[60] - Sales revenue from KN035 products to Sichuan Shilukangrui Pharmaceutical reached RMB 128,379,000 in 2023, compared to RMB 86,040,000 in 2022, reflecting a growth of approximately 49%[61] Corporate Governance and Management - The board includes Dr. Xu Ting as Chairman and Executive Director, highlighting leadership continuity[107] - The executive team also comprises Ms. Liu Yang as Executive Director, indicating a diverse leadership structure[107] - Independent non-executive directors include Dr. Guo Zijian, Mr. Wei Cheng, and Mr. Wu Dong, ensuring governance and oversight[107] - The board's composition reflects a commitment to diverse perspectives in decision-making[107] Future Outlook and Strategy - The company aims to enhance its market presence through strategic clinical trial advancements and potential future product launches[4][6] - The company is exploring market expansion opportunities and potential mergers and acquisitions to enhance its competitive position in the oncology sector[60] - The company believes that the next decade will see significant advancements in the development of innovative therapeutic biologics in China[19] Miscellaneous - The company has no significant contingent liabilities or major litigation that could adversely affect its financial position as of December 31, 2023[48] - The company did not declare any dividends for the year ending December 31, 2023, consistent with 2022[93] - The annual general meeting is scheduled for June 12, 2024, to discuss shareholder matters[105]

Financial Performance - The company reported a revenue of $150 million for Q2 2023, representing a 25% increase year-over-year[3]. - Revenue for the six months ended June 30, 2023, was RMB 136,465 thousand, a significant increase from RMB 53,569 thousand in the same period of 2022, representing a growth of 154.5%[20]. - Total revenue for the six months ended June 30, 2023, was RMB 136.5 million, a significant increase from RMB 53.6 million for the same period in 2022, representing a growth of approximately 154.3%[32]. - Revenue from drug sales and licensing fees amounted to RMB 117.0 million, up from RMB 53.5 million in 2022, indicating a year-over-year increase of about 118.5%[34]. - The company reported a pre-tax loss of RMB 39,862 thousand for the first half of 2023, a substantial improvement from a loss of RMB 147,309 thousand in the same period of 2022, marking a reduction of 72.9%[20]. - The company reported a loss of RMB 39,862,000 for the six months ended June 30, 2023, significantly improved from a loss of RMB 147,309,000 in the same period of 2022, representing a reduction of 72.9%[146]. Product Development and Pipeline - The company provided guidance for Q3 2023, expecting revenue to be between $160 million and $170 million, indicating a growth of 20% to 30% compared to Q3 2022[3]. - New product launches included two innovative therapies, which are expected to contribute an additional $50 million in revenue by the end of 2023[3]. - The management highlighted a strong pipeline with five products in late-stage clinical trials, projected to enter the market by 2025[3]. - The company reported a strong pipeline with one product approved by the National Medical Products Administration and three in late-stage clinical trials[12]. - KN046, a bispecific antibody targeting PD-L1 and CTLA-4, is undergoing approximately 20 clinical trials across more than 10 tumor types, showing promising safety and efficacy[12]. - The company has initiated pivotal clinical trials for KN046 in NSCLC and PDAC, seeking collaboration opportunities for combination therapies[12]. - The company is focused on expanding its proprietary biopharmaceutical platform in bispecific and protein engineering[11]. - The company aims to provide world-class innovative biopharmaceuticals through its drug discovery and development capabilities[11]. - The company has a differentiated internal pipeline consisting of monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates[12]. - The company continues to seek strategic partnerships to enhance the development of its product candidates[12]. Research and Development - The company invested $20 million in new technology development, focusing on improving production efficiency by 40%[3]. - Research and development expenses decreased to RMB 194,681 thousand from RMB 216,399 thousand year-over-year, reflecting a reduction of approximately 10%[20]. - The total R&D expenses for the six months ended June 30, 2023, amounted to RMB 194,681,000, a decrease from RMB 216,399,000 in the same period of 2022[185]. - The company has developed proprietary platforms for various antibody formats, enhancing its internal R&D and manufacturing capabilities[30]. Market Expansion and Strategy - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2024[3]. - A strategic acquisition was completed, enhancing the company's R&D capabilities and expected to generate $10 million in cost synergies annually[3]. - Future outlook remains positive, with an anticipated annual growth rate of 25% over the next three years[3]. - The company aims to expand its commercialization team across major provinces in China, particularly in economically developed areas[31]. Financial Position and Assets - Total assets as of June 30, 2023, were RMB 2,328,389 thousand, up from RMB 2,117,531 thousand at the end of 2022, showing an increase of 9.9%[21]. - The net asset value increased to RMB 1,846,820 thousand as of June 30, 2023, compared to RMB 1,557,672 thousand at the end of 2022, reflecting a growth of 18.6%[21]. - Cash and cash equivalents increased from RMB 1,069.2 million as of December 31, 2022, to RMB 1,136.3 million as of June 30, 2023, while term deposits with maturities over three months rose significantly from RMB 247.9 million to RMB 445.3 million[54]. - The company reported total employee compensation costs of RMB 85.3 million for the six months ended June 30, 2023, compared to RMB 86.7 million for the same period in 2022[69]. Corporate Governance and Compliance - The company has complied with all applicable corporate governance code provisions, except for the separation of the roles of Chairman and CEO[82]. - The audit committee reviewed the unaudited condensed consolidated financial statements for the six months ended June 30, 2023[86]. - The company will continue to review and monitor its corporate governance practices to ensure compliance with the corporate governance code[82]. Stock Options and Share Issuance - The company has adopted two pre-IPO stock option plans, with a total of 27,082,725 options granted, of which 63,000 were exercised and 97,750 were forfeited during the reporting period[88]. - The total number of options that will vest in 2024 is 1,400,000, with additional vesting amounts scheduled for 2025 and 2026[95]. - The company issued 25,000,000 ordinary shares during the reporting period, increasing the total issued shares to 964,779,387 as of June 30, 2023[166]. - The company raised approximately HKD 376.2 million from the placement and subscription of 25 million shares at HKD 15.22 per share in February 2023[25].

Financial Performance - For the six months ended June 30, 2023, the company reported revenue of RMB 136,465 thousand, a significant increase from RMB 33,165 thousand in the same period of 2022, representing a growth of approximately 311%[2] - The gross profit for the same period was RMB 103,300 thousand, compared to RMB 42,979 thousand in 2022, indicating a growth of about 140%[2] - The company incurred a pre-tax loss of RMB 39,862 thousand for the period, an improvement from a loss of RMB 147,309 thousand in the previous year, reflecting a reduction of approximately 73%[2] - Total revenue for the six months ended June 30, 2023, was RMB 136.5 million, a significant increase from RMB 53.6 million for the same period in 2022, representing a growth of approximately 154.3%[16] - The company recorded other income of RMB 43.0 million for the six months ended June 30, 2023, compared to RMB 21.7 million in the same period of 2022, marking an increase of approximately 97.2%[16] - The company reported a net loss of RMB 39.862 million for the period, an improvement from a net loss of RMB 147.309 million in the same period last year[48] - The total comprehensive loss for the period was RMB 40.434 million, compared to RMB 147.318 million in the previous year, indicating a significant reduction in losses[48] Asset and Liquidity Position - Non-current assets decreased to RMB 605,652 thousand from RMB 623,001 thousand year-over-year, while current assets increased to RMB 1,722,737 thousand from RMB 1,494,530 thousand, indicating a stronger liquidity position[3] - The net asset value increased to RMB 1,846,820 thousand from RMB 1,557,672 thousand, reflecting a growth of approximately 18.5% year-over-year[3] - The current ratio improved to 6.59 as of June 30, 2023, compared to 3.88 at the end of 2022, indicating better liquidity[42] - Cash and cash equivalents increased from RMB 1,069.2 million as of December 31, 2022, to RMB 1,136.3 million as of June 30, 2023, while time deposits with maturities over three months surged from RMB 247.9 million to RMB 445.3 million[34] Research and Development - The company achieved significant milestones in its drug pipeline, including the initiation of clinical trials for JSKN003 and KN052, with KN052's preclinical data showing superior anti-tumor activity compared to control antibodies[4][5] - The company plans to present six different research advancements related to KN046 and KN026 at the upcoming European Society for Medical Oncology conference in October 2023[6][7] - The new drug application (NDA) for KN046 is expected to be submitted in 2024, and for KN026 in 2025, highlighting the company's future growth prospects[15] - The company has a diverse pipeline of products, including one approved product and three in late clinical stages, indicating a robust development strategy[11] - The company is making steady progress in drug development and exploring strategic collaborations with business partners, aiming to achieve significant clinical development milestones[79] Production and Capacity Expansion - The company completed the expansion of its production facility to a capacity of 6,000L, which is expected to be used for clinical trial drug production in the second half of 2023[8] - The company is planning further expansion of its production capacity, with a design capacity exceeding 40,000L for the next phase of construction[8] - The company has established advanced manufacturing capabilities with a projected capacity exceeding 40,000L, enhancing its production capabilities[14] Strategic Collaborations and Partnerships - A strategic collaboration was established with Simi (Shanghai) Biotechnology Co., Ltd. to explore the combination therapy of KN052 and personalized mRNA tumor vaccine SWP1001 for certain solid tumors[4] - The company continues to explore strategic partnerships and collaborations to enhance its market presence and product offerings[51] - The company granted a license to Jinmant Biotechnology for the development and commercialization of KN026, with a non-refundable upfront payment of RMB 150 million and potential milestone payments totaling RMB 850 million[58] Expenses and Cost Management - Research and development expenses for the six months ended June 30, 2023, were RMB 194.7 million, down from RMB 216.4 million in 2022, reflecting a decrease of approximately 10.0%[16] - Administrative expenses decreased to RMB 33.2 million from RMB 44.1 million year-over-year, showing a reduction of about 24.0%[16] - Financing costs decreased from RMB 10.9 million for the six months ended June 30, 2022, to RMB 7.0 million for the same period in 2023, a reduction of 35.5%[28] Market and Sales Performance - For the six months ended June 30, 2023, the company recorded pharmaceutical sales and licensing income of RMB 117.0 million, compared to RMB 53.5 million for the same period in 2022, representing an increase of 118.5%[19] - Revenue from sales of the KN035 product to Sichuan Silu Kangrui Pharmaceutical amounted to RMB 71.5 million for the six months ended June 30, 2023, up from RMB 27.2 million in the same period of 2022, reflecting a growth of 162.5%[19] - The company recognized royalty income based on sales of RMB 45.5 million for the six months ended June 30, 2023, compared to RMB 25.4 million for the same period in 2022, marking an increase of 79.5%[19] Corporate Governance and Compliance - The company has adhered to all applicable corporate governance codes, except for a deviation regarding the separation of the roles of Chairman and CEO[82] - The company has established a set of insider information policies to comply with the Securities and Futures Ordinance and listing rules[83] Future Outlook - The company anticipates that the development of innovative therapeutic biologics will drive growth in the pharmaceutical industry over the next decade[79] - New policies in China are expected to accelerate drug development processes and enhance innovation standards in the pharmaceutical industry[79] Miscellaneous - There were no significant investments or acquisitions made during the six months ended June 30, 2023[43] - The company has not declared or recommended any dividends during the reporting period[71] - No significant events affecting the company occurred after June 30, 2023[88] - The interim report for the six months ending June 30, 2023, will be sent to shareholders in September 2023[88] - The company acknowledges the support and contributions from shareholders, management team, employees, business partners, and customers[89]

Clinical Development and Pipeline - The company has a diverse pipeline including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates, with one product approved and three in late-stage clinical trials[5]. - KN046, a bispecific antibody targeting PD-L1 and CTLA-4, is undergoing approximately 20 clinical trials across multiple tumor types, with promising safety and efficacy results reported[5]. - The company plans to submit two New Drug Applications (NDAs) for KN046 in 2023 for the treatment of sq NSCLC and PDAC[5]. - KN026, a next-generation anti-HER2 bispecific antibody, has shown good preliminary efficacy signals in heavily treated HER2-positive cancer patients during its clinical trials[6]. - KN035, an innovative anti-tumor immune therapy, is currently in a Phase III clinical trial for cholangiocarcinoma and has received fast-track designation from the FDA for certain indications[7]. - KN035 has been included in the 2022 CSCO guidelines for multiple cancer types, indicating its growing recognition in the medical community[7]. - The company has made significant progress in clinical trials, presenting data at major conferences such as AACR, ASCO, ESMO, and SABCS in 2022[6]. - The company is actively seeking collaboration opportunities for clinical trials involving KN046 with potential business partners[5]. - The company has achieved key milestones in its clinical trials, including successful patient dosing in various studies throughout 2022[6]. - The company aims to complete the dose escalation of KN052 and enter the verification Phase II stage within the year[16]. - The company expects to report on KN046 for squamous non-small cell lung cancer and pancreatic cancer within the year[16]. - The company plans to accelerate the development of JSKN003 and initiate two registration clinical trials within the year[16]. - The company reported a total of 206,313,000 shares purchased, including those issued and allocated under the over-allotment option[20]. - The company has developed proprietary platforms for protein engineering and drug discovery, enhancing its R&D capabilities and manufacturing capacity[47]. - The company is focused on developing differentiated, clinically valuable, and internationally competitive new drugs[16]. - Approximately 20 clinical trials covering over 10 types of tumors, including NSCLC, PDAC, TNBC, HCC, ESCC, and thymic carcinoma, are ongoing in China, the US, and Australia, showing good safety and significant efficacy for KN046[33]. Financial Performance - The company reported a revenue of HKD 1.2 billion for the fiscal year ending December 31, 2022, representing a year-over-year increase of 15%[25]. - The company provided guidance for the next fiscal year, projecting a revenue growth of 10% to 12%[23]. - Total revenue for 2022 was RMB 166,845,000, an increase from RMB 146,021,000 in 2021, representing a growth of approximately 14.5%[28]. - The company reported a net loss of RMB 325,722,000 for 2022, an improvement compared to a net loss of RMB 412,417,000 in 2021[28]. - The company reported a gross margin of 65%, maintaining strong profitability despite increased competition[25]. - Research and development expenses increased by 30% to HKD 300 million, reflecting the company's commitment to innovation[24]. - The company recorded other gains of RMB 63.1 million for the year ended December 31, 2022, compared to losses of RMB 30.6 million in 2021, mainly due to foreign exchange gains[57]. - The total comprehensive expenses for the year ended December 31, 2022, were RMB 326.2 million, down from RMB 411.3 million in 2021, indicating a reduction of 20.7%[51]. - The company has incurred significant net losses and may require substantial additional financing to fund its operations[145]. Market Expansion and Strategic Partnerships - The company is focused on expanding its market presence and enhancing its product pipeline through strategic partnerships and collaborations[20]. - The company announced a strategic partnership with a leading biotech firm to enhance its pipeline of oncology therapies[23]. - The company is expanding its market presence in Southeast Asia, targeting a 25% market share in the region by 2025[25]. - A strategic collaboration was established in February 2023 with Simi (Shanghai) Biotechnology Co., Ltd. to explore the combination therapy of KN052 with personalized mRNA tumor vaccine SWP1001[43]. - The company is actively seeking strategic collaboration opportunities for core products to maximize commercial value[50]. Corporate Governance and Management - The company has a strong focus on R&D in the biotechnology sector, with key personnel having backgrounds in both medical and pharmaceutical industries[87][92]. - The board includes independent directors with significant experience in investment and corporate strategy, enhancing governance and oversight[88][90][92]. - The company emphasizes innovation in product development, particularly in the medical field, as indicated by the backgrounds of its executives[92]. - The company reported a strong commitment to corporate governance, adhering to all applicable code provisions except for the separation of the roles of Chairman and CEO, which are currently held by the same individual[99]. - The board consists of two executive directors, one non-executive director, and three independent non-executive directors as of December 31, 2022[101]. - The company has established four committees: audit, remuneration, nomination, and strategy, to oversee various aspects of governance[109]. - The company has adopted a set of insider trading policies to comply with its obligations under the Securities and Futures Ordinance and Listing Rules[100]. - The company has implemented a comprehensive training program for new employees to better understand its corporate culture and policies[98]. Research and Development - The company emphasizes its proprietary drug discovery and development capabilities, supported by a strong R&D track record[4]. - The company is actively developing new technologies, including the CRAM and CRIB platforms for antibody modification[19]. - The company has developed a proprietary biopharmaceutical platform focused on bispecific and protein engineering, aiming to provide innovative therapeutic biologics globally[142]. - The company aims to leverage its innovative technology platform to develop pipeline products and expand its commercialization team[48]. Employee and Board Diversity - The company aims to enhance gender diversity on the board by increasing the number of female directors by the end of 2025[119]. - The board diversity policy considers various factors including gender, age, cultural and educational background, and professional experience[117]. - The company emphasizes equal employment opportunities and has a zero-tolerance policy towards discrimination based on gender, age, race, nationality, and disability[122]. - The company plans to continue promoting gender diversity at all levels, including senior management[119]. Risks and Challenges - The company may face challenges in obtaining regulatory approval for its candidate drugs, which could delay commercialization[145]. - The company has a comprehensive risk management strategy to address uncertainties in drug development and commercialization[145]. - The company has a limited experience in commercializing candidate drugs, which may impact future revenue generation[145]. Shareholder Information - The company has adopted a dividend policy with no preset dividend payout ratio, intending to retain most available funds for business expansion[125]. - The company has obtained annual written confirmation from controlling shareholders regarding compliance with non-competition commitments[168]. - The company has purchased liability insurance to provide appropriate protection for its directors[162].

Financial Performance - The company reported a total revenue of RMB 166,845 thousand for the year ended December 31, 2022, compared to RMB 146,021 thousand in 2021, representing a year-over-year increase of approximately 14.5%[2] - The total comprehensive expenses for the year amounted to RMB (326,162) thousand, a decrease from RMB (411,309) thousand in the previous year, indicating a reduction of about 20.7%[2] - The company achieved a gross profit of RMB 122,638 thousand, down from RMB 142,993 thousand in 2021, reflecting a decline of approximately 14.2%[2] - The net loss for the year was RMB (325,722) thousand, compared to a net loss of RMB (412,417) thousand in 2021, showing an improvement of about 21.0%[2] - The company reported a net asset value of RMB 1,557,672 thousand as of December 31, 2022, down from RMB 1,870,289 thousand in 2021[3] - The company’s total non-current assets were RMB 623,001 thousand, while current assets were RMB 1,494,530 thousand as of December 31, 2022[3] - The company recorded other income of RMB 57.8 million in 2022, up from RMB 47.0 million in 2021[25] - The company’s cost of sales for the year ended December 31, 2022, was RMB 442 million, a significant increase from RMB 30 million in 2021, primarily due to pharmaceutical sales costs of RMB 432 million[28] - The company incurred a net loss of RMB 325,722,000 for 2022, a decrease in loss compared to RMB 412,417,000 in 2021, reflecting an improvement of 21.0%[80] - Research and development expenses totaled RMB 468,238,000 in 2022, a slight decrease of 2.4% from RMB 481,361,000 in 2021[78] Clinical Development and Pipeline - The company has made significant progress in its drug pipeline, including the successful completion of a Phase III clinical trial for KN046 in February 2022[4] - The company received IND approval for multiple clinical trials involving KN046, including treatments for advanced non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC)[4] - As of June 29, 2022, the Phase III clinical trial for KN046 in combination with albumin-bound paclitaxel and gemcitabine successfully completed dosing for 110 patients, with approximately 90% patient enrollment completed by the end of 2022[5] - The company is conducting around 20 clinical trials across China, the United States, and Australia, covering over 10 types of tumors, demonstrating promising safety and efficacy results for KN046[7] - KN026 received IND approval for a Phase II/III clinical trial on January 4, 2022, to evaluate its efficacy and safety in HER2-positive gastric cancer patients who failed trastuzumab treatment[8] - As of August 18, 2022, the median progression-free survival for patients treated with KN026 combined with docetaxel in a Phase II trial was 25.4 months, with a 24-month overall survival rate of 91.2%[9] - A Phase II trial of KN026 combined with KN046 for previously untreated HER2-positive gastric cancer patients showed good efficacy and safety results, presented at the ESMO conference in September 2022[9] - The company’s partner, TRACON Pharmaceuticals, reported positive interim results for the KN035 pivotal trial in December 2022, indicating ongoing clinical benefits[10] - The IND application for JSKN003 was approved in October 2022, aimed at evaluating its safety and tolerability in HER2-expressing advanced solid tumors in China[12] - The company entered a strategic collaboration with Simi (Shanghai) Biotechnology Co., Ltd. in February 2023 to explore the combination therapy of KN052 and personalized mRNA tumor vaccine SWP1001 for several types of solid tumors[17] - In March 2023, preclinical results of KN052 were selected for presentation at the AACR Annual Meeting 2023, demonstrating acceptable pharmacokinetic properties and safety[17] - The first patient dosing in the Phase Ia/Ib clinical trial of JSKN003 was successfully completed in March 2023[17] - The company has a differentiated pipeline consisting of monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates, with one product approved by the National Medical Products Administration and three in late-stage clinical trials[19] Revenue Sources and Growth - Revenue from pharmaceutical sales and licensing fees reached RMB 147.5 million in 2022, compared to RMB 11.6 million in 2021, primarily driven by sales of KN035[26] - The group recognized collaboration and commercialization revenue of RMB 337,000 for KN035 in 2022, up from RMB 12,000 in 2021[68] - Revenue from sales of KN035 products to Sichuan Silu Kangrui Pharmaceutical was RMB 86,040,000 in 2022, compared to RMB 4,433,000 in 2021, indicating a substantial growth[69] - Licensing fee income related to KN035 reached RMB 61,504,000 in 2022, compared to RMB 7,175,000 in 2021, reflecting a significant increase[69] - The group confirmed revenue of RMB 13,002,000 from the delivery of research project deliverables to Tianmant Biotech in 2022, which was not applicable in 2021[70] - Revenue from providing consumables for research projects totaled RMB 5,962,000 in 2022, compared to RMB 1,614,000 in 2021, showing a notable increase[72] Operational and Financial Health - The company’s production capacity increased to 6,000L with a new production license obtained in December 2022, and further expansion to over 40,000L is planned[14] - The company aims to expand its commercialization team across major provinces in China, particularly in economically developed areas with higher disposable income[22] - The company confirmed collaboration and commercialization income of RMB 337,000 in 2022, up from RMB 12,000 in 2021, due to the commercialization of KN035[26] - The company’s total employee costs rose to RMB 191,983,000 in 2022, an increase of 38.4% from RMB 139,047,000 in 2021[79] - The total number of employees increased to 472 as of December 31, 2022, from 459 in 2021, marking an increase of about 2.8%[59] - The total compensation cost for employees was RMB 192,000,000 for the year ended December 31, 2022, up from RMB 139,000,000 in 2021, representing a rise of approximately 38.1%[59] - The company’s cash and cash equivalents increased from RMB 803.3 million as of December 31, 2021, to RMB 1,069.2 million as of December 31, 2022, while time deposits with maturities over three months decreased from RMB 1,128.2 million to RMB 247.9 million[44] - The current ratio improved from 3.32 as of December 31, 2021, to 3.88 as of December 31, 2022, indicating better short-term financial health[54] - The company had no significant investments or plans for major capital assets as of December 31, 2022[55] - There were no significant contingent liabilities or pending lawsuits that could adversely affect the company's financial condition as of December 31, 2022[57] Corporate Governance and Compliance - The company has adopted the corporate governance code as a benchmark for its governance practices, ensuring compliance with all applicable provisions except for the separation of the roles of Chairman and CEO, which are currently held by the same individual, Dr. Xu Ting[99] - The company has established an audit committee consisting of three independent non-executive directors, ensuring compliance with the listing rules and corporate governance standards[101] - The company is committed to high standards of corporate governance, regularly reviewing its compliance with the corporate governance code[99] - The company has a policy in place to manage insider information and ensure compliance with securities regulations[100] - The annual general meeting is scheduled for June 12, 2023, to discuss shareholder matters[108] - The company will suspend share transfer registration from June 7, 2023, to June 12, 2023, to determine shareholder eligibility for the annual general meeting[109] - The annual report for the year ending December 31, 2022, will be sent to shareholders in April 2023 and published on the stock exchange and the company's website[109] - The board expresses gratitude to shareholders, management team, employees, business partners, and customers for their support and contributions[110]

Financial Performance - The company reported a revenue of $50 million for the first half of 2022, representing a 25% increase compared to the same period in 2021[5]. - The company reported a net loss of $5 million for the first half of 2022, primarily due to increased R&D expenses[5]. - Revenue for the six months ended June 30, 2022, was RMB 53,569 thousand, compared to RMB 0 for the same period in 2021[24]. - Gross profit for the same period was RMB 38,749 thousand, with a gross margin of approximately 72.2%[24]. - The total comprehensive loss for the six months ended June 30, 2022, was RMB 147,318 thousand, compared to RMB 266,910 thousand in the same period of 2021[24]. - The company reported a pre-tax loss of RMB 147,309 thousand, an improvement from a loss of RMB 267,364 thousand in the previous year[24]. - The company reported a basic and diluted loss per share of RMB (0.16), an improvement from RMB (0.29) in the previous year[111]. - For the six months ended June 30, 2022, the company reported a loss of RMB 147,309 thousand, compared to a loss of RMB 267,364 thousand for the same period in 2021, representing a 45% improvement in loss[119]. Research and Development - The company has invested $10 million in developing its CRAM platform for antibody modification, aiming to improve product efficacy[5]. - The company has a strong R&D track record supported by proprietary technologies, platforms, and expertise[16]. - The company has initiated four key clinical trials for KN046 in China, including trials for NSCLC and PDAC[28]. - KN046 has shown significant efficacy in a Phase III trial for locally advanced or metastatic PDAC, with 110 patients dosed as of June 29, 2022[28]. - The company has a diverse pipeline with multiple products at various stages, including one approved product and three in late-stage clinical trials[38]. - R&D expenses for the six months ended June 30, 2022, amounted to RMB 81,789,000, a decrease of 36.2% from RMB 128,041,000 in the same period of 2021[180]. Product Development and Clinical Trials - New product KN046 is expected to enter clinical trials in Q3 2022, with anticipated FDA approval by the end of 2023[5]. - KN046, a bispecific antibody targeting PD-L1 and CTLA-4, is undergoing approximately 20 clinical trials across 10 tumor types, with promising safety and efficacy results reported in NSCLC, PDAC, HCC, and TNBC[17]. - KN026, a next-generation anti-HER2 bispecific antibody, is in multiple I/II/III clinical trials in China and the US, showing initial efficacy signals in heavily treated HER2-positive cancer patients[18]. - KN035 (Envafolimab), the first subcutaneously administered PD-L1 inhibitor, is in a pivotal III trial for cholangiocarcinoma and has received orphan drug designation from the FDA for advanced cholangiocarcinoma and soft tissue sarcoma[19]. - The company plans to submit two NDAs for KN046 in China in 2023 for treating sq NSCLC and PDAC[17]. - The IND application for JSKN003 has been accepted, marking it as the first bispecific antibody-drug conjugate to apply for clinical trials in China[36]. Market Expansion and Strategic Initiatives - The company plans to expand its market presence in Europe, targeting a 20% market share in the oncology sector by 2025[5]. - A strategic acquisition of a biotech firm is in progress, which is expected to enhance the company's R&D capabilities and product pipeline[5]. - The company is exploring partnerships with independent third parties to enhance its distribution network in Asia[5]. - The company plans to expand its commercialization team across major provinces in China, focusing on economically developed areas[41]. Financial Position and Assets - As of June 30, 2022, total assets were RMB 2,461,697 thousand, with net assets of RMB 1,728,432 thousand[25]. - Cash and cash equivalents increased from RMB 803.3 million as of December 31, 2021, to RMB 977.4 million as of June 30, 2022[61]. - The company's total liabilities increased to RMB 3,682,362 thousand as of June 30, 2022, compared to RMB 3,000,000 thousand as of January 1, 2021, reflecting an increase of approximately 23%[115]. - The current ratio as of June 30, 2022, was 3.57, compared to 3.32 as of December 31, 2021, indicating improved liquidity[69]. Corporate Governance and Compliance - The company has complied with all applicable corporate governance code provisions, except for the separation of the roles of Chairman and CEO[91]. - The company is committed to high standards of corporate governance to protect shareholder interests and enhance company value[90]. - The audit committee reviewed the unaudited condensed consolidated financial statements for the six months ending June 30, 2022, with discussions on accounting policies and internal controls[96]. Shareholder Information - Rubymab holds a significant stake of 314,000,000 shares, representing 33.43% of the total equity[82]. - Major shareholder Zhang Xitian owns 85,750,000 shares, accounting for 9.13% of the equity[82]. - The total number of shares issued as of June 30, 2022, is 939,231,735[87]. Employee Compensation and Stock Options - Total employee compensation for the six months ended June 30, 2022, was RMB 86.7 million, up from RMB 62.7 million for the same period in 2021, reflecting a 38.3% increase[74]. - The company plans to continue expanding its employee stock option plans to retain and incentivize talent[170]. - The total expense recognized for stock options under the pre-IPO stock option plan for the six months ended June 30, 2022, was RMB 216,000, a decrease of 73.6% compared to RMB 820,000 for the same period in 2021[171].

2021 中期報告 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） 股份代號 : 9966 | | | | --- | --- | | | 0 00 | | | 20000 | | | 0 0 0 | | | A | | ... | | | | | | . | A C . | | | | | | 00000 | | | 00000 | | | 0 0 0 0 0 | | . | | | | The Resident of the Resident of the Research | | | | ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 INTERIM REPORT 2021 中期報告 目錄 | 釋義及技術詞彙 | 2 | | --- | --- | | 公司簡介 | 10 | | 公司資料 | 12 | | 財務摘要 | 14 | | 業務摘要 | 15 | | 管理層討論與分析 | 17 | | 企業管治及其他資料 | 32 | | 簡明綜合財務報表審閱報告 | 44 | | 簡明綜合損益及其他全面收益表 | 45 | | 簡明綜合財務狀況表 | 46 | ...