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 | ...