R&D and Clinical Development - In 2021, the company achieved a significant increase in R&D investment, totaling RMB 421 million, which represents an 83% growth compared to the previous year[10]. - The company completed Phase I trials for the SHP2 inhibitor JAB-3312 and established recommended doses for Phase II trials, indicating strong progress in clinical development[10]. - The company received four IND approvals for the KRAS G12C inhibitor, including trials in combination with SHP2 inhibitors and other therapies, demonstrating its competitive position in the biotech sector[10]. - The company is focusing on six major tumor signaling pathways, which cover 70%-80% of tumor types, aiming to develop innovative therapies for billions of patients[10]. - The company is positioned among the top three biotech firms in China for the development of KRAS G12C inhibitors, reflecting its strong clinical advancement[10]. - The company has initiated clinical trials for its KRAS G12C inhibitor in multiple European countries, marking its first use of self-developed drugs in European patients[10]. - The company plans to start patient enrollment for two additional projects, CD73 (JAB-BX102) and Aurora A (JAB-2485), in Q2-Q3 of 2022 following FDA IND approvals[10]. - The company aims to submit the registration clinical trial application for KRAS G12C inhibitor (JAB-21822) in 2022, with NDA submission expected in 2023-2024[20]. - The clinical team has expanded rapidly, with operations in Beijing, Shanghai, and Boston, managing trials independently without relying on CROs[17]. - JAB-21822, a KRAS G12C inhibitor, has completed the dose escalation phase in China and is expected to expand into Europe and Israel in 2022[31]. - JAB-8263 is currently undergoing Phase I dose escalation trials in China and the US, showing excellent safety and tolerability with good pharmacokinetic characteristics[33]. - JAB-2485 received FDA approval for its IND application in January 2022, with plans to submit to China's National Medical Products Administration in Q2 2022[33]. - JAB-BX102's IND application was approved by the FDA in October 2021, with the first patient expected to be dosed in the US in H1 2022[33]. - The company plans to submit IND applications for JAB-24114 and JAB-BX300 in H2 2022, both targeting tumor metabolic signaling pathways[33]. - JAB-3068 and JAB-3312 are oral SHP2 inhibitors in clinical stages, targeting cancers driven by the RAS signaling pathway and immune checkpoint pathways[47]. - The Phase I trial for JAB-3068 in the US is nearing completion, confirming the maximum tolerated dose and RP2D[50]. - The Phase IIa trial for JAB-3068 in China has completed patient enrollment, with results expected in the second half of 2022[50]. - The company plans to explore the combination of SHP2 inhibitors with KRAS inhibitors, with the first patient dosing in China expected in the second quarter of 2022[46]. - The company emphasizes the potential of combining KRAS inhibitors with SHP2 inhibitors to address adaptive resistance mechanisms in cancer treatment[46]. - The company has established a strong patent portfolio for SHP2 inhibitors, enhancing its market position against competitors[47]. - The company is actively seeking opportunities to expedite regulatory approvals and explore collaborations to enhance the clinical and commercial value of its drug candidates[56]. - The company has initiated a global Ib/IIa trial for JAB-3312 combined with MEK inhibitors, with dose escalation currently ongoing[51]. - The company is committed to providing ongoing education and training programs for employees to enhance their skills and knowledge[113]. Financial Performance - Revenue for the year ended December 31, 2021, was RMB 152.8 million, primarily from the collaboration agreement with AbbVie for the SHP2 inhibitor[23]. - The company reported revenue of RMB 152.8 million for the year ended December 31, 2021, a significant decrease from RMB 486.3 million in 2020[85]. - The cost of revenue for the year ended December 31, 2021, was RMB 140.0 million, primarily due to clinical trial expenses for the SHP2 inhibitor, compared to RMB 44.1 million in 2020[86]. - Gross profit decreased from RMB 442.2 million in 2020 to RMB 12.8 million in 2021[87]. - Other income increased to RMB 11.0 million in 2021 from RMB 7.7 million in 2020, mainly due to an increase in government grants[88]. - The company recorded a net foreign exchange loss of RMB 27.3 million for the year ended December 31, 2021, down from RMB 31.7 million in 2020[89]. - Research and development expenses rose to RMB 280.8 million in 2021 from RMB 185.9 million in 2020, driven by progress in clinical candidates and increased employee costs[93]. - Administrative expenses decreased to RMB 44.6 million in 2021 from RMB 53.8 million in 2020, primarily due to the elimination of IPO-related expenses[94]. - Financial income increased to RMB 18.8 million in 2021 from RMB 3.1 million in 2020, attributed to increased bank interest income from global offering proceeds[96]. - The adjusted loss for the year 2021 was RMB (284,678) thousand, compared to an adjusted profit of RMB 227,044 thousand in 2020[98]. - The net cash used in operating activities for the year ended December 31, 2021, was RMB 147.5 million, an increase of RMB 226.3 million compared to the previous year[103]. - The net cash flow from investing activities for 2021 was RMB 161.7 million, an increase of RMB 377.2 million from 2020[103]. - As of December 31, 2021, the company's cash and bank balances were RMB 1,537.6 million, down from RMB 1,627.4 million in 2020[106]. - The company had capital commitments of RMB 152.2 million as of December 31, 2021, primarily related to the investment in Hebecell[110]. - Total employee compensation for the year ended December 31, 2021, was RMB 128.7 million, up from RMB 83.1 million for the year ended December 31, 2020, reflecting the company's business expansion strategy[113]. Corporate Governance - The company has adopted the Corporate Governance Code as per the Listing Rules, emphasizing the importance of independent judgment within the board[148]. - The independent non-executive directors have confirmed their independence according to the applicable Listing Rules, ensuring compliance with governance standards[153]. - The board is responsible for overseeing all major affairs, including policy formulation, overall strategy, and risk management systems[151]. - The company has maintained compliance with the Corporate Governance Code throughout the year ending December 31, 2021[148]. - The board believes that the current management structure is effective for the company's operations, despite deviations from certain governance codes[148]. - The company has purchased liability insurance for its directors and senior management to provide adequate protection against legal liabilities[151]. - The independent non-executive directors play a crucial role in providing impartial opinions and judgments on the company's strategy and performance[151]. - The board will regularly review the contributions of each director to ensure they are fulfilling their responsibilities adequately[151]. - The company has a commitment to high levels of corporate governance to safeguard the overall interests of shareholders[148]. - The board consists of 12 members, including 4 executive directors, 4 non-executive directors, and 4 independent non-executive directors, with a diverse age range from 38 to 67 years[154]. - The board diversity policy aims to enhance operational efficiency and maintain high standards of corporate governance, considering factors such as gender, skills, age, and professional experience[154]. - The board meets at least four times a year, with all directors actively participating either in person or via electronic communication[164]. - The attendance record for board meetings shows that all directors attended 4 out of 4 meetings held during the year ending December 31, 2021[165]. - The Audit Committee held two meetings during the reporting period to review the interim financial performance for the six months ended June 30, 2021, and the annual financial performance for the year ended December 31, 2020[168]. - The Remuneration Committee conducted two meetings to review the company's remuneration policies and structures, as well as the remuneration of executive directors and senior management[174]. - The Nomination Committee held one meeting to review the structure, size, and composition of the Board, ensuring a balance of skills, knowledge, and experience[178]. Strategic Partnerships and Market Focus - The company aims to maintain a global market focus for its innovative drug development, moving beyond solely targeting the Chinese market[15]. - The company emphasizes a strategic approach to patent licensing with multinational pharmaceutical companies to capture global market share while retaining rights in China[15]. - The company plans to seek complementary partnerships with international pharmaceutical companies while retaining full rights in the Chinese market[16]. - The collaboration with AbbVie aims to enhance the success rate of candidate drugs by leveraging complementary expertise and resources[40]. - The company is actively exploring combination therapies among its pipeline candidates to enhance clinical value[60]. - The company is exploring partnerships to expand its global market reach and enhance its drug pipeline, including a collaboration with AbbVie[77]. Talent and Management - The company has adopted a plan in August 2021 to attract and retain talent, with a maximum of 10 million shares available for employee incentives[66]. - The company has implemented various incentive and benefit programs for employees, including competitive salaries and bonuses, to attract and retain talent[114]. - The company is committed to providing ongoing education and training programs for employees to enhance their skills and knowledge[113]. - The management continuously monitors foreign exchange risks, as certain cash and cash equivalents are denominated in foreign currencies[111]. - The senior management team includes experienced professionals such as CEO Wang Yinxiang and CFO Wang Xiaojie, both of whom joined the company in July and September 2015, respectively[144]. - The company emphasizes its commitment to R&D, with Senior Vice President Hu Yunyan overseeing research and development since April 2017[144]. - The leadership team is well-versed in both operational and strategic aspects of the pharmaceutical industry, positioning the company for future growth and expansion[135]. Risk Management and Internal Control - The company has established a risk management and internal control system to manage risks associated with achieving business objectives[184]. - The Board is responsible for evaluating and determining the nature and extent of risks the company is willing to take to achieve its strategic objectives[184]. - The company has established a comprehensive internal control framework covering capital, revenue, receivables, costs, payables, R&D expenses, long-term asset management, taxes, contract management, and financial reporting[189]. - As of December 31, 2021, the board reviewed the risk management and internal control systems and deemed them sufficient and effective[189]. - The internal audit team is responsible for independently reviewing the adequacy and effectiveness of the company's risk management and internal control systems[189]. - The company conducts annual self-assessments to ensure compliance with control policies across all departments[189]. - The company has implemented a whistleblowing hotline for employees to report suspicious activities, with investigations initiated by the CEO within one week[193]. - The audit committee evaluates the effectiveness and appropriateness of the anti-corruption policy annually and reports to the board[193]. - The company has adopted a policy for handling and disclosing inside information in accordance with the Securities and Futures Ordinance and Listing Rules[192].
加科思-B(01167) - 2021 - 年度财报