KINTOR PHARMA(09939)
Search documents
开拓药业(09939) - 2020 - 年度财报
2021-04-29 08:38
Drug Development Pipeline - Kintor Pharmaceutical has developed a pipeline of six drug candidates currently in clinical stage[7]. - Proxalutamide (GT0918) is being developed for the treatment of COVID-19, mCRPC, and AR+ metastatic breast cancer[7]. - Pyrilutamide (KX-826) is under development as a potential first-in-class topical drug for androgenic alopecia and acne vulgaris[7]. - ALK-1 (GT90001) is being developed for the treatment of metastatic HCC and various solid tumors, with an exclusive global license obtained from Pfizer in 2018[7]. - Detorsertib (GT0486) is a second-generation mTOR inhibitor being developed for metastatic solid tumors such as breast cancer, prostate cancer, and HCC[7]. - Hedgehog/SMO Inhibitor (GT1708F) is being developed for the treatment of leukemia and BCC[9]. - AR-PROTAC compound (GT20029) is being developed for the treatment of androgenetic alopecia and acne vulgaris[9]. - The company aims to become a leader in the research, development, and commercialization of innovative therapies[7]. - Kintor Pharmaceutical is focused on addressing unmet clinical needs, particularly in AR-related diseases[7]. Clinical Trial Progress - Proxalutamide demonstrated a 100% reduction in hospitalization risk for male COVID-19 patients and a 90% reduction for female patients, with a 92% reduction in mortality for severely infected hospitalized patients[19]. - The company received U.S. FDA approval for Proxalutamide's phase III clinical trial for COVID-19 treatment, completing the first patient enrollment and dosing[19]. - The company is conducting phase II clinical trials for Pyrilutamide in China and has completed phase Ib trials in the U.S.[19]. - The phase II clinical trial of ALK-1 combined with Nivolumab for metastatic HCC in Taiwan showed a positive objective response rate of 40%[19]. - The company completed patient enrollment for Proxalutamide phase II clinical trials for metastatic castration-resistant prostate cancer in the United States[32]. - The company completed patient enrollment for Proxalutamide's phase III clinical trials for mCRPC in China on August 4, 2020[36]. - The company completed patient enrollment for Pyrilutamide (KX-826)'s phase II clinical trial for androgenetic alopecia in China on December 29, 2020[38]. - The clinical trial of Proxalutamide for COVID-19 outpatients in Brazil recorded the first patient enrollment for patients with mild to moderate symptoms on August 20, 2020[36]. - The interim data from the phase II clinical trial of combination therapy of ALK-1 antibody GT90001 and PD-1 monoclonal antibody Nivolumab showed an overall response rate (ORR) of 40.0% among 20 evaluable patients[38]. Financial Performance - Research and development costs increased by 53.6% from RMB214.0 million in 2019 to RMB328.8 million in 2020, primarily due to accelerated clinical trials for Proxalutamide[24]. - The company had cash and cash equivalents of RMB1,389.0 million as of December 31, 2020, with sufficient funds to support ongoing clinical trials and R&D[25]. - Total equity increased significantly from RMB 369.7 million in 2019 to RMB 1,507.9 million in 2020, reflecting robust financial health[30]. - Operating loss for the year was RMB 504.9 million, compared to RMB 228.7 million in 2019, indicating increased expenditures primarily in R&D and administrative expenses[28]. - The company reported an adjusted loss of RMB 459.4 million for the year, up from RMB 220.1 million in 2019, highlighting the impact of increased operational costs[28]. - The company recorded other income of RMB 25.1 million for the year ended December 31, 2020, representing an increase of 32.2% compared to RMB 19.0 million for the year ended December 31, 2019[87]. - The company's total comprehensive loss for the year ended December 31, 2020, was RMB 508.3 million, compared to RMB 232.6 million for the year ended December 31, 2019[87]. Strategic Partnerships and Collaborations - A framework agreement was established with JD Healthcare for the sales and marketing of Pyrilutamide on JD.com Pharmacy, enhancing market presence[32]. - The company entered into a strategic partnership agreement with Hainan Visum Pharmaceutical Limited on April 12, 2021, to expand Proxalutamide manufacturing[79]. - The company has established a partnership agreement with Jiangsu Alphamab Biopharmaceuticals to jointly develop combination therapies for various cancers[64]. Management and Governance - Dr. Youzhi Tong has over 18 years of experience in biopharmaceutical R&D and management, serving as the CEO since May 2018[156]. - The management team includes individuals with extensive backgrounds in investment and consulting, which supports the company's growth strategy[159]. - The Group is committed to high standards of corporate governance to safeguard shareholder interests and enhance corporate value[186]. - The Company has complied with all applicable provisions of the CG Code from the Listing Date to December 31, 2020[186]. - The board comprises three independent non-executive directors, meeting the requirement that they represent at least one-third of the board members[198]. Future Outlook and Growth Strategy - Looking forward to 2021, the company aims to commercialize Proxalutamide for COVID-19 and strengthen both international and domestic cooperation[21]. - The company expects to submit the NDA for Proxalutamide in 2021, with patient enrollment for combination therapy with Abiraterone expected to be completed in 2021[50]. - The company plans to enhance its R&D capabilities and industrialization platform to support future growth and innovation[19]. - The company aims to leverage its expertise in AR-related research to continue clinical development of Pyrilutamide for androgenetic alopecia and acne vulgaris in both China and the United States[151]. - The company plans to utilize its exclusive global license from Pfizer to develop ALK-1 as a potential first-in-class drug, enhancing its drug development capabilities[151].
开拓药业(09939) - 2020 - 中期财报
2020-09-25 09:27
Financial Performance - For the six months ended June 30, 2020, the company reported a loss of RMB 195,447,000, compared to a loss of RMB 98,505,000 in the same period of 2019, representing a 98.5% increase in loss year-over-year [12]. - Adjusted loss for the period was RMB 163,688,000, compared to RMB 95,462,000 in the previous year, reflecting a 71.4% increase [12]. - The company reported a total comprehensive loss of RMB 195.4 million for the six months ended 30 June 2020, compared to RMB 98.5 million for the same period in 2019, reflecting an increase of 98.5% [40]. - The operating loss for the period was RMB 193,462,000, compared to an operating loss of RMB 97,359,000 for the same period in 2019, representing an increase in losses of approximately 98.00% [101]. - The company reported a basic and diluted loss per share of RMB 0.72 for the six months ended June 30, 2020, compared to RMB 0.43 for the same period in 2019, indicating a loss increase of approximately 67.44% [101]. - The net loss for the six months ended 30 June 2020 was RMB 195.4 million, an increase of RMB 96.9 million or 98.4% from RMB 98.5 million in the same period of 2019 [58]. Research and Development - Research and development costs for the first half of 2020 were RMB 148,375,000, up from RMB 89,427,000 in 2019, indicating a 66% increase [12]. - The company is focused on developing potential first-in-class and best-in-class drugs for cancers and other AR-related diseases, indicating a strategic emphasis on innovative drug development [14]. - The drug pipeline includes a diversified portfolio targeting major cancer types and AR-related indications, with substantial market potential [22]. - The company is in the discovery phase for AR degraders aimed at treating prostate cancer and other AR-related diseases [36]. - The R&D platform supports drug development from discovery to clinical trials, ensuring quality standards are met [38]. - The R&D team includes senior scientists with extensive experience in pharmaceutical R&D and entrepreneurship [38]. Clinical Trials and Drug Development - The company’s lead drug candidate, Proxalutamide, is undergoing phase III clinical trials in China and phase II trials in the United States for metastatic castration-resistant prostate cancer (mCRPC) [14]. - Proxalutamide is being developed for metastatic breast cancer in China, with combination therapy planned with Exemestane, Letrozole, and Fulvestrant [22]. - The company commenced phase III clinical trials for Proxalutamide for mCRPC in China in May 2018, with patient enrollment completed by August 4, 2020, and plans to file the NDA application in Q4 2020 [24]. - An open and multi-centre phase Ic clinical trial is being conducted to evaluate Proxalutamide in combination with Exemestane, Letrozole, and Fulvestrant for AR+ metastatic breast cancer, with subject enrollment completed in June 2020 [26]. - Pyrilutamide is an AR antagonist currently in pre-clinical stages, targeting various indications [22]. - The company expects to file an IND for GT20029, a PROTAC targeting prostate cancer and AR-related diseases, in Q4 2020 [22]. Market Potential and Strategy - The population of male patients aged 30 to 70 with androgenetic alopecia in China reached over 92.8 million in 2018, highlighting a significant market potential for AR-related diseases [15]. - The company aims to address major cancer types with large market potential, as indicated by the growth rates of prostate and breast cancer in China [15]. - The company is focusing on expanding its market presence through strategic partnerships and collaborations in drug development [21]. - The company plans to continue advancing the clinical development and commercialization of Proxalutamide in both China and the United States, aiming to expand its indications [99]. Financial Position and Cash Flow - As of June 30, 2020, the company had cash and cash equivalents of RMB 1,792.2 million, an increase of RMB 1,596.6 million from RMB 195.5 million as of December 31, 2019, primarily due to net proceeds from the Global Offering [72]. - The company reported a net cash increase of RMB 1,597,546 thousand in cash and cash equivalents for the six months ended June 30, 2020, compared to a decrease of RMB (75,148) thousand in the same period of 2019 [74]. - The current ratio as of 30 June 2020 was 759.1%, a significant increase from 154.7% as of 31 December 2019 [86]. - The gearing ratio as of 30 June 2020 was 17.3%, down from 33.2% as of 31 December 2019 [86]. - The company reported a net cash used in operating activities of RMB 162,225 for the six months ended June 30, 2020, compared to RMB 89,643 for the same period in 2019 [129]. Administrative and Other Expenses - Administrative expenses increased to RMB 45,016,000 in the first half of 2020 from RMB 12,113,000 in 2019, marking a 271% rise [12]. - Employee benefit expenses surged to RMB 48,930,000 for the six months ended June 30, 2020, up from RMB 18,922,000 in the same period of 2019, reflecting a significant increase of 158% [178]. - Listing expenses increased significantly to RMB 20,761,000 for the six months ended June 30, 2020, compared to RMB 3,043,000 for the same period in 2019, a rise of 582% [178]. - The increase in administrative expenses was also attributed to recruitment-related activities and professional advisory expenses, indicating a strategic focus on enhancing operational capabilities [49]. Revenue and Income - The company reported a total revenue of RMB 4,497,000 for the six months ended June 30, 2020, compared to RMB 4,064,000 for the same period in 2019, reflecting an increase of approximately 10.67% [101]. - The company did not generate any revenue for the six months ended 30 June 2020 and 30 June 2019, resulting in no gross profit recorded during these periods [40]. - Other income rose by RMB 0.4 million or 10.7% from RMB 4.1 million for the six months ended 30 June 2019 to RMB 4.5 million for the six months ended 30 June 2020, mainly due to an increase in interest income from bank balances [44].