Financial Performance - The company reported total losses of RMB 954.4 million and RMB 1,060.8 million for the years ending December 31, 2022, and December 31, 2023, respectively, primarily due to R&D costs and administrative expenses[63]. - The company reported a total comprehensive loss attributable to equity holders of RMB 1,060.8 million for the year ended December 31, 2023, compared to a loss of RMB 954.4 million in the previous year[153]. - For the fiscal year ended December 31, 2023, the company reported a net loss of RMB 1,060,820,000, compared to a net loss of RMB 954,369,000 for the same period in 2022, reflecting an increase in losses of approximately 11.1%[190]. - The basic loss per share for the year ended December 31, 2023, was RMB (2.47), slightly improved from RMB (2.53) in 2022, indicating a reduction in loss per share by 2.4%[190]. - The company recognized a net loss of RMB 29 million due to foreign exchange losses during the reporting period[103]. - The company recorded a loss of RMB 3.1 million in foreign exchange for 2023, compared to a gain of RMB 16.3 million in 2022, indicating a significant shift in foreign exchange performance[185]. Clinical Trials and Drug Development - The company announced the successful completion of the U.S. Phase II clinical trial for KX-826 in treating male pattern hair loss, showing statistically and clinically significant results after 24 weeks of treatment[3]. - The company received approval for the Phase Ib/III clinical trial of KX-826 combined with minoxidil for treating male pattern hair loss in China[4]. - The Phase II clinical trial for GT20029 in treating hair loss has completed enrollment of 180 subjects, with top-line data results expected soon[6]. - GT20029 is the first topical PROTAC compound to enter Phase II clinical trials globally, demonstrating good safety and pharmacokinetic characteristics in previous trials[8]. - KX-826 demonstrated a statistically significant increase of 11.39 hairs per square centimeter compared to placebo after 24 weeks of treatment[14]. - The long-term safety Phase III clinical trial for KX-826 has completed enrollment of 271 male and female hair loss patients, with a treatment duration of 52 weeks[17]. - The KX-826 treatment for male androgenetic alopecia completed a Phase III clinical trial in China, showing a statistically significant increase in hair growth with an average increase of 22.73 hairs/cm² compared to baseline after 24 weeks of treatment (P<0.001)[39]. - The Phase II clinical trial for GT20029, a new generation treatment for hair loss and acne, has shown significant efficacy in promoting hair growth and reducing acne lesions in preclinical studies[46]. - The company is preparing to initiate Phase II clinical trials for GT20029 in treating acne based on positive results from Phase I trials[8]. - The company has developed a pipeline of six clinical-stage drugs, including KX-826 and GT20029, which are progressing through clinical trials in China, the United States, and other regions[36]. - The company is actively seeking commercialization pathways for its core products, with cash reserves expected to support clinical and R&D advancements necessary for product commercialization[27]. - The company is focused on developing a diversified pipeline of drugs to meet substantial clinical demands, with a strong emphasis on AR-targeted therapies[36]. - The company has initiated a long-term safety Phase III clinical trial for KX-826 and a combination trial with minoxidil, aiming to further explore the treatment's efficacy in hair loss[34]. - The company is continuing to explore two core drugs, KX-826 and GT20029, for the treatment of hair loss and acne, with KX-826 showing an average increase of up to 22.7 hairs/cm² in over 1,000 trial participants[199]. - GT20029 is the first topical PROTAC compound to enter Phase II clinical trials globally, with plans to disclose top-line results from the Chinese hair loss Phase II clinical trial soon[199]. Administrative and Operational Expenses - Administrative expenses decreased by RMB 45.8 million or 34.6% to RMB 86.4 million for the year ended December 31, 2023, primarily due to reduced employee compensation and equity incentive costs[1]. - Employee benefits expenses amounted to RMB 38.9 million, representing 43.7% of total administrative expenses, while share-based compensation expenses were RMB 10.7 million, accounting for 12.0%[67]. - Total administrative expenses decreased by RMB 45.8 million or 34.6% to RMB 86.4 million, excluding impairment effects, compared to RMB 132.2 million for the year ended December 31, 2022[68]. - Marketing costs decreased from RMB 203 million in 2022 to RMB 70 million in 2023, a drop of RMB 133 million or 65.5%[110]. - Research and development costs, excluding impairment and write-downs, decreased from RMB 735 million in 2022 to RMB 246 million in 2023, a decline of RMB 489 million or 66.6%[102]. - R&D expenses increased by RMB 110.9 million or 13.4% to RMB 938.9 million for the year ended December 31, 2023, primarily due to inventory impairment provisions and impairment tests on intangible assets[115]. Financial Position and Liquidity - As of December 31, 2023, the company's cash and cash equivalents, along with time deposits, amounted to RMB 456.3 million, with unused bank financing of RMB 110.5 million[27]. - Cash and cash equivalents decreased to RMB 444.0 million as of December 31, 2023, from RMB 864.5 million at the end of the previous year[124]. - The current ratio dropped from 474.0% to 210.3% due to the decrease in cash and cash equivalents and inventory impairment provisions[136]. - The company had no significant investments or acquisitions during the reporting period[123]. - The company's total liabilities decreased from RMB 559.9 million as of December 31, 2022, to RMB 411.1 million as of December 31, 2023[155]. - The company's cash and cash equivalents exceeded total borrowings as of December 31, 2023, indicating a favorable liquidity position[145]. - The company had bank borrowings totaling RMB 83.0 million in long-term loans and RMB 20.0 million in short-term loans as of December 31, 2023[144]. - The company reported a total asset value of RMB 869.2 million as of December 31, 2023, down from RMB 2,055.1 million in 2022, indicating a decrease of approximately 57.7%[176]. - Non-current assets decreased to RMB 396.7 million in 2023 from RMB 547.3 million in 2022, a decline of about 27.5%[176]. - Current assets fell to RMB 472.6 million in 2023, compared to RMB 1,507.9 million in 2022, representing a decrease of approximately 68.7%[176]. - The company had a net liquidity position of RMB 247.8 million as of December 31, 2023, indicating sufficient cash and cash equivalents to meet financial obligations[174]. Corporate Governance and Future Outlook - The board of directors resolved not to declare any final dividend for the year ended December 31, 2023[2]. - The company plans to commercialize core products in the dermatology field through external licensing partnerships[92]. - The company has not commercialized any investigational drugs as of the announcement date[92]. - The company is actively seeking commercialization and overseas collaboration opportunities for GT0918, including regulatory approvals for COVID-19 indications[49]. - The company plans to seek collaboration opportunities across various aspects of drug development, including preclinical technologies and clinical combination therapies, to expedite commercialization[200]. - The company has established an integrated R&D platform to support drug development from discovery to clinical trials[60]. - The company aims to address significant unmet clinical needs in dermatology, particularly in hair loss and acne, which affect millions globally[36].

[Supplementary Announcement to the 2022 Annual Report and 2023 Interim Report](index=1&type=section&id=Supplementary%20Announcement%20to%20the%202022%20Annual%20Report%20and%202023%20Interim%20Report) [Supplementary Information to the 2022 Annual Report](index=1&type=section&id=2022%E5%B9%B4%E5%BA%A6%E5%A0%B1%E5%91%8A%E8%A3%9C%E5%85%85%E8%B3%87%E6%96%99) Details the full utilization of 2,877.3 million HKD from Global Offering and 2021 Placing by Dec 2022, mainly for Proxalutamide and KX-826 development [Use of Proceeds — Global Offering](index=2&type=section&id=%E6%89%80%E5%BE%97%E6%AC%BE%E9%A0%85%E7%94%A8%E9%80%94%20%E2%80%94%20%E5%85%A8%E7%90%83%E7%99%BC%E5%94%AE) Net proceeds of 1,717.3 million HKD from the Global Offering were fully utilized by Dec 2022, mainly for Proxalutamide and KX-826 development Use of Proceeds from Global Offering | Purpose | Percentage of Net Proceeds (%) | Planned Use (million HKD) | Used in 2022 (million HKD) | Used as of December 31, 2022 (million HKD) | | :--- | :--- | :--- | :--- | :--- | | Development and Commercialization of Proxalutamide | 42.0 | 721.3 | 260.8 | 721.3 | | Development and Commercialization of KX-826 | 28.0 | 480.8 | 360.2 | 480.8 | | Clinical Trials for Other Clinical-Stage Drug Candidates | 14.0 | 240.4 | 115.5 | 240.4 | | R&D for Preclinical-Stage Drug Candidates | 6.0 | 103.1 | – | 103.1 | | Working Capital and General Corporate Purposes | 10.0 | 171.7 | – | 171.7 | | **Total** | **100.0** | **1,717.3** | **736.5** | **1,717.3** | [Use of Proceeds — 2021 Placing of Existing Shares and Subscription of New Shares](index=3&type=section&id=%E6%89%80%E5%BE%97%E6%AC%BE%E9%A0%85%E7%94%A8%E9%80%94%20%E2%80%94%202021%E5%B9%B4%E5%85%88%E8%88%8A%E5%BE%8C%E6%96%B0%E9%85%8D%E5%94%AE) Net proceeds of 1,160.0 million HKD from the 2021 Placing were fully utilized by Dec 2022, primarily for Proxalutamide Phase III trials and commercialization preparation Use of Proceeds from 2021 Placing of Existing Shares and Subscription of New Shares | Purpose | Percentage of Net Proceeds (%) | Planned Use (million HKD) | Used in 2022 (million HKD) | Used as of December 31, 2022 (million HKD) | | :--- | :--- | :--- | :--- | :--- | | Proxalutamide International Multi-center Phase III Clinical Trials | 60.0 | 696.0 | 306.9 | 696.0 | | Procurement of Research Materials and APIs for Proxalutamide Commercialization Preparation | 33.0 | 382.8 | 69.9 | 382.8 | | Working Capital for General Corporate Purposes | 7.0 | 81.2 | – | 81.2 | | **Total** | **100.0** | **1,160.0** | **376.8** | **1,160.0** | [Supplementary Information to the 2023 Interim Report](index=3&type=section&id=2023%E4%B8%AD%E6%9C%9F%E5%A0%B1%E5%91%8A%E8%A3%9C%E5%85%85%E8%B3%87%E6%96%99) Details the use of 782.1 million HKD net proceeds from 2022-I and 2022-II Placings as of June 2023, with 344.9 million HKD remaining for utilization by June 2024 [Use of Proceeds — 2022-I Placing of Existing Shares and Subscription of New Shares](index=4&type=section&id=%E6%89%80%E5%BE%97%E6%AC%BE%E9%A0%85%E7%94%A8%E9%80%94%20%E2%80%94%202022-I%E5%85%88%E8%88%8A%E5%BE%8C%E6%96%B0%E9%85%8D%E5%94%AE) Net proceeds of 273.0 million HKD from the 2022-I Placing were fully utilized by June 2023, mainly for Proxalutamide and KX-826 clinical development Use of Proceeds from 2022-I Placing of Existing Shares and Subscription of New Shares | Purpose | Percentage of Net Proceeds (%) | Planned Use (million HKD) | Used for Six Months Ended June 30, 2023 (million HKD) | Used as of June 30, 2023 (million HKD) | | :--- | :--- | :--- | :--- | :--- | | Clinical Development and Commercialization Preparation of Proxalutamide | 75.0 | 204.8 | – | 204.8 | | Clinical Development of KX-826 | 25.0 | 68.3 | 32.3 | 68.3 | | **Total** | **100.0** | **273.0** | **32.3** | **273.0** | [Use of Proceeds — 2022-II Placing of Existing Shares and Subscription of New Shares](index=4&type=section&id=%E6%89%80%E5%BE%97%E6%AC%BE%E9%A0%85%E7%94%A8%E9%80%94%20%E2%80%94%202022-II%E5%85%88%E8%88%8A%E5%BE%8C%E6%96%B0%E9%85%8D%E5%94%AE) Net proceeds of 509.1 million HKD from the 2022-II Placing, with 344.9 million HKD remaining as of June 2023, primarily for KX-826 and GT20029 clinical development Use of Proceeds from 2022-II Placing of Existing Shares and Subscription of New Shares | Purpose | Revised Allocation (%) | Amount (million HKD) | Used for Six Months Ended June 30, 2023 (million HKD) | Used as of June 30, 2023 (million HKD) | Unused as of June 30, 2023 (million HKD) | | :--- | :--- | :--- | :--- | :--- | :--- | | Clinical Development of KX-826 for Androgenetic Alopecia and Acne | 49.0 | 249.5 | 11.3 | 11.3 | 238.2 | | Clinical Development of GT20029 for Androgenetic Alopecia and Acne | 27.0 | 137.5 | 30.8 | 30.8 | 106.7 | | Clinical Development and Commercialization Preparation of Proxalutamide for COVID-19 | 15.0 | 76.4 | 76.4 | 76.4 | – | | General Working Capital | 9.0 | 45.8 | 45.8 | 45.8 | – | | **Total** | **100.0** | **509.1** | **164.3** | **164.3** | **344.9** | - The **unused proceeds** (primarily for the clinical development of KX-826 and GT20029) are expected to be **fully utilized by June 2024**[17](index=17&type=chunk)[18](index=18&type=chunk)

Financial Performance - For the six months ended June 30, 2023, net foreign exchange gains were RMB 827, compared to RMB 13,168 for the same period in 2022, representing a decrease of approximately 93.7%[4] - The company reported a current income tax expense of (507) for the six months ended June 30, 2023, compared to 9 in the same period of 2022, indicating a change in tax provision[7] - The net loss decreased by RMB306.3 million or 59.1% from RMB518.4 million for the six months ended June 30, 2022, to RMB212.1 million for the six months ended June 30, 2023, mainly due to reduced R&D and administrative expenses[35] - For the six months ended 30 June 2023, the company reported a total comprehensive loss of RMB212.1 million, compared to RMB518.4 million for the same period in 2022[114] - The adjusted loss for the same periods, after adding back share-based compensation expenses, was RMB170.3 million for 2023 and RMB468.6 million for 2022[114] - The company did not generate any revenue for the six months ended 30 June 2023 and 2022[114] - The total loss for the reporting period was RMB (212,111,000) in 2023, compared to RMB (518,423,000) in 2022, indicating a significant reduction in losses[127] - Adjusted loss for the period was RMB (170,322,000) in 2023, down from RMB (468,578,000) in 2022[127] Research and Development - The company completed Phase II clinical trials for KX-826 in China, showing a statistically significant increase in hair count of 15.34 hairs/cm² for males and 11.39 hairs/cm² for females compared to placebo after 24 weeks of treatment[14] - The company is actively planning to initiate Phase III clinical trials for KX-826 in female alopecia in the second half of 2023 based on positive Phase II trial data[14] - The company is developing Detorsertib (GT0486) primarily for the treatment of metastatic solid tumors, completing Phase I clinical trials[16] - The company’s pipeline includes a diversified portfolio of drug candidates targeting dermatology and oncology with substantial market potential[11] - R&D costs decreased by RMB296.5 million or 64.3% from RMB461.1 million for the six months ended June 30, 2022, to RMB164.6 million for the six months ended June 30, 2023, attributed to adjustments in core business and ongoing clinical trials for KX-826 and AR-PROTAC (GT20029) for AGA and acne[35] - The company aims to continuously advance clinical trials of core products, including KX-826 and AR-PROTAC, in response to market conditions[35] - As of the report date, the company has seven innovative potential first-in-class/best-in-class drug candidates in phase I-III clinical stages[51] - The company is exploring potential cooperation opportunities for KX-826 and GT20029 to advance commercialization in China and globally[43] Clinical Trials and Drug Development - KX-826 is in phase III clinical trials for male AGA in China, with all 740 subjects enrolled, and top-line data expected in Q4 2023[41] - The phase II clinical trial of KX-826 for acne vulgaris in China has been completed with initial positive results on efficacy and safety[41] - The phase II clinical trial of male AGA in the United States has been completed, showing statistically and clinically meaningful results, with preparations for phase III trials underway[41] - The first patient enrollment in the long-term safety phase III clinical trial of KX-826 in China for AGA treatment was completed on July 19, 2023[51] - The company aims to achieve the first commercialization of KX-826 for hair loss indication on or before 2025[56] - KX-826 is the world's first topical AR antagonist in phase III clinical trial for AGA, with a patent valid until September 8, 2030[64] - The primary endpoint of the phase III trial is the change from baseline in non-vellus TAHC after 24 weeks of treatment compared to placebo[67] - The company expects to release the top-line data of the phase III clinical trial in the fourth quarter of 2023[67] - A phase II clinical trial of KX-826 for the treatment of acne vulgaris has been completed, involving 160 patients, with results showing significant improvement in lesion counts compared to placebo[74] - The safety profile of KX-826 in the acne trial was good, with most adverse events being mild local skin irritation, similar to the placebo group[76] - The phase II clinical trial of GT20029 for treating AGA in China has commenced, with the primary endpoint being the change from baseline in non-vellus TAHC after 12 weeks of treatment[78] - The company is in communication with the U.S. FDA regarding a phase III clinical trial plan for KX-826 based on phase II results[70] - KX-826 is designed to competitively inhibit androgen binding to AR in targeted tissues, addressing significant unmet clinical needs in both AGA and acne vulgaris[74] - GT20029 is the first topical PROTAC compound in the world to enter phase II clinical stage, developed by the company's in-house PROTAC platform[87] Financial Position and Cash Flow - As of June 30, 2023, the Group had cash and cash equivalents of RMB701.9 million and unutilized bank facilities of RMB90.0 million, ensuring sufficient funds for clinical trials and R&D[35] - The operating loss for the six months ended June 30, 2023, was RMB 206.4 million, significantly improved from a loss of RMB 516.1 million in the same period of 2022, indicating a reduction of approximately 60%[167] - Cash and cash equivalents at the end of the period were RMB690.7 million, compared to RMB337.3 million at the end of the same period in 2022[183] - The Group's net current assets were RMB1,064.9 million as of June 30, 2023, indicating sufficient liquidity to meet financial obligations[192] - Cash flows from investing activities generated a net cash inflow of RMB 238,000 for the six months ended June 30, 2023, compared to RMB 42,010,000 in the prior year[198] - The company reported a loss of RMB 212,111,000 for the period, contributing to accumulated losses of RMB 2,935,955,000 as of June 30, 2023[197] - Borrowings increased slightly to RMB 100,600,000 as of June 30, 2023, from RMB 98,900,000 at the end of 2022[196] - The company’s cash flow from operating activities for the six months ended June 30, 2022 was RMB708.1 million, mainly comprising cash used in operations[160] - The company had net cash used in operating activities primarily from government grants, with R&D costs and administrative expenses being the main components[157] Market and Strategic Position - The company has established an integrated R&D platform to support drug development from discovery to clinical stages[111] - The development of AR inhibitors has led to significant expertise in AR-related technology, positioning the company as a leader in the field[111] - The company is exploring other potential drug candidates, including c-Myc inhibitors and bispecific antibodies for various indications[111] - The company has a diversified drug pipeline strategically focused on dermatology and oncology, addressing significant market potential and unmet medical needs[90] - The company has not yet commercialized any drug candidates as of the report date[137] - The Group's financial risk management policies have remained unchanged since December 31, 2022, focusing on minimizing potential adverse effects from market unpredictability[165]

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，概不對因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 本公告載有涉及風險及不明確因素的前瞻性陳述。除過往事實陳述以外的所有陳述均為前瞻 性陳述。該等陳述涉及已知及未知的風險、不明確因素及其他因素，當中部分並非本公司所 能控制，且可導致實際業績、表現或成果與該等前瞻性陳述所明示或暗示者存在重大差異。 閣 下不應依賴前瞻性陳述作為未來事件的預測。本公司概不承擔任何更新或修訂任何前瞻性陳 述的責任，無論是否由於新資料、未來事件或其他因素所致。 開 拓 藥 業 有 限 公 司 * KINTOR PHARMACEUTICAL LIMITED （於開曼群島註冊成立的有限公司） （股份代號：9939） 截至2023年6月30日止六個月之 中期業績公告 本公司董事（「董事」）會（「董事會」）欣然宣佈本集團截至2023 年6月30日止六個 月的未經審核簡明綜合業績，連同截至2022年6月30日止六個月的比較數字。 ...

Drug Development Pipeline - Kintor Pharmaceutical has developed a pipeline of seven drug candidates currently in clinical stages[6] - Pyrilutamide (KX-826) is being developed as a potential first-in-class topical drug for androgenic alopecia (AGA) and acne vulgaris[7] - Pruxelutamide (GT0918) is a second-generation AR antagonist targeting COVID-19, mCRPC, and AR+ metastatic breast cancer[9] - Detorsertib (GT0486) is a second-generation mTOR inhibitor aimed at treating metastatic solid tumors, including breast cancer and prostate cancer[18] - ALK-1 Antibody (GT90001) is being developed for metastatic hepatocellular carcinoma (HCC) and various solid tumors, with an exclusive global license obtained from Pfizer in 2018[19] - PD-L1/TGF-ß (GT90008) is a dual-target antibody with potential applications in treating multiple solid tumors, including non-small cell lung cancer and triple-negative breast cancer[20] - The drug pipeline includes a diversified portfolio targeting significant market needs, including androgenetic alopecia, acne, and COVID-19, with multiple candidates in various clinical stages[86] Clinical Trials and Results - The phase II clinical trials of KX-826 for male and female androgenetic alopecia (AGA) in China reached primary endpoints with positive safety profiles[34] - GT20029 became the first topical PROTAC compound to successfully enter phase II clinical trials globally, with the first subject enrolled in China on April 14, 2023[34] - KX-826 is currently in phase III trials for male AGA in China, with 740 patients enrolled[56] - The phase II clinical trial of KX-826 for acne in China is expected to release top-line data in Q2 2023[56] - The phase II clinical trial for male AGA in the U.S. was completed in under six months amid the COVID-19 pandemic[62] - The phase II clinical trial for Pyrilutamide in China for acne vulgaris completed enrollment of 160 patients by October 2022[64] - KX-826 phase II clinical trial for adult female AGA in China met primary endpoint, showing a statistically significant increase of 11.39 hair counts per cm² after 24 weeks compared to placebo (P=0.0087)[66] - Enrollment for the phase III clinical trial of Pyrilutamide for male AGA in China has been completed with 740 subjects, top-line data expected in Q4 2023[66] - The phase II clinical trial of GT20029 for AGA in China has commenced with the first subject enrolled on April 14, 2023[77] - The phase III clinical trial of Pruxelutamide in combination with Abiraterone for mCRPC in China has enrolled 718 patients, expected to complete in H2 2023 or H1 2024[71] - The phase II clinical trial of Pruxelutamide for Enzalutamide or Abiraterone resistant mCRPC patients in the U.S. is nearing completion[71] - The top-line data for the phase II trial of KX-826 for acne vulgaris in China is expected to be released in Q2 2023[79] - The phase II clinical trial of Pyrilutamide for male androgenetic alopecia in China has reached its predefined endpoints, with 740 patients enrolled in the ongoing phase III trial expected to release top-line data in Q4 2023[81] - The company plans to initiate the phase III clinical trial for female androgenetic alopecia in Q2/Q3 2023 based on positive phase II data[81] - The phase III trial of Pruxelutamide for COVID-19 has been completed with promising results, and the company is seeking conditional approval or EUA from NMPA and Southeast Asian countries[84] Financial Performance and Funding - In 2022, the Company achieved a 7.8% increase in R&D costs, rising from RMB767.9 million in 2021 to RMB828.0 million, primarily due to ongoing phase III clinical trials[47] - The Company raised approximately USD100 million through two capital raisings in 2022, enhancing stock liquidity and providing financial support for R&D[38] - As of December 31, 2022, the Company had cash and cash equivalents totaling RMB875.3 million, including utilized bank facilities of RMB276.5 million and unutilized bank facilities of RMB120.0 million, ensuring sufficient cash for clinical trials and R&D[48] - Total revenue from out-licensing contracts was RMB 34,231,000 in 2021, with no revenue reported in 2022[52] - Other income decreased from RMB 29,311,000 in 2021 to RMB 18,612,000 in 2022, a decline of approximately 36.3%[52] - Research and development costs increased from RMB 767,936,000 in 2021 to RMB 827,974,000 in 2022, representing an increase of about 7.8%[52] - The operating loss widened from RMB 839,601,000 in 2021 to RMB 944,529,000 in 2022, an increase of approximately 12.5%[52] - Total equity decreased from RMB 1,655,158,000 in 2021 to RMB 1,495,188,000 in 2022, a decline of about 9.7%[54] Market Presence and Strategic Goals - The company is focused on addressing unmet clinical needs, particularly in androgen receptor-related diseases[6] - Kintor Pharmaceutical aims to become a leader in the research, development, and commercialization of innovative therapies[6] - The company is committed to expanding its market presence through the development of novel therapies[6] - Future strategies include ongoing research and development of its drug pipeline to meet clinical demands[6] - The company has been recognized for its innovation capabilities, showcasing research results at major academic conferences such as AACR, ASH, and AAD[39] - The company has established a differentiated advantage in dermatology and is advancing innovative therapies in non-dermatological fields, including COVID-19 and prostate cancer[32] - The company is committed to addressing unmet clinical needs and aims to create long-term value for shareholders through innovative therapies[44] - The stock has been included in the MSCI China Index and Shanghai-Hong Kong Stock Connect, reflecting its growing market presence[87] Research and Development Infrastructure - The company has established an integrated R&D platform to support drug development from discovery to clinical stages, ensuring quality standards are met[167] - The manufacturing and R&D facility in Suzhou commenced operations in August 2020, preparing for the production of Pruxelutamide[175] - The Pinghu industrial base's construction officially started in July 2022, marking a significant step in the company's production capabilities[177] - The company has received IND approvals for multiple products, including ALK-1 antibody and PD-L1/TGF-ß dual-targeting antibody, expanding its R&D capabilities in macromolecule drugs[172] Clinical Trial Collaborations and Partnerships - The company is actively seeking collaboration opportunities for Pyrilutamide and GT20029 to expedite commercialization[80] - The company plans to prepare for commercialization through distribution and license-out partnerships, although no drugs have been approved for commercial sale yet[180] - The company is also exploring a Hedgehog/SMO inhibitor, mTOR kinase inhibitor, ALK-1 antibody, and PD-L1/TGF-ß dual targeting antibody in its pipeline[94]

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，概不對因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 本公告載有涉及風險及不明確因素的前瞻性陳述。除過往事實陳述以外的所有陳述均為前瞻 性陳述。該等陳述涉及已知及未知的風險、不明確因素及其他因素，當中部分並非本公司所 能控制，且可導致實際業績、表現或成果與該等前瞻性陳述所明示或暗示者存在重大差異。 閣 下不應依賴前瞻性陳述作為未來事件的預測。本公司概不承擔任何更新或修訂任何前瞻性陳 述的責任，無論是否由於新資料、未來事件或其他因素所致。 開 拓 藥 業 有 限 公 司 * KINTOR PHARMACEUTICAL LIMITED （於開曼群島註冊成立的有限公司） （股份代號：9939） (1) 截至2022年12月31日止年度之 年度業績公告； (2) 建議修訂組織章程大綱及細則； 及 (3) 建議增加法定股本 本公司董事（「董事」）會（「董事會」）欣然宣佈本集團截至2022 年12月31日止年 度的綜合年度業績，連同截至2021年12月31日止年度的比 ...

Financial Performance - No revenue was generated for the six months ended June 30, 2022, and June 30, 2021 [11]. - Adjusted loss increased by RMB168.7 million or approximately 56.3% from RMB299.9 million for the six months ended June 30, 2021, to RMB468.6 million for the six months ended June 30, 2022 [11]. - The company reported a total comprehensive loss of RMB518.4 million for the six months ended June 30, 2022, compared to RMB325.8 million for the same period in 2021, representing a 58.9% increase in losses [88]. - The loss attributable to equity holders for the period was RMB518.4 million, compared to RMB325.8 million in the previous year, indicating a worsening financial performance [151]. - Other income decreased by RMB2.9 million or 27.6%, from RMB10.5 million for the six months ended June 30, 2021, to RMB7.6 million for the same period in 2022 [88]. - The company has incurred operating losses in each year since its inception, with no drugs approved for commercial sale as of June 30, 2022 [88]. Research and Development - R&D costs increased by RMB178.9 million or approximately 63.4% from RMB282.2 million for the six months ended June 30, 2021, to RMB461.1 million for the six months ended June 30, 2022 [11]. - Clinical research expenses accounted for RMB306.1 million or 66.4% of total R&D costs for the six months ended June 30, 2022, compared to RMB158.2 million or 56.1% for the same period in 2021 [105]. - Employee benefit expenses, including share-based compensation, rose to RMB82.9 million or 17.9% of total R&D costs for the six months ended June 30, 2022, from RMB44.3 million or 15.7% in the prior year [105]. - The company has developed a pipeline of seven clinical-stage drug candidates, with approvals for clinical trials in the PRC, the U.S., and other regions [24]. - The company aims to cover indications including COVID-19, mCRPC, AGA, acne vulgaris, HCC, blood cancer, and BCC with its product pipeline [20]. Clinical Trials and Drug Development - On February 10, 2022, the first patient in China was enrolled in the phase III clinical trial of Pruxelutamide for COVID-19 treatment [11]. - The phase III clinical trial of Pruxelutamide in combination with Abiraterone completed enrollment of 718 patients on February 24, 2022 [16]. - Pyrilutamide's phase II clinical trial for male AGA patients in the U.S. completed patient enrollment in less than six months amid the COVID-19 pandemic [16]. - The phase II clinical trial of Pyrilutamide for male AGA patients showed a significant improvement in target area hair counts, with an increase of 22.73 hairs per cm² compared to baseline, P<0.001 [16]. - The first patient in the U.S. was dosed in the multi-regional phase II clinical trial of ALK-1 antibody and Nivolumab combination therapy for advanced HCC on May 2, 2022 [18]. Financial Position and Cash Flow - Cash and cash equivalents decreased from RMB930.1 million as of December 31, 2021, to RMB337.3 million as of June 30, 2022, a decline of RMB592.9 million [124]. - The current ratio fell from 694.4% as of December 31, 2021, to 343.7% as of June 30, 2022, primarily due to decreased cash and increased borrowings [125]. - Net cash used in operating activities for the six months ended June 30, 2022, was RMB708.1 million, an increase from RMB431.8 million for the same period in 2021, reflecting a significant rise in operational expenses [133][136]. - Net cash generated from financing activities was RMB66.6 million for the six months ended June 30, 2022, down from RMB842.2 million in the previous year [131]. - Total current assets decreased from RMB1,525.9 million as of December 31, 2021, to RMB1,176.8 million as of June 30, 2022, primarily due to a reduction in cash and cash equivalents [138][141]. Operational and Administrative Expenses - Administrative expenses rose by RMB15.9 million or 32.1%, from RMB49.6 million for the six months ended June 30, 2021, to RMB65.5 million for the six months ended June 30, 2022 [99]. - Employee benefit expenses, including share-based compensation, accounted for 65.9% of total administrative expenses in the first half of 2022, compared to 63.9% in the same period of 2021 [96]. - Marketing costs increased from RMB6.2 million for the six months ended June 30, 2021, to RMB10.6 million for the same period in 2022, a rise of 71% [90]. - Utilities and office expenses increased to RMB10.6 million, representing 16.3% of total administrative expenses for the six months ended June 30, 2022 [96]. - Depreciation and amortization expenses increased to RMB4.1 million, accounting for 6.3% of total administrative expenses for the six months ended June 30, 2022 [96]. Market and Strategic Initiatives - The company is actively seeking collaboration opportunities in the market from all business perspectives [20]. - The company is focusing on multiple indications for its AR-PROTAC compounds, targeting both male and female androgenetic alopecia and acne vulgaris [24]. - The company is exploring combination therapies for metastatic solid tumors, including those involving PD-1 inhibitors [24]. - The company is committed to advancing its clinical-stage products through ongoing research and development efforts [24]. - The company aims to leverage its clinical trial approvals to enhance its market presence and drive future growth [24].

Drug Development Pipeline - Kintor Pharmaceutical has developed a pipeline of seven drug candidates currently in clinical stage[9] - Pruxelutamide (GT0918) is being developed for the treatment of COVID-19, mCRPC, and AR+ metastatic breast cancer, positioning it as a potential best-in-class drug[9] - Pyrilutamide (KX-826) is under development as a first-in-class topical drug for androgenic alopecia and acne vulgaris[9] - ALK-1 (GT90001) is being developed for metastatic hepatocellular carcinoma and various solid tumors, with an exclusive global license obtained from Pfizer in 2018[9] - PD-L1/TGF-ß (GT90008) is a dual-target antibody with potential in treating various solid tumors, including non-small cell lung cancer and triple-negative breast cancer[13] - Detorsertib (GT0486) is being developed for metastatic solid tumors such as breast cancer and prostate cancer[15] - The company has a diversified product pipeline with 7 new drug projects undergoing clinical research in China, the United States, and other countries[26] - The product pipeline includes a diversified portfolio targeting COVID-19 and major cancer types, with substantial market potential[64] - The company has developed a pipeline of seven clinical-stage drugs, with approvals obtained for clinical trials in China, the U.S., and other regions[70] Financial Performance - The company recorded revenue from out-licensing contracts of RMB34.2 million, generated from upfront payments related to the out-licensing of Pruxelutamide for COVID-19 indications[33] - Research and development costs increased from RMB328.8 million in 2020 to RMB767.9 million in 2021, representing a 133.5% increase, primarily due to three phase III MRCTs of Pruxelutamide for COVID-19 initiated during the reporting period[34] - The operating loss for the year was RMB 839,601,000, compared to RMB 504,851,000 in the previous year, indicating a worsening of approximately 66%[40] - The adjusted loss and total comprehensive loss for the year was RMB 804,748,000, compared to RMB 459,381,000, marking an increase of about 75%[40] - Other income increased to RMB 29,311,000 from RMB 25,134,000, reflecting a growth of approximately 8.7% year-over-year[38] - The total comprehensive loss for the year ended 31 December 2021 was RMB842.1 million, compared to RMB508.3 million for the year ended 31 December 2020[126] - The company has never been profitable and has incurred operating losses in each year since its inception[126] Clinical Trials and Approvals - The company received FDA approval for the phase III clinical trial of Pruxelutamide for treating male COVID-19 patients with mild to moderate symptoms on March 5, 2021[44] - The company is actively pursuing two additional phase III MRCTs for COVID-19 indications, with positive efficacy and safety results reported for the ongoing trials[42] - On June 15, 2021, the pivotal study of Pruxelutamide for COVID-19 outpatients was approved by ANVISA and CONEP in Brazil[45] - On September 1, 2021, the NMPA approved two phase III clinical trials of Pruxelutamide for COVID-19 infections in China, targeting mild to moderate patients and hospitalized patients[48] - The Phase III clinical trial for Pruxelutamide in treating mild to moderate COVID-19 patients enrolled 736 patients, with over 95% from the U.S.[72] - The clinical trial for outpatients has received approvals from regulatory bodies in Brazil and China, with a focus on high-risk populations[74] - The IND application for the pivotal phase III clinical trial of Pyrilutamide for male AGA patients was cleared by NMPA, marking it as the first topical AR antagonist to enter phase III globally[53] - The company has received approval to commence clinical trials for ALK-1 antibody in the U.S. and globally[70] Strategic Focus and Market Position - The company aims to become a leader in the research, development, and commercialization of innovative therapies for unmet clinical needs[8] - Kintor Pharmaceutical is focused on androgen receptor-related diseases, indicating a strategic focus on niche therapeutic areas[10] - The company aims to accelerate the commercialization of Pruxelutamide and increase production capacity reserves[26] - The company has established strategic cooperation with several pharmaceutical companies to enhance its business development capabilities[26] - The company has been included in the Hang Seng Composite Index and Hong Kong Stock Connect, enhancing its market presence[26] - The company is strategically focusing on areas with significant market potential, including AR-related indications[64] Research and Development Investments - Continuous investment in R&D infrastructure and talent is planned to advance clinical-stage drug candidates and pre-clinical development[200] - The company is exploring combination therapy with KN046 for advanced or refractory solid tumors in a phase Ib/II clinical trial[110] - The company is developing additional drug candidates, including c-Myc inhibitors and ALK-1/VEGF bispecific antibodies, in the discovery phase[104] - The company aims to leverage its PROTAC platform for the development of small molecule drugs, including GT20029, and explore innovative drug strategies[200] Cash and Liquidity Management - As of December 31, 2021, the company had cash and cash equivalents of RMB1,055.2 million, indicating sufficient cash to support clinical trials and R&D[35] - The company raised HK$1.16 billion in mid-2021 to support its development after its listing[26] - The company has confirmed no material adverse change in its financial, operational, or trading positions during the reporting period[121] - The Group is exposed to various financial risks, including foreign exchange risk, cash flow and fair value interest rate risk, credit risk, and liquidity risk[184] - Liquidity needs are financed through the issuance of new shares, borrowings, and government grants, with management monitoring liquidity reserves based on expected cash flows[195]

Financial Performance - No revenue was generated for the six months ended June 30, 2021, and June 30, 2020 [12]. - Adjusted loss increased by RMB136.2 million or approximately 83.2% from RMB163.7 million for the six months ended June 30, 2020, to RMB299.9 million for the six months ended June 30, 2021 [12]. - The company has not generated any revenue from drug sales and has incurred operating losses each year since inception, with total comprehensive losses of RMB195.4 million and RMB325.8 million for the six months ended June 30, 2020, and 2021, respectively [96]. - The operating loss for the period was RMB 324,401,000, compared to an operating loss of RMB 193,462,000 for the same period in 2020, indicating a deterioration of 77.9% [168]. - The company reported a total comprehensive loss of RMB (325,821,000) for the period ended June 30, 2021, compared to a loss of RMB (195,447,000) for the same period in 2020, reflecting a worsening financial performance [176]. Research and Development - R&D costs increased by RMB133.8 million or 90.2% from RMB148.4 million for the six months ended June 30, 2020, to RMB282.2 million for the six months ended June 30, 2021 [12]. - Clinical research expenses accounted for RMB158.2 million or 56.1% of total R&D costs for the six months ended June 30, 2021, compared to RMB54.5 million or 36.7% for the same period in 2020 [109]. - The increase in R&D costs was mainly driven by the advancement of clinical trials for Proxalutamide for COVID-19 [114]. - The company has established an integrated R&D platform to support drug development from discovery to clinical trials [75]. - The company is employing PROTAC technology to develop compounds targeting AR and other unmet medical needs globally [78]. Clinical Trials and Product Development - Proxalutamide (GT0918) is being researched for COVID-19 treatment, showing positive effects on patients with mild to moderate symptoms [14]. - Two registered phase III MRCTs for Proxalutamide are being conducted for mild to moderate COVID-19 patients and one for inpatients in multiple regions including the United States and Europe [14]. - Pyrilutamide (KX-826) has met the primary endpoint in its phase II clinical trial for androgenetic alopecia in China, with plans to initiate phase III trials for males and phase II trials for females in Q4 2021 [19][20]. - ALK-1 (GT90001) is undergoing phase II clinical trials in Taiwan and the US for metastatic HCC, with potential for accelerated approval based on favorable data [22][25]. - Proxalutamide is in clinical trials for mCRPC and metastatic breast cancer, with patient enrollment completed on August 25, 2021 [29]. Financial Position and Cash Flow - Cash and cash equivalents increased by RMB167.3 million from RMB1,065.6 million as at 31 December 2020 to RMB1,232.9 million as at 30 June 2021, primarily attributable to net cash proceeds of approximately HK$1.16 billion received from the Subscription [129]. - The company reported net current assets of RMB 1,852.7 million as of June 30, 2021, indicating sufficient liquidity to meet financial obligations and fund R&D activities [166]. - The net cash used in operating activities was RMB431.8 million, compared to RMB162.2 million for the same period in 2020, representing a 166.5% increase [134][135]. - The company generated net cash from financing activities of RMB 842,207,000 for the six months ended June 30, 2021, compared to RMB 1,792,803,000 for the same period in 2020, showing a decline in financing inflows [178]. - The total assets of the company as of June 30, 2021, amounted to RMB 2,400,919,000, an increase from RMB 1,851,475,000 as of December 31, 2020, representing a growth of 29.6% [170]. Regulatory and Licensing - The company has received emergency use authorization (EUA) for Proxalutamide in Paraguay, marking it as the first of its kind globally, and has entered licensing agreements for commercialization in India, 28 African countries, and Indonesia [17][18]. - The company received FDA approval for the Phase III clinical trial of Proxalutamide for treating mild to moderate COVID-19 patients on March 5, 2021, and completed first patient enrollment in the U.S. by April 25, 2021 [41]. - The company announced a licensing agreement with Fosun Pharmaceutical for the commercialization of Proxalutamide in India and 28 African countries on July 14, 2021 [45]. Employee and Administrative Expenses - Administrative expenses increased by RMB4.6 million or 10.2% from RMB45.0 million for the six months ended June 30, 2020, to RMB49.6 million for the six months ended June 30, 2021 [12]. - Employee benefit expenses, including share-based compensation, accounted for RMB31.7 million or 63.9% of total administrative expenses for the six months ended June 30, 2021 [100]. - The increase in administrative expenses was mainly due to new recruitments and annual remuneration adjustments, as well as increased repair and maintenance expenses for self-owned properties [103]. - The company has established a sales and marketing team of 16 members as of June 30, 2021, to prepare for the commercialization of its core products [84]. Market Potential and Strategic Focus - The global patient population for COVID-19 exceeds 220 million, with prostate cancer being the fastest-growing cancer type from 2015 to 2019, and breast cancer being the most common among women in 2019 [23][26]. - The market for androgenetic alopecia includes over 133.7 million patients in China and 83.1 million in the US, highlighting significant commercial potential for the company's products [23][26]. - The drug candidate portfolio strategically targets COVID-19, major cancers, and other AR-related indications, reflecting a risk-balanced and diversified approach [25][28]. - The company is committed to developing its core products for various indications to address unmet clinical needs and contribute to global health [23][26].

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].