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之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部份內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 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) 自願公告 K X- 826 酊 1.0%治療中國成年男性雄激素脫髮 關鍵性臨床試驗 I II 期階段達完成全部患者入組 該項關鍵性臨床試驗是一項多中心、隨機、雙盲、賦形劑對照的 II/III 期適應性設計 研究，用以評估 KX-826 酊 1.0%和 0.5%外用治療中國成年男性 AGA 患者的有效性和 安全性。該 III 期階段試驗在全國 25 家臨床研究中心開展，按照規定的給藥劑量進行 為期 24 周的治療和 2 周的安全觀察，預計在 2026 年初完成 III 期臨床。 - 1 - 香港聯合交易所有限公司證券上市規則第 18A.08(3)條規定的警示聲明：除 826 外用 防脫液和祛痘膏等化妝品產品和化妝品原料外，本公司無法確保將能成功開發及最終 成功 ...

Core Insights - The company, 开拓药业-B (09939), has announced positive top-line data from the Phase II clinical trial of its self-developed KX-826 solution for treating hair loss, achieving primary endpoints with statistical significance and clinical relevance [1][2] Efficacy - The Phase II trial, which included 90 patients, demonstrated significant efficacy for both the 0.5% BID and 1.0% BID groups compared to the placebo group, with the 0.5% BID group showing an increase of 22.39 hairs/cm and the 1.0% BID group showing an increase of 21.87 hairs/cm, while the placebo group showed an increase of only 8.73 hairs/cm [1] - The 0.5% BID group had a statistically significant increase of 13.66 hairs/cm over the placebo (P=0.002), and the 1.0% BID group had an increase of 13.14 hairs/cm over the placebo (P=0.004) [1][2] - Hair Growth Assessment (HGA) metrics also showed significant improvement for both treatment groups compared to the placebo, with the 0.5% BID group showing statistical significance (P=0.000) and the 1.0% BID group also showing significance (P=0.013) [2] Safety - KX-826 demonstrated satisfactory safety and tolerability in the clinical trial, with a low incidence of adverse events and no reports of drug-related sexual dysfunction or new safety signals [2] - The Independent Data Monitoring Committee (IDMC) reviewed the results and recommended that the Phase III clinical trial continue based on the current safety and efficacy data, maintaining the same groups and sample sizes [2]

Investment Rating - The report maintains a "Strong Buy" rating for the pharmaceutical industry, indicating a positive outlook for investment opportunities [3]. Core Insights - The new centralized procurement regulations emphasize "stability in clinical use, quality assurance, prevention of collusion, and countering excessive competition," which are expected to promote the long-term healthy development of the industry [2][32]. - The report suggests focusing on recently launched innovative products, high-quality raw material suppliers, and key products that have passed the consistency evaluation for generic drugs [2][32]. Summary by Sections Market Review - The pharmaceutical and biotechnology index increased by 4% this week, outperforming the CSI 300 index by 2.91 percentage points, ranking second in industry performance [11]. - Year-to-date, the pharmaceutical and biotechnology index has risen by 16.59%, also surpassing the CSI 300 index by 13.45 percentage points [11]. - The chemical pharmaceutical sector showed the highest growth this week at 6.86%, while traditional Chinese medicine had the lowest decline at 0.88% [16][18]. Individual Stock Performance - In the A-share market, 397 out of 474 pharmaceutical stocks rose, with the top five performers being: - Borui Pharmaceutical (+42.35%) - Lisheng Pharmaceutical (+41.68%) - Nanxin Pharmaceutical (+34.95%) - Aosai Kang (+32.77%) - Yipin Hong (+32.13%) [22]. - In the Hong Kong market, 96 out of 106 pharmaceutical stocks increased, with the top performers including: - Clover Biopharma-B (+63.79%) - Lepu Biopharma-B (+62.04%) - Deqi Pharmaceutical-B (+47.04%) [25]. Industry News and Policies - The 11th batch of national centralized drug procurement was officially launched, including 55 varieties across various therapeutic areas, focusing on clinical needs and market realities [28]. - The new procurement rules are more refined, requiring production experience and quality control capabilities from manufacturers, which will help ensure drug quality and promote industry standardization [28]. - The establishment of the "Commercial Insurance Innovative Drug Directory" marks a significant step in building a multi-tiered medical security system, providing new economic support for innovative drug development [28]. Key Company Announcements - Heng Rui Pharmaceutical reported positive results from its GLP-1/GIP dual receptor agonist HRS9531 in a Phase III weight loss study, with an average weight reduction of 19.2% in the treatment group [29][31]. - The report highlights various corporate actions, including stock incentive plans and capital increases by several companies, indicating active corporate governance and strategic investments in the sector [36].

Core Viewpoint - After three consecutive years of stock price decline, Kintor Pharmaceutical (09939) appears to have found a way out in 2025, with a year-to-date stock price increase of 156.70% [1] Group 1: Stock Performance - Kintor's stock price has shown significant fluctuations, with notable increases in February (24.72%), March (17.12%), May (20.00%), and July (66.23%) [1] - Despite the recent gains, Kintor's stock price remains under pressure due to its exclusion from the Hong Kong Stock Connect, leading to a decline of over 40% last year [1][4] - The average trading volume of Kintor's stock has been below 1 million shares per day, indicating liquidity issues typical for small-cap companies [1] Group 2: Hong Kong Stock Connect Impact - Following its removal from the Hong Kong Stock Connect, Kintor's stock price dropped significantly, with an average decline of 24% among 27 stocks removed during the same period [4] - The proportion of Kintor's shares held by Hong Kong Stock Connect investors has decreased from approximately 35% to 24.16% over the past year [4][5] - Investors are concerned that the concentration of holdings may lead to increased selling pressure as the stock price rises [3] Group 3: Clinical Developments and Market Potential - Kintor's core product, KX-826, faced challenges in its Phase III clinical trials, but the company continues to pursue market expansion for the product [11] - The global hair loss treatment market was valued at $8.2 billion in 2022 and is expected to grow at a CAGR of 9.0%, reaching $16.02 billion by 2030 [12] - In China, the hair loss treatment market is projected to reach 15.5 billion yuan by 2031, with a CAGR of 32% from 2021 to 2031 [12] Group 4: Recent Clinical Trial Results - Recent clinical trials showed that KX-826 combined with minoxidil demonstrated statistically significant efficacy compared to minoxidil alone, with a notable increase in hair count [16] - The safety profile of the combination treatment was favorable, with no unexpected adverse events reported [16] - Kintor's strategy of entering the beauty market with KX-826 has matured, showing potential for scalable commercialization [17] Group 5: Valuation and Future Outlook - Kintor's current price-to-book (PB) ratio is 3.62, below the average for the biopharmaceutical industry and significantly lower than the beauty industry's 7.73 [17] - If Kintor's valuation aligns more closely with the beauty sector, there may be substantial upside potential for the company's stock price [17]

Group 1 - The Hong Kong biopharmaceutical stocks continue to show strong performance, with notable increases in share prices [1] - Clover Biopharmaceuticals (02197.HK) surged nearly 24%, while Innovent Biologics (09939.HK) rose over 20% [1] - Lepu Biopharmaceutical (02157.HK) and HeartCare Medical (02160.HK) both increased by over 10%, and Kelun-Biotech (06990.HK) saw a rise of more than 8.5% [1]

Group 1 - The core viewpoint of the article highlights the strong performance of Hong Kong pharmaceutical stocks, particularly China Biologic Products, which saw a significant increase of 13.84% [1] - Other notable gainers in the pharmaceutical sector include Akeso, Inc. with a rise of 7.14%, and Wondfo Biotech, which increased by 4.43% [1] - The overall trend indicates a positive sentiment in the pharmaceutical industry within the Hong Kong stock market [1]

Group 1 - The majority of Hong Kong pharmaceutical stocks showed strength, with notable increases in share prices [1] - Innovent Biologics (01801.HK) surged nearly 15%, indicating strong market performance [1] - Zai Lab (09939.HK) rose over 7%, reflecting positive investor sentiment [1] - CSPC Pharmaceutical Group (01093.HK) increased by more than 5%, contributing to the overall upward trend [1] - China Biologic Products (01177.HK) saw a rise of over 4%, further highlighting the strength in the sector [1]

Core Insights - The company has achieved a significant milestone with its topical androgen receptor antagonist KX-826 in treating male pattern hair loss, meeting the primary endpoint in clinical trials, leading to a 9.17% stock price increase [1] - The company has launched global sales for its skin-whitening and spot-removing cosmetic ingredient KT-939, which has been recognized as a key component in the 2025 NYSCC Inspiration Hive exhibition [1][14] - The company has seen a year-to-date stock increase of 47.42% as of May 22, indicating strong market interest and performance [1] Group 1: KT-939 Competitive Edge - KT-939 has a diverse mechanism for skin whitening, including inhibiting melanin production and promoting its removal, positioning it favorably against competitors [4][6] - The core technological barrier of KT-939 lies in its "precise targeting" and "high efficiency," with a potency significantly higher than existing ingredients [7][8] - The ingredient's safety profile is enhanced by its low dosage requirement, which minimizes potential skin irritation compared to traditional agents [8] Group 2: Global Expansion Strategy - The company aims to penetrate international markets with KT-939, focusing on compliance and market competition through a B2B and B2C strategy [11][12] - The regulatory landscape varies globally, with KT-939 already progressing through necessary approvals in multiple regions [12][13] - The company is targeting partnerships with raw material suppliers and cosmetic brands to enhance market reach and sales [13][14] Group 3: KX-826 Clinical Value and Commercial Path - KX-826 has shown superior results in clinical trials compared to minoxidil, addressing a significant market need in androgenetic alopecia treatment [17][18] - The global market for hair loss treatments exceeds $100 billion, presenting a substantial opportunity for KX-826 [17] - The product's differentiation lies in its non-hormonal mechanism and synergistic effects when used with minoxidil [18][19] Group 4: Strategic Transformation Logic - The company's shift from a single drug focus to a diversified model of "topical drugs + functional cosmetic ingredients + cosmetic products" is a proactive response to market trends [24][25] - The company emphasizes its commitment to the androgen receptor target area, leveraging its technological advancements to drive growth [24][25] - The strategic focus on skin health and cosmetic applications is seen as a sustainable path amid challenges in the biotech sector [25][26] Group 5: Milestones for Sustainable Profitability - Key milestones for achieving sustainable profitability include the commercialization of KT-939 and KX-826, with expectations for significant progress within the next year [28][29] - The company is optimistic about the B2B model's potential to stabilize revenue and expand customer resources [29] - The anticipated results from the Phase III trial for KX-826 are expected to enhance the company's market position and brand recognition [29] Group 6: Long-term Strategic Goals - The company aims to establish a leading position in the global healthcare market over the next 3-5 years through innovative partnerships and product commercialization [30][31] - The focus is on leveraging patented technologies and addressing global health challenges with Chinese innovations [31][32] - The company envisions KT-939 and KX-826 as pivotal products that will enhance its competitive edge in the international market [32]

Core Viewpoint - The announcement by the company regarding the clinical trial of KX-826 combined with minoxidil for treating androgenetic alopecia (AGA) in adult males in China indicates a significant advancement in the treatment's efficacy and safety profile, paving the way for future Phase III trials [1][4]. Group 1: Clinical Trial Overview - The clinical trial is an open-label, randomized controlled study aimed at evaluating the effectiveness and safety of KX-826 combined with minoxidil for AGA treatment [1][2]. - The trial has reached its primary endpoint, with results indicating a statistically significant efficacy advantage for the combination therapy compared to minoxidil alone [1][2]. Group 2: Efficacy Results - After 24 weeks, the combination therapy group showed an increase of 30.54 hairs/cm² in target area hair count (TAHC) compared to baseline, while the minoxidil group showed an increase of 10.29 hairs/cm², with a p-value of 0.0075 indicating statistical significance [2]. - The number of patients with a TAHC change of ≥20 hairs/cm² was 30 in the combination group versus 19 in the minoxidil group, and for ≥40 hairs/cm², there were 10 in the combination group versus 1 in the minoxidil group [2][3]. Group 3: Safety Profile - The combination therapy demonstrated good safety and tolerability, with no unexpected adverse events reported during the trial [3][4]. - Adverse events were comparable between the two groups, indicating that the combination therapy does not introduce additional safety concerns [3]. Group 4: Mechanism of Action - KX-826 operates through a differentiated mechanism compared to minoxidil, with both targeting the androgen microenvironment, which has been clinically validated for hair regrowth efficacy [4]. - The synergistic effect of the combination therapy is expected to significantly enhance treatment outcomes for AGA, potentially expanding the patient benefit population [4].

Drug Development and Clinical Trials - Kintor Pharmaceutical has five innovative drug candidates in phase I-III clinical stages, focusing on unmet clinical needs in dermatology and oncology[5]. - Kintor's drug candidates include KX-826 (AR antagonist), GT20029 (AR-PROTAC compound), GT1708F (Hedgehog/SMO inhibitor), GT0486 (PI3K/mTOR inhibitor), and ALK-1 antibody (anti-angiogenesis inhibitor)[6][7][8][9][10]. - The Group plans to complete the phase III clinical trial of KX-826 tincture 1.0% for male adult AGA treatment in China by the end of 2025[32]. - The phase II clinical trial for GT20029 for acne treatment in China is expected to be completed in the second half of 2025[32]. - The phase Ib/III clinical trial of KX-826 in combination with minoxidil for treating male adults with AGA was cleared by NMPA on February 1, 2024[51]. - The clinical trial of KX-826 tincture 1.0% for treating male adult AGA received clearance by NMPA on May 24, 2024, with preclinical studies showing increased retention concentration compared to the previous formulation[51]. - The phase IIa clinical trial of AR-PROTAC compound GT20029 for AGA treatment reached its primary endpoint with significant results on April 21, 2024[53]. - The pivotal phase II/III clinical trial of KX-826 tincture 1.0% for AGA treatment completed the first subject enrollment on October 16, 2024, with the trial expected to be completed by the end of 2025[55]. - The long-term safety phase III clinical trial of KX-826 tincture for AGA treatment achieved its primary endpoint with excellent safety and efficacy results announced on March 20, 2025[55]. - The Company completed the first subject enrollment in the phase II clinical trial of AR-PROTAC compound GT20029 for acne treatment in China on June 17, 2024[56]. - The phase II clinical trial of KX-826 for acne treatment in China involved 160 patients, with treatment success observed in all experimental groups by week 12[97]. - The phase II clinical trial for female AGA in China showed clinically meaningful and statistically significant improvement in hair growth[84]. - The phase II clinical trial for male AGA in the U.S. demonstrated statistically and clinically meaningful results after 24 weeks[84]. - The phase IIa clinical trial of GT20029 for AGA in China reached its primary endpoint, demonstrating statistically significant results and good safety and tolerability[109]. - The phase I clinical trial in the U.S. for GT20029 showed no systemic exposure at all dose levels, with maximum observed concentrations not exceeding 0.015 ng/mL after 14 days of administration[106]. - The phase I clinical trial in China for GT20029 included 92 healthy subjects, with no detectable drug concentrations after single dose administration and maximum concentrations below 0.05 ng/mL after multiple doses[105]. - GT1708F has completed phase I clinical trials for hematologic malignancies in China and received conditional approval for phase II trials for idiopathic pulmonary fibrosis (IPF)[71]. - The phase I clinical trial of GT1708F for hematologic malignancies included 18 patients, with preliminary efficacy observed starting from the 180mg dose level, showing a reduction of myeloid blasts by up to 62% in AML patients[119]. - The ALK-1 antibody (GT90001) has shown a 40% partial remission rate among 20 evaluable patients in a phase II trial for advanced HCC[124]. - The combination therapy of ALK-1 antibody and Nivolumab demonstrated a good safety profile and promising anti-tumor activity in advanced HCC patients, with durable remissions reported[127]. - GT0486, a second-generation mTOR inhibitor, has received IND approval and completed phase I clinical trials for metastatic solid tumors[128]. Financial Performance - The Group's revenue increased from RMB0 million for the year ended 31 December 2023 to RMB5.0 million for the year ended 31 December 2024, primarily due to global sales of the new high-end cosmetics brand KOSHINÉ[36]. - The Group's net loss decreased by RMB905.5 million or 85.4% from RMB1,060.8 million for the year ended 31 December 2023 to RMB155.3 million for the year ended 31 December 2024, mainly due to a reduction in R&D costs[37]. - R&D costs decreased by RMB860.8 million or 91.7% from RMB938.9 million for the year ended 31 December 2023 to RMB78.1 million for the year ended 31 December 2024, attributed to lower provisions for R&D related inventories and a focus on core dermatology pipelines[38]. - Administrative expenses decreased by RMB27.2 million or 30.6% from RMB89.0 million for the year ended 31 December 2023 to RMB61.8 million for the year ended 31 December 2024, mainly due to reduced employee benefit expenses[39]. - Marketing costs increased by RMB19.6 million or 280.3% from RMB7.0 million for the year ended 31 December 2023 to RMB26.6 million for the year ended 31 December 2024, primarily due to increased marketing and promotion expenses for the cosmetics business[40]. - For the year ended December 31, 2024, the company reported revenue from contracts with customers of RMB 5 million, a gross loss of RMB 4.73 million, and an operating loss of RMB 144.57 million[46]. - The company's total equity decreased to RMB 294.08 million as of December 31, 2024, down from RMB 458.11 million in 2023[47]. - The total comprehensive loss for the year ended December 31, 2024 was RMB155.3 million, a decrease from a loss of RMB1,060.8 million for the year ended December 31, 2023[154]. - The cost of sales for the year ended December 31, 2024 was RMB9.7 million, significantly lower than RMB42.2 million for the year ended December 31, 2023[159]. - Other income increased by RMB1.1 million or 5.2% from RMB20.9 million for the year ended December 31, 2023 to RMB21.9 million for the year ended 31 December 2024, mainly due to a RMB9.0 million increase in government grants[160]. - The adjusted loss for the year ended December 31, 2024, was RMB 164.4 million, compared to RMB 1,037.8 million for the year ended December 31, 2023[192]. - Cash and cash equivalents and time deposits decreased by RMB 308.9 million or 67.7% from RMB 456.3 million as of December 31, 2023, to RMB 147.4 million as of December 31, 2024[199]. - The current ratio decreased from 210.3% as of December 31, 2023, to 103.0% as of December 31, 2024, mainly due to the decrease in cash and cash equivalents[200]. - The Group utilized bank facilities of RMB 14.4 million and had unutilized bank facilities of RMB 35.6 million as of December 31, 2024[200]. - The company renewed a bank credit quota of RMB70 million in March 2025 and has drawn a bank loan of RMB35 million[158]. - The company is actively seeking equity financing and is in discussions with potential investors regarding subscriptions for new shares[158]. - The company has implemented measures to alleviate liquidity pressure, including renewing bank credit quotas, equity financing, and expanding cosmetics sales channels[72]. Product Development and Commercialization - The company is developing KX-826 and GT20029 as core products for treating androgenic alopecia (AGA) and acne vulgaris, aiming to establish a product matrix in anti-hair loss, acne treatment, and skin whitening[27]. - Kintor launched a new high-end cosmetics brand, KOSHINÉ, marking its transition from R&D to commercialization[27]. - The strategic pivot includes a twin-track strategy focusing on functional cosmetics and innovative topical drugs, enhancing the company's market presence[27]. - The Group aims to accelerate the launch of new cosmetic products and deepen collaborations with leading e-commerce platforms to enhance market penetration[32]. - The Company launched its new high-end cosmetics brand KOSHINÉ on July 10, 2024, with KX-826 as the main ingredient, expected to provide stable revenue and cash flow[55]. - A total of six products have been launched under the KOSHINÉ brand, including anti-hair loss solutions and acne cream, with new products expected in early 2025[61]. - The Company has established a multi-channel digital marketing strategy for its cosmetics business, focusing on both traditional and emerging e-commerce platforms[62]. - The official launch of the topical anti-hair loss solution under the new high-end cosmetics brand KOSHINÉ is expected to provide a solid stream of revenue and cash flow to the Group[90]. - The company is expanding its overseas sales channels, focusing on platforms like Amazon USA to meet global consumer needs[65]. - The company is prioritizing the development of topical compounds based on its PROTAC platform, with GT20029 being the first topical PROTAC compound globally to complete phase IIa clinical stage for AGA[141]. - The company is actively seeking opportunities to accelerate the commercialization of various pipelines both in China and globally[71]. - The company has launched a topical anti-hair loss solution containing KX-826 under its high-end cosmetics brand KOSHINÉ, marking its first commercial sale in dermatology[146]. - The company expects to submit a NDA for KX-826 to the NMPA in 2026, aiming for commercialization by 2027 if successful[150]. - The company plans to allocate more resources to enhance its commercialization capabilities and increase product penetration rates[147]. Research and Development - The company has established an integrated R&D platform to support drug development from discovery to clinical stages[137]. - The R&D work is led by experienced scientists with decades of expertise in pharmaceutical R&D and entrepreneurship[145]. - Employee benefit expenses (including share-based compensation) for R&D decreased by RMB81.7 million, mainly due to a reduction in R&D staff[176]. - Clinical research expenses decreased by RMB73.0 million due to the suspension or hold of one or more clinical trials related to other drug candidates[176]. - R&D costs for the two core products KX-826 and GT20029 accounted for RMB61.0 million, representing nearly 80% of total R&D expenditures during the Reporting Period[177]. - The decrease in R&D costs was mainly due to a reduction of RMB603.9 million in provision for inventories, as no provision for R&D-related inventories was recognized in the Reporting Period[180]. - The company warns that it may not be able to successfully develop and market its drug candidates, except for KX-826 for hair loss[136]. Market and Competitive Position - The product pipeline includes drug candidates targeting significant unmet medical needs, particularly for AGA and acne, affecting hundreds of millions of patients worldwide[75]. - The company has a diversified portfolio of drug candidates in various clinical stages, with significant potential for commercialization in multiple disease areas[75]. - The company owns patents for KX-826 in multiple countries, enhancing its market position[82]. - KX-826 is a targeted topical AR antagonist, addressing significant unmet clinical needs for acne vulgaris treatment in China[95][96]. - KX-826's low AR inhibitory activity in its metabolites helps reduce systemic side effects[80]. - The core patent for KX-826 is valid until September 8, 2030, with ongoing development for tincture and gel formulations[82]. - The company is exploring other potential drug candidates, including ALK-1/VEGF bispecific antibodies for treating blood cancers and solid tumors[135]. - The c-Myc molecular glue has significant R&D potential, with studies published in high-impact journals, indicating its potential in tumor treatment[129].