开拓药业(09939) - 2025 - 中期业绩

Announcement Summary Financial Highlights H1 2025 revenue reached RMB 6.0 million from cosmetics sales, but net loss widened by 16.5% to RMB 83.3 million, driven by increased R&D and marketing expenses H1 2025 Financial Highlights | Metric | For the six months ended June 30, 2025 (RMB million) | For the six months ended June 30, 2024 (RMB million) | Change (RMB million) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | 6.0 | 0.0 | 6.0 | N/A | | Net Loss | (83.3) | (71.5) | (11.8) | 16.5% | | R&D Costs | (48.6) | (39.3) | (9.3) | 23.6% | | Administrative Expenses | (25.2) | (33.9) | 8.7 | (25.6%) | | Marketing Costs | (8.3) | (1.8) | (6.5) | 369.0% | | Cash and Cash Equivalents (End of Period) | 52.9 | - | - | - | - The Board resolved not to declare any interim dividend for the six months ended June 30, 2025[3] R&D Milestones and Achievements The company's core dermatological pipelines, KX-826 and GT20029, achieved positive clinical progress in alopecia and acne indications, while new raw material KT-939 also launched global sales, forming a 'three-pronged' business model KX-826 KX-826 topical solution for Chinese alopecia showed positive topline data in long-term safety Phase III, combination therapy observation, and pivotal Phase II trials, demonstrating excellent safety and efficacy; Phase III has enrolled 666 patients, expected to complete by early 2026 - KX-826 topical solution for Chinese alopecia's long-term safety Phase III clinical trial achieved topline data, meeting primary endpoints with statistically significant and clinically meaningful results, demonstrating excellent safety and efficacy[4] - The clinical observation study of KX-826 combined with minoxidil for Chinese adult male alopecia met its primary endpoint, aiming to optimize future formal Phase III clinical trial design[4] - KX-826 topical solution 1.0% for alopecia's pivotal Phase II clinical trial achieved topline data, meeting primary endpoints with statistically significant and clinically meaningful results, demonstrating excellent efficacy and safety[4] - KX-826 topical solution 1.0% for alopecia's pivotal Phase III clinical trial has completed enrollment of 666 patients, expected to finish by early 2026[4] AR-PROTAC Compound (GT20029) GT20029 gel for acne's China Phase II clinical trial reported topline data, successfully meeting primary endpoints with excellent efficacy, safety, and PK characteristics, and determined the recommended Phase III dose at 0.5% - AR-PROTAC compound GT20029 gel for acne's China Phase II clinical trial reported topline data, successfully meeting primary endpoints with excellent efficacy, safety, and PK characteristics, and determined the recommended Phase III dose at 0.5%[5] New Raw Material (KT-939) KT-939, a whitening and spot-reducing cosmetic active ingredient, completed its first sale, marking the launch of the company's B2B active cosmetic ingredient business and forming a 'three-pronged' business model - KT-939 as a whitening and spot-reducing cosmetic active ingredient completed its first sale, marking the launch of global sales for active ingredients[6] - The company has formed a 'three-pronged' business model encompassing B2B active cosmetic ingredient business, B2C active cosmetic product business, and topical innovative drug R&D business[6] Management Discussion and Analysis Business Overview The company is a clinical-stage innovative drug enterprise focused on dermatology and functional cosmetics, with 5 drug candidates in Phase I-III clinical trials; its cosmetics business complements drug R&D by providing funding and market data, with core products KX-826 and GT20029 advancing to Phase II/III and Phase II, respectively, and the high-end cosmetics brand KOSHINÉ launched in H2 2024 - The company is a clinical-stage innovative drug enterprise in China focused on addressing unmet clinical needs and extending into functional cosmetics[7] - The cosmetics business provides funding for drug R&D activities and market data for future drug sales strategies[7] - The company has 5 potential first-in-class/best-in-class drug candidates in Phase I-III clinical stages, with a pipeline primarily covering dermatological (e.g., alopecia, acne) and oncology indications[7] - In H2 2024, the company officially launched sales of its new high-end cosmetics brand KOSHINÉ, with a total of eight products currently on the market, including anti-hair loss liquid series, anti-acne cream, and whitening series[8] - The company has developed a multi-channel digital marketing strategy, expanding to traditional e-commerce platforms like Tmall and JD.com, actively deploying on emerging content-driven e-commerce platforms like Douyin and Xiaohongshu, and also expanding global sales channels such as Amazon US[8][9] Corporate Strategy and Product Pipeline The company's strategy focuses on dermatology and functional cosmetics, aiming to develop first-in-class/best-in-class drugs to address unmet clinical needs; the cosmetics business supports drug R&D with funding and market insights, with 5 drug candidates in Phase I-III clinical trials, and core products KX-826 and GT20029 in Phase II/III - The company is committed to becoming a leader in the research, development, and commercialization of innovative therapies and high-end cosmetics[7] - The pipeline primarily covers dermatological (e.g., alopecia, acne) and oncology indications, with cosmetic categories including anti-hair loss, anti-acne, and whitening products[7] - Two core products, KX-826 and GT20029, have advanced to Phase II/III and Phase II clinical trials, respectively[7] Cosmetics Business Development and Marketing Strategy Since H2 2024, the company officially launched sales of its high-end cosmetics brand KOSHINÉ, with eight products already on the market; through outsourced production and prioritizing online sales channels, the company implements multi-channel digital marketing strategies, including traditional e-commerce platforms and content-driven platforms, and actively expands into overseas markets like Amazon US, to enhance brand awareness and market penetration - The KOSHINÉ brand has launched eight products, including anti-hair loss liquid series, anti-acne cream, and whitening series, with the KX-826-based anti-acne cream and KT-939-based whitening series launched in early 2025[8] - The company outsources cosmetics production, prioritizes online sales channels, and has developed a multi-channel digital marketing strategy[8] - Through data-driven precise advertising, conversion rates on major platforms like Tmall Global, Douyin Flagship Store, and JD Worldwide have significantly improved[9] - The company highly values fostering deep consumer interaction on high-quality content platforms like Xiaohongshu and WeChat, achieving a closed-loop marketing model of 'content seeding—brand cultivation—sales conversion'[9] Core Products and R&D Progress The company deeply focuses on AR targets in dermatology, with core products KX-826 and GT20029 achieving multiple positive clinical advancements in alopecia and acne indications, including completing several Phase II/III clinical trials and obtaining topline data; concurrently, other pipeline products such as GT1708F, ALK-1 antibody, GT0486, and c-Myc molecular glue have also progressed in oncology and other disease areas, and new raw material KT-939 has initiated commercialization - The company possesses a risk-balanced and diversified portfolio of drug candidates, committed to addressing numerous unmet clinical needs with significant market potential[13] - The company has developed 5 clinical-stage drugs and 1 new raw material, obtaining clinical trial approvals in China (including Taiwan), the US, and other countries and regions[14] KX-826 (AR Antagonist) KX-826 is a topical AR antagonist that treats alopecia and acne by blocking the AR signaling pathway, holding patents globally; for alopecia, several China and US clinical trials showed excellent safety, efficacy, and statistical significance, with China's Phase III trial completing patient enrollment; for acne, China's Phase II trial demonstrated preliminary efficacy and good safety - KX-826 is a topical drug that blocks the AR signaling pathway, reducing the sensitivity of AR in hair follicles and sebaceous glands to androgens, thereby minimizing systemic side effects[14] - The company holds patents for KX-826 in multiple countries globally and in China, with the core patent valid until September 8, 2030