2025.08. 18 本文字数：1207，阅读时长大约2分钟 作者 | 第一财经 林志吟 "白癜风是一种多基因、无明确靶点、多因素引发的自身免疫疾病，患者就诊时常表示'只要不再发展 就好'，可见疾病难治。"近日，在创新免疫治疗临床转化研究高峰论坛，杭州市第三人民医院皮肤病 研究所所长许爱娥讲述了白癜风患者当前面临的治疗困局。 白癜风被认为是由自身反应性T细胞破坏皮肤、黏膜或毛囊的黑素细胞所致，其特征是皮肤色素脱 失，并且可能出现在身体的任何部位，这种毁容性皮肤病，因反复发作和高复发率，给患者心理与社 会生活带来了沉重负担。 许爱娥说，临床主要采用外用糖皮质激素、钙调磷酸酶抑制剂等药物开展治疗，这类药物仅能抑制免 疫反应，既不能精准复色（指通过治疗或自身恢复，使白斑区域重新产生黑色素并恢复正常肤色的过 程），也无法阻止复发。外用糖皮质激素三个月以上可能出现皮肤萎缩、青春痘、毛囊炎等副作用。 2022年，美国FDA批准了JAK抑制剂芦可替尼乳膏可用于局部治疗12岁及以上患者的非节段型白癜 风，这是美国批准使用的第一种也是唯一一个复色疗法，但该药尚未在中国上市。与此同时，该药还 无法面向12岁以下的白癜风儿童患者 ...

Core Viewpoint - The treatment of vitiligo in China is currently limited and lacks effective drugs, with a significant patient population facing challenges in management and treatment options [1][3]. Group 1: Disease Overview - Vitiligo is an autoimmune disease characterized by the destruction of melanocytes, leading to skin depigmentation, and affects 1% to 3% of the global population, with approximately 30 million patients in China [1][3]. - A significant portion of patients (63.4%) experience onset before the age of 20, and 75% of patients suffer from anxiety and depression due to the condition [1][3]. Group 2: Current Treatment Landscape - Current treatment methods in China primarily involve topical corticosteroids and calcineurin inhibitors, which only suppress immune responses and do not promote repigmentation or prevent relapse [3]. - The FDA approved the JAK inhibitor ruxolitinib cream for the treatment of non-segmental vitiligo in patients aged 12 and older, but it is not yet available in China and cannot be used for children under 12 [3][4]. Group 3: Market Potential and Drug Development - There is a high demand for treatment among the 12 million patients aged 2 to 12 in China, representing 40% of the patient population [3]. - Several pharmaceutical companies are developing new drugs for vitiligo, including new JAK inhibitors and innovative treatments like CKBA ointment by TianKang, which targets T-cell fatty acid metabolism [3][4]. - According to Huafu Securities, the long-term market potential for innovative vitiligo drugs in China is estimated to reach 120 billion to 259 billion yuan under different scenarios, indicating a significant market opportunity [5].

Investment Rating - The industry investment rating is "Outperform the Market" [1][47]. Core Insights - The white spot market for vitiligo treatment is vast, with a potential market size expected to reach 21.7 billion yuan by 2030, driven by an increasing number of patients and the need for effective treatments [3][15][39]. - Current treatment options are inadequate, with no approved products specifically for vitiligo in China, highlighting a significant gap in the market that innovative drugs could fill [3][26]. - The competitive landscape is favorable, with several small pharmaceutical companies and leading firms vying for market share, and key products expected to receive approval soon [3][39]. Summary by Sections Part 1: Patient Demographics and Health Risks - The prevalence of vitiligo is significant, with approximately 22.83 million patients in China, of which 54.01% are receiving treatment [3][15]. - The condition is associated with severe psychological impacts, including a higher incidence of depression among patients [3][10]. Part 2: Current Treatment Limitations - Existing treatments, primarily involving drug therapy and phototherapy, have shown limited effectiveness, necessitating the introduction of new drugs with higher repigmentation rates [3][24]. - The current market lacks approved medications specifically for vitiligo, with existing drugs primarily approved for other conditions [3][26]. Part 3: Competitive Landscape and Drug Development - The vitiligo treatment sector is characterized by a lack of approved products, with several drugs in various stages of clinical trials, including one in Phase III and six in Phase II [3][39]. - JAK inhibitors are identified as key targets in drug development, with the first approved topical JAK1/JAK2 inhibitor, Ruxolitinib cream, showing promising sales growth [3][32][39]. - The innovative drug market for vitiligo is projected to reach 10 billion yuan, with significant interest in companies like Kangzheng Pharmaceutical and TianKang [3][39]. Part 4: Investment Recommendations - The report suggests focusing on the progress of drug development in the vitiligo sector and monitoring companies involved, including Kangzheng Pharmaceutical, TianKang, Huadong Medicine, and others [3][39].

Core Insights - The forum focused on innovative immunotherapy and clinical translation opportunities, attracting over a hundred participants from various sectors [2] - The clinical trial results for CKBA, an innovative drug for vitiligo, showed a 36% efficacy rate and good safety, particularly in children [2][4] - CKBA is positioned to fill a significant gap in the treatment of pediatric vitiligo, as there are currently no approved drugs for this age group [5] Group 1: Clinical Development - CKBA has completed Phase II clinical trials for vitiligo, with 18 out of 50 patients showing improvement and an adverse reaction rate of only 18% [4] - The drug is expected to enhance the efficacy of phototherapy while reducing side effects, providing a new strategy for combined treatment [4] - The company has submitted a breakthrough therapy designation application to the National Medical Products Administration (NMPA) and is advancing to Phase III trials [7] Group 2: Market Opportunity - The global prevalence of vitiligo is approximately 1% to 3%, with a significant portion of patients being children aged 2 to 12, indicating a high unmet medical need [3] - Current treatments in China lack effective targeted therapies, primarily relying on topical corticosteroids and other medications that have limited efficacy and potential side effects [3] - The domestic vitiligo treatment market is seen as a promising area for potential blockbuster products, with a large patient base and urgent demand [6] Group 3: Innovation and Strategy - The company is committed to innovation as a core driver of growth, with R&D investments exceeding 20% of revenue in 2023 and 2024 [6] - CKBA represents a shift in research focus from psoriasis to vitiligo, driven by the significant clinical needs in the latter [3][6] - The company aims to submit a new drug application for CKBA for both adult and pediatric vitiligo by 2027 [7]

Summary of Conference Call on CKBA Clinical Phase II Data Company and Industry - **Company**: CKBA - **Industry**: Pharmaceutical, specifically focusing on dermatological treatments and neurodegenerative diseases Key Points and Arguments Clinical Trial Results - CKBA demonstrated a differentiated advantage in treating vitiligo by inhibiting tissue-resident memory T cell binding and reducing reactive oxygen species (ROS) in melanocytes, achieving both immune modulation and melanin production [1][7] - The Phase II clinical trial results indicated that facial vitiligo treatment was more effective than neck treatment, attributed to greater natural light exposure promoting melanocyte differentiation and secretion [1][12] - In the high-quality group, the improvement rate for facial skin color reached 50%, significantly higher than the 18% in the MG group [1][16] Future Clinical Plans - The company plans to initiate Phase III clinical trials by the end of the year, focusing on facial efficacy and expanding the sample size to include patients aged 12-65 [1][2] - A breakthrough therapy application will be submitted soon to support the Phase III trial [2] Safety and Efficacy - CKBA's adverse event rate is only 18%, significantly lower than the 60% rate associated with traditional treatments like Jak inhibitors, making it suitable for long-term maintenance therapy, especially for children aged 2-12 [1][7][19] - The drug is expected to be the first treatment specifically for vitiligo in children aged 2-12 globally, addressing a strong demand in China where there are approximately 12 million such patients [3][18] Pricing Strategy - The annual treatment cost for CKBA is estimated to be around 10,000 to 20,000 yuan, significantly lower than the 150,000 yuan for traditional treatments, enhancing drug accessibility [3][8] Other Research Initiatives - NKBA, a high bioavailability derivative of AKBA, has initiated preclinical studies for Alzheimer's disease and anti-aging, with IND submission expected in Q3 next year [1][5] - The company has submitted a Phase II clinical application for rosacea and plans to start clinical trials shortly, with a treatment cycle of about three months [1][6] Market Position and Competitive Advantage - CKBA's unique mechanism of action and safety profile position it favorably against existing treatments, making it particularly appealing for long-term use in pediatric patients [1][7][19] - The company aims to conduct head-to-head comparisons with existing treatments like Ruxolitinib once it is approved, to establish a clear safety and efficacy advantage [18] Clinical Management Challenges - The management of clinical trials for vitiligo is complex due to long cycles and the need for placebo controls, but the company is confident in improving data collection and trial management in Phase III [15] Conclusion - CKBA is poised to make significant advancements in the treatment of vitiligo, particularly in pediatric populations, with a strong focus on safety, efficacy, and affordability, while also exploring new therapeutic avenues in neurodegenerative diseases.

Investment Rating - The report assigns an "Accumulate" rating for the company, with a target price of 21.06 CNY based on a 54 times P/E ratio for 2025 [3][6]. Core Views - The company is expected to experience rapid progress in its core business or key products over the next 1-2 years, with projected earnings per share of 0.26, 0.39, and 0.62 CNY for 2024-2026 [3]. - The company has a solid foundation as a comprehensive pharmaceutical enterprise, having established a research and development platform and acquired a pipeline of high-potential products [10][15]. - The treatment for vitiligo is scarce, and the company's CKBA product is anticipated to stand out in the market due to its unique mechanism and promising clinical trial results [10][50]. Financial Summary - The company's revenue for 2022 was 783 million CNY, with a projected decline to 757 million CNY in 2024, followed by a recovery to 951 million CNY in 2025 and 1,214 million CNY in 2026, reflecting a growth rate of 25.7% and 27.6% respectively [5]. - The net profit attributable to the parent company is expected to decrease from 175 million CNY in 2022 to 111 million CNY in 2024, before increasing to 165 million CNY in 2025 and 262 million CNY in 2026 [5]. - The gross margin is projected to improve from 58.2% in 2022 to 69.7% in 2026, indicating a positive trend in profitability [5]. Business Overview - The company started as an agent for gastrointestinal and ophthalmic medications and has gradually expanded into various fields, establishing a robust R&D platform since 2015 [10][15]. - The core business segments include gastrointestinal medications, sexual health products, and ophthalmic drugs, with stable growth in revenue from these areas [10][23]. - The company has significantly increased its R&D investment, leading to the development of important products such as dapoxetine and a rich pipeline of innovative drugs [32]. Market Opportunity - The prevalence of vitiligo is high, with over 12.33 million patients in China, and the demand for effective treatments is unmet, creating a significant market opportunity for CKBA [10][37]. - The competitive landscape for vitiligo treatments is favorable, with CKBA being the only non-JAK inhibitor drug in the domestic pipeline, currently in Phase II clinical trials [50][51].

Group 1 - The company, established in 1999 and listed on the Growth Enterprise Market in 2022, has developed a comprehensive pharmaceutical business starting from agency operations and has built a strong R&D platform through self-construction and acquisitions [1] - The main business segments include gastrointestinal, sexual health, and ophthalmic medications, with overall revenue and profit growth slowing, but core business continuing to grow [1] - Significant increases in R&D investment have been noted, leading to the development of key products such as Dapoxetine Hydrochloride Tablets, along with a rich pipeline of potential products [1] Group 2 - The treatment for vitiligo is scarce, with a high prevalence and strong patient treatment willingness, as evidenced by 12.33 million patients in China in 2021 [2] - The main treatment options currently available include hormones and topical calcineurin inhibitors, but there is a significant unmet clinical need as no new drugs have been approved domestically [2] - CKBA is the only non-JAK inhibitor drug in development for vitiligo, with promising results from its Phase II clinical trials and plans to expand into other indications such as psoriasis and atopic dermatitis [2] Group 3 - The core business includes gastrointestinal medications, with the company planning to shift to self-production to overcome limitations and achieve rapid growth [3] - In the sexual health segment, Dapoxetine Hydrochloride Tablets have become a leading brand, with additional products in development that are expected to drive growth [3] - The ophthalmic segment shows stable sales with growth potential, particularly with the upcoming application for a new drug for presbyopia, which could be the first approved in the domestic market [3] - The company forecasts earnings per share of 0.26, 0.39, and 0.62 yuan for 2024-2026, respectively, and sets a target price of 21.06 yuan based on a 54 times P/E ratio for 2025 [3]