Core Viewpoint - The stock of Gilead Sciences-B (01672) has risen over 4%, currently trading at 14.23 HKD, with a transaction volume of 26.83 million HKD, following the acceptance of its new drug application for Denifanstat by the CDE [1] Company Developments - Gilead's new drug Denifanstat (ASC40) is a potential first-in-class oral fatty acid synthase (FASN) inhibitor, aimed at treating moderate to severe acne [1] - The drug was originally developed by Sagimet Biosciences, and Gilead holds exclusive rights for it in Greater China [1] Market Positioning - According to Industrial Securities, Gilead is focusing on the weight loss metabolic field, addressing core pain points with a deep pipeline layout [1] - The company is expected to maintain a differentiated competitive advantage in the weight loss sector, especially with the potential readout of phase II data for small molecule GLP-1R agonists and further progress in the THRβ pipeline [1] - The acne treatment drug ASC40 is anticipated to gradually contribute to the company's revenue [1]

兴业证券此前指出，歌礼制药在减重代谢领域持续投入，聚焦减重赛道核心痛点进行深度管线布局。随 着小分子GLP-1R激动剂二期数据的潜在读出以及THRβ管线的进一步进展，公司在减重领域有望持续展 现差异化竞争优势。公司引进的痤疮治疗药物ASC40也有望逐渐为公司贡献收入。 消息面上，12月4日，CDE 官网显示，歌礼的1类新药地尼法司他片上市申请获得受理。根据该药的临 床研究进度，Insight 数据库推测本次申请的适应症为用于治疗中重度寻常性痤疮。地尼法司他 (Denifanstat，ASC40) 是一款潜在 First-in-class、每日一次口服脂肪酸合成酶 (FASN) 抑制剂。该药最初 由 Sagimet Biosciences 开发，歌礼拥有其在大中华区的独家权益。 智通财经APP获悉，歌礼制药-B(01672)涨超4%，截至发稿，涨4.25%，报14.23港元，成交额2682.71万 港元。 ...

Core Viewpoint - Mandi Inc., a leading company in China's hair loss treatment sector, has submitted its prospectus to the Hong Kong Stock Exchange for an IPO, attracting significant market attention. However, multiple hidden risks related to product structure, R&D capabilities, and financial health may hinder its sustainable growth post-listing and affect market valuation [1]. Group 1: Company Overview - Mandi Inc. is a leading consumer pharmaceutical company in China, focusing on skin health and weight management solutions, particularly in the hair health sector. The company's flagship product, the Mandi® series of minoxidil hair loss treatment products, has ranked first in retail sales for ten consecutive years, holding approximately 57% and 71% market shares in the hair loss and minoxidil markets, respectively, as of 2024 [2]. Group 2: Financial Performance - The company has shown revenue and net profit growth in recent years, with revenues of RMB 980 million, RMB 1.23 billion, and RMB 1.45 billion projected for 2022-2024, representing a compound annual growth rate (CAGR) of 21.7%. Net profits are expected to reach RMB 200 million, RMB 340 million, and RMB 390 million during the same period, with a CAGR of 39.1% [3][4]. - In the first half of 2025, revenue further increased to RMB 743 million, a year-on-year growth of 20.2%, while net profit reached RMB 170 million, up 64% year-on-year [3]. Group 3: Product Dependency and Risks - Mandi Inc.'s revenue structure is heavily reliant on minoxidil hair loss treatment products, with sales from the Mandi® series accounting for 91.7%, 92.3%, 92.1%, and 92.4% of total sales from 2022 to the first half of 2025, indicating a lack of diversification in its product matrix [4]. - The company's gross margin has declined from 82.7% in 2024 to 81.1% in the first half of 2025, while net margin decreased from 26.8% to 23.4%, reflecting increased market competition and cost pressures [5][10]. Group 4: R&D and Competitive Landscape - R&D investment has significantly decreased, with only RMB 19.5 million spent in the first half of 2025, a 67% drop from RMB 59.8 million in the same period of 2024. This reduction poses a risk to the development of new products in acne treatment and weight management, where competition is intensifying [7]. - The company faces competition from major players in the acne and weight management sectors, which may hinder the progress of its new product pipelines [7]. Group 5: Liquidity and Financial Health - Mandi Inc. declared a substantial dividend of RMB 770 million in the first half of 2025, exceeding the total dividends paid in the previous three years, leading to a significant decline in liquidity ratios. The current ratio fell from 4.3 at the end of 2024 to 1.0, indicating heightened short-term debt repayment risks [9]. - As of June 30, 2025, the company's net liquid assets were only RMB 400,000, a drastic reduction from RMB 595 million at the end of 2024, with RMB 670 million in dividends still payable against a cash balance of RMB 110 million [9]. Group 6: Inventory Management - The company's inventory has been on the rise, reaching RMB 70 million, RMB 110 million, RMB 120 million, and RMB 140 million from 2022 to the first half of 2025, while inventory turnover days have increased, indicating a slowdown in sales and potential inventory devaluation risks [10].

Core Viewpoint - The article highlights the widespread issue of acne among adolescents in China, emphasizing the psychological and social impacts it has on individuals, and the need for timely and effective treatment rather than the common misconception that it is a normal part of growing up [19][21]. Group 1: Prevalence and Impact of Acne - A study indicates that 95% of individuals experience some degree of acne, with 3% to 7% of patients developing scars [1]. - Many adolescents face self-esteem issues and social anxiety due to acne, which can affect their personal and professional lives [1][19]. Group 2: Treatment Challenges - Parents often resort to ineffective home remedies or delay seeking professional help, believing that acne will resolve on its own [19][21]. - The article discusses various treatment experiences, including the use of topical medications and oral antibiotics, which often come with side effects and limited effectiveness [20]. Group 3: Psychological Effects - Acne can lead to significant emotional distress, with many individuals feeling self-conscious and avoiding social interactions [19][21]. - The stigma associated with acne can exacerbate feelings of isolation and anxiety among affected adolescents [19]. Group 4: Need for Awareness and Education - There is a lack of understanding about acne among the general population, with 60.4% of people not fully aware of the condition [19]. - The article calls for increased awareness and education for both parents and adolescents regarding the importance of early intervention and proper treatment [21]. Group 5: Advances in Treatment - Recent guidelines and advancements in acne treatment are being introduced, aiming to provide safer and more effective options for patients [20]. - The introduction of new technologies and treatment methods is seen as a positive step towards addressing the acne epidemic among youth [20].

Core Insights - The company reported significant results from the Phase III study of denifanstat (ASC40) for the treatment of moderate to severe acne at the 2025 EADV annual meeting, indicating its potential clinical importance [1] - Denifanstat (ASC40) demonstrated statistically significant and clinically meaningful improvements compared to placebo across all primary and secondary endpoints, along with good safety and tolerability profiles [1] - The company is in communication with the National Medical Products Administration (NMPA) in China regarding the pre-New Drug Application (Pre-NDA) process, with positive feedback received [1] Group 1 - Denifanstat (ASC40) is an innovative therapy in the acne treatment field [1] - The company plans to submit a New Drug Application (NDA) for denifanstat (ASC40) for the treatment of moderate to severe acne after completing pre-NDA communications with NMPA [1] Group 2 - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]

Core Viewpoint - The company reported significant revenue growth and advancements in its drug pipeline, particularly in obesity treatment, indicating strong research and development capabilities and a commitment to addressing unmet clinical needs [1][2]. Financial Performance - Total revenue reached RMB 104 million, representing a year-on-year increase of 111.4% [1] - Research and development costs amounted to RMB 147 million, up 10.9% year-on-year [1] - Loss attributable to equity shareholders was RMB 87.95 million, a decrease of 32.5% compared to the previous year [1] - Loss per share was 9.14 cents [1] Drug Development Progress - ASC30, an oral medication for obesity, showed a significant average weight reduction of 6.5% after 28 days in a U.S. Phase Ib study, positioning it as a potential best-in-class treatment for obesity [1] - The company rapidly enrolled 125 participants in a U.S. Phase IIa study for ASC30, demonstrating efficient execution in clinical trials [2] - ASC30 also showed a 36-day half-life in a single subcutaneous injection study, supporting less frequent dosing [2] - ASC47, another obesity treatment, exhibited a 40-day half-life and has completed participant enrollment for a study combining it with semaglutide [2] - ASC50, an oral IL-17 inhibitor, has entered Phase I clinical trials with initial dosing completed [2] - ASC40, a daily oral FASN inhibitor for acne treatment, demonstrated statistically significant improvements in all primary and secondary endpoints in a Phase III study, indicating its potential for a breakthrough in acne treatment [2] Research and Development Commitment - The achievements highlight the company's strong R&D capabilities and commitment to developing best-in-class and first-in-class drugs to meet long-term clinical needs [2]

Core Viewpoint - Acne is a common issue faced by adolescents, particularly during the summer months when high temperatures and humidity can exacerbate the condition. Experts suggest that while mild acne can often resolve with daily care, moderate to severe cases should be treated promptly to prevent long-term skin damage and psychological effects [1][2]. Group 1: Causes and Mechanisms - Acne is a chronic inflammatory skin disease affecting the pilosebaceous unit, primarily seen in adolescents due to increased androgen levels and sebum production [1]. - Factors contributing to acne include excessive keratinization of hair follicles, bacterial infections, hormonal imbalances, immune factors, psychological stress, chemical irritants, and genetic predisposition [1]. - Lifestyle factors such as smoking, alcohol consumption, medication use, and inappropriate cosmetic choices can also trigger acne outbreaks [1]. Group 2: Treatment Recommendations - For mild acne, daily care such as using gentle cleansers, avoiding irritating skincare products, not squeezing pimples, and maintaining a balanced diet and regular sleep schedule is recommended [2]. - Moderate to severe acne, if untreated, can lead to scarring and impact mental health and social interactions, necessitating professional medical intervention [2]. - Acne typically improves with age as hormone levels stabilize, but moderate to severe cases may require targeted treatment strategies as self-resolution is less likely [2].