投资者关系活动类别为特定对象调研，活动时间覆盖2025年12月28日至29日，地点包括线上交流与线下 会议。参与机构涵盖公募基金、券商等多家主流投资机构，上市公司由董事会秘书姜英负责接待，活动 未涉及应披露重大信息。 核心产品泰欣赞放量显著 医保全覆盖激活市场潜力 调研中，公司重点介绍了核心产品泰欣赞的市场进展。作为1类创新药，泰欣赞属于P-CAB（钾离子竞 争性酸阻滞剂）类抑酸药物，2025年上半年在市场拓展与医保准入方面成效显著。数据显示，该产品上 半年进院数量已近2500家，销售量较上年同期增长近140%。随着其"反流性食管炎""十二指肠溃疡""根 除幽门螺杆菌"三大适应症全面纳入国家医保目录（分别于2023年3月、2025年1月、2026年1月起执 行），医保政策红利将进一步推动产品在抑酸治疗市场的渗透率提升。 近日，罗欣药业（维权）集团股份有限公司（下称"罗欣药业"）于2025年12月28日至29日以线上结合线 下形式接待了交银施罗德基金、广发基金、国海证券、中邮证券等多家机构的特定对象调研。公司董事 会秘书姜英就核心产品进展、财务表现、研发布局等投资者关注的问题进行了回应。调研信息显示，公 司核心 ...

Core Viewpoint - The A-share pharmaceutical sector has seen active refinancing activities in 2023, with eight companies completing private placements, raising over 8.5 billion yuan in total, indicating a focus on innovation and strategic investments in the industry [1][3]. Group 1: Fundraising Activities - Eight pharmaceutical stocks have completed private placements this year, raising a total of over 8.5 billion yuan, with Baili Tianheng leading at 3.731 billion yuan [1][3]. - Three companies raised over 1 billion yuan: Baili Tianheng (3.731 billion yuan), Dize Pharmaceutical (1.773 billion yuan), and Lukang Pharmaceutical (1.187 billion yuan) [3]. - The majority of these placements occurred in the first half of the year, with Baili Tianheng's significant placement completed in September [3]. Group 2: Fund Utilization - Baili Tianheng and Dize Pharmaceutical are directing their funds towards innovative drug research and development, with Baili Tianheng focusing entirely on this area [6]. - Dize Pharmaceutical's projects include new drug development and international standard innovative drug industrialization [6]. - Other companies like Aibo Medical and Lukang Pharmaceutical have varied uses for their funds, including production line construction and high-end formulation manufacturing [6][7]. Group 3: Financial Performance - Among the eight companies, only two reported net profit growth in the first three quarters, with Sanyou Medical showing a significant increase in both revenue and profit [8]. - Baili Tianheng experienced the largest decline in performance, with a revenue drop of 63.52% and a net loss of 4.95 billion yuan [8]. - However, Baili Tianheng reported a substantial revenue increase in the third quarter, attributed to successful collaborations and clinical trial milestones [9].

Group 1: Company Performance and Strategy - The company has strategically focused on the pharmaceutical industry, particularly in the digestive system sector, leading to continuous improvement in product structure and growth quality since 2025 [2]. - The core innovative drug, Tai Xin Zan (替戈拉生片), has seen significant growth, with nearly 2,500 medical institutions adopting it and a sales increase of approximately 140% year-on-year in the first half of 2025 [2][3]. - The gross profit margin for the first three quarters was 51.8%, an increase of 9.0 percentage points, and cash flow turned positive with an increase of 280 million [3]. Group 2: Product Development and Market Position - Tai Xin Zan has achieved full coverage in the medical insurance directory for its three approved indications, which is expected to further stimulate the acid suppression treatment market [5]. - Compared to PPIs, P-CABs like Tai Xin Zan have advantages such as rapid onset, prolonged acid suppression, and less dependency on food intake and genetic factors [4][6]. - The company is advancing its pipeline with the injection of LX22001 entering Phase II clinical trials and the completion of the Phase III clinical research report for Pucanate tablets [6]. Group 3: Financial and Operational Insights - The company plans to raise up to 842.4 million CNY through a specific issuance of A-shares, with the funds allocated for innovative drug research and development, raw material drug expansion, and working capital [9][10]. - The company has implemented a differentiated strategy for its generic drug products, focusing on maintaining supply and quality while controlling costs amid structural adjustments in the industry [8]. - The decrease in expense ratios is attributed to the scale effect from increased sales revenue and enhanced management practices, leading to optimized personnel allocation and budget control [12].

Core Viewpoint - Mingyu Pharmaceutical Co., Ltd. has submitted a prospectus for an IPO in Hong Kong despite not having commercialized any products in its six years of operation, accumulating losses exceeding 1.239 billion RMB [2][3][10]. Financial Performance - The company reported zero revenue for 2023 and 2024, with revenue of 26.415 million RMB in the first half of 2025, while losses for the same periods were -137.275 million RMB, -282.631 million RMB, and -167.008 million RMB respectively, totaling nearly 587 million RMB over two and a half years [3][5]. - As of June 30, 2025, the total accumulated losses reached 1.239 billion RMB, averaging over 200 million RMB in losses per year since its establishment in 2018 [3][4]. Research and Development Expenditure - The primary reason for the continuous losses is attributed to R&D expenses, which were 182.472 million RMB, 280.689 million RMB, and 98.379 million RMB during the reporting periods, representing 132.92%, 99.31%, and 58.91% of the respective annual profits [4][5]. - The company has a pipeline of 13 candidate products, with 10 in clinical stages, including three key products (MH004, MHB018A, MHB088C) that are progressing towards commercialization [6][7][9]. Product Pipeline and Market Potential - MH004 is a topical prodrug for atopic dermatitis and vitiligo, with a global market projected to grow from 1.2 billion USD in 2020 to 1.7 billion USD by 2024, reflecting a compound annual growth rate (CAGR) of 9.7% [7]. - MHB018A targets thyroid eye disease (TED), with a potential market size of 3.4 billion USD in 2024, expected to reach 13.4 billion USD by 2035, with a CAGR of 13.2% [7]. - MHB088C has been selected for presentation at the 2025 World Lung Cancer Conference, indicating its significance in the pipeline [8]. Financing and IPO Plans - The company has completed five rounds of financing, raising a total of 650 million RMB and 131 million USD, with a valuation increase from 300 million RMB to 3.936 billion RMB [10][12]. - The recent C round financing of 131 million USD was completed just three months before the IPO submission, raising questions about the urgency of the listing and potential investor confidence [12][13].

Investment Rating - The industry investment rating is "Outperform the Market" and is maintained [2] Core Insights - The domestic innovative drug research and development is experiencing a recovery, with a focus on investment opportunities in the non-clinical safety evaluation sector [4][16] - The non-clinical safety evaluation industry is characterized by high competitive barriers and is expected to see increased demand due to the growth of domestic innovative drug development [5][20] - The pricing of experimental monkeys, crucial for safety evaluations, is expected to rise due to limited supply and increasing demand from innovative drug research [20] Summary by Sections Industry Overview - The closing index for the industry is 8254.26, with a 52-week high of 9323.49 and a low of 6764.34 [2] Recent Market Performance - In the week from December 22 to December 26, 2025, the A-share pharmaceutical and biotechnology sector fell by 0.18%, underperforming the CSI 300 index by 2.13 percentage points [6][22] - The raw material drug sector ranked first in performance among sub-sectors, increasing by 2.05%, while the hospital sector declined by 2.82% [6][22] Industry Perspectives 1. **Innovative Drugs and Industry Chain**: The innovative drug sector is in a continuous correction phase, driven by a retreat from previously optimistic expectations. However, clinical data from recent conferences supports the maturity of domestic innovative drugs [7][24] 2. **Investment Opportunities**: Companies with high certainty and less volatility in business development (BD) expectations are recommended, including Innovent Biologics and 3SBio [9][25] 3. **Medical Devices**: The medical device sector is expected to attract more investment as the pressure from centralized procurement diminishes, with leading companies showing improved performance [10][28] Recommendations - Focus on companies like Zhaoyan New Drug and Yino Science in the non-clinical safety evaluation sector, and consider investment in WuXi AppTec and Tigermed in the CRO and life science services sectors [20][26] - In the medical device sector, companies such as Mindray and Kangli Medical are highlighted for their potential recovery and growth [30][28]

Investment Rating - The report indicates a cautious outlook on the pharmaceutical industry, with the overall investment rating reflecting a mixed performance in the sector [2][3]. Core Insights - The Shenwan Pharmaceutical and Biological Index decreased by 0.2% this week, while the Shanghai Composite Index rose by 1.88%, ranking the pharmaceutical index 25th among 31 Shenwan sub-industries [2][3]. - The current valuation of the pharmaceutical sector stands at 29.2 times earnings, placing it 10th among 31 Shenwan primary industries [5]. - Recent collaborations in the industry include significant licensing agreements, such as the partnership between JAKOS and AstraZeneca for the Pan-KRAS inhibitor, which could yield up to $20.15 billion in potential payments [11]. - The report highlights the ongoing challenges in the industry, including a decline in the number of retail pharmacies, which has seen a net reduction of over 8,800 stores in the last quarter alone [16]. Market Performance - The pharmaceutical sector's performance this week showed a decline of 0.2%, with various sub-sectors experiencing mixed results, such as raw materials (+2.0%) and hospitals (-2.8%) [2][5]. - The report notes that the pharmaceutical index's performance is lagging compared to other sectors, indicating a need for strategic adjustments [3][5]. Recent Developments - The sixth batch of national procurement for medical consumables has been officially launched, which may impact pricing and availability in the market [14]. - Several innovative drugs and medical devices have received approval for market entry, including Novo Nordisk's oral semaglutide, marking a significant advancement in obesity treatment [19][21]. - The report also mentions the IPO applications of several companies, including Xinnowei and Frontera, indicating a trend of new entrants seeking capital in the pharmaceutical sector [26][29].

Core Viewpoint - The recent IPO of Hansai Aitai, a Wuhan-based innovative drug development company, faced significant market rejection, with its stock price plummeting by 46.25% on the first day of trading, leading to a market capitalization of approximately 20 billion RMB, making it the largest case of a biotech stock breaking below its IPO price in Hong Kong this year [3][4][6]. Group 1: IPO and Market Performance - Hansai Aitai completed its IPO after three submissions to the Hong Kong Stock Exchange, raising a net amount of approximately 5.31 billion HKD [7][10]. - Despite a reported oversubscription of about 3000 times during the public offering phase, the stock opened significantly lower than its issue price of 32 HKD, indicating a severe market correction [4][6]. - The company’s market debut has raised questions about the valuation and investor confidence in a company that is still in the high-investment, no-revenue stage of drug development [7][11]. Group 2: Financial Performance and Funding - The company has not yet commercialized any products, with its revenue primarily derived from licensing fees related to previous asset transfers [12][15]. - Financial data shows that the company’s research and development expenses increased from 46.66 million RMB in 2023 to 74.72 million RMB in 2024, while administrative expenses surged from 17.22 million RMB to 46.19 million RMB during the same period [17][19]. - The company’s income from other sources, including government grants and interest income, has been minimal, with total other income reported at 6.66 million RMB in 2023 and 7.68 million RMB in 2024 [19]. Group 3: Product Development Challenges - Hansai Aitai's core product, HX009, targets challenging pathways in cancer treatment, specifically late-stage melanoma and cholangiocarcinoma, but is still in the early clinical trial phases [20][24]. - The company faces significant hurdles in meeting its financing obligations, as it must submit new drug applications by the end of 2026 to avoid triggering redemption rights for investors [23][24]. - The lack of substantial clinical data and the high failure rate associated with the targeted pathways raise concerns about the feasibility of advancing its products to market [25][26]. Group 4: Corporate Governance and Related Transactions - The company has engaged in related party transactions with entities controlled by its founder, which raises questions about governance and financial transparency [27]. - High executive compensation has been noted, with significant salaries paid to top management despite the absence of commercialized products [28]. - The reliance on related companies for critical services and testing further complicates the operational landscape for Hansai Aitai [27]. Group 5: Industry Outlook - The biopharmaceutical sector's value ultimately hinges on clinical breakthroughs and commercialization capabilities, suggesting that reliance on capital market operations without solid R&D foundations may not sustain long-term growth [29]. - The future trajectory of Hansai Aitai remains uncertain, with ongoing monitoring required to assess its ability to navigate these challenges [30].

Core Viewpoint - The report from Guojin Securities indicates that Xiansheng Pharmaceutical (02096) is expected to experience strong growth due to the resonance of short-term pipeline expansion and long-term innovation iteration, forecasting revenue of 7.63 billion, 9.10 billion, and 11.04 billion yuan for 2025, 2026, and 2027 respectively, with year-on-year growth of +15.0%, +19.3%, and +21.4% [1] Group 1 - The company has significantly improved its innovation transformation, with the revenue share of innovative drugs rising to 77% by the first half of 2025, up from 45% in 2020 [2] - The company focuses on four core therapeutic areas: neurology, oncology, autoimmune diseases, and anti-infection, leveraging a dual approach of self-research and business development [2] Group 2 - In the short term, the core pipeline is entering a concentrated harvest period, with accelerated inclusion in medical insurance expected to boost performance; key products in oncology and neurology are anticipated to see rapid market release [3] - The insomnia drug Dali Leisheng, which has a fast onset and non-addictive properties, is expected to have significant market potential due to its consumer attributes [3] Group 3 - In the long term, the self-research pipeline focuses on differentiated targets, with several products already achieving business development; the innovative capabilities of the company continue to be validated [4] - The NMTiADC new technology platform is expected to overcome ADC resistance, with related products entering clinical trials to accelerate the validation of platform strength [4]

Core Viewpoint - China Biopharmaceutical (01177) announced that its self-developed innovative drug TQH3906, a TYK2/JAK1 JH2 allosteric inhibitor, has completed Phase II clinical trials for moderate to severe plaque psoriasis, demonstrating good safety and efficacy [1][2]. Group 1: Clinical Trial Results - TQH3906 showed good safety and tolerability across all dosage groups, achieving the primary endpoint of the Phase II study [1]. - The study was a randomized, double-blind, placebo-controlled, multi-center trial involving 209 patients, with a daily oral administration regimen [1]. - At the recommended Phase II dose (RP2D), after 12 weeks of treatment, the PASI75 response rate exceeded 90% and the PASI90 response rate exceeded 70%, significantly outperforming the placebo group, which had PASI75 and PASI90 response rates of approximately 10% and 5%, respectively [2]. Group 2: Efficacy and Safety Comparison - The efficacy level of TQH3906 is comparable to IL-17/IL-23 targeted biologics and shows superior efficacy compared to other marketed oral psoriasis treatments like Deucravacitinib and Apremilast [2]. - The overall safety profile of TQH3906 is good, with the incidence of adverse events similar to the placebo group, and most treatment-emergent adverse events (TEAEs) were of grade 1-2 severity [2]. - No new safety signals were observed, and the safety characteristics are similar to other TYK2 inhibitors [2]. Group 3: Market Context and Future Research - Oral small molecule targeted therapies like TQH3906 offer advantages over antibody-based biologics, including convenience of administration, high tolerability, and better patient compliance [3]. - Currently, the only approved oral small molecule drugs for plaque psoriasis in China are PDE-4 inhibitors and Deucravacitinib, which have lower PASI75 and PASI90 response rates compared to TQH3906 [3]. - TQH3906 targets the pseudo-kinase domain (JH2) of TYK2/JAK1, enhancing selectivity against JAK2, JAK3, and other kinases, potentially leading to better safety profiles [3]. - The company plans to explore TQH3906 for new indications in inflammatory bowel disease, psoriatic arthritis, and other autoimmune and dermatological conditions [3].

Core Viewpoint - The biopharmaceutical company Harmony Pharmaceuticals has submitted its prospectus to the Hong Kong Stock Exchange, aiming to address its financial pressures and advance its commercialization efforts for its drug pipeline, particularly Mufemilast, which is set to be approved in September 2025 [3][4]. Company Overview - Harmony Pharmaceuticals focuses on developing small molecule drugs for autoimmune diseases and tumors, with a pipeline that includes seven candidate drugs. However, only Mufemilast, aimed at treating moderate to severe plaque psoriasis, is expected to be approved by September 2025, while the others are still in clinical trials [4][12]. - The company has accumulated losses of 350 million yuan from 2023 to mid-2025 and has not yet achieved profitability due to the lack of product sales [4][18]. - Harmony Pharmaceuticals has raised a total of 950 million yuan through financing, with a post-E round valuation of 3.9 billion yuan [4][20]. Financial Situation - As of June 2025, the company has only 140 million yuan in cash and cash equivalents, with 77.94 million yuan in short-term debt, indicating a tight liquidity situation [20][22]. - The company has incurred significant R&D expenses, totaling 270 million yuan from 2023 to mid-2025, with 167 million yuan allocated to Mufemilast [18][19]. Ownership Structure - The majority of shares are held by founder Zhang Hesheng and his family, controlling approximately 46.51% of the voting rights. This includes Zhang's direct and indirect holdings through various entities [6][7]. - The company has established an employee stock ownership plan, but the majority of shares are concentrated among family members, raising concerns about talent retention and employee motivation [10][11]. Product Pipeline and Market Strategy - Mufemilast is positioned as a dual-action drug with a unique mechanism, but it faces competition from 17 other approved psoriasis treatments in China, including both small molecules and biologics [12][16]. - The company plans to set the annual treatment cost for Mufemilast between 52,700 and 119,900 yuan, which is higher than some competitors but lower than others, indicating a differentiated pricing strategy [16][22]. - Hemay022, another core product for treating advanced breast cancer, is currently in Phase III clinical trials, but patient recruitment has been slower than expected due to competition in the oncology space [17][22]. IPO and Future Prospects - The upcoming IPO is seen as a critical step for Harmony Pharmaceuticals to alleviate its financial constraints and support the commercialization of Mufemilast and the advancement of its pipeline [22][23]. - The company faces challenges in attracting talent and maintaining team stability due to its family-centric ownership and incentive structure, which may impact its long-term innovation capabilities [22][23].