Core Viewpoint - Nocera Biopharma's stock has experienced a significant decline recently, despite a strong year-to-date performance, indicating potential volatility in the market [1][2]. Group 1: Company Overview - Nocera Biopharma, established on November 3, 2015, and listed on September 21, 2022, is primarily engaged in the research, production, and commercialization of biopharmaceuticals, focusing on unmet clinical needs in oncology and autoimmune diseases [2]. - The company's revenue composition includes 87.67% from drug sales, 12.04% from technology licensing, and 0.15% each from testing and research services [2]. - Nocera Biopharma operates mainly in China and the United States, with a product pipeline that includes ICP-022, ICP-B04, ICP-490, ICP-192, and ICP-723 [2]. Group 2: Financial Performance - For the period from January to September 2025, Nocera Biopharma reported a revenue of 1.115 billion yuan, reflecting a year-on-year growth of 59.85%, while the net profit attributable to shareholders was -64.41 million yuan, an increase of 76.61% year-on-year [2]. - The company's stock price has increased by 78.99% year-to-date, but it has seen declines of 7.76% over the last five trading days, 9.06% over the last 20 days, and 18.29% over the last 60 days [1]. Group 3: Shareholder Information - As of September 30, 2025, Nocera Biopharma had 16,500 shareholders, an increase of 8.66% from the previous period [2]. - The top ten circulating shareholders include various funds, with notable changes such as a decrease in holdings by 富国精准医疗灵活配置混合A and new entries like 万家优选 and 平安医疗健康混合A [3].

Core Insights - The A-share market has shown a fluctuating upward trend since 2025, with the pharmaceutical and biotechnology sector performing exceptionally well, dominating the top ten stock fund rankings in the first half of the year [2] - Jin Xiaofei, a representative mid-generation fund manager at Penghua Fund, has achieved remarkable performance with his managed funds, utilizing a unique "dual-line resonance" framework to navigate crowded sectors [2][3] Investment Performance - Jin Xiaofei has been with Penghua Fund since July 2012, accumulating a tenure of 9 years and 174 days, managing assets totaling 5.375 billion yuan, with a best-term return of 239.59% [3] - The Penghua Medical Technology Stock A fund, under Jin's management, has shown significant excess returns, with a total return of 74.19% since its inception on June 2, 2015, and a return of 73.03% this year [5] - The Penghua Innovation Upgrade Mixed A fund has also performed well, with a year-to-date return of 88.72% and a one-year return of 74.60% [15] Investment Strategy - Jin's investment strategy is centered on "fundamental trend investing," integrating a dual-dimensional analysis framework that focuses on both visible driving factors and market sentiment [3][4] - The "bright line" strategy emphasizes significant industry changes, while the "dark line" strategy identifies undervalued opportunities through reverse analysis of market emotions and capital flows [4] - Jin's approach includes a three-dimensional decision-making framework that considers long-term, mid-term, and short-term performance metrics to ensure robust investment logic [14][16] Stock Holdings and Performance - The fund has made strategic purchases in various stocks, including: - 1,126,260 shares of Nuocheng Jianhua, which saw a price increase of 213% during the holding period [7] - 217,760 shares of Dizhe Pharmaceutical, with a price increase of 90.49% [9] - 119,040 shares of Baijishenzhou, which appreciated by 257% [11] - 211,230 shares of Rongchang Bio, with a price increase of 121% [13] - The fund's holdings in stocks like Hailan Pharmaceutical and Zexing Pharmaceutical also demonstrated significant price increases during their respective holding periods [18][20] Market Outlook - Jin Xiaofei anticipates a new investment cycle in the pharmaceutical sector, with institutional holdings recovering from historical lows, and emphasizes the importance of beta opportunities in the current market [5][16] - The need for continuous optimization of risk control systems is highlighted, as the industry faces increasing competition and innovation [25]

Group 1 - The innovative drug concept stocks have declined again, with notable drops in share prices for several companies [1] - Innovent Biologics (09969.HK) fell by 5.09%, trading at HKD 12.86 [1] - CSPC Pharmaceutical Group (01093.HK) decreased by 3.99%, with shares priced at HKD 7.21 [1] - Sinopharm Group (01801.HK) saw a decline of 3.36%, with its stock at HKD 79 [1]

Summary of the Conference Call for 诺诚健华 Company and Industry Overview - The conference call focuses on 诺诚健华 (Nuo Cheng Jian Hua) and its drug 奥布替尼 (Obutinib) for the treatment of systemic lupus erythematosus (SLE), a chronic autoimmune disease affecting over 8 million patients globally, with more than 1 million in China [2][3]. Key Points and Arguments Clinical Trial Results - The IIb clinical trial results for 奥布替尼 show a significant SL4 response rate at week 48 of 57.1% in the 75 mg QD group compared to 34.4% in the placebo group (p<0.05), indicating substantial efficacy in treating SLE [2][5]. - In a subgroup of patients with more severe disease (baseline steroid dose ≥10 mg/day or baseline urine protein ≥1 g/24 hours), the 75 mg QD group demonstrated even greater efficacy, with differences of 30% and 36% compared to the placebo group [5][8]. - 奥布替尼 exhibited good safety and tolerability, with no new safety signals identified, aligning with the BTK inhibition mechanism and SLE disease biology [2][6]. Steroid Reduction - The treatment group showed a significant reduction in glucocorticoid use, with 71.1% of patients successfully reducing their steroid dose to below 7.5 mg/day compared to 43.6% in the placebo group, highlighting the potential to minimize long-term steroid-related side effects [2][6]. Future Clinical Trials - 诺诚健华 plans to initiate a Phase III clinical trial with 484 patients, focusing on the same efficacy endpoints as the IIb trial, expected to start patient enrollment in Q1 2026 [2][7]. - The trial design aligns with international standards, incorporating mandatory steroid reduction protocols to meet the higher requirements set by the CDE for SLE drug trials [4][9]. Market Potential and Commercialization - 奥布替尼 is the first BTK inhibitor to enter Phase III trials for SLE, presenting a significant market opportunity, especially given the limited availability of new small molecule drugs in the past 20 years [3][8]. - The company plans to establish its own commercialization team post-approval and has synergistic effects with other T2 inhibitors to support market promotion [4][10]. Regulatory Landscape - The CDE has tightened clinical requirements for SLE drugs, necessitating lower steroid doses and more rigorous trial designs. 诺诚健华's Phase III study aims to meet these stringent standards to ensure data consistency with global results [9][10]. International Collaboration - 诺诚健华 has partnered with Xenios to advance overseas market opportunities, focusing on SLE and multiple sclerosis (MS) projects, with expectations for the IIb results to inform future international development strategies [12][13]. Additional Important Information - 奥布替尼's mechanism of action shows high selectivity for BTK, with significant inhibition in preclinical models, supporting its development as an effective SLE treatment [3][8]. - The drug's oral formulation offers advantages in convenience and compliance, avoiding issues associated with large molecule biologics [8]. This summary encapsulates the critical insights from the conference call regarding 诺诚健华's developments in SLE treatment with 奥布替尼, highlighting its clinical efficacy, safety profile, market potential, and strategic plans for future trials and commercialization.

智通财经APP获悉，创新药概念股再度走低，截至发稿，诺诚健华(09969)跌5.09%，报12.86港元；石药 集团(01093)跌3.99%，报7.21港元；信达生物(01801)跌3.36%，报79港元。 中邮证券指出，下半年以来，国内的BD出海交易虽有短暂真空，但仍在持续，Q4以来亦诞生了多个 MNC为合作方的交易。该行认为，海外MNC的购买行为系对国内创新药公司创新研发的实力的背书认 可。进一步看，该行认为系中国创新药产业链能力、管线数量和质量、研发效率在全球的强大竞争优势 催生出的结果，坚定看好长期的产业趋势。 值得关注的是，A股创新药大牛股一品红昨日意外跌停，今早再跌超13%。该公司参股的美国Arthrosi公 司收到收购要约，交易总金额最高可达15亿美元。有分析称，一品红的交易可能改变了一些市场预期。 此前市场预期的这个标的是按现在的收购价进行BD，但现在是直接卖出。而此前，股价上涨太多，并 且反应的是BD，现在预期走弱，故而股价跌停。 ...

值得关注的是，A股创新药大牛股一品红（300723）昨日意外跌停，今早再跌超13%。该公司参股的美 国Arthrosi公司收到收购要约，交易总金额最高可达15亿美元。有分析称，一品红的交易可能改变了一 些市场预期。此前市场预期的这个标的是按现在的收购价进行BD，但现在是直接卖出。而此前，股价 上涨太多，并且反应的是BD，现在预期走弱，故而股价跌停。 创新药概念股再度走低，截至发稿，诺诚健华(09969)跌5.09%，报12.86港元；石药集团(01093)跌 3.99%，报7.21港元；信达生物(01801)跌3.36%，报79港元。 中邮证券指出，下半年以来，国内的BD出海交易虽有短暂真空，但仍在持续，Q4以来亦诞生了多个 MNC为合作方的交易。该行认为，海外MNC的购买行为系对国内创新药公司创新研发的实力的背书认 可。进一步看，该行认为系中国创新药产业链能力、管线数量和质量、研发效率在全球的强大竞争优势 催生出的结果，坚定看好长期的产业趋势。 ...

证券日报网讯12月15日，诺诚健华在互动平台回答投资者提问时表示，截至2025年11月28日公司A股股 东户数约为1.79万户。 ...

Core Insights - Orelabrutinib is the first BTK inhibitor to show significant clinical activity in a Phase 2 clinical trial for Systemic Lupus Erythematosus (SLE) [1] - Zenas BioPharma has acquired exclusive rights to develop, manufacture, and commercialize orelabrutinib for Multiple Sclerosis (MS) globally, and for non-oncology fields outside Greater China and Southeast Asia [1][5] Clinical Trial Results - In the Phase 2b study, 187 patients were randomized into three groups: orelabrutinib 75 mg once-daily, orelabrutinib 50 mg once-daily, and placebo [2] - The primary endpoint, SLE Response Index-4 (SRI-4) response rate at week 48, was met with the 75 mg group showing a response rate of 57.1% compared to 34.4% for placebo (p < 0.05) [2] - Secondary endpoints, including SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates, were also significantly higher in the 75 mg group compared to placebo (p < 0.05) [3] Safety and Tolerability - Orelabrutinib was well tolerated, exhibiting a safety profile consistent with BTK inhibition and the disease biology of SLE [3] Development Pipeline - Zenas is advancing orelabrutinib into a Phase 3 trial for Primary Progressive MS (PPMS) and plans to initiate a Phase 3 trial for Secondary Progressive MS (SPMS) in Q1 2026 [6] - Orelabrutinib is already approved for B cell malignancies in mainland China and Singapore, marketed by InnoCare [6] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [7] - The company is advancing two late-stage molecules: obexelimab and orelabrutinib, with obexelimab being a bifunctional monoclonal antibody targeting CD19 and FcγRIIb [7][8]

生物医药高科技公司诺诚健华（上交所代码：688428；香港联交所代码：09969）12月14日宣布，公司 自主研发的新型BTK抑制剂奥布替尼在治疗系统性红斑狼疮（SLE）的IIb期临床研究中达到主要终点， 同时获得国家药品监督管理局（NMPA）药品审评中心（CDE）批准开展III期注册临床试验。 临床IIb期结果展示，在接受治疗48周的患者中，奥布替尼展现了卓越的有效性以及良好的耐受性和安 全性。本次研究共入组187例患者，按1:1:1随机分成三组，即口服奥布替尼每天一次75毫克和50毫克两 个剂量组，以及一个安慰剂组。 本次研究的主要终点是第48周时的SLE反应指数-4（SRI-4）应答率。第48周时，每天一次75毫克奥布替 尼剂量组的SRI-4应答率显著高于安慰剂组（57.1% vs. 34.4%），具有统计学意义（p＜0.05），达到主 要终点。此外，每天一次75毫克奥布替尼剂量组的疗效优于每天一次50毫克剂量组，这表明疗效呈剂量 依赖性的改善趋势。 奥布替尼显示出良好的耐受性和安全性，安全性特征与BTK抑制剂的作用机制和SLE的疾病生物学相一 致。 第48周时，每天一次75毫克奥布替尼剂量组的SRI- ...

12月14日晚，多只医药股发布利好消息。 九安医疗公告，公司美国子公司四联检、三联检产品获得美国FDA上市前通知，涉及的产品包括甲型流 感、乙型流感、COVID-19及RSV呼吸道合胞病毒四联检测家用试剂盒等。这些产品取得上市前通知 后，均可在美国市场正常销售。 君实生物公告，公司旗下EGFR/HER3双特异性抗体偶联药物用于治疗晚期实体瘤的临床试验申请获得 美国FDA批准。 诺诚健华公告，公司自主研发的BTK抑制剂奥布替尼治疗系统性红斑狼疮IIb期研究达到主要终点并获 批III期注册性临床试验。 一品红公告，芩香清解口服液获批国家中药二级保护品种。此外，公司于2025年12月获瑞典制药巨头 Sobi以9.5亿美元（折合人民币约67.13亿元）首付款及最高5.5亿美元（折合人民币约38.87亿元）付款收 购，该药为新型URAT1抑制剂，具备强效溶解痛风石能力，已获FDA快速通道资格，关键III期临床已 完成入组。 （文章来源：21世纪经济报道） ...