Core Viewpoint - Nocera Biopharma (09969) shares rose over 3%, currently up 3.5% at HKD 18.63, with a trading volume of HKD 133 million, ahead of the board meeting scheduled for August 19 to approve mid-term results [1] Group 1: Financial Performance - Nocera Biopharma's first-quarter revenue increased by 130% year-on-year, with net profit turning positive at HKD 1.8 billion, exceeding expectations due to strong growth of its core product, Oubreti, and confirmation of upfront payment from Prolium [1] - CICC has revised its profit forecasts for Nocera Biopharma, narrowing expected losses for the next two years from HKD 436 million and HKD 256 million to HKD 415 million and HKD 225 million, respectively [1] Group 2: Product Insights - Oubreti, a BTK inhibitor developed by Nocera Biopharma, is primarily used for treating chronic lymphocytic leukemia and is gaining market share, holding a significant position in the domestic BTK inhibitor market [1] - In 2024, Oubreti's sales revenue is projected to exceed HKD 1 billion, representing a year-on-year growth of 49.14%, capturing a 30% market share in the domestic BTK inhibitor market [1]

Core Viewpoint - Nocera Health (09969) has seen a stock increase of over 3%, currently at 18.63 HKD, with a trading volume of 133 million HKD, ahead of its board meeting scheduled for August 19 to approve mid-term results [1] Financial Performance - Nocera Health's first-quarter revenue increased by 130% year-on-year, with net profit turning positive at 1.8 billion HKD, exceeding expectations due to strong growth of its core product, Oubreti [1] - CICC has revised its profit forecasts for Nocera Health, narrowing expected losses for the next two years from 436 million HKD and 256 million HKD to 415 million HKD and 225 million HKD respectively [1] Product Insights - Oubreti, a BTK inhibitor developed by Nocera Health, is primarily used for treating chronic lymphocytic leukemia and has been gaining market share, holding a significant position in the domestic BTK inhibitor market [1] - In 2024, Oubreti's sales revenue is projected to exceed 1 billion HKD, representing a year-on-year growth of 49.14%, capturing a 30% market share in the domestic BTK inhibitor market [1]

Financial Data and Key Metrics Changes - Revenue reached $1.3 billion in Q2 2025, representing a 42% year-on-year growth [5][17] - GAAP earnings per ADS grew by $2 compared to Q2 of the previous year [5] - Free cash flow generated in Q2 was $220 million, an increase of over $400 million year-on-year [5] - Gross margin improved to approximately 87% from 85% in the prior quarter [21] - Non-GAAP net income reached $253 million, reflecting an increase of $230 million compared to the previous year [23] Business Line Data and Key Metrics Changes - Brukinza global revenues were $950 million, growing 49% year-on-year, driven by strong performance across all geographies [17] - Tovembra reported a 22% increase in revenue, reflecting continued market leadership in China [19] - In-licensed products showed continued strength, growing 27% year-on-year [19] Market Data and Key Metrics Changes - The US market generated $685 million with a year-on-year growth of 43% [20] - China revenue totaled $429 million, a 23% increase [20] - Europe contributed $152 million with 87% year-on-year growth [20] - Rest of world markets grew by 168% driven by market expansions and new launches [20] Company Strategy and Development Direction - The company aims to maintain leadership in the hematology franchise and expand its solid tumor pipeline [6][15] - Plans to combine assets in multiple phase three trials to improve outcomes for CLL patients [15] - The company is focused on serial innovation in CLL and aims to build a deep pipeline across various disease areas [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in long-term market leadership for Brukinza despite competitive pricing pressures [18] - The company anticipates stable pricing for the remainder of the year [46] - Future impacts from potential US tariffs are expected to be manageable within the context of the P&L [73] Other Important Information - The company is preparing for the initial global approval of Sonro and anticipates pivotal data for its BTK CDAC by 2026 [15] - The tablet formulation of Brukinza is expected to achieve a lower cost of goods and improve patient convenience [24] Q&A Session Summary Question: Update on Brukinza's US net pricing and inventory changes - Management anticipates stable pricing for the remainder of the year and has no significant inventory levels to comment on [46][47] Question: Reaction to Bruin CLL 314 data for PERTO versus IMBRUVICA - Management noted that the OR superiority was not formally tested and emphasized the importance of PFS data [48][49] Question: Delay in starting the second line phase three trial for CDK4 - Management stated that the delay is modest and aims to let data mature for better dose level selection [53] Question: Impact of US tariffs on gross margin - Management indicated that current guidance contemplates known tariffs and that impacts have been mitigated through supply chain strategies [73] Question: Specifics on access to Brukinza and revenue mix - Management confirmed that Brukinza continues to be listed on all Medicare Part D formularies and access is strong [99][100]

Group 1 - The global market for Multiple Sclerosis (MS) products is approximately $20 billion, with a significant focus on Relapsing Multiple Sclerosis (RMS) treatments [1][2] - The existing approved products primarily target RMS, while there is a notable unmet clinical need in the Progressive Multiple Sclerosis (PMS) area, with only one product, Ocrelizumab, approved for Primary Progressive Multiple Sclerosis (PPMS) [2][3] - The patient base for MS is substantial, with projections indicating that the number of MS patients globally will reach 3.71 million by 2030 [1] Group 2 - BTK inhibitors are expected to address the treatment gap in PMS, with their ability to penetrate the blood-brain barrier and modulate key immune cells [3] - Sanofi's Tolebrutinib and Roche's Fenebrutinib are anticipated to release Phase III clinical trial data in the second half of 2025, which could enhance the value of BTK inhibitors in PMS [3][4] - Tolebrutinib has received priority review from the FDA for the treatment of non-relapsing Secondary Progressive Multiple Sclerosis (nrSPMS), with a PDUFA date set for September 28, 2025 [4]

Investment Rating - The investment rating for the biotechnology industry is "Positive" (maintained) [1] Core Insights - The global stock of multiple sclerosis (MS) patients is significant, with the market size exceeding $20 billion, primarily focused on relapsing forms of MS (RMS) [6][9] - BTK inhibitors are expected to fill the treatment gap in primary progressive MS (PPMS) and non-relapsing secondary progressive MS (nrSPMS) [7][9] - The anticipated release of clinical data for BTK inhibitors in the second half of 2025 is expected to enhance the attractiveness of the sector [9] Summary by Sections 1. Multiple Sclerosis Overview - MS is an immune-mediated inflammatory demyelinating disease of the central nervous system, characterized by "spatial" and "temporal" multiplicity [5][27] - The global and Chinese stock of MS patients is projected to reach 3.71 million and 60,000 respectively by 2030, with a CAGR of approximately 2.7% and 2.1% from 2025 to 2030 [19][22] 2. Market Size and Product Landscape - The global MS market is approximately $20 billion, with a focus on RMS treatments [6][40] - Existing products include monoclonal antibodies and oral therapies, with CD20 monoclonal antibodies expected to account for over 60% of sales by 2024 [6][46] 3. BTK Inhibitors and Clinical Development - BTK inhibitors are positioned to address unmet needs in the treatment of PPMS and nrSPMS, with several candidates in late-stage clinical trials [7][51] - Tolebrutinib and Fenebrutinib are expected to release pivotal clinical data in the second half of 2025, which could significantly impact their market potential [8][51] 4. Investment Recommendations - The ongoing clinical developments and the large patient base present significant investment opportunities in companies like 诺诚健华, 翰森制药, 云顶新耀, 恒瑞医药, and 百济神州-U [9]

Core Viewpoint - The latest phase data from the 1b/2a clinical trial of EVER001 shows promising efficacy and safety in treating primary membranous nephropathy (pMN), supporting its potential as a treatment for autoimmune glomerular diseases characterized by proteinuria [2][3][4]. Group 1: Clinical Trial Results - As of March 21, 2025, the ongoing 1b/2a clinical trial has collected long-term data, with 11 patients in the low-dose group followed for 52 weeks, and 16 and 12 patients in the high-dose group completing 24 and 36 weeks of treatment, respectively [1][3]. - The geometric mean levels of anti-PLA2R antibodies decreased by 62.2% and 87.3% in the low and high-dose groups at 12 weeks, with both groups showing over 93% reduction at 24 weeks [1][3]. - The 24-hour proteinuria geometric mean values decreased by 57.0% and 67.6% at 24 weeks for the low and high-dose groups, respectively, with further reductions to 76.7% and 80.6% at 36 weeks, maintained until the 52-week follow-up [4][5]. Group 2: Safety and Tolerability - EVER001 demonstrated good safety and tolerability, with most adverse events being mild to moderate and transient, consistent with previous observations [1][3][6]. - No clinically significant adverse events commonly associated with other BTK inhibitors, such as bleeding or severe infections, were observed [3][6]. Group 3: Market Potential and Future Development - The company aims to accelerate the global clinical development of EVER001, which has the potential to address the unmet medical needs of over 10 million patients with pMN and other autoimmune kidney diseases [5][15]. - Currently, there are no approved drugs for the treatment of pMN globally, highlighting the significant market opportunity for EVER001 [4][6]. - The company plans to initiate Phase 3 clinical trials and engage with regulatory authorities in the U.S. and China to expedite the development process [6][17]. Group 4: Mechanism and Advantages - EVER001 is a next-generation covalent reversible BTK inhibitor, offering advantages such as better selectivity and reduced off-target toxicity compared to traditional irreversible BTK inhibitors [5][13]. - The drug's mechanism allows for rapid and sustained immune and clinical responses, with significant reductions in antibody levels and proteinuria observed early in treatment [11][12][13]. Group 5: Broader Applications - The company believes that EVER001 may also be effective for other autoimmune diseases, including IgA nephropathy and lupus nephritis, due to its mechanism of action [15][18]. - There is a significant unmet need in these conditions, with millions of patients potentially benefiting from this treatment [15][18].

Core Insights - The approval of multiple BTK inhibitors in China is transforming the treatment landscape for Chronic Lymphocytic Leukemia (CLL) and B-cell lymphomas, with a notable shift towards second-generation BTK inhibitors [1][3][4] Group 1: Market Overview - As of now, five BTK inhibitors have been approved in China, including three imported drugs and two domestic drugs, with the first-generation inhibitor ibrutinib and three second-generation inhibitors [3] - The global incidence of CLL is significant, with 191,000 new cases and 61,000 deaths annually, primarily affecting elderly patients with a median age of 65 in China [2] Group 2: Treatment Efficacy and Safety - The five-year survival rate for CLL patients is high, ranging from 80% to 90%, with low-risk patients having a median survival of nearly 20 years [2] - Newer BTK inhibitors demonstrate improved safety profiles compared to first-generation inhibitors, which have seen a decline in global recommendation levels due to safety concerns [3][4] Group 3: Future Directions - The development of BCL2 inhibitors is underway, with ongoing clinical trials combining these with BTK inhibitors, indicating a potential new direction for CLL treatment [5] - The increasing elderly population in China presents challenges for long-term management of CLL patients, necessitating systematic approaches to address treatment adherence and adverse effects [5]

Core Viewpoint - The innovative drug companies have turned losses into profits in the first quarter of 2025, driven by supportive policies, accelerated international expansion, and business development (BD) licensing agreements [1][2]. Financial Performance - In Q1 2025, Innovent Biologics reported a total revenue of 380 million yuan, a year-on-year increase of 129.9%, primarily due to the strong sales of its core product, Orelabrutinib, which grew by 89.2% to 310 million yuan [1][2]. - The gross profit margin for Q1 2025 increased by 5.1 percentage points year-on-year to 90.5%, with a net profit of 14 million yuan, marking the company's first profitable quarter [1][2]. Product Development and Market Strategy - Orelabrutinib, a selective BTK inhibitor, has been pivotal for the company's financial success, with its inclusion in the national medical insurance contributing to its sales growth [4]. - The company has entered into a licensing agreement with Prolium Bioscience, which could yield up to $520 million in total payments, enhancing its revenue stream [3]. Market Trends and Challenges - The BTK inhibitor market is projected to grow significantly, with estimates suggesting it will reach $20 billion by 2025 and $26 billion in China, driven by increasing patient numbers and new indications [6][7]. - Despite the promising market outlook, the industry faces challenges such as intense competition and the need for sustainable business models, particularly regarding the "selling seedlings" strategy for profitability [8][9]. Industry Outlook - The biopharmaceutical industry in China is experiencing robust growth, with a market size of 1.87 trillion yuan and new product sales increasing by over 250% [10]. - Long-term success will depend on balancing R&D investments with commercialization efficiency, as companies navigate clinical failures, policy fluctuations, and international competition [10].

Core Insights - Nuo Cheng Jian Hua achieved profitability for the first time since its establishment, reporting a net profit of 0.18 billion yuan in Q1, with total revenue reaching 3.81 billion yuan, a year-on-year increase of 129.92% [1] - The growth in revenue is primarily attributed to the strong sales performance of its core product, Oubutini (brand name: Yinuokai), which saw a sales revenue increase of 89.2% to 3.1 billion yuan, driven by its inclusion in medical insurance and enhanced commercialization efforts [1] Financial Performance - In Q1, Nuo Cheng Jian Hua's total revenue was 3.81 billion yuan, marking a 129.92% increase year-on-year [1] - The company reported a net profit of 0.18 billion yuan, indicating its first profitable quarter since inception [1] Product Development and Market Strategy - Oubutini is positioned as a BTK inhibitor, with plans to expand its application from hematological malignancies to autoimmune diseases, which represent the second-largest pharmaceutical market globally [4] - The company is initiating global Phase III clinical trials for Oubutini in treating primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS), with an NDA submission expected in mid-2026 for immune thrombocytopenic purpura (ITP) [4] Strategic Partnerships - In January, Nuo Cheng Jian Hua entered a licensing agreement with Prolium Bioscience for the development and commercialization of the CD20×CD3 bispecific antibody ICP-B02, with potential total payments of up to 520 million USD [2] - The agreement allows Prolium to develop and commercialize ICP-B02 in non-oncological fields globally and in oncology outside Asia, while Nuo Cheng Jian Hua will receive tiered royalties on future product sales [2] Cash Position - As of March 31, 2025, Nuo Cheng Jian Hua held approximately 77.8 billion yuan in cash and cash equivalents, providing a strong financial foundation for ongoing and future projects [4] Future Outlook - The company plans to strengthen its global R&D pipeline and actively explore international collaborations and licensing opportunities to expand its business beyond the Chinese market [5]

Core Viewpoint - BeiGene has achieved its first quarterly profit under GAAP, with a net profit of $1.27 million, driven by rapid global revenue growth and effective management of operating expenses [1] Financial Performance - In Q1 2025, BeiGene reported a revenue of 8.048 billion yuan, a year-on-year increase of 50.2%, with product revenue reaching 7.985 billion yuan, up 49.9% [1] - The company transitioned from losses to profits, achieving an operating profit and total profit of approximately 150 million yuan [1] - The company maintains its 2025 financial guidance, expecting annual revenue between 35.2 billion yuan and 38.1 billion yuan, with positive operating profit and cash flow from operations [2] Product Performance - The BTK inhibitor, Brukinsa (Zebutinib), generated sales of 5.692 billion yuan in Q1 2025, a 63.7% increase year-on-year, and ranked 20th globally in oncology drug sales with projected sales of $2.6 billion in 2024 [2] - In the U.S. market, Brukinsa's sales reached 4.041 billion yuan in Q1 2025, reflecting a 61.9% year-on-year growth, and it became the market leader in the BTK inhibitor segment [2] - The PD-1 monoclonal antibody, Tislelizumab (BGB-A317), achieved sales of 1.245 billion yuan, a 19.3% increase, driven by new patient demand from recently approved indications included in the national medical insurance catalog [2] Market Dynamics - The global BTK inhibitor market has six approved products, with BeiGene's Brukinsa being a second-generation BTK inhibitor that has shown continuous sales growth due to its efficacy over first-generation inhibitors [3] - The competitive landscape includes Eli Lilly's Jaypirca (Pirtobrutinib), the only third-generation BTK inhibitor, which addresses resistance issues through a unique mechanism [4] Research and Development - BeiGene is developing a new BTK degrader, BGB-16673, which has shown therapeutic advantages in patients with prior BTK treatment, and is expected to enter Phase 3 clinical trials comparing it to non-covalent BTK inhibitors [5]