Core Viewpoint - Microchip Biotech's stock fell over 5% following the announcement of a patent invalidation decision by the National Intellectual Property Administration, declaring the patent related to its drug, Sidabamine, completely invalid [1][2]. Group 1: Patent Invalidation Impact - The invalidation decision regarding the patent for Sidabamine does not affect the overall patent protection system that the company has established around the drug, which includes multiple patents covering various aspects such as compound, crystal form, key processes, formulations, and indications [2][3]. - The invalidated patent pertains specifically to the indication for peripheral T-cell lymphoma (PTCL), but the company maintains that this does not undermine the validity of other patents protecting Sidabamine [2][3]. Group 2: Drug Approval and Market Position - Sidabamine has received approvals for three indications in China: PTCL in December 2014, breast cancer (BC) in November 2019, and diffuse large B-cell lymphoma (DLBCL) in April 2024, with PTCL and DLBCL being conditionally approved [3]. - The breast cancer indication has not yet been included in the national medical insurance catalog, and the market is competitive with several lower-priced alternatives already listed, resulting in a minor contribution to the company's revenue [3]. Group 3: Financial Performance - For the first half of 2025, Microchip Biotech reported a revenue of 407 million yuan, representing a year-on-year increase of 34.56%, and a net profit attributable to shareholders of 29.59 million yuan, up 172.16% year-on-year [3][4]. - The growth in revenue is attributed to increased sales of Sidabamine and Siglecatin [4].

关于收到国家知识产权局《无效宣告请求审查决定书》的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 深圳微芯生物科技股份有限公司（以下简称"公司"）于近日收到中华人民共和国国家知识产权局（以下 简称"国家知识产权局"）出具的《无效宣告请求审查决定书》（第589684号）。国家知识产权局专利局 复审和无效审理部对无效宣告请求人南京正大天晴制药有限公司提出的公司所持有的"一种E构型苯甲 酰胺类化合物及其药用制剂与应用"（专利号：ZL201410136761.X）的专利权之无效宣告请求进行了审 查，审查结论为宣告专利权全部无效。现将有关情况公告如下： 证券代码：688321 证券简称：微芯生物 公告编号：2025-058 深圳微芯生物科技股份有限公司 案涉专利系公司产品西达本胺的外周T细胞淋巴瘤适应症专利，公司围绕西达本胺已形成化合物、晶 型、关键工艺、制剂、适应症等多项专利共同构建的专利保护体系，最长专利保护期已延长至2042年8 月30日。案涉专利属于西达本胺专利保护体系中的适应症专利之一,该适应症专利被宣告无效，并不意 ...

Company Overview - Microchip Biotech Co., Ltd. is located in Shenzhen, Guangdong Province, and was established on March 21, 2001. The company went public on August 12, 2019. Its main business involves providing affordable and urgently needed innovative molecular entity drugs for patients [1]. Financial Performance - As of the latest report, Microchip Biotech's stock price increased by 5%, reaching 36.74 CNY per share, with a trading volume of 458 million CNY and a turnover rate of 3.12%. The total market capitalization stands at 14.982 billion CNY [1]. - The revenue composition of the company is as follows: 75.92% from Sidabone, 21.30% from Siglitazone, 2.04% from other supplementary products, 0.37% from other sources, and 0.36% from technology licensing [1]. Fund Holdings - According to data from the top ten heavy stocks of funds, Huatai Baoxing Fund has a significant holding in Microchip Biotech. The Huatai Baoxing Kelong A (009124) fund held 53,000 shares in the second quarter, accounting for 2.49% of the fund's net value, making it the third-largest heavy stock. The estimated floating profit today is approximately 92,800 CNY [2]. - The Huatai Baoxing Kelong A fund was established on May 11, 2020, with a current scale of 20.8067 million CNY. Year-to-date returns are 7.5%, ranking 5711 out of 8178 in its category. Over the past year, the return is 12.91%, ranking 6293 out of 7978, and since inception, the return is 33.71% [2]. Fund Management - The fund managers of Huatai Baoxing Kelong A are Zhou Yongmei and Chen Qiwei. As of the latest report, Zhou Yongmei has a cumulative tenure of 7 years and 214 days, managing assets totaling 8.897 billion CNY, with the best fund return during her tenure being 43% and the worst being -1.86% [3]. - Chen Qiwei has a cumulative tenure of 2 years and 80 days, managing assets totaling 24.594 billion CNY, with the best fund return during his tenure being 19% and the worst also being -1.86% [3].

Group 1 - The core viewpoint of the news is the performance and financial status of Microchip Biotech, which saw a stock price increase of 5.01% to 38.38 CNY per share, with a total market capitalization of 15.651 billion CNY [1] - Microchip Biotech's main business involves providing affordable, urgently needed innovative molecular entity drugs, with revenue composition being 75.92% from Sidabone, 21.30% from Siglitazone, and 2.04% from other sources [1] - The company is located in Shenzhen, Guangdong Province, and was established on March 21, 2001, with its listing date on August 12, 2019 [1] Group 2 - From the perspective of fund holdings, Minsheng Jianyin Fund has one fund heavily invested in Microchip Biotech, specifically the Minsheng Jianyin Selected Mixed Fund (690003), which reduced its holdings by 16,300 shares in the second quarter [2] - The Minsheng Jianyin Selected Mixed Fund currently holds 61,000 shares, accounting for 3.98% of the fund's net value, ranking it as the ninth largest holding [2] - The fund has achieved a year-to-date return of 50.88% and a one-year return of 73.04%, with a total fund size of 36.408 million CNY [2]

Core Viewpoint - MicuBio reported a significant improvement in its financial performance for the first half of 2025, with revenue growth exceeding 30% and a return to profitability, driven primarily by the sales increase of its innovative drugs [2][3]. Financial Performance - MicuBio achieved revenue of 407 million yuan, representing a year-on-year growth of 34.56% [2]. - The company recorded a net profit attributable to shareholders of 29.59 million yuan, marking a turnaround from previous losses [2]. Product Performance - The sales of the two innovative drugs, Westadbenamide and Siglitazone, saw substantial growth, with sales increasing by 125.70% and 15.14% respectively [3]. - Siglitazone is recognized as the world's first PPAR full agonist and has been included in the national medical insurance directory for two consecutive years [2][3]. Market Expansion - MicuBio has expanded its sales channels significantly, covering over 5,300 hospitals and 6,700 pharmacies nationwide for Siglitazone [3]. - The company is also accelerating its online channel presence through platforms like JD.com, Alibaba, and Meituan [3]. Research and Development - MicuBio is advancing multiple projects in clinical development and preclinical research across five major areas: malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antiviral treatments [3][5]. - The company is prioritizing the promotion of Siglitazone for Type 2 diabetes patients with MASH/MAFLD based on existing clinical trials and real-world evidence [5]. Future Prospects - Analysts expect continued revenue growth for MicuBio as new indications for Westadbenamide are launched, and Siglitazone sales increase [5]. - The company is actively pursuing international clinical and commercial collaborations for Westadbenamide and exploring licensing opportunities for other products [5]. Industry Context - The domestic innovative drug sector has seen a surge in overseas licensing deals, with 97 transactions completed by June, reflecting a 45% year-on-year increase [6]. - The total contract value for overseas licensing deals reached $44.2 billion, accounting for approximately 82% of the projected total for 2024 [6].

Group 1 - The company achieved operating revenue of 407 million yuan in the first half of 2025, a year-on-year increase of 34.56% compared to 302 million yuan in the same period last year, and turned a profit with a net profit attributable to shareholders of 29.59 million yuan, marking a turnaround from losses [1] - The core product, Seglitazone, saw a doubling in sales revenue, with sales continuing to grow after the approval of Sitarabin for the treatment of DE-DLBCL patients in April 2024, despite a 15% reduction in its medical insurance price at the end of 2024, resulting in a year-on-year sales revenue increase of 15.14% in the first half of 2025 [1] - Seglitazone's sales revenue experienced rapid growth after its approval in July 2024 for use in combination with Metformin for type 2 diabetes, with a year-on-year increase of 125.7% in the first half of 2025 [1] Group 2 - The clinical trial data for Xioroni in first-line treatment of pancreatic cancer is promising, with a 6-month progression-free survival (PFS) rate of approximately 80%, compared to 44%-56.4% for standard chemotherapy, indicating strong anti-tumor activity [2] - The company has developed a series of candidate drug molecules based on its AI-assisted design and chemical genomics integration platform, including CS08399 (potential BIC brain-penetrating PRMT5 molecule), CS1011 (fibrosis disease inhibitor), CDCS04 (FIC molecule targeting genetic risk factor ApoE4 for Alzheimer's), and CDCS28 (non-incretin weight loss small molecule) [2] - The company has raised its revenue forecasts for 2025-2027 to 880 million, 1.35 billion, and 1.787 billion yuan, with net profits of 57 million, 171 million, and 333 million yuan respectively, maintaining a "buy" rating with corresponding price-to-sales ratios of 17.4, 11.3, and 8.6 times [2]

Core Insights - The company reported a significant increase in revenue and net profit for the first half of 2025, with total revenue reaching 407 million yuan, a year-on-year increase of 34.6%, and a net profit of 29.59 million yuan, successfully turning around from losses [1] - The growth in performance is primarily driven by two core products, with significant expansion in indications [2] - The company is actively pursuing business development opportunities and has a strong pipeline of innovative drug candidates [4] Financial Performance - For Q2 2025, the company achieved revenue of 244 million yuan, a year-on-year increase of 42.4%, and a net profit of 48.75 million yuan [1] - The company forecasts revenues of 907 million, 1.402 billion, and 2.265 billion yuan for 2025-2027, with growth rates of 37.87%, 54.58%, and 61.54% respectively [4] Product Performance - Sales of the drug Xidabena increased by 15.14% during the reporting period, with its DLBCL indication included in medical insurance from January 1, 2025, leading to sustained sales growth [2] - Sales of the drug Siglitazone surged by 125.7%, with coverage extending to over 5,300 hospitals and 6,700 pharmacies nationwide [2] Clinical Development - The clinical progress of Xidabena in treating cold tumors is promising, with a 6-month PFS rate of approximately 80% in a Phase II trial for pancreatic cancer [3] - Ongoing clinical trials for Xidabena in combination with immunotherapy for colorectal cancer and melanoma are progressing well [3] Research and Development - The company is leveraging an AI-assisted design and chemical genomics integration platform to focus on oncology and metabolism, while also exploring opportunities in neurodegenerative and autoimmune diseases [4] - A series of drug candidates with first-in-class potential are in the pipeline, which could form the core value of the company in the future [4]

Summary of Key Points from the Conference Call Company Overview - **Company**: 微芯生物 (Microchip Biotech) - **Industry**: Biotechnology, specifically focusing on innovative drug development for cancer and metabolic diseases Core Insights and Arguments 1. **Sales Growth**: In the first half of 2025, total sales increased by 126% year-on-year, driven by strong growth in 西格列他纳 (SGLT2 inhibitor) and expansion of online and offline channels [2][3] 2. **西达本胺 (Sydanib) Performance**: Sales of 西达本胺 grew by 15% year-on-year despite a 15% price reduction at the beginning of the year, with expectations for continued growth due to the normal release of DLBCR next year [2][3] 3. **Clinical Trial Success**: The phase II clinical trial of 西奥罗尼 (Xiaoroni) for pancreatic cancer showed a 6-month PFS rate of 79.7%, significantly higher than standard therapies, with good safety profiles [2][6] 4. **Global Clinical Development**: The company is actively advancing global clinical development and business cooperation for 西罗尼 (Xiaoroni) in pancreatic cancer and plans to develop ORL b inhibitor CS231,295 for brain tumors [2][9] 5. **Focus on HDAC Pathway**: The company is focusing on the combination of 西达本胺 and immunotherapy for colorectal cancer and melanoma, with phase III trials ongoing and data expected in Q1 2026 [2][10] 6. **New Drug Development**: New drugs NW001 (PD-1/Sydanib ADC) and CS23,546 (oral PD-1 small molecule) are in development, showing superior preclinical results compared to PD-1 antibodies [2][13] Additional Important Insights 1. **Financial Health**: The company reported a revenue of 410 million yuan in H1 2025, a 35% increase, and achieved a net profit of approximately 29.59 million yuan, marking a 173% year-on-year improvement [3] 2. **Market Strategy**: The explosive growth of 西格列他纳 is attributed to the company's decision to take back commercial promotion rights from a previous partner, allowing for better market coverage [17] 3. **Alzheimer's Disease Research**: The company is developing CDCS04, targeting the APOE4 gene, which is linked to Alzheimer's disease, showing protective effects on nerve axons and strong blood-brain barrier permeability [4][14] 4. **Metabolic Disease Projects**: The company is focusing on GLP-1 class drugs, with promising candidates CDCS2,828 and CDCS2,829 showing good weight loss effects without muscle loss [15] 5. **Future Plans**: The company aims to maintain strong sales growth for 西格列他纳 and continue advancing clinical trials for various drugs, with a focus on expanding into international markets [16][22] Conclusion The conference call highlighted 微芯生物's strong sales performance, promising clinical trial results, and strategic focus on innovative drug development in oncology and metabolic diseases, positioning the company for future growth and market expansion.

Core Viewpoint - Microchip Biotech (688321) reported significant growth in revenue and profitability for the first half of 2025, indicating a strong performance in the innovative drug sector [1] Financial Performance - The company achieved a revenue of 407 million yuan, representing a year-on-year increase of 34.56% [1] - Net profit attributable to shareholders was 29.59 million yuan, marking a substantial turnaround from losses [1] - Net cash flow from operating activities reached 62.06 million yuan, an increase of 299.15% compared to the end of the previous year [1] Product Portfolio and Market Presence - Microchip Biotech has two innovative drugs with multiple indications globally marketed, focusing on oncology, metabolic diseases, autoimmune diseases, central nervous system diseases, and antiviral fields [1] - The sales revenue for the drug Sidabamine grew by 15.14%, while the drug Siglitazone saw a remarkable increase of 125.7% [2] - Sidabamine has been included in the national medical insurance catalog for eight consecutive years and has received approvals for various indications in China, Japan, and Taiwan [1] - Siglitazone is also included in the national medical insurance catalog and has shown efficacy and safety in treating type 2 diabetes and fatty liver disease [1][2] Production Capacity and Expansion - The company is actively expanding its production capacity to meet growing market demand, with its subsidiary Chengdu Microchip Pharmaceutical passing GMP compliance checks for the production line of Siglitazone [2] - The construction of the Pengzhou Microchip Innovative Drug Manufacturing Base is progressing as planned, with a new capacity of 1.2 billion tablets for Siglitazone expected [2] Future Growth Catalysts - Future revenue growth is anticipated from the continuous launch of new indications for Sidabamine, increased sales of Siglitazone, and the approval of the drug Xioloni for pancreatic cancer [3] - Key catalysts include the market expansion of Siglitazone, data from Xioloni for pancreatic cancer, and presentation of Sidabamine data at ESMO [3]

Core Insights - Shenzhen Micron Biotechnology Co., Ltd. reported a revenue of 407 million yuan for the first half of 2025, representing a year-on-year growth of 34.56% and a net profit of 29.59 million yuan, marking a turnaround from losses [1] - The growth in performance is primarily attributed to increased sales of its innovative drugs, namely Sidabenan and Siglecatin [1] Company Overview - Micron Biotechnology is a pioneer in China's original innovative drug sector, focusing on creating globally competitive product lines driven by core technologies [1] - The company adheres to the philosophy of "original, safe, effective, and Chinese," aiming to provide revolutionary therapeutic drugs that meet clinical needs [1] - It has established a complete industrial chain from early exploratory discovery to commercialization, offering original innovative drugs to global patients [1] Product Pipeline - The company has developed two innovative drugs that are globally marketed, with multiple indications in areas such as malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antiviral treatments [1] - Sidabenan is the world's first subtype-selective histone deacetylase (HDAC) inhibitor, approved for multiple indications in China and Japan, and is undergoing clinical trials for additional indications globally [2] - Siglecatin is the first PPAR full agonist globally, included in the national medical insurance catalog, and shows efficacy in treating type 2 diabetes and fatty liver disease [2] Sales Performance - Sales revenue for Sidabenan and Siglecatin increased by 15.14% and 125.7% year-on-year, respectively [3] - Sidabenan has achieved coverage in major cities and hospitals across the country, while Siglecatin is available in over 5,300 hospitals and 6,700 pharmacies nationwide [3] - The company is accelerating its online channel presence through platforms like JD, Alibaba, and Meituan in response to changes in the pharmaceutical industry [3] Research and Development - Micron Biotechnology has multiple original innovative drug product lines, including several in clinical development and preclinical research stages, covering various disease areas with global first-in-class or differentiated advantages [3]