先声药业(2096.HK)2025年全年业绩发布会
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会议摘要
The 2025 performance conference of Xinsheng Pharmaceutical Co., Ltd. demonstrated the research and development and global expansion strategy of innovative drugs. The annual revenue was 7.7 billion yuan, the revenue of innovative drugs accounted for more than 80%, and the net profit increased significantly. It focuses on the clinical progress and market potential of innovative drugs in non-oncology areas, such as Deripin and Zepustinib, as well as global platform cooperation and sea-going strategies. The company has set a target of 20 billion yuan in operating income, 3 billion yuan in adjusted net profit and 4 billion yuan in research and development investment in 2030. Management highlighted R & D progress in neuroscience, oncology and self-immunity, and planned the listing of its oncology subsidiary, demonstrating its determination to continue innovation and globalization.
会议速览
Newborn Pharmaceuticals 2025 earnings conference announced that the full-year revenue exceeded 7.7 billion yuan, innovative drug revenue accounted for more than 80%, the parent net profit increased significantly. The meeting interpreted the business performance, research and development progress and medium-and long-term planning, and emphasized the company's high-quality development strategy driven by innovation and research and development.
The board highly values the new CEO's political integrity and industry experience, and believes that his leadership will help effectively implement the company's innovation and transformation strategy. The new CEO reviews his professional experience, emphasizes the importance of learning and change, and looks forward to the company's steady development under his leadership and a better future.
The company achieved revenue 7.731 billion in 25 years, up 16.5 percent year-on-year, revenue from innovative drugs 6.3 billion, up 28 percent year-on-year, and net profit attributable to the parent company 1.3444 billion, up 86 percent year-on-year. The fields of neuroscience and anti-tumor have grown significantly, and the autoimmune field has slowed down due to the impact of collection. The company has set a 26-year revenue and net profit growth target of 30% each, with the neurological sector, insomnia medicine Kovic, tumor treatment and external licensing as the growth drivers.
He reported on the important progress of pharmaceutical research and development in 2025, including the application of several new drugs, the promotion of clinical trials and the expansion of the pipeline of innovative drugs. The focus is on the treatment strategy of the core tumor species in the tumor field, as well as the significant improvement of the research and development pipeline in the non-tumor field. Looking forward to 2026, we will continue to promote the research and development of innovative drugs and strengthen the potential for the combination of tumor and non-tumor disease treatments.
Drug development strategies in the field of autoimmune diseases and neuroscience are discussed, including the application of new drug forms such as bispecific antibodies and ADCs, as well as disease repair targets based on precision immunoassays. The importance of personnel data in the screening of neurological disease targets and the potential of innovative delivery platforms in the treatment of neurological diseases are highlighted.
CM0270 shows the curative effect of the whole population in the treatment of breast cancer, Sim 0237 bispecific molecule shows excellent performance in non-primary origin bladder cancer, Deripin anti-interleukin four receptor monoclonal antibody shows the advantage of deep relief in the treatment of atopic dermatitis, all three products are in the late clinical stage, and are expected to become innovative therapies in their respective fields.
The dialogue elaborated on the excellent efficacy and marketing plan of the new generation of oral inhibitor zepuxitinib in the treatment of type wind, as well as the potential of the white-mediated receptor in cross-indication. In addition, the TC multi-antibody, ADC and next-generation IO platforms built in the field of oncology are also introduced, emphasizing the innovative advantages of differentiated CD3 agonist, non-cytotoxic toxoids and three-specific molecular projects. At the same time, the long-term design of the antibody platform in the non-tumor field and the high-efficiency CNS delivery technology in the neural field are discussed, and the importance of the technology platform for high-quality clinical molecular output and normalization of external licensing is demonstrated.
The meeting reviewed the company's performance in 2025, with innovative drugs accounting for 81% of revenue, research and development investment accounting for 27% of revenue, and strong cash flow from operating activities. At the same time, looking forward to 2026, the company expects to add 9-12 RND and phase I clinical, a record high, and the external license revenue is expected to reach 0.154 billion US dollars, some of which will be confirmed in 2027. The company also proposed a profit distribution plan for 2025, with a distribution of 0.18 yuan per share, and plans to confirm a down payment income of 42 million euros in January 2026.
It reported Mr. Pharmaceutical's medium-and long-term development strategy in 2030, including the sales expectation of existing and future new varieties, the growth of BD cooperation and authorized income, as well as the business objectives and R & D investment plan, stressed the necessity of achieving high-speed growth under the changes of the industry, and invited analysts to ask questions.
The dialogue focused on the company's overseas strategy, emphasizing the achievements of Chinese innovative pharmaceutical companies in overseas markets and the deepening trend of international pharmaceutical companies' cooperation with China. Management said it would strengthen overseas clinical and registration capacity building, focus on core tracks, deepen global cooperation and build a global system to support the company's long-term international development.
This paper discusses the broad prospect of insomnia drug market, especially the sales potential and strategy of dora drug Kevico, emphasizes its unique mechanism and non-addictive advantages, and mentions the sales plans of hospital channel strengthening, chain coverage and e-commerce optimization. The latest monthly sales volume exceeds 40 million, and the future growth expectation is optimistic.
Discussed the C33-0500 molecular clinical progress of the collaboration with Abelway, including patient enrollment, efficacy and safety performance in the first ramp phase, and the timing of the $90 million milestone payment and revenue recognition. At the same time, the clinical progress of platinum two fusion protein 0278 is introduced, emphasizing its advantages in t rag activation and good safety. Several phase II clinical studies have been launched, and preliminary efficacy data are expected by the end of the year.
The consideration of cooperation with Boehringer Ingelheim and the expectation of 0709 double resistance progress, as well as BD introduction strategy and antiviral drug cooperation, emphasize the focus on high synergy areas and differentiated product introduction, target expansion of product matrix, and enhance the innovation pipeline.
Discussed the company's potential for external licensing in the field of tumor and non-tumor in 2026, including ABC's new toxin platform, TC platform, and 100-mediated 15PDL1 bispecific molecules, emphasizing the importance of the quality of external licensing and deep participation in overseas clinical development.
Discussed the impact of the 2026 health insurance catalog update on innovative drugs, especially the possibility of access to the first Bixin injection, sublingual tablets and new multi-class II sleeping pills. Under the expert recommendation system, the importance of product efficacy and patient base to the inclusion of medical insurance catalogue is emphasized, as well as the preparation and promotion strategy of enterprises for product access.
The reasons for the spin-off and listing of the new station residents are discussed, and the importance of resource focus, team focus and market opportunity seizing is emphasized. It is pointed out that the spin-off does not affect the holding position of New Pharmaceuticals, which is conducive to the development of both sides in the field of anti-tumor and protects the interests of investors.
Management detailed the Company's repurchase plan, which has been approved to 0.5 billion the repurchase quota in 2025 and plans to continue to submit a repurchase plan in 2026 in an amount of not less than RMB 0.5 billion. The company attaches importance to shareholder returns, promises to continue to innovate research and development, deepen product pipeline layout, expand global market cooperation, and give back to investors with high-quality products and performance.
要点回答
Q:What is the company's performance in 2025?
A:In 2025, Mr. Pharmaceutical achieved a full-year operating income of 7.731 billion yuan, up 16.5 percent year-on-year. Among them, the revenue of innovative drugs reached 6.3 billion, up 28% year on year, accounting for more than 80% of the total revenue. Net profit was 1.3444 billion, up 86% YoY. R & D investment was 2.08 billion, up about 36% year-on-year, and the growth rate reached a new high in recent years.
Q:What is the growth of sales revenue in each major area of the company?
A:In 2025, the company's three major areas-neuroscience achieved 2.75 billion sales revenue, with a year-on-year increase of 27%; anti-tumor field achieved about 2 billion, with a year-on-year increase of more than 50%; autoimmune field achieved 1.89 billion sales revenue, with a year-on-year increase of 4.5, but Affected by provincial centralized procurement. Compared with the data from 20 to 25 years, the revenue of innovative drugs has increased significantly, while the revenue of generic drugs and other drugs has decreased, which indicates that the company's revenue structure and quality continue to improve.
Q:What are the company's plans for future development?
A:The company has set a 26-year "double 30" development goal, that is, operating income will increase by 30% year-on-year, and the challenge will reach 10 billion; the adjusted net profit will increase by 30% year-on-year, achieving the goal of 1.6 billion yuan. The company is confident that it will achieve this goal through market and operational analysis, with core drivers including the growth of a range of products in the neurological sector such as the Xian Bixin series (injections and sublingual tablets), the new generation of insomnia drugs, and the growth of Enze Book in the oncology treatment sector, as well as the serialization and normalization of externally licensed projects.
Q:What are the developments and prospects in R & D?
A:In 25 years, the company has received market approval for two products, the anti-insomnia drug Kevic and the new generation of anti-epidemic VGF Enze book. At the same time, two new varieties have been submitted for listing, and a number of new clinical trials have been added, especially the research and development of innovative drugs and ADC small molecule drugs in the field of oncology has been greatly improved. At present, the company has a number of products in the late clinical and NDA stages that are expected to be launched in the near future, and the products in the early and clinical trial stages also show good efficacy and global competitiveness.
Q:Which solid tumors have your self-developed degrade of pa rus on been expanded in phase I clinical studies?
A:our pa rus on degrade is currently in the first phase of clinical study, mainly for a variety of solid tumors to expand, including but not limited to renal cancer, prostate cancer and so on.
Q:What is your R & D strategy in oncology?
A:In the field of oncology, our core research and development strategy is to focus on the core tumor species, starting from the tumor species to provide patients with a treatment rather than a single molecule. At present, many products in the lung, digestive tract, urinary system and other fields have entered the clinical or will enter the clinical stage.
Q:What are the advances in your non-oncology R & D pipeline?
A:The non-oncology research and development pipeline has been significantly thickened, with two drugs in the NDA and BIA phases awaiting approval, while a number of products have completed or are close to completing clinical Phase III studies, such as oral selective inhibitors and antiviral infection molecules.
Q:What is your R & D strategy in the area of immunity and neurology?
A:In the field of self-immunity, we hope to realize the transformation from symptom control to disease repair through cutting-edge technology and accurate immune analysis, and conduct in-depth research on molecules with multi-indication potential, focusing on disease-driving cytokines and key transcription factors, and using new generation biologics, ADC and protein degradation technology to different targets. In the field of neuroscience, we will rely on innovative targeted delivery platforms to focus on extremely difficult pharmaceutical diseases such as stroke, AD, Parkinson's disease, etc., to screen targets through human data and fully verify them in brain tissue or cell models related to human diseases.
Q:What is the progress of research and development in the field of wind-like customs?
A:At present, it is promoting an efficient selective new generation of JAK inhibitor zepusitib. As the first selective JAK1 inhibitor in China, this product has shown excellent curative effect and response rate in patients with moderate to severe wind-like customs. Relevant indications are expected to be submitted for listing this year, ranking the second in China.
Q:What is the specific data of your products in the later clinical stage?
A:The oral drug CM0270 is undergoing phase III clinical studies and is expected to become the first CDK4/6 inhibitor to be submitted for marketing in China, and to show the therapeutic potential of the whole population. In addition, the bispecific molecule SIM 0237 against non-basal origin bladder cancer also showed positive efficacy and the potential to be best in class.
Q:What is the performance of derapine, an anti-interleukin-4 receptor monoclonal antibody, in atopic dermatitis indications?
A:Data from Phase III clinical studies of derapine in atopic dermatitis indications show that its deep remission treatment indicators are better than similar benchmarks, and its safety is good. We are striving to make it the second domestic approved interleukin receptor antibody drug, and strive to be the first approved in asthma indications.
Q:What is the progress of the white medium two receptor as a potential product across indications?
A:The BCG fusion protein has achieved good results in phase I clinical trials, with increased activation and good safety, and does not activate T helper cells and other immune cells. Phase II clinical trials of AD have been laid out, and research on other indications has been promoted, and relevant clinical trials have been carried out with partners.
Q:In the field of oncology, what are the three platforms the company is building? What are the core competitive advantages of the TC multi-anti platform?
A:The three platforms we are currently building in the field of oncology are TC multi-anti platform, ADC platform and next generation IO platform. The core competitive advantage of the TC polyantibody platform is that we have a differentially designed CD3 agonist, combined with costimulatory factors, to construct a set of T cell-activated MIT, and combined with the validated 8-point combination. Our clinical products show the advantages of longer PK and lower CIS, and we are gradually expanding our research from hematological tumors to solid tumors.
Q:What are the core projects and characteristics of the next generation IO platform?
A:The core project of the next generation IO platform is PD one plus VEGF plus engineered cytokine trispecific molecules. This project can convert cold tumors ineffective by PDY inhibitors into hot tumors. Compared with in vivo verification, it shows better curative effect, higher tumor T cell infiltration and lower immunotoxicity.
Q:What is the focus of the ADC platform?
A:The ADC platform is an indispensable platform in the field of oncology, and we have four molecules in clinical development. However, the next generation of ADC is more likely to be realized in the new pillow. In addition to laying out a variety of new non-cytotoxic mechanism toxins, we also overcome tumor inhibition through dual-target design to expand the therapeutic window, and at the same time develop ADC with anti-VGF activity.
Q:In the non-oncology sector, how do companies build technology platforms?
A:In the non-tumor antibody platform, we pursue long-term design, extend the drug delivery cycle and reduce the risk of ADA, providing a convenient way of subcutaneous administration. In the neurological field, we focus on brain delivery technologies, such as the self-developed AUC project, to achieve efficient CNS delivery without the need for traditional intra-pry IT administration.
Q:What are the outstanding achievements of the company's technology platform in terms of systematic antidote?
A:Our systemic antidote significantly increased the rate of brain entry in primates and was evenly distributed to different parts of the brain, significantly reducing the risk of anemia associated with brain targets. Based on these technology platforms, we are expected to produce high-quality clinical molecules and achieve external licensing, while also promoting platform cooperation.
Q:What are the company's globally competitive molecules in the field of oncology?
A:The company's globally competitive molecules include clinical-stage PD one white medium 15 bispecific molecules, MTI-based ADCs, etc. These molecules exhibit good cell-killing effects and proliferation dependence in the treatment of bladder cancer, TC, and the like.
Q:What is the company's potential for external licensing in the field of oncology in 2026?
A:In 2026, the company expects to have three newly approved Ksera indications for expansion, as well as four new listing applications, four clinical phase III top-line data publications, and a number of mid-early clinical and new RNT phase projects to start. In addition, the Company will add 9 to 12 new RNDs and Phase I clinical studies, both record highs.
Q:For the company's overall operating performance, can you share the main data?
A:In 2025, the company's revenue reached 7.7 billion, up 16.5 percent year-on-year, and its net profit was 1.34 billion, up 86 percent year-on-year. R & D investment was 2.08 billion, up about 36% YoY. Although the sales expense rate and management expense rate decreased steadily, the net cash flow from operating activities was 2.01 billion, an increase of 45% year-on-year.
Q:What is the company's plan for future globalization?
A:Based on the seven new varieties approved in the past five years plus the original innovative drugs, the company will divide the ten innovative drugs into two categories: steady growth and rapid release, with peak sales expected to exceed 7 billion and 8.5 billion respectively. In addition, more varieties will be listed in the next three years. At the same time, the BD department is also actively introducing new varieties, and the total amount of authorized transactions has exceeded 4.6 billion. Based on this, the company has formulated a medium-and long-term development goal for 2030. It is expected that operating income will exceed 20 billion, adjusted net profit will exceed 3 billion, and R & D investment will exceed 4 billion.
Q:In the past 25 years, how many Chinese innovative pharmaceutical companies have entered into authorized cooperation with overseas companies? What are the characteristics and trends of these cooperation?
A:According to incomplete statistics, in the past 25 years, about 54 Chinese innovative pharmaceutical companies have conducted authorized cooperation with overseas. China's innovative drugs have achieved remarkable results, especially at the Morgan Stanley conference in January, when large international pharmaceutical companies (such as MAC) and other overseas companies paid great attention to China's innovative drugs. The mode of cooperation has shifted from simple single product authorization to platform cooperation and strategic R & D cooperation.
Q:How will Mr. Pharmaceutical further strengthen the capacity building of overseas clinical research and registration?
A:Mr. Pharmaceutical plans to build the core capabilities to support the company's long-term international development by strengthening overseas clinical and registration capacity building. Next, the company will gradually enhance its strength in overseas clinical trials and registration, and carry out strategic upgrades around three major directions: deepening the core track and building a global high-quality pipeline; Continue to focus on superior treatment areas, increase innovative research and development efforts, and launch innovative drugs with global competitiveness; Deepen global cooperation, carry out authorization and joint development with top pharmaceutical companies, reduce the risk of going to sea with the help of partner resources, and quickly open up the international market, and gradually enhance the ability of independent global development, build a global system, set up a professional clinical team and registration team, layout of overseas commercial network.
Q:Can you share the market potential of insomnia drug Dora products and the key operating indicators and sales trends in 2026?
A:Insomnia medicine market has a broad space, especially Dora drugs, because of its unique mechanism of action, non-addictive, can improve daytime function, effectively improve sleep duration and quality, not only can seize the traditional insomnia medicine market, but also has the potential to replace melatonin health products and soothing brain products. At present, the company is promoting the origin of Dora products to reduce costs, which is conducive to the sustained and steady growth of products. For the key operating indicators and sales dynamics in 2026, the company will strengthen the academic promotion of hospital channels, establish the concept of drug use, and strengthen the chain channel coverage and e-commerce sales to facilitate patients to purchase drugs. The latest data show that the monthly sales of Dora drugs have exceeded 40 million, and the company will continue to resume its sales strategy and is expected to further improve.
Q:Could management please update the clinical progress, down payment and milestone achievement, cash arrival and revenue recognition point of the C33-0500 molecule in collaboration with Abelway? What is the clinical progress and performance of the platinum 2 fusion protein 0278 molecule, as well as the latest progress of related clinical trials?
A:The C33-0500 is undergoing the first phase of ramp-up, with simultaneous dose ramp-up in China and the United States, and about 40 patients have been enrolled. Clinical data show that in the case of significantly lower than the competing dose, its effectiveness shows a good trend, CR and PR response rate is very high, the safety is also relatively good. Subcutaneous administration of the drug by special CD3 design, showed a good PK trend. At present, the project has entered the optimization stage of exploring the administration cycle once a month, and has maintained good communication with FV, and actively promoted the research on the combination of immunomodulatory drugs. According to the contract, a total of US $90 million has been paid for the down payment and the second milestone in the previous period, and all milestones are expected to be completed around 2027. The 0278 project has demonstrated significant advantages in the field of T-activated diseases, with a better multiple of t rag activation and good safety in clinical trials completed in the United States and China. The company has initiated multiple clinical phase II studies, including domestic atopic dermatitis and overseas alopecia areata, and is also actively studying other t reg therapies. Preliminary efficacy data are expected to be released by the end of this year, so stay tuned.
Q:Why did Mr. Pharmaceutical choose BI as the partner and what are its expectations for the potential progress of future 0709 projects?
A:The cooperation between Mr. Pharmaceutical and BI is based on the in-depth understanding and complementarity of the advantages of both parties, and the details of the cooperation are not detailed here. In addition, Mr. Pharmaceuticals continues to implement the BD in strategy and recently reached a cooperation with Boehringer Ingelheim on the SM0709 double resistance. The company will update the cooperation of antiviral drugs in due course.
Q:Can you please ask the management to help us introduce the potential pipelines for external authorization in 2026 and whether there will be a possibility of cooperation with MAC's potential strategy and platform?
A:Okay, thank you, Mr. Yu. I made some introductions in the film. Our external licensing is undergoing a transformation from early sporadic unplanned external licensing to clinical plus platform external licensing. In the tumor field, the focus is on ABC's new toxin platform, TC platform and 100-mediated 15PDL1 bispecific molecule. In the non-tumor field, there are many potential molecules such as oral protect and self-immunized brain a beta double antibody, as well as long-term subcutaneous injection of CDR2 monoclonal antibody. In addition, advanced sublingual tablets have been recognized as a breakthrough therapy in the United States in the non-tumor field, and are expected to help stroke and progressive freezing patients overseas. In 2026, we will continue to carry out external licensing, focusing on the quality of external licensing and deep participation in overseas clinical development.
Q:Looking forward to the update of the new version of the minutes catalog and instrument catalog by 2026, what products are expected to benefit from the company?
A:The first is the new version of the summary catalogue, because the relevant policies to encourage innovative drugs in hospital access, clinical use and grass-roots promotion, into the summary catalogue will greatly increase the use of products and sales. For example, the first Bixin injection, because of its curative effect, widely used and has a good application basis, has the conditions to be included in the new version of the summary catalog. For the update of the health insurance catalogue, the new sublingual tablets and Keweico (new multi-class second-class sleeping pills) are expected to be included, because their large patient base will significantly enhance the accessibility of the product.
Q:Why did you choose to spin off the new stationer plan in Hong Kong, and how will the spin-off help the entire new drug industry and the subsequent development of the first in Min?
A:The main reason for choosing to spin off the new station plan in Hong Kong is that the tumor field is a field with great opportunities, high R & D investment and fierce competition, and resource focus and team focus are very important. After the spin-off, the freshman station team can feel the market competition more directly, which is conducive to the team's agility to grasp market opportunities and promote its continuous learning and growth. At the same time, the spin-off does not affect the company's controlling position in Xinsheng Station, and it is expected that the statements will be consolidated in the future. This move is conducive to the sustainable development of Xinsheng Station in the anti-tumor field, and is also in the common interests of investors and shareholders.
Q:What is our buyback plan for this year? Can we expect this year's buyback?
A:The company, which has always attached great importance to shareholder returns, has spent RMB 0.45 billion on share buybacks in the past two years and has written off repurchased shares. At the 2025 Annual General Meeting of Shareholders, the General Meeting of Shareholders approved a repurchase quota of 0.5 billion RMB, and there is still nearly 0.4 billion RMB remaining that can be used before the 2026 Annual General Meeting of Shareholders. The company plans to continue to submit a share repurchase plan at the 2026 annual general meeting of shareholders, and the amount is not expected to be less than RMB 0.5 billion.

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