Shuanglu Pharmaceutical: Menerima survei institusional pada 7 April, dengan partisipasi dari banyak institusi seperti Western Securities dan Invesco Great Wall

Securities Star News, 7 April 2026, Shuanglu Pharmaceutical (002038) announced that the company accepted institutional research on April 7, 2026, with participation from Western Securities, Invesco Great Wall, and China Merchants Asset Management.

The specific content is as follows:

Q: Please introduce the company’s production and operation situation.

A: In recent two years, due to factors such as the inclusion of main varieties into centralized procurement and the increase in new products listed, the product structure has changed. The main varieties include Temozolomide capsules, Lenalidomide capsules, and Oxytocin injections, which have been included in national centralized procurement or continued after procurement expiration, with significant price reductions. Several biological products and other varieties participate in regional alliance procurement, with some price declines. This has had a considerable impact on the company’s performance in the past two years. The company’s product structure has transitioned from mainly supporting performance with large varieties to supporting with multiple varieties. Newly launched products such as Voriconazole, Vogliptin, and Ipratropium have benefited from procurement, with rapid volume increases after winning bids. Products like Dihydroartemisinin, Telmisartan, Cyclosporin injections, and Octreotide injections, which are under continued procurement, are also gradually increasing in volume. As the company’s subsequent new products like PEG-human granulocyte colony-stimulating factor injections (3mg/ml, 6mg/ml) are approved, the sales proportion of biological products in the company’s product structure will continue to grow. The impact of centralized procurement will gradually weaken, and market share of new advantageous varieties will steadily increase.

Q: Please introduce the progress of the company’s innovative drug R&D?

A: The company’s current key innovative drug varieties under research include multiple projects. The ones already submitted for registration are long-acting recombinant human FSH injection (Long-acting FSH), GLP-1-Fc fusion protein (Dulaglutide), and PEG-human granulocyte colony-stimulating factor injections (3mg/ml, 6mg/ml). Key varieties in Phase II and III clinical research include DT678, MBT-1608, Degludec insulin, PHP0101, etc. Currently, four biopharmaceuticals are in the application and review stage for listing, and 18 chemical drugs are in development.

Q: Please introduce the current clinical progress of Thienopyridine Disulfide Coupling Compound Mixture (DT678)).

A: This compound is jointly developed by DT Company, invested by the University of Michigan, and our company. We hold exclusive rights for its development and use in China. The overseas development rights belong to DT, which holds 30% equity. The product has entered Phase II clinical trials. It is the world’s first innovative drug in the antiplatelet aggregation field, a more suitable version of clopidogrel for Asians, which does not require hepatic P450 enzyme metabolism, making it more suitable for Asian populations. It acts quickly, has fewer side effects, and demonstrates strong competitiveness.

The Phase I clinical study of DT678 tablets for single and multiple doses used healthy volunteers. Results show that DT678 tablets and clopidogrel tablets both inhibit platelet aggregation, with effects increasing with dosage. Multiple dosing results indicate that the PK parameters of MP-H4 (active metabolite) show linear kinetics with dose. Pharmacodynamically, 6mg DT678 tablets have a higher inhibitory effect on platelet aggregation than 3mg and are close to positive control (clopidogrel). Safety after single and multiple doses is good. The Phase II study is titled “Efficacy, Safety, and Pharmacokinetics of DT678 Tablets in Patients with Non-ST Elevation Acute Coronary Syndrome Undergoing PCI,” using a randomized, open-label, positive drug-controlled parallel design, aiming to evaluate efficacy, safety, and pharmacokinetics in NSTE-ACS patients (including unstable angina and NSTEMI). Domestic data suggest about 14% of patients are slow metabolizers. The leading hospital is Peking University First Hospital. Currently, five centers are involved, with plans to add more. To date, 50 subjects have been enrolled and are ongoing.

Q: Please introduce the newly launched product Nitroglycerin Spray.

A: Currently, the company’s Nitroglycerin Spray, as a domestically exclusive formulation, has good market prospects. It is important for rapid relief in angina and myocardial infarction emergencies. Compared to lozenges and inhalers, it is more convenient, faster-acting, and safer. In recent years, the incidence of sudden cardiac death due to myocardial infarction has increased annually, with a trend toward younger patients, mainly related to high stress, irregular diet, and lifestyle. There are about 330 million cardiovascular disease patients in China, including approximately 11 million with coronary heart disease, and angina patients need to keep emergency medication ready. We believe this product has strong market potential. The company will develop targeted promotion strategies for different terminals and populations, increase promotional efforts through academic conferences, clinical trial data sharing, and expert consensus to convey product value. The company will also strengthen cooperation with various sales channels to improve market coverage and public awareness. The goal is to establish this product as a flagship brand and lead in the emergency treatment field.

Q: Please forecast the company’s operating performance for 2026 and 2027.

A: The company’s performance in the next two years depends on the volume of newly launched products in the past two to three years and the speed of approval for new products. Based on sales data from January to February, the top 10 products by sales include Voriconazole tablets, Dihydroartemisinin injection, and Telmisartan tablets. Newly launched products like Ipratropium, Vogliptin, and Cilostazol capsules have entered the top 20. Continued procurement products such as Paclitaxel injections, Calcium folinate injections, and Cyclosporin injections are also significant. As the impact of price reductions from procurement gradually diminishes, the company’s special medicines like arsenic trioxide and exclusive varieties will occupy an increasingly important position, becoming the main products. The newly launched exclusive formulation Nitroglycerin Spray is also being promoted. The approval of biological products like PEG-human granulocyte colony-stimulating factor injections (3mg/ml, 6mg/ml) and long-acting FSH will further support performance. These will be key drivers for future growth.

Q: Which companies does the company currently hold equity investments in that are publicly listed?

A: Currently listed companies include Changfeng Pharmaceutical (3.68%) on the Hong Kong Main Board, Xuanzhu Biological (0.34%), and domestically listed companies such as Shouyao Holdings (4.28%), Xinghao Pharmaceutical (6.34%), and Xinlilun (not directly held). The company holds 55.69% equity in Jiaxing Yihe Equity Investment Fund Partnership (Limited Partnership), indirectly owning Beijing Xinlilun Health Industry Group Co., Ltd. Jiaxing Yihe is the largest shareholder of Xinlilun (stock code 002219). The company also holds 49% equity in Beijing Xinlilun Medical and Health Management Co., Ltd., a subsidiary of Xinlilun Group, which possesses high-quality medical resources. According to Xinlilun’s disclosures, the company needs to complete the acquisition of its subsidiary within the stipulated timeframe.

Q: Please introduce the progress of the US joint venture ATGC’s therapeutic antibody development platform based on transgenic rabbits.

A: The company’s US joint venture TGC possesses gene editing and related technologies for transgenic rabbit production, currently the only platform worldwide capable of developing therapeutic antibodies from transgenic rabbits. Since establishment, TGC has used these core technologies to build a therapeutic antibody platform (RbTx) based on transgenic rabbits. Over 90% of the rabbit immune system humanization tasks have been completed. There is also one product targeting immune cells, a humanized rabbit polyclonal antibody, in preclinical development. After the platform is established, the company plans to develop 1-3 “blockbuster” antibodies focusing on cancer immunotherapy and autoimmune diseases within 3-5 years, completing preclinical studies. Once operational, the RbTx platform will accelerate antibody drug development, offering new options with high affinity, high specificity, and low immunogenicity, greatly improving product quality. It will also provide an alternative to existing mouse platforms, breaking the monopoly of a few multinational companies on advanced antibody technologies. The platform can be used for emergency development and application of humanized antibodies for infectious diseases. Currently, TGC’s overseas collaborations and technology imports are progressing simultaneously. During the research, the company strictly followed disclosure regulations and did not leak any major undisclosed information.

Shuanglu Pharmaceutical (002038) mainly focuses on the research, development, production, and operation of genetic engineering and related drugs, closely aligned with disease spectrum changes in layout, R&D, manufacturing, and service fields.

Shuanglu Pharmaceutical’s 2025 Q3 report shows that in the first three quarters, main revenue was 459 million yuan, down 15.13% year-on-year; net profit attributable to parent was 141 million yuan, up 943.1%; non-recurring net profit was 29.33 million yuan, down 62.39%. In Q3 2025 alone, revenue was 154 million yuan, up 3.63%; net profit attributable to parent was 20.05 million yuan, up 143.28%; non-recurring net profit was 3.33 million yuan, up 107.83%. The debt ratio is 5.44%, investment income is 12.16 million yuan, financial expenses are -3.85 million yuan, and gross profit margin is 61.6%.

Margin trading data shows that in the past three months, net financing inflow was 22.4 million yuan, with an increase in margin balance; net securities lending inflow was 1.83 million yuan, with an increase in securities lending balance.

The above content is compiled from public information by Securities Star, generated by AI algorithm (Network Information Verification No. 310104345710301240019), and does not constitute investment advice.