Shuanglu Pharmaceutical: On April 7th, it received institutional research, with multiple institutions including Western Securities and Invesco Great Wall participating.

Securities Star News, on April 7, 2026, Shuanglu Pharmaceutical (002038) issued an announcement stating 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:

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

Answer: In recent two years, due to factors such as the inclusion of main products in centralized procurement and the increasing number of new products launched, the product structure has changed. The main products, such as Temozolomide capsules, Lenalidomide capsules, and Ornidazole injections, have been included in national centralized procurement or follow-up bidding after expiration, with significant price reductions. Several biological products participate in regional alliance procurement, also experiencing certain price declines, which have 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 in the past to supporting with multiple varieties. Newly launched products like Voriconazole, Vogeletolose, and Ipratropium have quickly increased sales after winning bids in procurement. Products such as Dihydroartemisinin, Tamsulosin, Cyclosporin injections, and Octreotide injections, which are also part of ongoing procurement renewals, are gradually increasing in volume. As the company’s subsequent new products, such as PEGylated 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 procurement will gradually weaken, and market share of new advantageous varieties will steadily increase.

Question: Please introduce the progress of the company’s innovative drug R&D.

Answer: The company’s key innovative drugs under research include several varieties. Currently, the registered applications submitted include Long-acting Recombinant Human FSH injection (Long-acting FSH), GLP-1-Fc fusion protein (Dulaglutide), and PEGylated Granulocyte Colony-Stimulating Factor injections (3mg/ml, 6mg/ml). Key varieties in Phase II and III clinical research include DT678, MBT-1608, Degludec insulin, and PHP0101. Currently, the company has 4 biological drugs in the application for listing review and approval, and 18 chemical and biochemical drugs.

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

Answer: This compound is co-developed by DT, a company in Michigan, USA, in which our company holds a stake, and our company owns exclusive development rights for this patented compound in China. The development rights for overseas markets belong to DT, in which our company holds 30% equity. The product has entered Phase II clinical trials. It is the world’s first innovative drug in the field of antiplatelet aggregation, a more suitable form of Clopidogrel for Asians, which does not require hepatic P450 enzyme metabolism, making it more suitable for Asian populations. It also 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-dose results indicate that the PK parameters of MP-H4 (active metabolite) show linear dose-dependent kinetics. Pharmacodynamically, 6mg DT678 tablets have a higher inhibitory effect on platelet aggregation than 3mg and are close to the positive control group with Clopidogrel. Safety after single and multiple doses is good. The Phase II clinical study is designed as a randomized, open-label, positive drug-controlled parallel trial to evaluate the efficacy, safety, and pharmacokinetics of DT678 tablets in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) scheduled for PCI, including unstable angina and NSTEMI. The study is led by Peking University First Hospital, with currently five research centers participating, and plans to expand further. The enrolled subjects number 50, and recruitment is ongoing.

Question: Please introduce the newly launched product Nitroglycerin Spray.

Answer: Currently, the company’s Nitroglycerin Spray, as a domestically exclusive formulation, has promising market prospects. It is crucial for rapid relief during angina and myocardial infarction emergencies. Compared to lozenges and inhalers, the spray is more convenient, acts faster, and has higher safety. In recent years, the incidence of sudden cardiac death due to myocardial infarction has increased annually, with a clear trend of 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 at hand. We believe this product has strong market potential. The company will develop targeted promotion strategies for different terminal points and populations, increase promotional efforts through academic conferences, clinical trial data sharing, and expert consensus to convey product value. Additionally, the company will 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.

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

Answer: 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 and market entry of newly approved products. Based on sales data from January to February, the top 10 in sales include Voriconazole, Adenosylmethionine injection, and Tamsulosin tablets. Products that have entered the top 20 include newly launched Ipratropium, Vogeletolose, and Cilostazol capsules, as well as procurement renewal products like Paclitaxel injections, Calcium folinate injections, and Cyclosporin injections. As the impact of price reductions from procurement gradually diminishes, the company’s special drugs like arsenic trioxide and exclusive varieties will occupy an increasingly important position. These products are expected to become the company’s new main varieties. The newly launched exclusive formulation product Nitroglycerin Spray is also being promoted. The approval of biological products like PEGylated Granulocyte Colony-Stimulating Factor injections (3mg/ml, 6mg/ml) and Long-acting FSH will also significantly impact performance, providing strong support for future growth.

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

Answer: 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 holding shares in Beijing Xinlilun Health Industry Group Co., Ltd., which is the largest shareholder of Xinlilun (stock code 002219). Additionally, the company owns 49% of 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 is required to complete the acquisition of the subsidiary Beijing Xinlilun Medical and Health Management Co., Ltd. within the stipulated timeframe.

Question: Please introduce the progress of the R&D platform for therapeutic antibodies based on transgenic rabbits developed by the US joint venture ATGC.

Answer: The company’s US joint venture TGC possesses gene editing and other related technologies for transgenic rabbit production, making it currently the only platform worldwide capable of developing therapeutic antibodies using transgenic rabbits. Since its establishment, the company has been leveraging these core technologies to gradually build a therapeutic antibody development platform based on transgenic rabbits (RbTx). TGC’s rabbit immune system humanization engineering has completed over 90% of the tasks. There is also one product targeting immune cell humanized rabbit polyclonal antibodies in preclinical development. Once established, the platform plans to develop 1 to 3 “blockbuster” antibody drugs focusing on key targets in cancer immunotherapy and autoimmune diseases within 3-5 years, completing preclinical studies. The future RbTx platform will accelerate antibody drug development, offer new antibody options, and produce antibodies with ultra-high affinity, high specificity, and low immunogenicity, greatly improving product quality. It will also provide a new pathway to bypass existing mouse platform technology barriers and break the monopoly of advanced antibody technology platforms held by a few multinational pharmaceutical companies. The platform can also be used for emergency R&D and application of humanized antibodies for acute infectious diseases. Currently, TGC’s overseas collaborations and technology introductions domestically are progressing simultaneously. During the research, the company strictly followed the “Information Disclosure Management System” and related regulations, with no major undisclosed information leaks.

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

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

Margin trading data shows that in the past three months, the net inflow of margin financing was 22.41 million yuan, with the balance increasing; the net inflow of securities lending was 1.83 million yuan, with the balance increasing.

The above content is compiled from public information by Securities Star, generated by AI algorithms (Network Information Backup 310104345710301240019), and does not constitute investment advice.