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Grand Shuyang's Omalizumab for Injection Shuyang Shule® Receives Marketing Approval

2026-07-31 15:30

Recently, the Omalizumab for Injection (trade name: Shuyang Shule®) developed by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. (hereinafter referred to as "Grand Shuyang"), a subsidiary of Grand Life Sciences Group Co., Ltd. (hereinafter referred to as "Grand Life Sciences"), was officially granted marketing approval from the National Medical Products Administration (NMPA) of China for the treatment of chronic spontaneous urticaria and moderate to severe persistent allergic asthma.

 

Dual Indications Covering Patients Across Multiple Age Groups

According to the approved indications, Shuyang Shule® is indicated for adults and adolescents (aged ≥12 years) with chronic spontaneous urticaria who remain symptomatic despite treatment with H1 antihistamines; it is also indicated for adults, adolescents (aged ≥12 years), and children (aged 6 to <12 years) with moderate to severe persistent allergic asthma inadequately controlled by inhaled corticosteroids and long-acting inhaled β2-adrenoceptor agonists.

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Addressing the Clinical Needs of Allergic Diseases

Chronic spontaneous urticaria has a recurrent course, which can affect patients' sleep, work, and social activities. Relevant surveys show that the prevalence of chronic urticaria is 2.6% in Chinese adults, affecting approximately 36 million adult patients. The China Pulmonary Health Study shows that the prevalence of asthma is 4.2% in the Chinese population aged ≥20 years, corresponding to an estimated 45.7 million adult patients based on 2015 demographic data. The large patient pool, together with the ongoing need for standardized diagnosis and treatment, offers substantial clinical application opportunities for Shuyang Shule®.

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Deepening Engagement in Recombinant Biopharmaceuticals; Extending the Frontiers of Innovation

Grand Shuyang has long been dedicated to blood products while continuously expanding into biopharmaceutical fields, such as recombinant biopharmaceuticals. The approval of Shuyang Shule® marks an important milestone in our efforts to expand technology platforms and upgrade the product portfolio. Grand Shuyang will strictly adhere to relevant regulations and regulatory requirements to steadily advance product launch and supply, medical information communication, and pharmacovigilance activities, thereby better serving clinical and patient needs.

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About Grand Life Sciences

Grand Life Sciences is an innovation-driven, internationally oriented pharmaceutical and healthcare group with a solid industrial foundation. Its business spans five major sectors: blood products, probiotics, vaccines, medical nutrition, and perioperative care. Guided by a dual strategy of "independent innovative R&D + precise licence-in", the group is building a portfolio of specialty products and a differentiated R&D pipeline rooted in clinical needs.

Grand Life Sciences maintains an industry-leading position across multiple sectors, including blood products, live biotherapeutic products, perioperative hemostasis, and vaccines, and currently possesses over 30 core innovative products in its pipeline. The group has established 5 R&D centers in Beijing, Chengdu, Nanjing, Wuhan, and Hangzhou, has achieved pharmaceutical breakthroughs in 9 projects, and currently has over 30 varieties in clinical development. Grand Life Sciences has established production bases featuring high-standard construction and advanced quality management across nearly ten cities in China. Its sales network spans all provinces and cities nationwide, reaching hundreds of thousands of points of sale. Its blood products are exported to over 20 countries. The group continues to accelerate its global market expansion.

 

About Grand Shuyang

Grand Shuyang operates under a dual‑engine model, with Chengdu as its platform for plasma-derived blood products and Beijing as its platform for genetically recombinant blood products. In the sector of blood products, it has achieved full technological coverage across plasma-derived, recombinant protein, and gene therapy, and built the world's most comprehensive product pipeline in this sector. It is committed to becoming a domestic-leading, world-class blood products enterprise, distinguished by its full‑lifecycle capabilities and state‑of‑the‑art technologies for expressing complex recombinant proteins. Grand Shuyang's product portfolio encompasses three major categories: albumins, immunoglobulins, and coagulation factors, making it a leader in China's blood products industry in terms of plasma utilization efficiency, product variety, and specification diversity. Grand Shuyang has established a globally leading Industry 4.0 intelligent manufacturing base for blood products, enabling full coverage of market demands across the entire product chain and positioning itself as a world-class industrial base for blood products.