Recently , Yiling Pharmaceutical issued an announcement stating that the National Medical Products Administration has officially approved the marketing of Lianhua Cold Granules for children, a Class 1.1 new traditional Chinese medicine , with the approval number Z20260006.
In terms of indications, Lianhua Cold Granules for Children are mainly used to clear heat and relieve exterior symptoms, and to promote lung function and relieve heat. They are used for children aged 4-12 years with wind-heat colds , characterized by symptoms such as nasal congestion, runny nose with thick nasal discharge, sore throat, cough, headache, red tongue, thin yellow coating, and floating and rapid pulse. This means that it is not a simple reduced-dose version of adult cold medicine, but an innovative traditional Chinese medicine specifically for pediatric children with wind-heat as the main syndrome.
In terms of R&D attributes, this product belongs to the innovative traditional Chinese medicine guided by Yiling Pharmaceutical's "Collateral Disease Theory" . The company owns its independent and complete intellectual property rights. The dosage form is granules, and the specification is that each 1g is equivalent to 2.0g of decoction pieces. For innovative traditional Chinese medicines, Class 1.1 usually means a new compound, a new structure, or a traditional Chinese medicine product with clear innovative attributes. Approval for marketing indicates that it has completed the registration review and formed a registered status that can be commercially produced.
However, approval does not equate to immediate sales volume. Yiling Pharmaceutical also explicitly stated in its announcement that this product is not expected to have a significant impact on the company's recent operating performance, and that subsequent steps such as production, channel distribution, end-user access, and clinical usage education are still needed.
Within the pediatric cold medicine market, this product's significance lies more in " filling gaps in the product matrix ." In recent years, the overall market size of pediatric traditional Chinese medicine has remained above 10 billion yuan, with pediatric cold medicine being one of the largest subcategories. However, overall sales are somewhat volatile, and there is still a need for more new products with clear clinical positioning. Yiling Pharmaceutical already has products such as pediatric cold granules, and the approval of Lianhua pediatric cold granules will help the company form a clearer product division in the specific scenario of pediatric wind-heat colds.
Looking at Yiling Pharmaceutical's innovation pipeline, the approval of Lianhua Cold Granules for children marks a significant milestone in its pediatric strategy. The company currently has several other new traditional Chinese medicines in the application or clinical trial stages, including Qigui Luobitong Tablets and Banxia Baizhu Tianma Granules. Its product portfolio in the respiratory, pediatric, and chronic disease fields is gradually being improved.

Source: https://news.yaozh.com/archive/49345.html