According to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration and public information, Shandong Xinbo Pharmaceutical Research Co., Ltd. (hereinafter referred to as "Shandong Xinbo") has assisted Yingkerui in obtaining an implied clinical trial license (IND) for the first innovative Chinese medicine for treating precocious puberty in children, "Xiao'er Linglong Early Maturity Granules".

       As an important partner in the research and development process, the Drug Safety Evaluation Research Center of Shandong Xinbo Pharmaceutical Research Co., Ltd. strictly follows the guidelines of NMPA and ICH. With its rich project experience and mature technology platform, it undertakes the preclinical safety evaluation research of the drug, helping partners to obtain clinical trial permits smoothly.

  Pediatric Linglong Early Maturity Granules  

Pediatric Linglong Early Maturity Granules are derived from the clinical experience formula of Professor Chen Yonghui, an expert from the Capital Institute of Pediatrics. They are made by modifying and cutting the "Er Chen Tang" from the Song Dynasty's "Tai Ping Hui Min He Zhi Ju Fang" and the "Da Bu Yin Wan" from the Yuan Dynasty's "Dan Xi Xin Fa". They have the effects of resolving phlegm, clearing heat, softening hardness, and dispersing lumps. They are intended for use in girls with precocious puberty (phlegm heat internal knot syndrome).

        Premature puberty is closely related to the kidneys, liver, and spleen and stomach. The basic pathological mechanism is kidney yin deficiency and excessive phase fire, with phlegm fire and phlegm dampness as key pathological factors throughout. Er Chen Tang is the first prescription for regulating qi and resolving phlegm, and Da Bu Yin Wan is praised by later medical practitioners as the "first divine product for replenishing true water and nourishing yin". Both have the effects of stopping cough and resolving phlegm, as well as regulating internal heat. The formula is precise and has been clinically used for many years, with remarkable therapeutic effects.

  Precocious puberty  

With the improvement of children's nutrition level and the impact of various food safety problems, the incidence rate of precocious puberty in children is on the rise, about 1/5000-1/10000, and girls are about 5-10 times as many as boys. The main harm is the series of reactions caused by premature development, which will have a negative impact on children's physical growth and mental health in the short term, such as anxiety, depression, etc., and may harm adult reproductive health in the long term. It is a high-risk factor for breast cancer and metabolic diseases. Once the optimal treatment time is missed, its impact is often irreversible, so timely, safe, and effective intervention measures are necessary. At present, the main Western medicine treatment for precocious puberty is GnRHa injection, but it is expensive and may lead to adverse reactions such as slow growth rate, obesity, hair loss, allergies, and polycystic ovary syndrome. Xiao'er Linglong Early Maturing Granules have the advantages of low price, low toxicity and side effects, and higher long-term medication safety, effectively compensating for the shortcomings of Western medicine in clinical application.

  About Yingkelui  

Beijing Yingkerui Innovative Medicine Co., Ltd., a national high-tech enterprise, was founded in 1999. It is a private traditional Chinese medicine research and development enterprise that focuses on independent research and development, emphasizes research and development, and has unique characteristics in new formulations. It integrates research and development, achievement transformation, and industrialization. It has long been committed to the research and development of innovative Chinese medicine drugs and new formulations, serving the inheritance, innovation, and development of the traditional Chinese medicine industry. Accumulated 12 new drug certificates, 59 production approvals, and 54 clinical approvals; 735 patent applications have been filed, 229 patents have been granted, and 15 PCT international patents have been obtained; Obtained 15 national level projects such as the National 863 Program, the Ministry of Science and Technology's "Eleventh Five Year Plan", "Twelfth Five Year Plan", and "Thirteenth Five Year Plan" major new drug creation projects, and 27 other provincial and municipal level projects; Received 200 honors and qualifications, including 79 national level ones.

  Pediatric medication safety evaluation platform  

Shandong Xinbo has established a mature platform for evaluating the safety and pharmacodynamics of pediatric drugs. Based on the special physiological and metabolic characteristics of children, a young animal model suitable for pediatric drug evaluation has been used. The gavage administration technology for rodent rats at 4 days old and non rodent dogs at 7 days old has been established, and multiple safety evaluations of pediatric drugs have been completed. This provides professional, safe, and compliant non clinical research support for the development of new and generic drugs for children, and helps promote the safe development of pediatric drug research.

● Single dose toxicity test (rodent, non rodent)
● Repeated administration toxicity test (rodent, non rodent)
● Toxicokinetic tests (rodent, non rodent)
● Growth and development testing of young animals
● Detection of reflex development in young animals
● Detection of behavioral indicators in young animals
● Evaluation of Immune System Development in Young Animals
● Detection of skeletal structure and metabolism in young animals
● CNS assessment of young animals
● Pharmacokinetic testing
● Establishment of pituitary model