Three Chinese Domestic Class 1 New Drugs Approved in October: Qingfeng, Yiling, and Jianmin Launch Innovative Therapies

　　【Pharmaceutical Network Industry DynamicsAccording to the review, in October, five Class 1 new drugs were approved for marketing in China, three of which are domestically produced new drugs: Jiangxi Qingfeng Pharmaceutical Industry Co., Ltd.'s Fructus Aurantii Flavonoids Tablets, Shijiazhuang Yiling Pharmaceutical Co., Ltd.'s Tongluo Mingmu Capsules, and SHANDONG JIANMIN MEDICINE INDUSTRY CO., LTD.'s Pediatric Zibei Xuanfei Syrup. The other two are Pfizer’s Ritlecitinib Tosylate and Bristol-Myers Squibb’s Deucravacitinib.
 

The main component of Jiangxi Qingfeng Pharmaceutical Co., Ltd.'s Citrus Aurantium Flavonoids Tablets is the total flavonoids extracted from "Citrus Aurantium," a native medicinal herb from Jiangxi, which can be used for the treatment of functional dyspepsia.
 

This medicine has conducted a multi-center clinical trial with randomized, double-blind, and parallel control. The clinical trial results showed a statistically significant difference compared to the placebo control group, and it can be used for the treatment of postprandial fullness, early satiety, upper abdominal burning sensation, and upper abdominal pain associated with functional dyspepsia. The market launch of this product will provide another treatment option for patients with functional dyspepsia.
 

Tongluo Mingmu Capsule of Shijiazhuang Yiling Pharmaceutical Co., Ltd. is an innovative traditional Chinese medicine developed under the guidance of TCM meridian disease theory and based on clinical experience formulas. Its functions and indications are: activating blood circulation to remove stasis, promoting meridian flow, replenishing qi and nourishing yin, stopping bleeding, and improving eyesight. It is used for moderate non-proliferative diabetic retinopathy caused by type 2 diabetes, characterized by blood stasis obstructing the meridians and dual deficiency of qi and yin, presenting with fundus dot-like or patchy hemorrhages, dry eyes, dull complexion, fatigue, pale tongue, or dark red tongue with little fluid, or petechiae, thin pulse, or fine and rapid pulse, or rough pulse.
 

Shijiazhuang Yiling Pharmaceutical Co., Ltd. conducted a multi-center clinical trial for this drug, which was randomized, double-blind, double-dummy, and parallel-controlled with calcium dobesilate capsules. The clinical trial results showed that after 12 weeks of treatment, the test group had better outcomes than the control group in terms of dot and blot hemorrhages in moderate non-proliferative diabetic retinopathy.
 

SHANDONG JIANMIN MEDICINE INDUSTRY CO., LTD.'s Pediatric Zibei Xuanfei Syrup is functional in dispersing wind-heat and relieving cough by ventilating the lungs. It is used for cough due to wind-heat invading the lungs in children with acute bronchitis, accompanied by expectoration, sweating, sore throat, thirst, thin yellow tongue coating, and floating rapid pulse.
 

This medicine has conducted a randomized, double-blind, parallel-controlled multi-center clinical trial. The results showed a statistically significant difference compared with the placebo control group. This medicine disperses wind-heat and promotes lung function to stop coughing, used for pediatric acute bronchitis due to invasion of wind-heat in the lungs, characterized by coughing accompanied by expectoration, sweating, sore throat, thirst, thin yellow tongue coating, and floating rapid pulse. The market launch of this medicine provides another treatment option for children suffering from cough due to acute bronchitis.
 

In addition, on October 19, the National Medical Products Administration announced that it had approved Pfizer's application for the innovative drug Ritlecitinib Tosylate Capsules (hereinafter referred to as "Ritlecitinib") through the priority review procedure. The drug is suitable for adolescent and adult patients aged 12 years and above with severe alopecia areata.
 

It is reported that companies in China are also actively deploying in the billion-dollar hair loss treatment track. For instance, the marketing application for Zelgen Pharma's innovative Class 1 drug Jaktinib (a JAK1/2/3 inhibitor) was accepted by the National Medical Products Administration last year, indicated for myelofibrosis as a first-generation pan-JAK inhibitor. The marketing authorization application for Hengrui Medicine's JAK1 inhibitor SHR0302 (Emapalumab) for treating moderate to severe atopic dermatitis was submitted in June this year and has been accepted by the National Medical Products Administration. This drug is also under development for the indication of alopecia areata and is currently in Phase III clinical trials. Kelun Pharmaceuticals' independently developed and intellectual property-owned innovative small molecule JAK1/2 inhibitor KL130008 capsule received approval for clinical trials in March 2022 for treating severe alopecia areata.
 

On the same day, the National Medical Products Administration approved the listing of Bristol-Myers Squibb's Class 1 innovative drug Deucravacitinib Tablets (trade name: Sotyktu). This medication is suitable for adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Data shows that Deucravacitinib is a Tyrosine Kinase 2 (TYK2) inhibitor and is currently the approved TYK2 allosteric inhibitor. It exerts its therapeutic effects by highly selectively targeting TYK2 through an "allosteric inhibition" mechanism, thereby inhibiting the signaling pathways of key cytokines involved in the pathogenesis of psoriasis, such as Interleukin (IL)-23, IL-12, and Type I Interferon (IFN), while demonstrating favorable safety.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.