Newly Approved Drugs: Dautocallixtinib, Methylsulfonic Acid Ritlecitinib, Tongluo Mingmu Capsules, Pediatric Purple Pearl Lung Syrup, Fructus Aurantii Total Flavone Tablets

1. Dautocallixtinib Tablets

Dautocallixtinib is a first-class innovative drug developed by Pfizer. Its trade name is "Songdiduo." The drug is indicated for adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy. Dautocallixtinib is a tyrosine kinase 2 (TYK2) inhibitor.

Dautocallixtinib is a deuterated drug, which means that specific hydrogen atoms in the drug molecule are replaced with deuterium atoms. Deuterated drugs offer advantages over non-deuterated drugs, including improved pharmacokinetics, reduced dosing frequency, inhibition of drug-drug interactions, and decreased adverse reactions. However, deuterated reagents are expensive, and the reaction conditions are stringent. Dautocallixtinib was approved by the FDA for marketing on September 9, 2022. On September 26, 2022, it was also approved in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis.

2. Methylsulfonic Acid Ritlecitinib Capsules

Methylsulfonic Acid Ritlecitinib Capsules (Ritlecitinib) is a first-class innovative drug developed by Pfizer. Its trade name is "Le Funuo." The drug is indicated for patients aged 12 and above with severe alopecia areata. Methylsulfonic Acid Ritlecitinib is a kinase inhibitor that irreversibly inhibits JAK3 and the tyrosine kinase family.

Ritlecitinib received FDA approval for the treatment of patients aged 12 and above with severe alopecia areata in June of this year. On September 19, Ritlecitinib was also granted EMA approval based on the ALLEGRO study, which included the Phase IIb/III ALLEGRO study (NCT03732807):

The study aimed to evaluate the efficacy and safety of Ritlecitinib in patients aged 12 and above with alopecia areata, including totalis (complete loss of scalp hair) and universalis (complete loss of all body hair). The results showed that after 24 weeks of treatment with 50mg of Ritlecitinib, 13.4% of patients achieved a hair coverage rate of 90% or higher (SALT≤10), compared to 1.5% in the placebo group. The study also assessed the Patient Global Impression of Change (PGI-C), and the results showed that at week 24, 49.2% of patients reported "moderate" to "great" improvement in their alopecia areata condition, compared to 9.2% in the placebo group.

3. Tongluo Mingmu Capsules

Tongluo Mingmu Capsules is a Chinese herbal medicine of the 1.1 class developed by Shijiazhuang Yiling Pharmaceutical Co., Ltd. The drug has undergone a randomized, double-blind, calcium dobesilate capsule parallel-controlled multicenter clinical trial.

Clinical trial results showed that after 12 weeks of treatment, the point-and-patch hemorrhage test in patients with moderate non-proliferative diabetic retinopathy was superior in the experimental group compared to the control group. The drug promotes blood circulation, removes blood stasis, nourishes qi and nourishes yin, and stops bleeding and improves vision. It is used for point-and-patch hemorrhage in diabetic retinopathy caused by type 2 diabetes and blood stasis obstruction, qi and yin deficiency syndrome, eye dryness, and other related symptoms.

The launch of this drug provides a new treatment option for patients with the above-mentioned conditions.

4. Pediatric Purple Pearl Lung Syrup

Pediatric Purple Pearl Lung Syrup is a Chinese herbal medicine of the 1.1 class developed by Jianmin Pharmaceutical Group Co., Ltd. The drug has undergone a randomized, double-blind, parallel-controlled multicenter clinical trial, and the clinical trial results showed statistically significant differences compared to the placebo control group. The drug disperses wind-heat, promotes lung function, and relieves cough. It is used for cough caused by wind-heat invading the lungs in children with acute bronchitis, accompanied by coughing, phlegm, sweating, sore throat, and thirst. The tongue coating is thin and yellow, and the pulse is floating and rapid.

The launch of this drug provides another treatment option for children with cough caused by acute bronchitis.

5. Fructus Aurantii Total Flavone Tablets

Fructus Aurantii Total Flavone Tablets are a type 1.2 class innovative Chinese herbal medicine. The main component of this drug is total flavones extracted from Fructus Aurantii. The marketing authorization holder for this drug is Jiangxi Qingfeng Pharmaceutical Co., Ltd.

The drug has undergone a randomized, double-blind, parallel-controlledmulticenter clinical trial, and the clinical trial results showed that it has significant efficacy in the treatment of functional dyspepsia. Fructus Aurantii Total Flavone Tablets regulate gastrointestinal motility, improve gastric emptying, and relieve symptoms such as upper abdominal discomfort, bloating, early satiety, and belching.

Functional dyspepsia is a common disorder characterized by chronic or recurrent pain or discomfort centered in the upper abdomen. It is often associated with symptoms such as early satiety, bloating, and belching. Fructus Aurantii Total Flavone Tablets offer a new treatment option for patients with functional dyspepsia.