China SXT Pharmaceuticals, Inc., a specialty pharmaceutical company focusing on the research, development, manufacturing, marketing, and sales of Traditional Chinese Medicine Pieces (“TCMPs”), including Advanced TCMPs (Directly-Oral TCMP and After-Soaking-Oral TCMP), fine TCMPs, regular TCMPs, and TCM Homologous Supplements (“TCMHS”) announced today that it develops and commercializes the Kuihuapan After-Soaking-Oral TCMP and Zhudanfen Directly-Oral TCMP products.
The Kuihuapan products are produced according to the four processing specifications of Chinese Pharmacopoeia (2020 Edition) No. 34 of China Heilongjiang food and Drug Administration Note Letter [2020], and have the functions of clearing heat, calming liver, dredging collaterals and relieving pain. Its indications include dizziness, tinnitus, joint pain, hyperuricemia, gout, hypertension and other symptoms. The Zhudanfen products are produced according to the processing specifications of Chinese Pharmacopoeia (2020 Edition), it has the functions of clearing heat and moistening dryness, relieving cough and asthma, and detoxifying, and is suitable for sudden cough, asthma, fever, thirst, red eyes, throat obstruction, jaundice, diarrhea, dysentery, constipation, sores, carbuncle, swelling and poison. Zhudanfen is also listed in the National Medical Insurance Catalogue (No. 697 of the National Medical Insurance Catalogue). We expect that the annual output of both Kuihuapan and Zhudanfen to reach 300,000 bottles, and achieve the sales of about RMB 5 million during the fiscal year ending March 31, 2023.
In addition, although the GMP compliance inspection conducted by Jiangsu Province Medical Products Administration (JSMPA) for the Company’s new lyophilization production facilities in June 18, 2021 delayed the production cycle and the production capacity decreased consequently, compared with the same period. JSMPA completed its inspection in June 20, 2021. As of December 31, 2021, there are 12 batches of Luxuejin Directly-Oral TCMP products produced by lyophilization process. The Company has consumed 2.08 tons of fresh bloods of Cuerus Nippon as the raw materials, and the total amount of Luxuejin after freeze-drying is 316.92 kilogram, which is expected to achieve the sales of more than RMB 3 million during the fiscal year ending March 31, 2022. With the continuous increased market demand for Luxuejin, we will work to increase our production capacity and we believe the output value will grow rapidly.
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According to the definition of Directly-Oral TCMP and the preclinical research and development strategies of new medicine of FDA and CFDA, our R&D Department chose the standards under the “processing” and “usage” parts of the corresponding TCMPs in the Chinese Pharmacopoeia (2015 Edition), and applies the latest technology and analysis methods to systematically invent a new type of Directly-Oral TCMP product which can be directly taken orally or infused without decoction, and maintains all the original effective components. Thus, it improves clinical curative effects, saves medicinal materials, is easy to carry, and can be stored easily.
After-Soaking-Oral TCMP products are another new type of Advanced TCMP that can be brewed in boiling water (similar to tea drinking method), which first appeared in part 4 of Chinese Pharmacopoeia (2015 Edition). Its research and development method is similar to that of Directly-Oral TCMP, and our R&D Department systematically developed a new product series of After-Soaking-Oral TCMP according to the characteristics of its which can be directly brewed with boiling water (or decocted with the traditional TCMP formula), so as to maintain the original effective ingredients to the greatest extent and improve the clinical effects.
“The developed R&D and production of Advanced TCMP products will greatly help us make continuous efforts in leading the R&D of Advanced TCMP and pursuing higher quality products. We believe that this will further expand the market shares of our Directly-Oral TCMP and After-Soaking-Oral TCMP products “, Mr. Feng Zhou, Chief Executive Officer of China SXT, commented.
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