Hard Power Improvement

New Drug R&D

Evaluation of the consistency

Good News on Enterprises in the Park Coming Again!

 

          About "CM338"

 

       CM338 targeted MASP-2, a Class 1 innovative drug of Conmed Biosciences with global independent intellectual property rights. It is the second co-target drug in the world and the first one in China to get permission to enter the clinical research stage.

 

       The activation of lectin pathway is that mannose binds lectin to identify various pathogen-related target molecules and then binds with MASP-2 to activate complement cascade reaction, where MASP-2 is the key rate-limiting enzyme.

 

       Pre-clinical studies have shown that CM338 has clear mechanism of action and remarkable efficacy in vivo and in vitro. Compared with foreign co-target drugs, the affinity and in vitro inhibitory activity of CM338 are higher, up to over 30 times. In addition, the pharmacokinetic characteristics of CM338 are consistent with the performance of antibody drugs, and the toxicological results showed good safety, which supported the treatment of diseases related to the activation of complement lectin pathway.

 

       About "diseases related to complement lectin activation"

       The activation of lectin pathway is widely involved in a variety of disease processes. Studies have shown that 90% of patients with IGA nephropathy have co-localization of C3 and IGA, and complement deposition such as C3 and C4 is often tested, which are closely related to kidney tissue pathological damage and local inflammation.

 

       By 2020, there are about 150 million patients with chronic kidney disease in China, and the estimated number of IGA patients can be as high as 8.23 million. So far, the treatment of IGA nephropathy is relatively single, and angiotensin inhibitor ACEIS and angiotensin receptor antagonist ARBS are the only recommended therapies. Therefore, there is an urgent need for new treatment regimens to meet the unmet clinical needs. Complement related target blockers have great potential for the treatment of IGA nephropathy. Conmed Biosciences plans to continue to carry out a number of clinical trials including IGA nephropathy in the future.

 

         About "CM326"

 

       CM326 targeted thymic stromal lymphopoietin (TSLP), a Class 1 innovative drug of Conmed Biosciences with global independent intellectual property rights. It is the first co-target drug in China to get permission to enter the clinical research stage.

 

       TSLP is one of the promoters of inflammatory cascade reaction, and the intervention to inhibit TSLP can be carried out from the early stage of inflammation to prevent immune cells from releasing proinflammatory cytokines. TSLP is closely related to the occurrence of allergic diseases such as atopic dermatitis, asthma and chronic sinusitis, and it is the only target that is proved effective for low TH2 asthma.

 

       Pre-clinical studies show that CM326 has good safety and excellent efficacy. Different in vitro pharmacodynamic studies have confirmed that the biological activity of this product is significantly stronger than that of foreign co-target drugs.

 

       So far, the safety data of phase I clinical study of healthy volunteers of CM326 have been obtained, showing that this product has good safety.

 

       About "Atopic Dermatitis"

       Atopic dermatitis (AD) is a common chronic allergic skin disease, mainly manifested by recurrent chronic eczema-like rash, accompanied by significant skin dryness and pruritus, which seriously affects the quality of life of patients.

 

       According to the data of Frost & Sullivan, in 2019, there were 19.7 million people with AD in China and 190 million people in the world respectively, among which the prevalence rate of children and adolescents was up to 20%. It is estimated that by 2030, there will be 81.7 million people with AD in China and 750 million people in the world, of which about 30% will be moderate and severe patients.

 

       The main purpose of AD treatment is to improve the severity of the disease, alleviate or eliminate the clinical symptoms and improve the quality of life of patients. At present, external use of glucocorticoid and calcineurin inhibitor is still the main therapy for AD. Long term topical hormones often have various side effects. Calcineurin inhibitors may also have certain adverse reactions, and its efficacy on moderate to severe atopic dermatitis is not good, so there are a large number of unmet clinical needs.

 

 

       Recently, the official website of National Medical Products Administration (NMPA) of China announced that SUNNYHOPE's donepezil hydrochloride orally disintegrating tablets passed the consistency evaluation of the quality and efficacy of generic drugs.

 

 

       Donepezil hydrochloride orally disintegrating tablets are mainly suitable for the treatment of mild, moderate or severe symptoms of Alzheimer's disease.

 

 

       #  Clinical advantages of orally disintegrating tablets

       Reducing dysphagia and improving compliance;

       Rapid onset, reduced first-pass effect and high bioavailability;

       Reducing gastric mucosal irritation and adverse reactions;

       Medication for special population: Dysphagia and long-term bedridden patients;

       Medication in anhydrous environment;

       Reducing the burden of care;

 

 

       Indications for severe Alzheimer's disease were added in this consistency evaluation.

 

       The efficacy of donepezil hydrochloride decreased gradually after stopping treatment in adult/elderly patients. There was no rebound after discontinuation of treatment.

 

       For patients with renal insufficiency, the method of taking donepezil hydrochloride is similar to that of normal people because it does not affect the clearance of donepezil hydrochloride.

 

 

       ShengNuo Biology (688117.SH) disclosed the Q3 Report of 2021. During the reporting period, the company achieved revenue of RMB 85,482,900 and net profit of RMB 19,024,900, up 83.9% year-on-year.

 

       As a leading enterprise of polypeptide drugs in China, the company keeps building its brand with innovative pharmaceutical research services of polypeptide drugs and customized production services of polypeptide products, and keeps a foothold in the large-scale production and sales of APIs. In the meantime, it makes efforts toward the preparation market, form the primary business of polypeptide innovative pharmaceutical research services and customized production services of polypeptide products in parallel with the production and sales of polypeptide APIs and preparations, strengthens the company's competitive advantage in the polypeptide field through coordinated development among businesses, thus forming a growth point of performance.

 

 

       ShengNuo Biology has had a whole process R&D pipeline and a whole industry chain platform for polypeptide APIs and preparations, which can provide pharmaceutical research services for polypeptide innovative drugs and generic drugs from process route design to small-scale test, pilot scale test, process validation and quality research, as well as whole-chain customized production services for APIs and preparations required for drug R&D and commercial production, covering the complete drug development cycle from drug discovery, preclinical research, to clinical trials and marketing.

 

 

       In addition, the company has many years of industrialization experience in the polypeptide field, and has realized the scale production of multiple polypeptide API varieties. Its quality standards have been recognized by customers at home and abroad, and the products have been exported to many countries and regions, including the United States and the European Union, which can meet the needs of rapid, large-scale and high-quality polypeptide synthesis, and at the same time, the production cost has a comparative competitive advantage.

 

 

Source: Sichuan Shenghe Pharmaceutical Co., Ltd.,

Conmed Biosciences, ShengNuo Biology