Congratulations to Wuxi Beta for providing the Koren Pharmaceutical KL060332 Capsule labeled with carbon 14 isotope, which has been accepted by the National Food and Drug Administration Clinical Trial Notice and FDA Drug Clinical Trial Application
Release time:
2019-07-31
On July 25, 2019, Sichuan Kelun Pharmaceutical Co., Ltd., an A- share listed company, issued the notice on the company's KL060332 capsule obtaining clinical trial notice and the acceptance of SKB264 new drug clinical trial application. The innovative drug KL060332 capsule developed by the company's holding subsidiary Sichuan Kelun Botai Biopharmaceutical Co., Ltd. has obtained the clinical trial notice of the State Drug Administration, and the KLUSPharmaInc of the company's holding subsidiary. Has been submitted to the United States Food and Drug Administration (hereinafter referred to as FDA) antibody conjugate drugs (AntibodyD
On July 25, 2019, Sichuan Kelun Pharmaceutical Co., Ltd., an A- share listed company, issued the notice on the company's KL060332 capsule obtaining clinical trial notice and the acceptance of SKB264 new drug clinical trial application. The innovative drug KL060332 capsule developed by the company's holding subsidiary Sichuan Kelun Botai Biopharmaceutical Co., Ltd. obtained the clinical trial notice of the State Drug Administration, and the company's holding subsidiary KLUS Pharma Inc. has submitted to the U.S. Food and Drug Administration (hereinafter referred to as FDA) an application for antibody conjugate drug (Antibody Drug Conjugate,ADC) "SKB264 for injection" to carry out drug clinical trials and has been accepted.
In October 2017, Wuxi Beta Pharmaceutical Technology Co., Ltd. and Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. signed a "Technology Development Contract" to provide carbon 14(C14) isotope labeling services for the innovative drug KL060332 capsule compounds developed by Kelun Pharmaceutical Holdings. Synthesis [14C] KL060332 is an important part of the study of absorption, distribution and pharmacokinetics of the innovative drug in vivo. After the C14 labeling is completed, the isotope-labeled sample will be transported to the domestic third-party pharmacokinetic research institution designated by Kelun Pharmaceuticals for follow-up research.
C14 isotope labeling refers to the use of C14 isotope as a labeling tracer to make a labeled compound containing C14 instead of the original non-labeled compound. Using the nuclear physical properties of C14 radioisotope continuously releasing soft beta rays, the position, quantity and transformation of the compound in vivo or in vitro can be traced at any time. It is equivalent to installing a navigation and positioning system for target molecular compounds, which is convenient for positioning and tracking during animal experiments and human clinical experiments. The radioactive tracer method can measure 10-14-10-18grams level, that can be from 1015One radioactive atom was detected in one non-radioactive atom, which is more sensitive than the current sensitive gravimetric balance.7-108times, and by far the most accurate chemical analysis is difficult to determine to 10-12gram level. The positioning accuracy of tissues and organs can reach the cellular level, subcellular level and even molecular level.
The former State Food and Drug Administration issued the "Technical Guidelines for Non-clinical Pharmacokinetics of Drugs" in May 2014:
"Application of radioisotope labeling techniques for non-clinical pharmacokinetic studies of drugs. In the process of new drug development, it is very important to understand the changes of candidate drugs in human body and animals for toxicology and efficacy research. Therefore, various in vivo and in vitro pharmacokinetic tests must be conducted at different stages of new drug development to elucidate the absorption, distribution, metabolism and excretion (ADME) properties of candidate drugs. Although LC-MS techniques have been widely used in these tests, radioisotope labeling techniques are still widely used."
"Low-energy radioisotopes (such as C14, H3) labeled compounds are used in pharmacokinetic studies. Because of their low biological background values, they are easy and sensitive to detect, and have a long half-life without the need to correct the test results according to the radioactive half-life. They can quantitatively analyze the metabolites produced by candidate drugs without knowing their structures, and the energy of non-ionized β-rays produced is very low without special protection, it has been proved to be a safe and effective special technology. The results are simple, clear and reliable. At present, there is no other replacement method in most cases."
"The low-energy radioisotopes commonly used in the study of small molecule chemical drugs ADME are carbon -14(C14) and tritium (H3). The C14 marker is most commonly used,Its biological background is low, biology almost no isotope effect and affect metabolism, rarely occur isotope exchange, sensitivity is higher than H3 and easy to quantify. In vivo testing H3 labeling is used unless the C14 labeling is very difficult or impossible to label and very low doses require very high specific activity."
In recent years, Wuxi Beta Pharmaceutical Technology Co., Ltd. has conquered dozens of C14 labeled key intermediate compound preparation technologies, and is committed to using C14 and other isotope labeling technologies to provide technical support for the research and development of new drugs by Chinese pharmaceutical companies, providing high-quality services with lower cost, higher efficiency and more convenient communication than sending labels abroad, meeting and exceeding customer needs, helping Chinese pharmaceutical companies reduce the research and development costs of original new drugs and improve research and development efficiency, to contribute to the cause of human health.
Attached:
Sichuan Kelun Pharmaceutical Co., Ltd.
About the company KL060332 capsule to obtain clinical trial notice
and SKB264 New Drug Clinical Trial Application Acceptance Announcement
the company and all members of the board of directors to ensure that the contents of the announcement is true, accurate and complete, false records, misleading statements or major omissions in the announcement of joint and several liability.
Sichuan Kelun Pharmaceutical Co., Ltd. (hereinafter referred to as "the company" or "our company" or "Kelun Pharmaceutical") recently learned that the innovative drug KL060332 capsule developed by Sichuan Kelun Botai Biomedical Co., Ltd., a holding subsidiary of the company, has obtained the clinical trial notice of the State Drug Administration, and the company's holding subsidiary KLUS Pharma Inc. has submitted to the U.S. Food and Drug Administration (hereinafter referred to as FDA) an application for antibody conjugate drug (Antibody Drug Conjugate,ADC) "SKB264 for injection" to carry out drug clinical trials and has been accepted. The relevant announcement is as follows:
I. Basic information of drugs
(I) KL060332 Capsules
1. Drug Name: KL060332 Capsule
Dosage form: Capsule
Specifications: 5mg,25mg,50mg, 200mg
Registration classification: Class 1 chemicals
Declaration stage: clinical
Applicant: Sichuan Kelenbotai Biopharmaceutical Co., Ltd.
acceptance number: CXHL1900154,CXHL1900155,CXHL1900156,CXHL1900157
Review conclusion: According to the "the People's Republic of China Drug Administration Law" and relevant regulations, after review, the KL060332 capsule meets the relevant requirements of drug registration, and it is agreed to carry out clinical trials of chronic hepatitis B in accordance with the submitted plan.
2. Other relevant information of drugs
KL060332 capsule is developed by our company with independent intellectual property rights of hepatitis B virus nucleocapsid assembly regulator, the mechanism of action is clear, intended for the treatment of chronic hepatitis B. Non-clinical research data show that KL060332 capsules can efficiently and broadly inhibit the proliferation of hepatitis B virus of various genotypes, and have good pharmacokinetic properties and safety, single drug or combined with existing drugs for the treatment of chronic hepatitis B is expected to improve the ideal end point of clinical treatment of chronic hepatitis B. At present, no drug with the same mechanism has been approved for marketing in the world.
Up to now, the company has invested about 20 million yuan in research and development on the KL060332 capsule project.
The company will organize and implement clinical trials of KL060332 capsules in accordance with the requirements of the clinical trial notice issued by the State Drug Administration.
(II) SKB264 for Injection
1. Drug Name: SKB264 for Injection
Dosage form: injection
Applicant: KLUS Pharma Inc.
IND： 143682
2. Other relevant information of drugs
On July 23, 2019, the Company's holding subsidiary, KLUS Pharma Inc. The application for clinical trial of SKB264 for injection was submitted to FDA and accepted. This product is the second innovative ADC drug declared by our company in FDA after HER-2 ADC "A166 for injection.
SKB264 for injection is an ADC drug targeting the high expression of antigen in tumor cells. Its coupling method and small toxin molecules have independent intellectual property rights and are intended to be used for the treatment of malignant tumors. Non-clinical research data show that SKB264 for injection achieves high toxin load through a new coupling method, which is more stable than the traditional maleimide-cysteine coupling method, and the process is stable and controllable, easy to scale up, and has good consistency between product batches. The anti-tumor activity in target-positive breast cancer, gastric cancer, lung cancer, colorectal cancer and other animal tumor models is significant, with good safety and tolerability. There are currently no drugs on the market for this target in the world.
Up to now, the company has invested about 25 million yuan in research and development in the SKB264 project for injection.
II. Risk Tips
Due to the long cycle and many links in the process of innovative drug research and development, there is a certain degree of uncertainty during the period. Investors are advised to make cautious decisions and pay attention to preventing investment risks. The company will be based on the follow-up progress in a timely manner to fulfill the obligations of information disclosure.
It is hereby announced.
Board of Directors of Sichuan Kelun Pharmaceutical Co., Ltd.
25 July 2019
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