2016/05/23 | Biotech & Medical Aesthetics | Cheng Jingming
On April 28, 2016, Uni Pharma Co., Ltd.. was notified by the Food and Drug Administration (TFDA) to approve the new ingredient rare disease drug “K-Li Xie Intravenous Infusion”, and is currently in the process of obtaining the certificate. Since its research and development in 2010, it has taken five years to finally obtain approval and be approved for marketing. It is a small number of Chinese people who independently develop and produce new drugs for rare diseases with new ingredients, providing them for use by a small number of acute and severe patients, and filling the risk of clinical drug shortage.
Uni Pharma Co., Ltd. cooperated with Jianya Biotechnology Co., Ltd. (4130) to develop “Kang Lijie”, and Jianya was responsible for the formulation development and subsequent production matters. The drug is used in clinical practice as an “antidote to methanol or ethylene glycol poisoning”, and will apply for health insurance to pay the price in the future, and be stored in major key hospitals and poison centers in China, in case of the first time to rescue patients with methanol or ethylene glycol poisoning. After methanol or ethylene glycol poisoning, the damage to the organs and nervous system is extremely serious, and if the ingestion dose is slightly larger or the emergency treatment is not immediately sent, there is a possibility of poisoning, blindness and even death. In the past decade, although the number of patients suffering from methanol or ethylene glycol poisoning caused by the accidental consumption of fake wine is not large, there are still a few cases, but all of them have left serious sequelae or death.
Chen Zheng, chairman of Uni Pharma, said that K-Link will release the supply of domestic medical needs and will also develop the international market. There is currently no antidote to glycol (alcohol) poisoning on the market; According to statistics, there are about 100 million adult emergency room visits in the United States every year, of which about 10% are related to alcoholism; The treatment of “Kang Lijie” can shorten the time in the emergency room, and the market potential should not be underestimated.
Regarding the market extension of K-Solution, Lin Liangguang, general manager of Uni Pharma, further said that with the efforts of the new drug team, the design and planning of the oral dosage form of the drug has been completed, and the inspection and registration of oral K-Lix will be proposed in the near future.
“Kang Lix” is the first drug in China to competitively inhibit alcohol dehydrogenase (ADH), which can directly prevent/reduce the production of the toxic metabolite “Acetadehyde” in the metabolic pathway of alcohol. Studies have shown that acetaldehyde produced by excessive alcohol consumption and poisoning may cause oral cancer, esophageal cancer, stomach cancer and other diseases due to long-term accumulation. The control mechanism of alcohol metabolism can reduce the production of acetaldehyde; This will lead to the development of other new indications with significant market value.
Since 2010, Uni Pharma has been actively stepping into the field of new drug research and development, in addition to the research and development of new ingredients and new drugs, it is also committed to the development of a variety of biomarkers for clinical needs. These biomarkers are used for tumor detection, polyneuropathy, monitoring of tumor associated syndromes, etc., which are all services that cannot be provided in domestic clinical practice. With its core values: providing products for medical needs, filling clinical gaps, giving back to investors and taking care of the company’s employees, Uni Pharma continues to develop various new drugs, new medical devices and new testing tools.
