“Breast cancer treatment’Orasol’
Concern about reduction of neutrophils in white blood cells”
Clinical trial in the U.S. needs to be re-established
The status of Hanmi Pharm, which is called the national representative’new drug master’, is shaking. In recent years, global pharmaceutical companies that have bought new drug candidates have suffered a’return relay’, and this time, an anticancer drug that has been approved for marketing in the US has been judged as’pending’. In the sense that the US Food and Drug Administration (FDA) has requested a re-clinical trial, there is an interpretation that “Isn’t the marketing out of business?”
According to Hanmi Pharmaceutical on the 2nd, the FDA recently decided that “there is a need for supplementation” for the marketing authorization of’Orasol’, a metastatic breast cancer drug that Artenex applied for. Axol is a new drug that has changed the form of taking an anticancer drug’paclitaxel’ that is suitable for intravenous injection, and Hanmi Pharmaceutical’s platform technology’Oras Covery’ that converts injections into oral use has been applied. Hanmi Pharmaceutical handed over this technology to Artenex in 2011.
The FDA pointed out that oxisol has concerns about neutropenia compared to intravenous anticancer drugs. If neutrophils in leukocytes are abnormally reduced due to anticancer drugs, etc., they become susceptible to infection and may lead to death.
The FDA also expressed concern about the results of the objective response rate (ORR), which is the primary clinical evaluation variable, and said, “It is necessary to conduct a new clinical trial in the United States for further safety evaluation.” Hanmi Pharmaceutical has only clinical results for patients in Latin America. An official in the pharmaceutical industry said, “To do a new clinical trial, you have to spend a lot of money and time.”
Hanmi Pharmaceutical plans to request a meeting with the FDA after discussing the design and scope of clinical trials to be complemented with Artenex.
Hanmi Pharmaceutical’s reputation as a’national pharmaceutical company’ with its new drug development technology began to crack in 2016. This is because five of the 10 overseas technology exports (total of 8,643.1 billion won) that were successful in the 2010s were returned. It was also bad news that the strong management leadership, which had been playing a pivotal role, was shaken when Chairman Lim Seong-gi died last year. As a result, last year’s sales and operating profit declined together, giving up the position of’Big 5’in the pharmaceutical and bio industry that has been kept for a long time.
In this situation, the protagonist of Hanmi Pharm’s’No. 1 technology export’, Roksol, was’retired’. This is the reason why some of the industry is saying, “It seems that all possible bad news is pouring into Hanmi Pharmaceutical.” An official from Hanmi Pharm said, “There are no other new drugs to apply for approval to the FDA within this year, such as “Rolontis,” a neutropenia treatment, and 28 pipelines, such as “Rolontis,” a drug for neutropenia. As long as we have it, we will soon regain the status of the New Testament celebrity.”
Reporter Oh Sang-heon [email protected]
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