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- 2026-04-12 08:46:34
- Company
- Hanmi’s new biologic receives orphan designation in Europe
- by Chon, Seung-Hyun Jun 10, 2022 05:42am
- New drug products being developed by Hanmi Pharmaceutical have received a total of 20 orphan drug designations from regulatory authorities in Korea and abroad. Hanmi Pharmaceutical announced on the 9th that the European Medicines Agency granted an orphan drug designation for its new triple action biologic drug LAPS Triple Agonist (HM15211) for the treatment of Idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis is a rare condition caused by an unknown pulmonary inflammatory process and fibroblast hyperproliferation. Patients with IPF experience a rapid decline in lung function from tissue fibrosis and even death. Although it occurs in less than 100 cases per 10,000, its treatment had been rendered difficult due to the lack of efficacy in its approved treatments. LAPS Triple Agonist is a triple-action biologic drug that activates GLP-1, Glucagon, and GIP. It simultaneously targets▲ Glucagon, which inhibits fibrosis ▲ GLP-1, which facilitates insulin secretion and helps suppress appetite, and ▲ GIP, which facilitates insulin secretion and anti-inflammatory effect. Hanmi Pharmaceutical had confirmed its drug’s antiinflammatory and antifibrotic in animal models with idiopathic pulmonary fibrosis. With the designation Hanmi Pharmaceutical received a total of 20 orphan drug designations for its 10 indications in 6 pipelines (9 FDA designations, 8 EMA designations, and 3 Korea MFDS designations). LAPS Triple Agonist received a total of 6 orphan drug designations from both the FDA and EMA for the treatment of ▲primary biliary cholangitis, ▲primary sclerosing cholangitis, and ▲IPF. The FDA and EMA grant orphan drug designations to facilitate smooth development and approval of drugs that treat rare, incurable, or life-threatening diseases. In Europe, drugs that receive the designation pay reduced fees for marketing-authorization applications and may benefit from ten years of market exclusivity once they receive marketing authorization in the European Union (EU). An official from Hanmi Pharmaceutical said, “All the indications that the drug received orphan drug designation on induces fibrosis in specific tissues and has high unmet needs. LAPS Triple Agonist’s designation has meaning in that the drug's innovativeness is receiving attention from regulatory agencies in advanced countries.
- Company
- Jeil and Amgen agree to co-sell PCSK9 inhibitor Repatha
- by Nho, Byung Chul Jun 10, 2022 05:42am
- Noh Sang-kyung, CEO of Amgen Korea (left), and Sung Seok-je, CEO of Jeil (right), pose after signing a joint sales contract for Repatha.Jeil Pharmaceutical (CEO Seong Seok-je) and Amgen Korea (CEO Noh Sang-kyung) announced on the 7th that they signed a joint sales contract for Repatha for patients with atherosclerosis cardiovascular disease and hypercholesterolemia as of the 1st of this month. With this joint sales contract, Jeil Pharmaceutical and Amgen Korea will conduct Repatha's sales and marketing activities at hospitals, and Jeil Pharmaceutical will be in charge of sales and marketing activities for clinics. Through Repatha's joint sales cooperation, the two companies expected synergy to provide improved treatment benefits for patients with ultra-high-risk cardiovascular systems in Korea and strengthen market competitiveness. Repatha is a PCSK9 inhibitor that lowers the reuse rate of LDL-C receptors by inhibiting the activity of PCSK9 proteins that decompose LDL cholesterol (hereinafter referred to as 'LDL-C') receptors, and obtained domestic approval in April 2017 and further adaptation to treatment of ▲ atherosclerosis in August 2018, and ▲ primary hypercholesterolemia and mixed dyslipidemia In particular, Repatha showed superior LDL-C drop effects and cardiovascular risk reduction effects in patients with atherosclerosis cardiovascular disease in a large-scale three-phase global clinical trial. In addition, a 5-year follow-up study, the longest among PCSK9 inhibitors, confirmed that the consistent LDL-C drop effect of Repatha treatment was maintained in long-term treatment. Meanwhile, ESC/EAS revised the guidelines and recommended that LDL-C targets for preventing recurrence of cardiovascular events in ultra-high risk groups of cardiovascular disease be less than 55 mg/dL, and more than 50% of the base level. CEO Sung Seok-je said, "We expect that this joint sales contract will create synergy with Amgen's innovative product/clinical data and will try to provide Repatha's clinical benefits to more cardiovascular patients." He also said, "We look forward to continuously expanding and developing cooperative relations with Amgen Korea through this contract." "Repatha is a representative product of Amgen's cardiovascular disease treatment, and based on innovative mechanisms, it provides new treatment opportunities for patients who had limitations in reducing cardiovascular risk with only existing treatment options," said Noh Sang-kyung, CEO of Amgen Korea. He said, "I hope that this joint sales contract with Jeil will deliver the clinical benefits of Repatha to more ASCVD patients and medical staff in Korea, which will serve as an opportunity for Repatha to firmly settle into a new treatment standard."
- Policy
- Govt skeptical about using existing vaccines on monkeypox
- by Lee, Jeong-Hwan Jun 09, 2022 06:25am
- The government has said that the use of licensed human smallpox vaccines, antivirals, or vaccinia immune globulin intravenous (VIGIV) to prevent the domestic outbreak of monkeypox should be carefully considered in terms of efficacy and safety. In particular, the authorities explained there is a plan to study whether the 3rd generation smallpox vaccine that is being jointly developed with a Korean pharmaceutical company is effective in preventing monkeypox. The Korea Disease Control and Prevention Agency announced so in its measure to respond to monkeypox that it submitted to the National Assembly on the 8th. Cases of monkeypox are currently arising in western countries such as the United Kingdom, Portugal, Spain, Germany, the Netherlands, and the United States. However, due to the possibility of its influx the disease control and prevention authorities are working to introduce the monkeypox vaccine ‘Jynneos’ that received marketing authorization from the US Food and Drug Administration. Jynneos is a ‘third-generation smallpox vaccine,’ while other smallpox vaccines approved in Korea are classified as ‘second-generation smallpox vaccines.’ The government is skeptical about using the approved second-generation smallpox vaccines, antivirals, and VIGIVs on monkeypox. Although the second-generation smallpox vaccines are known to be 85% effective against monkeypox, KDCA explains that no proper efficacy and safety data exists and their method of administration is too complicated. Thus it is expected that the KDCA will not seriously review the use of approved second-generation smallpox vaccines and treatments until a monkeypox case arises in Korea. KDCA said, “We currently have no monkeypox treatments or vaccines in stock. The US CDC (Center for Disease Control) is guiding the use of smallpox vaccines, antivirals, and VIGIVs to control monkeypox, but recommends its use according to new drug clinical trials.” The KDCA added, “If monkeypox outbreaks in Korea, we plan to discuss the use of VIGIVs that we have in stock as treatment with experts. Also, we are monitoring the development and supply status of monkeypox antivirals in Korea and abroad for their use.” In particular, KDCA announced that a study is being planned to evaluate whether the approved second-generation smallpox vaccine and the third-generation smallpox vaccine that is being jointly developed with a domestic pharmaceutical company show effect in preventing monkeypox. The smallpox co-developer that KDCA mentioned seems to be HK Inno.N. HK Inno.N is the only Korean pharmaceutical company that manufactures a second-generation smallpox vaccine. HK Inno.N is conducting a clinical trial to confirm the preventive effect of its second-generation smallpox vaccine against monkeypox while working to develop a third-generation smallpox vaccine. Third-generation smallpox vaccines are attenuated live vaccines that are expected to improve safety and have reduced toxicity compared to second-generation smallpox vaccines. The KDCA said, “As of now, no vaccine is being developed for the prevention of monkeypox in Korea. However, there are plans to study whether the approved smallpox vaccines and the third-generation smallpox vaccine in joint development with a Korean company is effective against monkeypox.”
- Policy
- Cases for Pre-approval of Ultomiris exceeds 100
- by Lee, Tak-Sun Jun 09, 2022 06:25am
- Soliris (left) and UltomirisThe number of approved Ultomiris administered was 101 until April. Ultomiris, a treatment for paroxysmal nocturnal hemoglobinuria (PNH), has been shown to have completely replaced Soliris, the existing treatment since its benefits in June last year. Both are expensive rare drugs, and must be approved in advance by the Board of Review and Assessment before administration. According to the HIRA on the 8th, a total of 101 cases of Ultomiris were approved in advance by April for PNH patients after their benefits in June. Soliris did not have any prior approval applications for PNH patients at this time. Ultomiris has completely replaced Soliris, at least for new patients. The prospect that Ultomiris, which has improved convenience, would replace Soliris was predicted even before Ultomiris' benefits. This is because the number of Ultomiris injections is once every eight weeks, while Soliris is once every two weeks. The number of injections decreased, so the patient levy decreased compared to Soliris. Price for Ultomiris is 5,598,942 won per bottle and price for Soliris is 5,132,364 won, which is not much different. Considering the number of shots per year, Ultomiris administration is much more economical. Alexion Pharmaceuticals, the developer of the two drugs, succeeded in transforming Soliris' patent expiration crisis into an upgraded Ultomiris. Soliris' biosimilar is about to be released. The domestic vendors of Soliris and Ultomiris are Handok. The difference in the number of pre-approval cases is also reflected in the performance. Based on IQVIA, Ultomiris' sales in the first quarter of this year were 9.6 billion won, overwhelming Soliris, which recorded 2.8 billion won. PNH is a rare blood disease caused by the destruction of red blood cells by complement, which is part of the immune system. Urine color is red, and bruising or bleeding easily occurs. It is a fatal disease in which four out of ten people die within five years if not treated after diagnosis, and requires drug administration. There are about 200 patients in Korea.
- Policy
- Monkeypox becomes Class 2 infectious disease in Korea
- by Lee, Jeong-Hwan Jun 09, 2022 06:24am
- The viral zoonosis monkeypox will be designated and managed as a ‘Class 2 infectious disease’ by law starting today (8th). With its level raised, monkeypox will now be managed and considered to have the same level of risk as COVID-19, tuberculosis, and chickenpox. If a person is confirmed with a Class 2 infectious disease, this must be reported to the quarantine authorities within 24 hours, and the infected person is required to undergo mandatory quarantine. The Korea Disease Control and Prevention Agency said, “In consideration of the characteristics of monkeypox including its severity, monkeypox will be designated as a ‘Class 2 infectious disease that is designated through discussion between the KDCA commissioner and MOHW minister.’ Other notices that have been partially revised include the notification on the diagnostic criteria for infectious diseases and the notification of infectious diseases that the KCA commissioner deems in need of emergency quarantine measures. The main content of the revised notice is to classify monkeypox as a second-class infectious disease and give treatment and quarantine obligations to confirmed patients. Under the Infectious Disease Prevention Act, patients confirmed with statutory infectious diseases are obligated to report their infection. 22 diseases including COVID-19, tuberculosis, and chickenpox are designated as Class 2 Infectious Diseases that require isolation in consideration of the possibility of its transmission. The authorities have issued an “interest” alert for monkeypox after holding a risk assessment meeting on monkeypox with the Infectious Disease Risk Management Committee at the end of last month. Also, due to the increase of overseas visitors and infected cases abroad, the authorities had set up a separate task force to preemptively respond to the rising possibility of its influx to Korea. Previously, the KDCA had evaluated that there is an ‘intermediate’ risk of infection in high-risk groups that have contacted confirmed or symptomatic patients without appropriate personal protective equipment (sexual contact, cohabitant), and a ‘low’ risk of infection in the general public. Monkeypox is mainly transmitted through close physical contact and has a lower transmission rate than COVID-19. Monkeypox, originally an endemic that had previously been confined to Central and West African countries, was first reported in the UK early last month, followed by sporadic reports of the disease globally including in the United States, Spain, Germany, France, Morocco, and Israel. According to the WHO, 780 cases of the disease in 27 countries have been confirmed in non-endemic areas as of the 5th of this month. The authorities are also in the process of introducing a ‘third-generation’ vaccine that has proven efficacy against monkeypox. Bavarian Nordic’s ‘Jynneos’ is being considered a likely candidate. The KDCA already owns 35 million courses of a second-generation smallpox vaccine in preparation for a public health crisis but is not considering using the stockpile for public vaccination. The authorities plan to treat confirmed patients in isolation wards as soon as a case of monkeypox occurs in Korea. Whether to impose quarantine on those in close contact is still being discussed. The authorities have asked those who visit countries where monkeypox occurred to practice good personal hygiene and contact the KDCA call center (1339) if suspicious symptoms occur within three weeks after returning to Korea.
- Policy
- Evusheld is expected to be introduced this month
- by Lee, Jeong-Hwan Jun 09, 2022 06:24am
- The government is expected to introduce Evusheld, a COVID-19 antibody treatment that is administered to patients who do not form antibodies well even with vaccinations, to Korea this month. Lee Ki-il, the first general coordinator of the Central Disaster and Safety Countermeasures Headquarters, presided over a meeting at the Sejong Government Complex on the 8th and said, "We will complete the EUA procedure of the Evusheld within June and guide local governments and the medical community." Lee Ki-il, the first general coordinator, explained, "It is a preventive antibody treatment for those who are difficult to form antibodies through vaccines because they are receiving immunosuppressants such as blood cancer patients and organ transplant patients." He added, "As the additional budget was confirmed last week, we will quickly push for the supply of Evusheld in Korea." From that day on, all overseas immigrants will be exempted from quarantine regardless of whether they have completed vaccination or their nationality. All restrictions on flights at Incheon International Airport will also be lifted. However, pre- and post-entry inspections are maintained to manage the inflow of new mutations. All entrants must submit PCR test results conducted within 48 hours before entering the country or rapid antigen test results conducted within 24 hours, and submit PCR test results within 3 days after entering the country. Recently, the COVID-19 situation has been managed stably. The number of weekly confirmed patients decreased for 11 consecutive weeks, and the number of critically ill patients and deaths last week also decreased by 29.5% and 56.5% compared to the previous week, respectively. As of the 8th, the operation rate of inpatient bed was also reduced to within 10%, including 8.8% for severe beds, 9.4% for semi-critical patients, and 6.8% for moderate beds, stressing that there is enough room for medical response. The infectious reproduction index was 0.74, which has remained less than 1 for 10 consecutive weeks. The first general coordinator said, "Experts continue to warn of the possibility of a COVID-19 pandemic in the summer. There are still many risks of re-pandemic, including local festivals and vacations in summer and the use of indoor air conditioners in an enclosed environment," he said.
- Company
- Genomictree's colorectal cancer business is booming
- by Lee, Seok-Jun Jun 09, 2022 06:23am
- FS Research highly evaluated Genomictree's growth potential in a report on the 8th. Genomictree is a company that discovers biomarkers, verifies clinical efficacy, and develops and sells early diagnosis products for various cancers (colonial cancer, lung cancer, bladder cancer, etc.). According to the report, sales of Genomictree's colorectal cancer diagnostic kits are soaring in Korea. Sales of colon cancer diagnostic kits, which recorded 300 million won last year, are estimated to be about 900 million won in the first half of this year, with 3 billion won annually. Hwang Se-hwan, a researcher at FS Research, said, "Genomictree's diagnostic kit is much simpler than colonoscopy because it can diagnose colon cancer with just 1 to 2g of feces. The sensitivity and specificity are 90%, which is significantly higher than the fractional occlusion test. This advantage is that the number of hospitals in sales and supply has increased rapidly since this year," he analyzed. Researcher Hwang said, "Assuming that 11.5 million people aged 35 to 49 undergo colonoscopy once every five years, the number of people subject to colonoscopy is estimated to be about 2 million per year. Due to the large size of potential customers, the domestic market alone has very high growth potential," he predicted. He also mentioned the possibility of expanding global businesses. Genomictree began selling in Southeast Asia and Europe this year, and the U.S. and China are undergoing clinical trials. The U.S. is conducting exploratory clinical trials (1st), and plans to conduct confirmatory clinical trials (2nd) next year and release them in 2024. Researcher Hwang said, "Competitor Exact Sciences, which has a market capitalization of 10 trillion won, has grown 30% by achieving 2.21 million inspections in 2021, seven years after its launch. Genomictree has a similar level of sensitivity and specificity to that of Exact Sciences. It is expected that it will expand its market share in the U.S. with advantages such as low inspection costs, short inspection time, and very small amount of stool inspection." The surge in domestic sales of colorectal cancer diagnostic equipment is evidence that the possibility of success in the global market is increasing. We should pay attention to Genomictree as these expectations can be reflected in the stock price, he added.
- Company
- Impurity data on schizophrenia and asthma drugs submitted
- by Chon, Seung-Hyun Jun 08, 2022 05:56am
- Pharmaceutical companies are submitting results of their impurity inspections on the schizophrenia treatment ‘Quetiapine’ and asthma and allergic rhinitis treatment ‘Montelukast’ one after another. As of now, no product has been recalled due to excessive impurities, and the health authorities plan to take follow-up measures after reviewing the drug companies' impurity inspection data. According to industry sources on the 7th, pharmaceutical companies submitted data on their schizophrenia treatment ‘Quetiapine’ to the Ministry of Food and Safety by May 27th. The data contained the companies’ evaluation of the possibility N-Nitroso-Aryl Piperazine (NNAP) impurities, process safety review data, provisional management standards, and grounds for setting such standards. This is a follow-up measure made after the MFDS requested the companies to submit impurity data on drugs that contain quetiapine in late April. The MFDS ordered companies to submit test results on the companies’ representative batch numbers among finished quetiapine products that can be sold in the market by July 28th. A representative batch number refers to three or more batches that are nearing expiry every year. Products manufactured in 3 batches or less are required to submit test results of all batches. This precautionary measure was made according to the safety information that NNAP impurity was detected in a single-agent quetiapine product. The MFDS had ordered pharmaceutical companies to submit data including those evaluating the possibility of NNAP impurities in quetiapine products by May 27th. NNAP is a new nitrosamine impurity that has been identified in the market. .Since 2018, two types of nitrosamine impurities, - ‘N-nitrosodimethylamine (NDMA)’ and ‘N-nitrosodiethylamine (NDEA)’ were detected in valsartan, ranitidine, and nizatidine .Quetiapine is a generic used to treat schizophrenia .Its original is Alvogen Korea’s ‘Seroquel.’ Around 30 Korean companies are currently selling quetiapine generics, and the domestic market grosses ₩30 billion a year .No quetiapine product in the market has been detected to have excess impurities in Korea yet, but it is impossible to rule out the possibility that some products with excess impurities may be found in the tests of finished quetiapine products .Based on the submitted data, the MFDS plans to closely review the impurity risk of quetiapine products in Korea .An MFDS official said, “We plan to make follow-up measures after the test results are submitted and a comprehensive review of all the results are made.” None of the montelukast products, on which the impurity issue had arisen earlier this year, have been recalled either .The Ministry of Food and Drug Safety had previously ordered pharmaceutical companies to investigate their montelukast ingredient and finished products for impurities and submit the reports by April 25th .This precautionary measure was issued after the ministry received safety information that N- nitrosodipropylamine (NDPA) was detected in the API montelukast .Manufacturers and importers of montelukast were then required to submit test results on representative batch numbers that can be distributed in the market .The MFDS asked the companies to conduct additional follow-up measures if necessary .Manufacturers and importers of finished products are required to conduct evaluations on the possibility of impurities in the manufacturing process .If necessary, the companies are also required to conduct tests and follow-up measures like the API companies .The MFDS ordered companies that produce raw materials and finished products to immediately report NDPA impurities found during inspection even before the submission deadline .Montelukast is used to treat allergic rhinitis and asthma .The original drug is Organon Korea’s ‘Singulair.’ In Korea101 domestic pharmaceutical companies are selling generic versions with the same ingredient .Its domestic market grosses around ₩100 billion a year .The pharmaceutical companies had submitted impurity inspection results on montelukast products by April according to MFDS instructions, and no impurity issue has been identified in the products sold in Korea as of now .In April, Organon Korea had announced that no impurities were detected in ‘montelukast sodium,’ the active ingredient of its allergic rhinitis and asthma treatment ‘Singulair.’ An MFDS official said, “We are currently reviewing impurity review data on montelukast, and will take the necessary safety measures according to the plan we have previously prepared.”
- Opinion
- [Reporter's view]Will arbitrary manufacturing be eradicated?
- by Kim, Jin-Gu Jun 08, 2022 05:56am
- A revision to the Pharmaceutical Affairs Act, which allows the imposition of "punitive fines" on pharmaceutical companies that violate GMPs, passed the National Assembly. It also included canceling the judgment of suitability for the GMP if a violation is found, and allowing a prison term of up to five years or a fine of up to 50 million won, apart from the fine. It contains the will of the MFDS that there is no longer tolerance for deceiving the authorities of permission by false or fraudulent means. What is noteworthy in the revised Pharmaceutical Affairs Act is that a 'GMP exclusive investigator' was appointed. In order to increase the administrative efficiency of GMP investigation and evaluation work, GMP manufacturing and quality control investigators were appointed and pharmaceutical manufacturers were allowed to enter and investigate. It is interpreted that the GMP Special Planning and Inspection Team, which was temporarily operated after a series of GMP violations were detected last year, will be changed to a regular operating system. There has been a role in managing and supervising pharmaceutical companies' compliance with GMP. Article 36 of the current Pharmaceutical Affairs Act designates a "Manufacturing Manager" and manages and supervises the overall drug manufacturing work. But it's actually a private law. Many manufacturing managers have long acquiesced in the evil practice of the name. There are also many expedient ways to fill out related documents in double and then take a new pharmacist to sign them. Manufacturing managers were unable to make a proper opinion from the standpoint of receiving a salary from the company. Pharmaceutical companies forced them to be loyal, and the Ministry of Food and Drug Safety remained unaware. It means that there is no role in managing and supervising drug manufacturing, so GMP violations have not continued. It's just that the law hasn't been used properly. The MFDS has steadily detected GMP violations through the pharmacist monitoring system. According to data released at last year's parliamentary audit, the MFDS conducted 1,277 pharmacist monitoring (regular monitoring + special monitoring) for 5 years and 9 months from 2016 to September 2021. In the process, 485 violations of 189 companies were detected. It means that four (38%) of the pharmacist monitoring were caught 10 times. The problem is that 118 companies have been caught twice or more. There were 45 companies caught more than four times, and two companies were caught more than 10 times. This means that there was no appropriate follow-up by the MFDS even after detecting GMP violations. The main point of the new system is to strengthen surveillance and punishment. The plan is to strengthen surveillance through GMP investigators and impose strong penalties on companies caught to prevent recurrence. Strengthening surveillance and punishment in the new system require appropriate interaction. The focus should not only be on detecting GMP violations. Without proper follow-up measures to prevent recurrence, it is meaningless even if the number of GMP violations is doubled or tripled.
- Policy
- Bringing 3rd gen monkeypox vaccine to Korea in discussion
- by Lee, Jeong-Hwan Jun 08, 2022 05:56am
- The government announced on the 7th that it has started discussions on the quantity and schedule for bringing a ‘3rd generation monkeypod vaccine’ to Korea with its manufacturer. The authorities decided to accelerate the introduction of this third-generation vaccine with proven efficacy as the number of confirmed cases of monkeypox continues to increase worldwide and the possibility of its inflow to Korea rises. The Danish company Bavarian Nordic’s ‘Jynneos’ is the only monkeypox vaccine that received marketing authorization in the world. Jynneos is currently available for vaccination in the US and Canada after receiving FDA approval in 2019. Jynneos is an attenuated, live, non-replicating smallpox and monkeypox vaccine used for the prevention of smallpox or monkeypox in adults over 18 years of age that is known to provide 85% protection against monkeypox. Geun-Young Kwon, head of the vaccination management team of the Vaccination Response Promotion Bureau of the Korea Disease Control and Prevention Agency (KDCA), said, “We are currently discussing the introduction of a third-generation smallpox vaccine to Korea with its manufacturer. We will provide information on its quantity and schedule as soon the discussions are complete.”
