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- 2026-05-20 21:57:46
- Policy
- NIH, urgently promotes 2019n-CoV vaccine research
- by Kim, Jung-Ju Feb 07, 2020 06:32am
- Health authorities urgently push forward research to develop 2019n-CoV treatments and vaccines. After the MERS outbreak, it will strengthen its research capabilities and begin research on viral pathogenicity within this month. The National Institutes of Health (Director Hyun-Young Park), in the Centers for Disease Control and Prevention (Director Eun-kyung Chung), announced on the 5th that it is urgently pursuing research on the development of treatments and vaccines to cope with 2019n-CoV that threaten public health worldwide. The National Institutes of Health has conducted research on new and variant viruses in Korea through the development of antibody therapeutics and high-sensitivity gene diagnostics after the MERS outbreak in 2015. Based on the accumulated technology, the NIH will collaborate with domestic researchers to launch 2019n-CoV treatment, vaccine development, and viral pathogenicity research in February. In detail, the cost of this research is ₩800 million, which is divided into clinical, therapeutic, vaccines, and pathogenic analysis. In the clinical and therapeutic sectors, the hospital-centered network is used to study the clinical immunological characteristics of domestic patients and to develop a wide range of antigens and antibodies for the development of therapeutic antibodies. The vaccine division studies DNA vaccines, major antigen production, various types of vaccines including vaccine antigen carriers and inactivated vaccines, and development of efficacy evaluation techniques for vaccines. Pathogenicity analysis includes the analysis of the major genetic variants of the 2019n-CoV and the prediction of its evolution. In addition, the Ministry of Health and Welfare and the Ministry of Science and ICT will cooperate with relevant ministries and industry-university research institutes to expand preemptively prepare for and respond to the emergence of new and variant viruses including 2019n-CoV. In the case of the Ministry of Welfare, the Ministry of Science and ICT and the Ministry of the Interior and Safety will undertake the National Life Safety Emergency Response Study. Sung-soon Kim, director of the Center for Infectious Disease Research at the National Institutes of Health, said, "This urgent research project will play a pivotal role in the research of new and transformed infectious diseases and lay the groundwork for the development of 2019n-CoV treatments and vaccines at the national level". Meanwhile, there are no specific treatments or vaccines for 2019n-CoV infections, so countries around the world are using symptomatic therapy and existing antiviral agents and developing vaccines and treatments. Overseas funding and technology are supported by the international cooperation, the Coalition for Epidemic Preparedness Innovations (CEPI). Ebola virus treatment (Remdesivir) and HIV treatment (Lopinavir, Ritonavir) are also being evaluated for efficacy.
- Policy
- Feb shortage prevention drug list: 641 items with Vivaquine
- by Lee, Hye-Kyung Feb 07, 2020 06:32am
- Myung In Pharmaceutical’s Vivaquine tablet (primaquine phosphate) has been designated as a shortage prevention drug as compensation for high production cost. The maximum price is set at 309 won. Health Insurance Review and Assessment Service (HIRA) recently disclosed new list of shortage prevention drug as of February 2020. ‘Shortage prevention drug’ is defined as an essential drug the government designates to prevent pharmaceutical company from stop supplying the drug due to poor profitability. The drug is then categorized as ‘compensation for usage incentive and high production cost,’ ‘compensation for high production cost,’ or ‘compensation for usage incentive.’ All shortage prevention drugs added to the list this month would receive National Health Insurance benefit as compensation for high production cost. Along with Vivaquine, Shin Poong Pharm’s Malafree tablet (primaquine phosphate) and Richwood Trading’s Richnight tablet (doxepin hydrochloride) have been designated as shortage prevention drugs with maximum prices set at 309 won and 89 won, respectively. The designation was finalized on Jan. 22, when Ministry of Health and Welfare (MOHW) revised the ‘List of Reimbursed Drug and Maximum Reimbursement Price.’ As the mandatory reporting regulation of drug manufacturing, importing or suspending supply stipulates, pharmaceutical manufacturer or importer with approved drug planning suspend the drug supply is required to report the plan with justifiable reason to Minister of Food and Drug Safety 60 days prior to the estimated date. Companies not complying with the regulation would be imposed with administrative measure of manufacturing or business operation suspension—three months for the first offence, six months for the second and business license revocation for the third.
- Policy
- DREC to deliberate drug reevaluation as originally planned
- by Kim, Jung-Ju Feb 07, 2020 06:32am
- Although committee meetings and events by Korean government and associated agencies have been either canceled or postponed due to the novel coronavirus, Drug Reimbursement Evaluation Committee (DREC) plans to push on with its original schedules as it plays the role of the first threshold to drug reimbursement listing and criteria negotiation. Pharmaceutical industry insider reported Health Insurance Review and Assessment Service (HIRA) has decided to convene DREC meeting on Feb. 6 as initially planned. DREC’s objective is to deliberate and decide on issues regarding new and generic drug listing, alleviating or adjusting reimbursement criteria and other National Health Insurance reimbursement. The committee regularly convenes a meeting on every first Thursday of a month, and reports outcomes to Ministry of Health and Welfare (MOHW). The ministry then sort out drugs for listing to either report them to Health Insurance Policy Deliberation Committee (HIPDC) or order National Health Insurance Service (NHIS) to schedule further negotiations with the pharmaceutical companies, if need be. The industry carefully assumed DREC would also postpone its meeting schedule, as HIPDC meeting, as well as other government and public events and meetings, have been affected by the novel coronavirus outbreak. But the industry was still skeptical of the committee rescheduling the meeting as DREC consists of only about 20 or so members and its decision-making procedure is more urgent than any other committee’s as it affects company’s business schedule and patient’s treatment access. The industry is naturally quite keen on this specific DREC meeting as it the agenda includes the pharmaceutical reevaluation standard and method. HIRA has been hinting the industry of a plan to adopt reevaluation system for already-listed drug and accordingly adjust pricing and reimbursement conditions, but it has yet to finalize related guideline and subject drug list. The industry has been highlighting the finalization of the reevaluation guideline and subject list as reevaluating last year’s hot potato, choline alfoscerate, would be also decided at the same time. Overall, the industry is mostly convinced the upcoming DREC meeting would deliberate and decide on the guideline and the list considering the general flow and time needed of Comprehensive National Health Insurance Plan and revised drug pricing system.
- Company
- Opdivo retries expanding reimbursement without NSCLC
- by Eo, Yun-Ho Feb 06, 2020 06:31am
- Seemingly have given up on expanding reimbursement, Opdivo has turned around and started taking actions again. Nevertheless, its health coverage application excluded indication for lung cancer. According to industry sources, Ono Pharmaceutical and BMS have recently applied for expanding reimbursement on PD-1 inhibitor-based immunotherapy Opdivo (nivolumab). The application is for the use as second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic squamous cell carcinoma of the head and neck (SCCHN), and second-line treatment for typical Hodgkin’s disease. The issue-making indication treating non-small cell lung cancer (NSCLC) regardless of expressed PD-L1 was dropped from the new application. Although the companies may have left the NSCLC indication behind, they are determined to continue improving access to Opdivo. Since early 2019, the government has been negotiating with respective pharmaceutical companies on Opdivo, Roche’s Tecentriq (atezolizumab), and MSD’s Keytruda (pembrolizumab) all together for expanded reimbursement. In the process, Ministry of Health and Welfare (MOHW) engaged in preliminary negotiation with the companies and laid a condition to limit reimbursement only to patients showing response and the ‘trade-off’ initiative, which would reduce off-patent drug’s pricing as a compensation for recognizing value of new drug. The preliminary negotiation is a type of special procedure, not a part of regular deliberation process for reimbursement expansion, such as Cancer Disease Deliberation Committee, Drug Reimbursement Evaluation Committee (DREC) of Health Insurance Review and Assessment Service (HIRA) or drug pricing negotiation with National Health Insurance Service (NHIS). Immunotherapy has been a game changer that shifted the paradigm of anticancer therapy. However, it is extremely expensive and its indication can expand out indefinitely. Preliminary negotiation is a unique tool the Korean government has established to discuss easing reimbursement criteria for drugs necessary for treatment but comes with significant financial burden. The purpose of the tool is to expedite the procedure with DREC and NHIS by reaching an agreement on financial issues and reimbursement criteria prior to the regular procedure. But, only Roche reached an agreement with the government. Although the second round of negotiation fell through, MSD applied for reimbursement expansion again with another indication approved at the end of last year and is now waiting for Cancer Disease Deliberation Committee’s decision. Whereas, Ono Pharmaceutical and BMS have not taken any other actions after the first negotiation ruptured last May. Many suspected the companies have basically ‘given up’ on Korean market. For now, the industry is keeping close eyes on Opdivo putting aside the discrepancy experienced last year and yet again applying for expanding reimbursement without the NSCLC indication. Initially, Opdivo was indicated ‘regardless of expressed PD-L1,’ but it was listed in August 2017 with a set expression rate of PD-L1 under refund and expenditure cap type risk sharing agreement.
- Company
- Pelubi’s indication expansion, seeking for breakthrough
- by Kim, Jin-Gu Feb 06, 2020 06:30am
- Pelubi & Pelubi CR Daewon Pharm challenges the expansion of Pelubi's patented indication. Pelubi's indication for osteoarthritis is extended to dysmenorrhea. Recently, Pelubi CR’s phase III trial plan by Daewon was approved from the Ministry of Food and Drug Safety. This is a phase III clinical trial in Korea to evaluate the efficacy and safety of DW9801 in primary dysmenorrhea patients. Currently, Pelubi has indications for osteoarthritis, rheumatoid arthritis and low back pain. There are two related patents. There are formulation patents for Pelubi and formulation patents for Pelubi CR, respectively. The attempt to expand the indication is related to the recent patent challenge. Pelubi has been patented by six pharmaceutical companies since late last year. Yungjin Pharm filed a judgement on passive confirmation of the scope on the Dec 27 last year, followed by Futecs, Huons, Chong Kun Dang, Nexpharm, and Mother’s Pharmaceutical. This is why Daewon Pharm is attempting to expand the indications to Pelubi CR rather than Pelubi. The six companies' patent challenges are headed for Pelubi. Successful overcoming this patent, which expires in November 2028, will be available after September 2021, when the PMS expires. However, even if the patent is overcome, it can be prescribed only for the treatment of osteoarthritis, rheumatoid arthritis, and low back pain, which is an indication limited to Pelubi. Under the assumption that Pelubi CR is extends the indications, it cannot be used for the treatment of dysmenorrhea. So far, no patent challenge has been confirmed for the Pelubi CR. Last year, the combined Rx amount of Pelubi & Pelubi CR amounted to ₩ 28.9 billion. Prescriptions, which amounted to ₩4.6 billion and ₩5.7 billion respectively in 2014-2015, surged to ₩8.5 billion in 2016, ₩13.5 billion in 2017, ₩23.9 billion in 2018, and ₩28.9 billion in 2019. The rapid growth of Pelubi's prescription is analyzed that to there was not a little impact on the release of Pelubi CR. Pelubi was released in 2007 as the new domestic drug No.12. Since its launch. By the first half of 2015, the half-yearly prescription performance was just around ₩2.3 billion. However, since the launch of the Pelubi CR in June 2015, the semi-annual earnings have been on the rise, and since the second half of 2017, it has grown into a blockbuster drug with full-fledged operations by Daewon Pharm. Pelubi RX results (Unit: ₩100 million, Data:UBIST) for the past six years. Since the release of Pelubi CR tablet in June 2015, it has been on the rise.
- Policy
- 2019n-CoV was successfully isolated from infected patients
- by Kim, Jung-Ju Feb 06, 2020 06:30am
- Health authorities have successfully isolated the new coronavirus (wuhan pneumonia) from patients with infectious diseases, It is very good news for developing vaccines and treatments The KCDC(Director, Eun-kyung Chung) announced on the 5th that 2019n-CoV was isolated and will share with the scientific community for the development of vaccines and treatments. The new isolate of Korean coronavirus is BetaCoV/ Korea /KCDC03/2020. STR of isolated new Korean coronavirus The KCDC inoculated the patient's respiratory specimens (sputum, etc.) into cells and confirmed the growth of the new coronavirus and analyzed the viral gene sequences to prove the new coronavirus. The culture is to divide, grow and multiply the cells, which are the basic life units, so that the population increases. Viruses can be cultured only in living cells. According to the virus genetic information released by the KCDC, the isolated virus was identical in sequence (99.5 ~ 99.9%) with viruses isolated from China (Wuhan, Guangdong), France, Singapore, Germany, etc. No significant genetic variation was found. .The nucleotide sequence information of the new isolates of the new coronavirus is registered in the GISAID of the World Health Organization (WHO) and can be used by researchers at home and abroad .GISAID is WHO's world influenza surveillance network, which contains information on the gene sequence of new coronaviruses in each country .The director, Eun-kyung Chung said, "Isolated viruses will be distributed to relevant ministries and relevant competent institutions so that they can be used for research and development as an indispensable resource for the development of diagnostics, treatments, and vaccines, and distribution procedures and methods will be announced later".
- Company
- Pharmaceuticals are focusing on domestic actions for NDMA
- by Chon, Seung-Hyun Feb 06, 2020 06:30am
- Investigations have shown that Metformin's impurity content is safe in the US and EU. In Korea, the Ministry of Food and Drug Safety has also begun inspections after deriving the test method. The US Food and Drug Administration (FDA) announced on the website that some of the Metformin products sold under the FDA approval and carcinogenic substance 'N-nitrosodimethylamine (NDMA)' was detected, but the daily intake (96 ng) was not exceeded. Of the 10 products examined, NDMA was detected only in six lots of two Metformin 1000mg ER & Metformin 500mg ER products by Actavis. Detection amount was 0.01 ~ 0.02 microgram (mcg) per tablet. NDMA test results of 10 Metformin products conducted by FDA (Source: FDA) The FDA said that the test did not confirm a sample of Metformin with NDMA detected above the maximum daily intake and currently does not recommend the recovery of Metformin in the United States. In the near future, it will be posted on the website the method for detecting NDMA of Metformin used in the laboratory. On December 6, last year, the European Medicines Agency (EMA) said on its homepage, “There are very few NDMA detected in some Metformin products sold outside of the EU. Metformin products in the European Union have not yet been detected for NDMA detection". In the near future, it is expected that the results of the investigation of Metformin NDMA detection will be released in Korea. The risk of NDMA in metformin was triggered in Singapore. On December 4, last year, the Singapore Health and Science Agency (HSA) surveyed 46 metformin products sold locally, recovering three products and detecting NDMA above the daily allowance. The whole view of the MFDS The MFDS received data on the use of Metformin from pharmaceutical companies. The MFDS has received data on the production of pharmaceuticals containing Metformin hydrochloride and the systematic investigation of raw materials used until December 17 last year. Pharmaceutical companies submitted the total number of drugs containing Metformin, items and number of production records, items and quantity without production record to the MFDS. The Metformin lineage survey at the MFDS is a preliminary activity to prepare for the detection of impurities. If a problem occurs in a particular drug substance or drug product, the intention is to follow up quickly and accurately based on the results of the systematic investigation submitted by the pharmaceutical company. The MFDS unveiled Metformin's NDMA test on January 15, a month and a half after the Metformin NDMA risks were raised in Singapore. It was suggested to test by Gas Chromatography (GC) method. The industry is alert on the results of Metformin's NDMA inspection in Korea. It is not easy for pharmaceutical companies to test whether they detect Metformin's NDMA. That's because there aren't enough institutions with analyzers to make self-checks. Some pharmaceutical companies are reportedly considering buying their own analyzers. However, it costs ₩300 to 500 million for each analyzer and every year, ₩ tens of millions in management costs are inevitable. Pharmaceutical companies fear that if Metformin is the case, with massive losses in Valsartan and Ranitidine, irreversible losses can occur. Metformin is overwhelmingly larger than Valsartan and Ranitidine. According to UBIST data of drug research institutes, the outpatient prescription market of Metformin-containing drugs in 2018 was estimated at ₩420 billion. Ranitidine, which had been suspended from selling all its products, has formed a prescription scale of about ₩200 billion, which is more than double the market. The unit price of Metformin is less than ₩100. That's an overwhelming amount of ranitidine. Outpatient Rx performance of Metformin-containing medicines by year (Unit:₩100 million, Source: UBIST) Tensions are heightened by pharmaceuticals, as the MFDS has taken tough measures on impurities-detecting drugs. In the case of Valsartan, the MFDS discontinued the sale of drug products that used the ingredients in question at least once in January 2015. Many products are likely to be discontinued even though they did not use the raw materials in question. In the United States, only the products using the Zhejiang Huahai Pharmaceutical raw materials were recovered by manufacturing unit. No action was taken to sell the entire item. In Europe, the measure of action was similar. All ranitidine products have been discontinued in Korea. while in the US and Europe, pharmaceuticals were collected by their own lot numbers. In the case of 13 items of Nizatidine have been discontinued, but some of the products have been recalled in Japan, and no products have been ordered in the United States and Europe. An official from the MFDS said, "We are in the process of inspecting the Metformin NDMA test after deriving it".
- Company
- HIV drug as alternative treatment for new coronavirus?
- by Nho, Byung Chul Feb 06, 2020 06:30am
- In the midst of the novel coronavirus outbreak, a few countries are using HIV medication as an alternative treatment. 48 hours after receiving HIV drug, a confirmed patient with initial symptoms in China and a 40-year-old female patient in Thailand have been tested negative for the novel coronavirus. In Korea, the 14th patient has been reportedly treated with HIV drug and Tamiful together. Then why is HIV drug used on a patient against the novel coronavirus? The notion started with the unique inserts in the novel 2019 coronavirus that could be blocked from viral replication with similar mechanism used in HIV drug. HIV medication does not eliminate the virus itself, but inhibits replication of body cell infected with the human immunodeficiency virus. The mechanism repurposes the quality of virus naturally dying when the viral replication has been shut off. In other words, it is unrelated to human immune system. Such mechanism is named ‘repurposing combination therapy,’ because it repurposes combination of existing HIV drug and new flu treatment Tamiflu as an alternative treatment option for the novel coronavirus without a corresponding treatment at the moment. Professor Kim Young-bong of molecular virology at Konkuk University explained, “HIV treatment has protease inhibitor designed to obstruct the action of protease enzyme. While virus repeats producing and fusing polypeptide to replicate (polyprotein), HIV treatment hinders protein from cleaving to become a new virus.” For example, if virus “A” are to produce protein to replicate as virus “B,” “C,” and “D,” the protease inhibitor prevents further replication by blocking out protease connected to B, C, and D. Virus stops replicating when protein-breaking-down enzyme, protease, secretion is inhibited. In short, if coronavirus were to have infiltrated and infected 100 human cells, HIV drug could prevent those infected cells from cleaving into thousands and billions of viruses and let them die naturally. The novel influenza virus treatment, Tamiflu also does not kill the virus itself, but uses neuraminidase mechanism of inhibiting infected cell from proliferating in non-infected cells. The HIV drug currently prescribed to novel coronavirus-infected patients is confirmed to be protease inhibitor Kaletra (ritonavir plus lopinavir). Presumably, the HIV medication is prescribed as first-line treatment to focus on preventing replication of the novel coronavirus and relieving symptoms. Meanwhile, there are approximately 21 HIV treatments available in the market, including nucleoside reverse transcriptase inhibitor (NTRI) Kivexa, non-NTRI Edurant, fusion inhibitor Fuzeon, and CCR5 inhibitor Senzentry.
- Company
- Global companies work from home due to outbreak
- by Kim, Jin-Gu Feb 06, 2020 06:29am
- Impact of the novel coronavirus is spreading through the Korean pharmaceutical industry. Currently, at least nine pharmaceutical companies have been confirmed to work from home and the number is increasing. The industry reported on Feb. 3, Pfizer Korea, Novartis Korea, MSD Korea, AstraZeneca Korea, Bristol-Myers Squibb Korea, Sanofi-Aventis Korea, AbbVie Korea, Amgen Korea and UCB Korea have decided to have their employees work from home. Apparently, all nine of them are multinational companies. On last weekend, MSD Korea has notified all employees that “Employees assigned at a contact point with all clients should work from home from Feb. 3, and employees at office are strongly recommended to work from home.” As for AbbVie, all expecting employees have been recommended to work from home from Jan. 28. The rest of the employees are also working remotely from home from Feb. 3 to coming Friday. Other global pharmaceutical companies have been notified similarly. Pifzer and Novartis have been advised to work from home from Feb. 3. Most of the companies plan to do so until coming Friday. Bristol-Myers Squibb, on the other hand, only advised salespeople to work from home. Employees at Sanofi may work from home upon request. However, employees who are expecting or have young child at home are strongly advised to work from home, unless there is an urgent circumstance. Amgen Korea has been quick to call the decision and had every employee work from home from Jan. 30. Other multinational companies, yet to have recommended working from home, are watching the general industry taking steps. A multinational company insider commented, “The company has not finalized the decision, but it’s contemplating on various measures including working remotely from home watching the spread of novel coronavirus infection.” Meanwhile, none of Korean pharmaceutical company has been confirmed to be working from home. Still, they have required all employees to wear mask when in contact with others, to self-quarantine when having suspicious symptoms, and to tend personal hygiene. A Korean pharmaceutical company insider explained, “The company officially advised employees to refrain from visiting hospitals, where confirmed patient either visited or is admitted, and to must wear mask when enter those hospital.” The insider added, “Although employees with suspicious symptoms like high fever are required to stay at home, no specific guidance on working from home was disseminated.” Another Korean company’s insider explained, “Unlike multinational companies, it would be highly unlikely that a Korean company would ask all of their employees work from home. Majority of global company employees usually visit general hospitals, but Korean company employees usually visit local clinics. So it would be impractical.” But the industry’s concern is deepening as more hospitals and clinics are banning salespeople from visiting. Major general hospitals like Konkuk University Hospital, Inje University Seoul Paik Hospital, and Konyang University Hospital have requested salespeople to not visit the hospitals. Sources report clinic-level healthcare institutes are also asking pharmaceutical company salespeople to refrain from visiting. The Korean company’s salesperson noted, “Some of the hospitals have contacted and requested us to avoid visiting them until the spread subsides. Hearing from many other colleagues, increasing number of clinics is also asking the same.” “On the contrary, the salespeople, whose assigned hospitals have confirmed cases, are afraid of contracting the disease as the latest news have confirmed feasibility of secondary and tertiary infection,” the salesperson added.
- Company
- Boryeong Holdings establishes a US subsidiary
- by An, Kyung-Jin Feb 06, 2020 06:29am
- Boryeong Holdings announced on January 22 that it established a local corporation in San Francisco, USA and officially started business. The local corporation name is ‘HAYAN HEALTH NETWORKS’, and Sung-won Choi, currently the executive director of the global business headquarters of Boryung Pharmaceutical, will be the first director. Boryeong Holdings explained that it had established a base in San Francisco called Hub of Bio and Life Sciences Venture Investment in the Western United States to network and accumulate information with global pharmaceutical companies, investors and early stage R & D companies in the US and Europe. The company is also planning to strengthen strategic alliances and cooperation with business companies such as Boryeong Pharmaceutical, Boryeong Bio Pharma, and Boryeong Consumer. Boryeong pharmaceutical, a subsidiary of Boryeong Holdings, is expected to accelerate the development of the next-generation target cancer drug 'BR2002'. BR2002 is a new drug candidate material that Boryung Pharmaceutical received from Korea Chemical Research Institute in 2016. It represents a mechanism that simultaneously inhibits PI3Kδ (phosphoinositide-3 kinase delta) and DNA-PK (oxyribonucleotide protein kinase), which are the major growth and regulatory factors of cancer cells. Boryung Pharm has proposed the goal of promoting global technology exports while simultaneously conducting clinical trials of 'BR101801' in Korea and the United States. Sung-Won Choi, the first director of the company, said, “The competitiveness of the biohealth care industry, where the borders of AI and digital disappear and speed becomes important, is information and networks. We will increase investment efficiency and strengthen R & D cooperation by opening a local subsidiary in the United States, which is the world's largest pharmaceutical market and has infrastructure including universities, research institutes, experts and capital”.
