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- 2026-05-19 15:19:07
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- SG&A ratio fell in 3 out of 4 MNCs...a COVID-19 Impact?
- by An, Kyung-Jin Apr 20, 2021 06:03am
- Korean subsidiaries of multinational pharmaceutical companies have lowered their selling, general & administrative (SG&A) to sales ratio last year due to the prolonged COVID-19 crisis. Analysts predict that the cost-cutting measure was made in response to the disruptions in face-to-face sales and marketing activities caused by the pandemic. According to the Financial Supervisory Service (FSS) on the 19th, the SG&A expense of 34 major subsidiaries of multinational pharmaceutical companies in Korea last year amounted to 1.7 trillion won, a 0.8% increase from the previous year. The result is based on audit reports of the 34 subsidiaries that submitted reports to FSS. 31 companies that close accounts in December - Sanofi-Aventis Korea, Novartis Korea, AstraZeneca Korea, GlaxoSmithKline Korea, Bayer Korea, Roche Korea, Zuellig Pharma Korea, Baxter Korea, Janssen Korea, Merck, Korea Otsuka Pharmaceutical, BMS Korea Pharmaceutical, Amgen Korea, Boehringer Ingelheim Korea, GSK Consumer Healthcare Korea, Lilly Korea, AbbVie Korea, Mundipharma Korea, Menarini Korea, Novo Nordisk, Fresenius Medical Care Korea, Galderma Korea, Sanofi Pasteur, Alcon Korea, Kyowa Kirin Korea, Lundbeck Korea, Ferring Korea, Teva-Handok, UCB Korea, Guerbet Korea, Leo Pharma - as well as Servier Korea (closes account in September), Pfizer Korea · Viatris Korea (closes account in November) were included for analysis. Despite the increase in the total amount of SG&A expenses, The SG&A to sales ratio of the companies had declined 1.9% points from the previous year’s 23.6% to mark 21.7%. At the same time, sales of the 34 companies have increased 9.6%. The SG&A to sale ratio declined as the SG&A expense of the companies did not increase as much as their sales. 15 of the 34 companies reduced their SG&A expense compared to the previous year. Alcon Korea's SG&A expense was 17.4 billion won last year, which was 71.3% lower than the previous year. During the same period, the company's sales revenue increased 22.1% from 165 billion won to 201.4 billion won, decreasing the SG&A to sales ratio by as much as 28.0% points. Guerbet Korea spent 8.7 billion won as SG&A expense last year. Guerbet Korea’s SG&A to sales ratio last year was 21.8%. Although its SG&A expense fell greatly, its sales also fell by 6.9%, resulting in a decrease in SG&A to sales ratio of only 2.4% points. Merck Korea and Teva-Handok also cut costs by reducing their SG&A expense by over 15%. 19 companies, which accounts for over half of the surveyed companies, increased their SG&A expense. SG&A expense of Lilly Korea, GSK Healthcare Korea, Leo Pharma, BMS Korea Pharmaceutical, Sanofi-Aventis Korea, Abbvie Korea, Roche Korea, Pfizer Korea, and Amgen Korea increased over 5% compared to the previous year. Viatris Korea, which officially launched last November, reported its SG&A expense as 72.5 billion won. The amount is an aggregate of its performance from December 2019 to November of last year. However, as the SG&A expense written for the previous year - 39.9 billion won - was expense spent from May to November 2019, the change in SG&A to sales ratio (81.5%) cannot be considered significant. 25 of the 34 companies showed a reduced SG&A to sales ratio. This means 3 out of 4 MNC companies lowered their SG&A to sales ratio. Amgen Korea is known to have a relatively higher SG&A to sales ratio in the industry. Until 2019, its SG&A to sales ratio was 59.9%, however, the ratio fell to 41.6% last year. As its sales revenue increased by 51.6% but its SG&A expense only increased by 5.4%, the overall SG&A to sales ratio fell 18.2% points. Merck Korea reduced SG&A expenses to 15.9% while increasing sales revenue by 20.9%. As a result, its SG&A to sales ratio fell 8.0% points from 26.2% to 18.2%. In companies like Galderma Korea and GSK Consumer Healthcare Korea, their SG&A to sales ratio decreased because their sales growth exceeded their SG&A expense. Galderma Korea had increased its SG&A expense last year by 1.9% from the previous year to mark 26.2 billion won, however, as its sales revenue grew 16.6%, its SG&A to sales ratio fell 6.7% points. For GSK Consumer Healthcare Korea, although its SG&A expense increased 13.4%, its sales revenue increased by 33.5%, resulting in a 6.2% point decrease in its SG&A to sales ratio. The SG&A to sales ratio varies greatly from company to company. Menarini Korea’s SG&A to sales ratio decreased by 1.5% point from the previous year, however, its ratio still exceeded half of its sales revenue. On the other hand, Zuellig Pharma Korea and Alcon Korea’s SG&A to sales ratio fell short of 10%.
- Company
- Rx drug market recovers after flu season
- by Chon, Seung-Hyun Apr 20, 2021 06:02am
- The outpatient prescription drug market, which was slow in winter, is showing a recovery trend. Since the end of last year, the total prescription drug volume has been on a decline compared to the previous year, but in March it turned to an upward trend. It is analyzed that COVID-19 showed sluggishness due to a sharp decline in infectious disease patients due to the prolonged aftermath of the prolonged aftermath, but rebounded at the end of the flu season. According to the drug research institute UBIST on the 18th, the total outpatient prescription amount in the first quarter of the year was ₩3.5697 trillion, down 3.6% from the same period last year. Compared to the first quarter of 2019, it also decreased by 0.9%. The prescription size has increased every year, but this year has decreased. The prescription size in the first quarter of last year was ₩3.701 trillion, an increase of 2.7% from the previous year. In the first quarter of 2018 and 2019, prescriptions rose 8.9% and 5.5%, respectively, compared to the previous year. This is the aftermath of the sluggish prescriptions in January and February. The prescription size in January was ₩1,166.6 billion, down 7.0% from the previous year, and 5.6% in February compared to the same period last year. Monthly outpatient prescription amount trend (Unit: ₩100 million, Source: UBIST) However, the prescription performance in March was ₩1.253.7 trillion, up 1.9% from the previous year. Since December of last year, the total prescription drug volume has declined compared to the previous year for three consecutive months, and then turned to an upward trend in April. The sluggish prescription market in January and February was largely attributed to the prolonged COVID-19. Since the spread of COVID-19, it is highly likely that the incidence of infectious diseases has greatly decreased due to reinforced personal hygiene management such as hand washing and wearing a mask, leading to a decrease in visits to medical institutions. Since the end of last year, no flu pandemic warning has been issued this winter. According to the KCDA, the number of suspected flu patients per 1,000 outpatients during the 1st to 8th week of this year is 2.4, 2.4, 2.6, 2.3, 1.9, 1,9, 1.9, 2.0, etc. Compared to 49.1, 47.8, 42.4, 40.9, 28.0, 16.4, 11.6, and 8.5 outpatients per 1,000 outpatients during the 1st to 8th week of last year, there have been few recent flu cases. Since the end of last year, it is possible that visits to medical institutions have further decreased as the social distancing stage has been elevated due to the rapid increase in the number of COVID-19 confirmed patients. As more than 300 confirmed cases occurred from November 18 last year, the government raised the social distancing from November 24 to the second stage from the previous 1.5 stage. From then on, only packaging and delivery were allowed for cafes regardless of business hours, and only packaging and delivery were allowed after 9 pm for restaurants. Nevertheless, as the number of COVID-19 confirmed rapidly increased, the government raised the social distance in the metropolitan area to 2.5 steps from December 8 last year. Accordingly, in the metropolitan area, the operation of singing practice centers and indoor sports facilities in addition to the existing five types of entertainment facilities such as entertainment bars was additionally suspended. Shops, marts, department stores, movie theaters, PC cafes, and other facilities that are closely related to life must also close after 9 pm. Despite the rise in social distancing, the number of COVID-19 confirmed exceeding 1,000 and hitting a daily high, the Seoul Metropolitan Government implemented a super-precipitation measure that banned ``private gatherings with more than 5 people'' from December 23 last year, and such measures have been taken across the country since. Was applied to spread. Since last February, the social distancing step in the metropolitan area has been eased to two stages, but strengthened distancing measures are being implemented, such as “private gatherings for more than 5 people” are still banned. However, as the flu season ended in March, it is analyzed that the growth rate of the previous year has recovered. The number of suspected flu patients per 1,000 outpatients during the 9th to 13th week of this year was 1-2, similar to that of January and February. There is no significant difference from the 9th to 13th week of last year. Last year, it recorded 6.3 in the 9th week, but as the flu season ended, it decreased to 3.9 in the 10th week, 2.9 in the 11th week, 3.2 in the 12th week, and 2.8 in the 13th week. The industry diagnoses that the prolonged COVID-19 will inevitably hurt the prescription market for drugs used by flu or cold patients. However, as the use of medicines continues to increase due to the increase in the elderly population and the number of chronic diseases, the overall prescription market is expected to show an increase at the level of previous years. Although social distancing is still in place, it is observed that unlike the tourism and cultural industries that fell into extreme crises after COVID-19 outbreak, the pharmaceutical industry is affected by the demands of patients rather than the external environment, so it is difficult to lead to a sudden downturn.
- Company
- Domestic Sputnik V CMO meets with MOHW for discussions
- by Kim, Jin-Gu Apr 20, 2021 06:02am
- Photo of Sputnik V With the possibility of using ‘Sputnik V' rising in Korea, various industry sources have confirmed that a Korean CMO of this Russian vaccine has had a meeting with Korea's Ministry of Health and Welfare (MOHW). According to industry officials, one of the companies that signed a CMO deal for Sputnik V has recently had a meeting with an official from the Vaccine Procurement Task Force at the MOHW Sejong Office. The meeting was held at the request of the MOHW, during which the CMO company briefly explained its production volume, schedule, and agreement process for Sputnik V. Future meetings between the company and MOHW have not been scheduled yet. An industry official said, "A director-level personnel of the pan-government vaccine procurement task force and one of the CMO companies of Sputnik V has recently had a meeting at the MOHW Sejong Office. During the meeting, the MOHW official looked over the basics of the CMO deal." On this, an official from the CMO company said, "It is true that a meeting was held. At the meeting, the MOHW simply verified the progress of the CMO deal, and nothing else was discussed. However, we cannot disclose any more specifics about the meeting." Recently, the possibility of using Sputnik V in Korea has been rising due to the global shortage in vaccine supply and the issue of blood clots in AstraZeneca and Janssen vaccines. The demand to introduce a new vaccine to Korea has never been stronger. Based on the same idea, the industry speculates that the meeting is the government's attempt to get a grasp of the present state of Sputnik V under the premise of introducing the vaccine to Korea. However, several steps are required for the government to introduce Sputnik V to Korea. First, the government needs to make a deal with the Russian Direct Investment Fund (RDIF). Like any other vaccines, the amount and schedule of the vaccines should be negotiated with the supplier. Also, a formal approval by the MFDS is required. The key to whether Sputnik V will be approved by MFDS may partially depend on the European Medicines Agency (EMA) decision. EMA is currently conducting a formal review of Sputnik V. The results are expected to be announced in May at best. If EMA approves Sputnik V, this may also speed up the process of introducing the vaccine to Korea. In Korea, the Hankook Korus Consortium and Huons Global Consortium have each signed a CMO agreement for Sputnik V. Under the agreement, the Hankook Korus Consortium will be producing 500 million doses and Huons Global Consortium will be producing 100 million doses. The consortia have already completed the transfer of technology from Russia for the production of Sputnik V. Mass production of the vaccine will become possible as soon as the production facilities are completed. Another industry official said, “If the government wishes to officially introduce Sputnik V to Korea, they have to first negotiate the terms with RDIF, as it has made the CMO agreement with the domestic companies. With the possibility of introducing Sputnik V rising in Korea, it seems that the government trying to get a grasp of the current state of affairs through working-level meetings." Sputnik V is a COVID-19 vaccine developed by Russia. Like AstraZeneca and Janssen vaccines, it is a viral-vector vaccine. Earlier this year, the vaccine was found to be 91.6% effective against COVID-19 according to a Phase III clinical trial results published in the Lancet.
- Company
- Hemophilia B tx, Benefix, took the lead with weekly therapy
- by Apr 20, 2021 06:02am
- Pfizer Korea's Benefix (nonacog alfa)', which has been used for the treatment of hemophilia B patients in Korea for 15 years, has taken the lead as a once-a-week prophylaxis. The strategy for treating hemophilia has now become routine prophylactic therapy. The World Federation of Hemophilia recommended prophylaxis as standard treatment in its guidelines revised last year. In the past, the concept of prophylaxis was also aimed at preventing simple bleeding, but now, the goal is to lead a similar life to the general public and achieve a quality of life. In February, Benefix added an indication of daily prophylaxis with a weekly dosage. What was previously administered 2-3 times a week can now be administered only once a week. As a result of clinical studies, once-a-week prophylaxis reduced the annual bleeding rate to 94% compared to supplementary therapy. There was no significant difference in the annual bleeding incidence between the once-weekly prophylaxis and the twice-weekly prophylaxis. A similar effect can be obtained by administering Benefix 100IU/kg once a week instead of Benefix 50IU/kg twice a week. From the patient's point of view, fewer visits to the hospital can increase compliance and lower the risk of infection. In particular, once a week prophylaxis is most recommended for children under 6 years of age, where it is difficult to secure medical staff through intravenous infusion. In celebration of 'World Hemophilia Day (April 17)', Pfizer Korea held an online press conference on the 15th of 'The Present and Future of Hemophilia Type B Treatment Through Benefix' once-a-week prophylaxis. At the meeting, Professor Eun-jin Choi of Catholic University of Daegu Hospital said, "About half of patients with hemophilia B in Catholic University of Daegu Hospital are receiving Benefix once a week." Pfizer Korea's 'Benefix (nonacog alfa)', which has been used for the treatment of hemophilia B patients in Korea for 15 years, has taken the lead as a once-a-week prophylaxis. With the new indication, Benefix will be able to extend the range of half-life extension formulations. Benefix is a factor 9 standard half-life treatment. With the release of a half-life extension formulation, the relatively large number of doses is a disadvantage. For example, the half-life extension drug Alprolix 50IU/kg is administered once a week, and Alprolix 100IU/kg is administered once every two weeks, which is less frequent than Benefix twice a week. Benefix also expanded its area as weekly therapy became possible and occupied the first place in the hemophilia B market. Professor Choi said, "With the development of half-life extension drugs, drugs that fit once every two weeks and once every three weeks are emerging, depending on the patient's lifestyle. In some cases, the peak level is considered more important than the lowest coagulation factor activity level." If a patient wants to exercise such as soccer, he needs more than a certain percentage of the coagulation factor that the patient has, but if a patient has a peak level and shows low activity for 2 to 3 weeks (half-life extension drugs), it may not be suitable for that patient." She explained. There is no difference in the total dose for the twice-weekly or once-weekly therapy. Professor Choi said, "The current benefit is recognized as 30~40 IU, and if there is joint bleeding, it is possible up to 50 IU twice a week. Since there is no case written, 100 IU once a week is expected to be sufficient.”
- Policy
- Donepezil patch has been applied for permission
- by Lee, Tak-Sun Apr 19, 2021 05:56am
- Donepezil patch (Source: Icure)While Icure applied for permission for the world's first dementia treatment Donepezil patch, it was found that domestic competitors are still in the Phase I stage. Icure is expected to preoccupy the domestic market if it obtains a license because it is faster to commercialize than its competitors. In particular, Donepezil is most often used for the treatment of dementia, and due to the characteristics of dementia patients, it is expected that it will become a competitive drug for the original Aricept because it is a patch formulation that is applied rather than an oral formulation. On the 13th, Icure and Celltrion announced that they applied for an item license for Donerion patch for Alzheimer's dementia treatment with the MFDS. The Donerion patch was developed by Icure, and after completing phase I clinical trials, a joint domestic copyright contract was signed with Celltrion. Icure conducted phase III clinical trials in about 400 patients with mild and severe dementia in four countries, including Korea, Taiwan, Australia, and Malaysia, proving non-inferiority compared to oral Donepezil. Donepezil patch is currently not commercialized worldwide. Icure will begin applying for permits in Korea and will proceed with worldwide development. In March, the US FDA applied for a phase I trial protocol. The sales volume of the domestic Donepezil market is about ₩230 billion, and the global market is known to be around ₩7 trillion. Because the patch has good patient compliance, it is expected to rapidly erode the market share of existing oral drugs. After launch, Icure aims to achieve 50% of the domestic market share of Donepezil. In particular, as it is ahead of competitors in terms of commercialization speed, Icure is expected to dominate the market through patch formulation. Domestic pharmaceutical companies that are currently developing the Donepezil patch are Dong-A ST, Daewoong, and Boryung. The three companies are currently in phase I. In the case of Dong-A ST, both clinical phase Ia to evaluate safety, tolerability, and pharmacokinetic characteristics when administered once and phase Ib to evaluate safety, pharmacokinetic and pharmacokinetic characteristics during repeated administration have been completed. Initially, Dong-A expected that it would be possible to apply for permission if it confirmed equivalence through Phase I clinical trials, but it is known that the MFDS is also requesting long-term safety data. In addition, since Icure applied for approval through phase III clinical trials, if the application for approval was accepted only in phase I clinical trials, it is expected to raise issues in terms of equity. Dong-a is also preparing for clinical trials in India. Boryung has completed Phase Ia clinical trials and is analyzing the results. Boryung has also conducted joint development with Icure in the past, but has now moved to Celltrion. Instead, Boryung is working with Raphas on commercialization development. In May of last year, it took its first clinical steps. Daewoong was approved for Phase I clinical trial in July 2019, but it is said that it has not been completed. If the MFDS demands them for phase III clinical trials, the completion of commercialization will be further delayed. Therefore, if Icure and Celltrion receive product approval, the possibility of preoccupying the market as the first product will increase. Since the patch is a product that competes with original Aricept, it is expected to lead the entire dementia treatment market.
- Policy
- Abbott Korea·Medtronic Korea caught subsidizing doctors
- by Lee, Tak-Sun Apr 19, 2021 05:56am
- Abbott Korea Co. and Medtronic Korea Co. were found to have unfairly supported doctors to participate in overseas seminars to encourage the use of their cardiovascular stents. As a result, the Korea Fair Trade Commission (KFTC) decided to impose a 16 million won fine on Abbott Korea. Both companies have kept a record of sales for each doctor and encouraged the use of their company's stent by providing unfair support to the doctors as an expense for overseas conferences. More specifically, sales representatives of both companies used this support for overseas academic conferences as a sales promotion strategy to increase the use of its products for doctors that show decrease usage or to manage sales. Overview of the support provided for attending overseas academic conferences (Before event) From May 2014 to April 2018, while providing support to a Korean medical society in accordance with the Fair Competition Code, Abbott Korea had violated the same Code that prohibits direct support to a specific doctor by notifying its Hong Kong branch and the overseas academic society in advance to issue invitations to 21 doctors in 21 hospitals. In the process, the company requested the Hong Kong branch make exemptions and issue invitations to doctors that submitted their case presentations after the deadline or pressed the branch and academic society to issue invitations in line with the registration period set in Korea. Also, 14 of the 21 doctors that received invitations used the invitations to attend the conferences and received financial support for their participation from the Korean medical society. During the period, Abbott Korea had supported a total of 16.99 million won as expenses to doctors that participated in 2 conferences. In addition, the company had proposed to provide the expense for a business class upgrade to doctors that participated in overseas education·training sessions in 2018 and provided local tours in China to 17 doctors in 2014. From August 2017 to June 2019, Medtronic Korea had internally selected doctors to attend overseas conferences and offered support for their participation. Then, the company sent the list and role of the 34 doctors in 36 hospitals that accepted the offer to the overseas conference organizers to issue invitations. Also, the company requested the conference organizers to issue the invitations to the company so they could personally hand over the invitations to the doctors. 23 of the doctors that received the invitations attended the conferences using the invitations and received financial support for their participation in an overseas conference. During the period, Medtronic Korea had supported a total of 27.72 million won as expenses to doctors that participated in 2 conferences. FTC explained that the acts by the two companies violate Article23(1)-3 of the Monopoly Regulation and Fair Trade Act in "unfairly soliciting customers." By providing unfair or excessive profits to doctors, the companies have induced doctors to do business with their companies rather than their competitors, which counts as an unfair trade act by unfairly soliciting customers. As a result, the government issued a fine (16 million won) and a corrective order (cease and desist order) to Abbott Korea and a corrective order (cease and desist order) to Medtronic Korea. The FTC said that the measure was meaningful in that they were able to expose a roundabout rebate act of supporting specific doctors that violates the Fair Competition Code, and that they will continue to take stronger measures to prevent companies from conducting acts that hinder competition under the pretense of supporting overseas conferences or education and training in the overall medical device market, including the stent market.
- Company
- Novartis Korea surpassed ₩500 billion in annual sales
- by An, Kyung-Jin Apr 19, 2021 05:55am
- Novartis Korea has surpassed ₩500 billion in annual sales for the first time since entering Korea. Despite the confusion of COVID-19, representative medicines and new products generated synergy, which led to the highest sales ever. According to the Financial Supervisory Service on the 15th, Novartis Korea last year recorded ₩532 billion. With a 7.8% increase in sales compared to the previous year, it achieved the most sales among multinational pharmaceutical companies that entered Korea for the second consecutive year following 2019. This is the first time Novartis Korea has exceeded the annual sales of ₩500 billion since the inauguration of Novartis Korea in 1997. Operating profit was aggregated to ₩5.3 billion, down 12.4% from the previous year. Novartis Korea Novartis Korea is a foreign-invested company established in September 1984 under a joint venture agreement between Dongwha and Swiss pharmaceutical company Sandoz (now Novartis AG). In April 1997, the company changed its name from Sandoz Korea to Novartis Korea. Novartis AG and Novartis Pharma AG own 98.3% of the shares, while Dongwha owns the remaining 1.7%. Among the bad news for Corona 19, new products that were recently released showed high growth, generating the largest sales ever. According to IQVIA, a drug market research organization, the sales of Entresto, a chronic heart failure treatment, were ₩21.7 billion last year, up 64.7% from the previous year. Entresto is a combination drug consisting of two ingredients: Valsartan, an angiotensin receptor blocker (ARB) family, and Sacubitril, a neprilysin inhibitor (NEPI). It is prescribed to reduce the risk of death from cardiovascular disease and hospitalization due to heart failure for chronic heart patients with decreased left ventricular contractile function (NYHA class II-IV). In Korea, since October 2017, it has been receiving benefits as a treatment for chronic heart failure patients whose left ventricular ejection rate has decreased to 40% or less. Psoriasis treatment Cosentyx (Secukinumab) has established itself as a blockbuster product with annual sales of ₩20 billion by introducing a self-injectable pen in addition to the existing PFS. The two types of Cosentyx and Cosentyx Sensoready Pen made a joint venture of ₩20.9 billion, with a 51.5% increase in sales from the previous year. The metastatic breast cancer drug Kisqali (Ribociclib), launched at the end of last year, made the first sales of ₩1.7 billion. Existing representative products are also performing well. ARB-based hypertension combination drug Exforge (Amlodipine Besylate/Valsartan) sold ₩71.4 billion last year. Novartis has the largest sales volume among products sold in Korea. In July 2018, the impurity isuue gave a reflective profit. Macular degeneration treatment Lucentis (Ranibizumab) is also on the rise in sales with the release of PFS type. Last year's sales of Lucentis were ₩37 billion, up 23.0% from the previous year. The DPP-4 inhibitor-based diabetes combination drug Galvusmet (Metformin HCl/Vildagliptin) sold worth ₩31.5 billion last year. Glivec, a leukemia drug, posted sales of ₩41.2 billion. In the process of launching new products, expenditures increased and profitability decreased slightly, but it is evaluated that the sales of existing products and new products harmonized, resulting in stable performance. Novartis Korea is focusing on improving earnings by sorting out some items with relatively low profitability. It handed over the domestic copyright of the anti-epileptic drug Trileptal and the Alzheimer-type dementia treatment Exelon to Handok, and also stopped investing in sales marketing for the rest of the items, including the anti-epileptic drug Tegretol and Parkinson's disease treatment Stalevo and Comtan. It is expected to focus on introducing biologics known as ultra-high-priced drugs such as Zolgensma, a treatment for spinal muscular atrophy (SMA), starting with Kymriah, the first licensed CAR-T treatment in Korea.
- Policy
- Leclaza’s clinical trial targeting Tagrisso is launched
- by Lee, Tak-Sun Apr 19, 2021 05:55am
- 'Leclaza (Lazertinib)', a Korean anticancer drug developed by Yuhan, is conducting a Sponsor Initiated Clinical Trial for patients with non-small cell lung cancer Leptomeningeal metastasis. Since the competitive drug Tagrisso (Osimertinib, AZ) has proven effective in metastasis to the central nervous system such as brain and soft meninges, if this test of Leclaza is successful, it is expected to be competitive in the 3rd generation EGFR-TKI market. The MFDS approved Leclaza's Sponsor Initiated Clinical Trial plan submitted by Seoul National University Hospital on the 5th. This trial is a phase II clinical trial in which Lazertinib and Pemetrexed Disodium Heptahydrate (Alimta) are used in combination in EGFR mutation-positive non-small cell lung cancer with leptomeningeal. Bum-seok Kim, a professor of hematology and oncology at Seoul National University Hospital, applied for approval for a clinical trial. Leclaza was approved as a treatment for patients with EGFR T790M mutation-positive local advanced or metastatic non-small cell lung cancer who had been treated with EGFR-TKI before last January, subject to the submission of Phase III clinical trial. On the 8th, it passed the HIRA's Pharmaceutical Benefits Advisory Committee, the first step in the reimbursement. The final drug price is announced after a drug price negotiation with the NHIS. When the drug price is announced, it is used in earnest for patients. Leclaza is expected to be Tagrisso's competitor. In particular, a fierce fight is expected to unfold in patients who are resistant to second-generation ERFR-TKI treatments such as Iressa, Tarceva, and Alimta. Tagrisso is expanding the market by advocating that it is effective for patients with central nervous system metastasis such as brain and leptomeningeal. As a result of confirming the status of cancer cells through MRI in the BLOOM phase I study, Tagrisso was found to reduce progressive lesions of the central nervous system regardless of the patient's T790M mutation. In particular, it was found to reduce the degree of EGFR mutations in the cerebrospinal fluid (leptomeningeal). In the AURA3 clinical trial using Tagrisso as a second-line treatment, the response rate to brain metastasis was 40%. Therefore, it is analyzed that Tagrisso lowered the risk of death due to metastasis to the central nervous system. In order for Leclaza to compete with Tagrisso, data showing that it is effective in patients with central nervous system metastasis is needed. Therefore, the results of this Sponsor Initiated Clinical Trial are drawing attention. This test was named LAZARUS. It also means 'Lazaros' resurrected by Jesus, and it is expected that Leclaza will become a valuable remedy that can restore life like this.
- Company
- Will ‘Keytruda’ be reviewed for reimbursement in May?
- by Eo, Yun-Ho Apr 16, 2021 06:03am
- MSD Korea threw a game-changer for the reimbursement expansion of the immunotherapy drug ‘Keytruda.’ According to industry sources, the company has once again submitted a revised cost-sharing proposal to the Health Insurance Review & Assessment Service (HIRA) to expand the reimbursement of ‘Keytruda (pembrolizumab)’ to cover first-line treatment of non-small cell lung cancer (NSCLC). With the submission, the industry’s eyes are on whether the issue will put on the agenda for deliberation by the Cancer Drug Review Committee in May. If selected, this will be the 8th discussion held by the Committee for Keytruda. The decision for the drug was put on hold at the committee meeting in August last year as the committee determined that MSD Korea’s proposal lacked compromise on the company’s part. In September of the same year, HIRA handed the proposal back to MSD Korea and requested a 're-revision.' A month later, MSD Korea submitted a re-revised proposal, which was discussed by the Reimbursement Standard Sub-committee meeting but to no avail. The agenda of Keytruda’s reimbursement was not discussed by the Cancer Drug Review Committee. So, once again, MSD Korea submitted a cost-sharing plan to HIRA this year. The proposal submitted by MDS this time contains an offer equivalent to the company ‘covering the initial 3 cycles’ worth of administration cost’ through measures including adjusting the reimbursement rate. If the new cost-sharing proposal is reviewed and, again, rejected by the Cancer Drug Review Committee, expanded reimbursement for Keytruda will likely be difficult to achieve. An MSD official said, “Although we cannot share details as discussions with the government are still ongoing, we will do our best so that our patients in Korea can promptly receive the global standard-of-care treatment.” Meanwhile, MSD Korea has submitted additional applications to expand the indication of its PD-1 inhibitor Keytruda (pembrolizumab) ▲ as first-line treatment in patients with microsatellite instability-high (MSI-h) or mismatch repair deficient (dMMR) advanced colorectal cancer; and ▲ as first-line treatment in combination with platinum-based chemotherapy for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that is not amenable to surgical resection
- Policy
- Korean CMO will produce MNC's COVID-19 vaccine from August
- by Kim, Jung-Ju Apr 16, 2021 06:03am
- A COVID-19 vaccine developed by a multinational pharmaceutical company will be produced by a Korean pharmaceutical company under a CMO deal. The government plans to officially announce the specific company and manufacturing plan in the near future. Young-Ha Baek, head of vaccine procurement at the pan-government vaccine procurement task force, announced the news today (15th) during the morning briefing. In a press gaggle, Baek said, “A Korean pharmaceutical company is currently working out the details on a contract manufacturing organization (CMO) deal to produce a COVID-19 vaccine that has been developed abroad. Under the CMO deal, the vaccine will be manufactured in Korea from August.” However, Baek did not disclose specifics on which company will manufacture how much for distribution, as the talks between the two companies are still in progress. Emphasizing how the deal will increase Korea’s manufacturing capacity, Baek added, “We will promptly organize the details in writing for an official announcement. Also, we will continue to promptly inform the public on matters related to vaccine procurement whenever they arise.”
