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- 2026-04-13 01:42:36
- Company
- Outpatient prescriptions slow for MNCs...Viatris in the lead
- by Jan 26, 2022 05:57am
- Outpatient prescription sales of multinational pharmaceutical companies in Korea had slowed down in general last year. Viatris held the lead among multinational pharmaceutical companies for two consecutive years, but its amount of prescriptions also decreased 0.3% compared to the previous year. The top prescription drug companies such as MSD (Organon), AstraZeneca, Novartis, Astellas, all saw a decline in sales. According to the market research institution UBIST on the 26th, Viatris Korea held the lead in outprescription sales with ₩463.9 billion among multinational manufacturing companies last year. The total prescription amount of the company had fallen 0.3% compared to the ₩465.4 billion in 2020. Lipitor and Celebrex sold ₩205.2 billion and ₩46.3 billion respectively, increasing 0.7% and 3.6%, but Lyrica and Norvasc’s sales fell 3.6% and 1.7% respectively to record ₩69.9 billion and ₩69 billion, respectively. Viatris is a spin-off of Pfizer that was established in 2020 after merging with Mylan in 2020. At the time of the spin-off, the company received Pfizer’s off-patent drugs. With key products such as ‘Lipitor (dyslipidemia treatment),’ ‘Lyrica (neuropathic pain),’ ‘Norvasc (hypertension),’ the company has maintained the lead in outpatient prescriptions ever since its establishment. The outpatient prescription performance of large multinational pharmaceutical companies had decreased in general. MSD (including Organon) recorded ₩437.5 billion in prescriptions last year, which was a 2.4% decrease from the previous year. For MSD, its off-patent drugs and women’s health products are in the process of being transferred to its spin-off Organon. If the product transfers become complete, over half of MSD’s off-patent drugs will be recorded as Organon’s products. These future Organon products account for approximately 58% of the ₩437.5 billion that was sold last year as MSD’s prescriptions. ‘Atozet,’ one of the key products that will be transferred to Organon, had recorded ₩86.8 billion in sales last year, which is a 4.9% increase from the previous year. On the other hand, MSD’s DPP-4 inhibitor ‘Januvia family (Januvia, Janumet, Janumet XR)’ did not perform so well. Sales of Janumet fell 4.1% to ₩78.7 billion, Januvia fell 5.7% to ₩45.9 billion. Only sales of Janumet XR rose 2% to ₩51.8 billion. AstraZeneca, which recorded the 3rd most in sales, recorded 424.7 billion last year, a 6.4% decrease from the previous year. The sales drop was affected by the drop in sales of its lead product, the cholesterol drug ‘Crestor,’ falling 3.4% (₩90.8 billion). Fortunately, the outpatient prescription sales of its SGLT-2 inhibitor ‘Forxiga’ and combo ‘Xigduo’ had driven the outpatient prescription sales of AstraZeneca. The two products sold ₩42.6 billion and ₩37 billion, an 11.9% and 21.1% increase, respectively. Novartis’s sales performance also slowed down, recording a 0.1% decrease from the previous year to ₩422.5 billion in sales. Products that sold over ₩10 billion in outpatient prescriptions last year fell to 8 from the 11 in 2016. All companies other than Boehringer Ingelheim among the Top 5 grossing companies among multinational pharmaceuticals saw a decline in prescription sales last year. However, companies that sold NOAC, antidiabetic, and eye drops such as Daiichi Sankyo, BMS, Janssen, Lilly, and Santen fared better in the previous year. Daiichi Sankyo recorded ₩181.7 billion in sales, a 7% increase from the previous year, benefitting from the 16% sales increase of the NOAC anticoagulant ‘Lixiana.’ Sales of BMs’s prescription drugs also increased 7.6% to record ₩181.7 billion, with sales of the NOAC ‘Eliquis’ rising 18.6%. Lilly’s sales also increased 16.1% to record ₩104.9 billion, with the even expansion in sales of GLP-1 analog ‘Trulicity’ antidepressant ‘Cymbalta,’ JAK inhibitor ‘Olumiant,’ CDK 4/6 inhibitor ‘Verzenio.’ Also, the ‘no Japan’ boycott that started in 2019 in Korea did not affect sales of Japanese pharmaceutical companies. Other than Astellas, other Japanese pharmaceutical companies saw steady growth since 2019. In particular, outpatient prescriptions of Santen Pharmaceutical rose 42.3% from ₩68.4 billion in 2018 to ₩97.3 billion last year. Sales of Santen Pharmaceutical’s eyedrop ‘Cosopt-S’ that it received the license from MSD arose significantly, and prescriptions of the eye drop ‘Cravit’ and the glaucoma treatment ‘Taflotan-S,’ as well as eye drop ‘Ikervis’ had expanded greatly.
- Policy
- PVA price reduction needs to be improved
- by Lee, Jeong-Hwan Jan 26, 2022 05:57am
- Professor Lee Jonghyuk of Chung-Ang University.There is a problem that the reduction rate of small items relatively increases compared to the financial impact by using the same formula for PVA negotiations. It was pointed out that the current PVA is operating too rigidly without reflecting the reality that medicines affect health insurance finances. Critics say that drugs that reduce health insurance finances are not considered or that the criteria for excluding PVA drug prices are unreasonable, adversely affecting sales of some drugs. Professor Lee Jong-hyuk of Chung-Ang University, who was in charge of the presentation at the National Assembly's policy meeting on the 25th, made the remarks. The current PVA cuts and adjusts prices within the range of up to 10% through negotiations if the amount of drug claims listed as benefits increases by more than a certain percentage. With the health insurance authorities announcing their plan to partially revise the current PVA, the pharmaceutical community pointed out some irrationalities in the system and asked to actively reflect their opinions in the revision. Professor Lee believes that it is necessary to examine whether the current PVA is fully considering drugs that contribute to fiscal savings as usage increases. He also said that the validity of the claim amount standard excluding PVA negotiations should be discussed aggressively now as the need for revision is emerging. In particular, Professor Lee believes that it is reasonable to apply the same formula regardless of the financial impact of health insurance or change the exclusion criteria to less than 90% of the arithmetic average during the PVA negotiations. Professor Lee said, "It is pointed out whether it is right to cut drug prices by applying collective standards to drugs that have contributed to financial savings." "We need to think about how to reasonably apply financial savings drugs to PVA negotiations," he explained. Professor Lee said, "It is necessary to fully explain the reasons and grounds for the health insurance authorities to change and revise the standard for claims excluding PVA negotiations from the current 1.5 billion won to 2 billion won." He added, "There is also an evaluation that the annual fiscal savings are about 120 million won when revised." Seo Jung-sook, the People Regardless of the financial impact, there is a problem that the reduction rate of small items is relatively large in fiscal impact by using the same formula in PVA negotiations, he said. "Change of standards excluding negotiations changes rules, so many discussions and agreements between health insurance authorities and pharmaceutical circles are needed." Rep. Seo Jung-sook of the People's Power pointed out that the current PVA is unreasonable due to the application of a uniform system and is causing reverse discrimination against innovative pharmaceutical companies in Korea. She said, "Small and medium-sized pharmaceutical products, whose claims have increased by 600 million won from 1 billion won to 1.6 billion won, have to cut their drug prices, but products with an increase of 4.9 billion won from 10 billion won to 14.9 billion won will be excluded from the cut." Unlike global new drugs that are released after fully equipped with a product line, there is also a side effect of reversely lowering the price of innovative new drugs in Korea, she pointed out.
- Company
- SK Bioscience wins 3rd EU-GMP for its vaccine plant
- by Ji Yong Jun Jan 26, 2022 05:57am
- (Picture of Andong L House=SK Bioscience)SK Bioscience, which has signed a CMO deal to manufacture the Novavax vaccine, has additional received EU-GMP certification from the European Medicines Agency. This is the third EU-GMP certification the company received. On the 25th, SK Bioscience announced that it had received additional EU-GMP certification for the manufacturing facility, process, and quality system of Andong L House that is being operated for the manufacture of the Novavax COVID-19 vaccine. SK Bioscience has been producing the drug substance of Novavax’s COVID-19 vaccine under a CMO (contract manufacturing organization) deal. With the approval, SK Bioscience’s L House received the third EU-GMP approval as a vaccine manufacturing facility. One of SK Bioscience’s vaccine manufacturing facilities for AstraZeneca’s COVID-19 vaccine and one of the three SK Bioscience’s vaccine manufacturing facilities received EU-GMP certification last year. SK Bioscience is also working for EU-GMP certification for its last facility. The company explained that it plans to receive an on-site inspection from the EMA within the first quarter at the earliest. The EU-GMP system evaluates and certifies the entire process of vaccine production, from the purchase of raw materials to manufacturing, quality control, to shipment. It is considered to be the highest level of certification in the world along with the US’s cGMP certification. SK Bioscience passed the on-site investigation and document review of the EMA that took two months since November last year. By receiving EU-GMP certification in 2 of its Novavax COVID-19 vaccine manufacturing facilities, the company will speed up the supply of its Novavax vaccine. Novavax received approval for the use of its COVID-19 vaccine from the EMA, WHO, India, Indonesia, Philippines, France, Australia, among other countries. In Korea, SK Bioscience received marketing approval for Novavax’s COVID-19 vaccine ‘Nuvaxovid’ on the 12th, and is preparing a total of 40 million doses of the vaccine. SK Bioscience plans to further expand its CMO business with global vaccine companies based on the vaccine manufacturing and quality control capabilities proven through its EU-GMP certification in the future. L House is equipped with the base technology including ▲cell culture ▲bacterial culture ▲gene recombination ▲protein conjugation and the R&D personnel necessary including the base technology to mass-produce various vaccines immediately upon development. SK bioscience CEO Jae-Yong Ahn said, “It is a great pleasure that the manufacturing facilities of the L House Plant have been recognized for its global capabilities, receiving a series of the highest-level certifications in the globe. Based on the company’s verified vaccine manufacturing and quality control capabilities, we will continue to expand our CMO business in partnership with global companies.”
- Policy
- The presidential candidate's pledge to expand NIP is fierce
- by Lee, Jeong-Hwan Jan 26, 2022 05:57am
- 3 HPV vaccines that have been approved for sale in Korea The expansion of free HPV vaccine vaccination is spreading to a competition for pledges of presidential candidates between the ruling and opposition parties. As the ruling party candidate adopted the application of the NIP of the bivalent and HPV vaccine as a pledge, the opposition candidate is fiercely fighting, promising to support the cost of vaccination of the expensive 9-ga HPV vaccine. On the 23rd, politicians of the ruling and opposition parties are busy promoting their pledge to strengthen health and welfare, which includes free HPV vaccine vaccination. Currently, HPV vaccine NIP targets 12-year-old female adolescents, and NIP applications are Cervarix, a divalent vaccine, and Gardasil, a quadrivalent Influenza Vaccines. As President Moon Jae In announced last year, the health insurance authorities plan to expand the age of free HPV vaccine vaccination in the first half of this year to 12 to 17 years old. Furthermore, Democratic Party of Korea candidate Lee Jae-myung and the people's power candidate Yoon Seok-yeol are determined to increase the number of HPV vaccine NIP targets and expand free vaccination items. Democratic candidate Lee Jae-myung has repeatedly emphasized the pledge since announcing the policy of expanding the HPV vaccine NIP beyond female youth to male youth as his first pledge on the first day of the new year. As candidate Lee's pledge is to expand the existing HPV vaccine vaccination age and gender, the items to be applied are expected to be divalent Cervarix and tetravalent Gardasil. In a recent video, candidate Yoon Seok-yeol promised to apply the NIP of Gadasil 9 that is more expensive than other vaccines. Candidate Yoon predicts vaccination insurance benefits for women aged 9 to 45 and men aged 9 to 26, which is the recommended age for Gadasil 9, so in some cases, it is expected to require significantly greater financial expenditure compared to the expansion of NIP. Except for the NIP application age group, the cost of inoculation of Cervarix, Gardasil, and Gardasil 9 varies considerably. Candidate Lee Jae-myung of the Democratic Party of Korea and candidate Yoon Seok-yeol of the People Cervarix's total cost is about 300,000 won, Gardasil's cost is about 400,000 won, and Gardasil 9's cost is about 600,000 won, which is about 1.5 times more expensive than other Gardasil products. The presidential candidates of the ruling and opposition parties plan to receive public support for their pledge to expand the relatively expensive HPV vaccine NIP. The National Assembly is also steadily proposing a bill to expand the HPV vaccine NIP to support pledges for presidential candidates. Rep. Han Moo-kyung of the People's Power submitted a revision to the Infectious Disease Prevention and Management Act on the 21st, which provides HPV vaccinations to all children aged 12 regardless of gender. Prior to this, Baek Jong-heon of the same party also proposed a bill in December last year to expand the scope of HPV vaccine NIP to 11-year-old and 12-year-old children regardless of gender. In addition, Rep. Choi Hye-young of the Democratic Party of Korea also proposed a bill in November 2020 to expand the target of HPV vaccine NIP to all children and adolescents under the age of 18. As a result, the policy to expand the HPV vaccine NIP after the upcoming presidential election in March is going smoothly. This is because both ruling and opposition candidates have made pledges, and specific directions for NIP expansion and applicable items are expected to be determined according to the results of the presidential election and details of subsequent pledges.
- Company
- Montelukast sales 22%↓ in 2 years and adds impurity issue
- by Kim, Jin-Gu Jan 25, 2022 05:55am
- The market for the montelukast ingredient used to treat allergic rhinitis and asthma has contracted for two consecutive years. The reduction is analyzed to be due to the combined effect of the US FDA’s side effect warning request for the ingredient in 2020 and the prolonged COVID-19 crisis. Industry eyes are on how the impurity issue that recently emerged would additionally affect the market. ◆Conflicting results by product… Singulair ↓ 32% vs Monterizine ↑ 15% According to the industry research institution UBIST on the 25th, outpatient prescription sales of the allergic rhinitis and asthma treatment market for montelukast was ₩94.8 billion last year. The market had risen from ₩76.1 billion in 2016 to 121 billion in 2019 but had seen a decline for two consecutive years since. Compared to 2019 when the market expanded to its greatest, the market had shrunk 22% over the recent 2 years. Montelukast is one of the most common drugs used to treat allergic rhinitis and asthma. The original drug is Organon Korea’s Singulair. In Korea, MSD Korea received approval for the original drug in 2000, and around a hundred domestic pharmaceutical companies are selling generic versions with the same ingredient. Most of the key products were unable to avoid the reduction in their prescription amount. Sales of the market lead Singulair shrunk 32% from ₩39.2 billion in 2019 to ₩26.5 billion last year. Other montelukast drugs also saw a double-digit reduction in sales. HK Inno.N’s ‘Lukio’ dropped 31% (₩12.8 billion→₩8.8 billion), Hanmi Pharmaceutical’s ‘Montezal’ dropped 35% (₩7.3 billion→₩4.7 billion), Hutec Korea Pharmaceutical’s ‘Singuldown’ dropped 26% (₩5.3 billion→₩3.9 billion), Daewon Pharmaceutical’s ‘Singuluka’ dropped 42%(₩3.1 billion→1.5 billion). On the other hand, prescription of some products has increased greatly. Sales of Hanmi Pharmaceutical’s ‘Monterizine’ increased 15% from ₩8 billion to ₩9.3 billion in the same period. Monterizine is a combination of montelukast and a third-generation antihistaminic agent ‘levocetirizine.’ It is the only combination drug sold in Korea. ◆ FDA’s ‘black box warning’ and ‘prolonged COVID-19 crisis’ cause combined effect Analysts believe that this was a combined effect from the prolonged COVID-19 and FDA’s side effect warning. The FDA required a ‘Black box warning’ on montelukast products in March 2020. The black box warning is the FDA's most stringent warning for drugs and medical devices in the market. In particular, the FDA strongly advised health care providers to avoid prescribing montelukast to patients with mild allergic rhinitis, as it is the FDA’s judgment that the risk outweighs the benefits for mild patients. According to the FDA, serious adverse reactions, including suicide, have been reported with the use of Singulair since 2008. Some of these side effects occurred while the patients were treated with montelukast and disappeared after discontinuing the drug. The prolonged COVID-19 incidence had also reduced the prescriptions. The pediatric clinics have been one of the areas most affected by the COVID-19 crisis. Since most patients with allergic rhinitis and asthma are children and adolescents, the prolonged COVID-19 crisis has aggravated the reduction in prescriptions of montelukast. ◆MFDS orders NDPA impurity tests…rises as a ‘new variable’ in market The industry has also been paying attention to the impurity issue that had arisen recently. The Ministry of Food and Drug Safety had recently ordered pharmaceutical companies to conduct an investigation into 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. The NDPA is a new nitrosamine impurity that has been identified. Since 2018, two types of nitrosamine impurities, - ‘N-nitrosodimethylamine (NDMA)’ and ‘N-nitrosodiethylamine (NDEA)’ were detected in valsartan, ranitidine, and nizatidine. The MFDS predicts that NDPA occurred in the API manufacturing process of montelukast. Contrasting opinions have been produced on how the impurity concern may affect prescriptions in the field. Those who believe that impurity will not affect the market are focusing on the fact that such impurity issues have risen every year. After the valsartan incident in 2018, impurities were consecutively detected in ranitidine, nizatidine, metformin, losartan, varenicline, etc., building resistance among frontline clinics and hospitals regarding the issue. The government had also initially suspended the sale of all items, but recently ordered only specific lot numbers to be recalled. Others who have opposing views argue that it is too soon to predict that the impurity concern will not be significant, given that the montelukast are mainly prescribed to children and adolescents, unlike other items.
- Policy
- The MOHW has won the original drug price lawsuit
- by Lee, Jeong-Hwan Jan 25, 2022 05:55am
- The government won all dozens of lawsuits to cancel drug prices due to the expiration of original drug patents, but no civil lawsuits have been filed to get back drug benefits paid during the suspension period. The government says it is practically impossible to file a civil suit against individual pharmaceutical companies against dozens of drug price reduction lawsuits and get back the loss of health insurance finances. In response, the pharmaceutical community is confronting the need for the government to dispute in court over the feasibility of the redemption through a separate civil suit, rather than enacting the retroactive redemption of drug benefits already paid under the drug price reduction refund bill. On the 24th, the MOHW and the pharmaceutical industry disagree over some amendments to the National Health Insurance Act, which includes provisions for the return and refund of drug prices. Of a total of 64 lawsuits from 2011 to last year, a total of 20 lawsuits were filed to cancel drug prices due to the first generic registration after the expiration of the original patent. The MOHW was recognized by the court that the disposition of drug price reduction was valid without losing 20 original drug price reduction lawsuits. The MOHW did not file a civil lawsuit for redemption to receive the drug benefits paid within the suspension period after winning the case. The MOHW believes that recovering drug benefits through additional lawsuits is not a solution to preserve fundamental health finances, and that it is reasonable to stipulate the regression and refund provisions of drug prices as legislation. The MOHW said, "It is difficult to apply it in practice to file a civil lawsuit." The MOHW said, "It is inefficient and virtually impossible to file multiple civil lawsuits against each pharmaceutical company for each dozens of drug lawsuits." The MOHW said, "Excessive administrative power consumption, litigation costs are triggered, and the government has a burden of causing additional judicial disputes over cases that have already been filed," and added, "It is reasonable to clearly define health insurance losses by law to prevent waste of cost and administrative and cost." Some in the pharmaceutical industry say that the MOHW needs to file a separate civil suit for redemption rather than legalizing refunds according to the results of the administrative dispute over drug prices. The judiciary's decision to suspend the execution of drug cuts applied by pharmaceutical companies should be recognized separately from the original ruling, and whether or not drug benefits already paid can be redeemed retroactively due to winning the original bill should be judged again by the court. A pharmaceutical company's pharmaceutical manager said, "The decision to suspend execution is the authority of the judiciary, and the MOHW, the executive branch, should not affect that authority. If the drug price reduction refund bill is implemented, the court's decision to suspend execution itself could become meaningless." In particular, the judiciary has not determined whether the MOHW has the authority to recover drug benefits paid to pharmaceutical companies during the suspension period in line with the results of the lawsuit on the merits. The bill to redeem drug prices is feared to cause excessive damage to the pharmaceutical industry,"he added.
- Company
- United to complete P2T enrollment for its inhaled Covid drug
- by Lee, Seok-Jun Jan 25, 2022 05:55am
- Korea United Pharm will complete patient enrollment of its Phase II trial for the world’s first inhaled COVID-19 treatment ‘Corobin Activair (budesonide+ arformoterol).’ According to the company on the 24th, Korea United Pharm had been enrolling patients for its trial at specialized COVID-19 hospitals in Seoul to assess the safety and efficacy of Corobin Activair in patients with moderate-to-severe COVID-19 since last year. Korea United Pharm aims to receive conditional approval for its drug within the first half of this year after demonstrating its efficacy and safety in the Phase II trial. The company had completed manufacturing investigational Corobin Activair for the clinical trial last year. Its Sejong plant 2 is equipped with cGMP manufacturing facilities that can produce several million courses of Corobin Activair per year according to domestic and global demand immediately upon approval. A company official said, “With the COVID-19 virus continuing to prevail around the globe with variants such as the Omicron variant, Korea United Pharm will work with various institutions and focus all its capabilities on developing the world's first inhaled COVID-19 treatment.”
- Policy
- MFDS has completed verification of the efficacy of Retevmo
- by Lee, Tak-Sun Jan 25, 2022 05:55am
- The RET (Rearranged during transfection)) gene target anticancer drug developed by Lilly seems to be at the end of the domestic approval process. It is a drug called Retevmo (Selpercatinib), which began licensing last year, and safety and efficiency evaluation have recently been completed and is about to be approved. According to the pharmaceutical industry on the 21st, Retevmo's safety and efficiency evaluation by Lilly applied for permission, has recently ended. Analysts say that the end of safety and efficiency evaluation has further increased the possibility of product approval. In the case of new drugs, the MFDS will conduct GMP review to check safety, effectiveness, product quality, and compliance with manufacturing process standards through analysis of result data such as clinical trials to determine final product approval. The termination of safety and efficiency evaluation, which verifies drug efficacy, is interpreted as meaning that it is almost done. Retevmo is highly likely to obtain a domestic product license in that it has already received approval from the U.S. FDA based on multinational clinical trials such as data on safety and efficiency evaluation by the MFDS. At the time of FDA approval in May 2020, the drug was approved for use in adult patients with metastatic RET fusion-positive non-small cell cancer, medullary thyroid carcinoma over the age of 12, and Radioiodine-Refractory Thyroid Cancer. The RET gene is a phosphate enzyme that can cause cancer and is known to promote the proliferation of cancer cells when mutated or combined with other genes. About 2% of non-small cell carcinoma patients are found to have RET gene mutations. As RET gene mutations are also found in various carcinomas, Lilly is conducting an expanded study on Retevmo's indications. Retevmo was also designated as a rare drug in Korea by the MFDS in February last year. In addition to Retevmo, Roche's Gavreto (Pralsetinib) targeting the RET gene is also being introduced in Korea. In addition, among domestic pharmaceutical companies, HK inno.N introduced the RET target anticancer drug "VRN061782" from Voronoi in February last year and began commercialization development.
- Company
- Hanmi & Celltrion are producing generic COVID tx
- by Chon, Seung-Hyun Jan 25, 2022 05:55am
- Hanmi and Celltrion produce oral COVID-19 treatments developed by MSD and supply them to underdeveloped countries. According to the industry on the 20th, Hanmi and Celltrion have completed a license-in contract with the MPP for the production of generic drugs for Molnupiravir (Lagevrio) treatment for COVID-19. The license contract is based on the granting of a non-exclusive license by MSD, the original developer of "Molnupiravir," that allows the sale of mid- to low-income countries through MPP, an international institution, to expand access to COVID-19 treatments. A number of pharmaceutical companies around the world submitted letters of intent to select licensees, and only 27 companies were given licenses. Hanmi Pharmaceutical and Celltrion will receive know-how in manufacturing Largevrio from Merck, and patent fees will be exempted until the WHO declares the end of the pandemic. Among domestic companies, DongbangFTL, a raw material company, was also selected. Under this contract, Hanmi Fine Chemical, a raw material drug company of Hanmi Pharmaceutical Group, will start producing raw materials for Largevrio. The produced raw materials will be transferred to Hanmi Pharmaceutical's smart plant located in Paltan, Gyeonggi-do, and put into the production of finished drugs. In the case of Celltrion, the development and production of Molnupiravir generic finished products will be handled by its affiliate Celltrion Pharmaceutical and supplied overseas by Celltrion. Celltrion Pharmaceutical has launched a formulation study with the aim of completing product development by the end of this year. Celltrion and Hanmi Pharmaceutical plan to produce generic for Largevrio and supply and sell them to some of the 105 underdeveloped countries. MPP is a UN-supported non-profit medical organization that signed an agreement with MSD in October last year on the provision of patent licenses for Molnupiravir. The contract between Hanmi Pharmaceutical and MPP was made in a surprise move in line with the aim of adding strength to the world's efforts to end COVID-19 by greatly increasing accessibility to underdeveloped countries. Largevrio is RNA analog and is a drug that is inserted instead of normal ribonucleic acid necessary for the virus replication process to induce virus death. Largevrio received EUA in the UK in November last year and was approved in the United States in December last year to administer it to patients who were unable to use "other approved COVID-19 treatments." Currently, the screening is being conducted in Korea. The "COVID-19 Treatment/Vaccine Development Pan-Government Support Committee" under the MOHW began behind-the-scenes support for the selection of Korean pharmaceutical companies by conducting prior consultations with MPP for the domestic production of oral COVID-19 treatments since November last year. In this regard, the government said it plans to continue to support the domestic production and global expansion of oral COVID treatments through corporate meetings. An official from Hanmi Pharmaceutical said, "Hanmi's decision has begun to end the COVID-19 pandemic." He said, "We will do our best to start production as soon as possible in close consultation with MPP and MSD and quickly supply high-quality medicines to the world based on Korea and the United States' excellent drug manufacturing technology and production capabilities." An official from Celltrion Group said, "Through this license acquisition process, we were able to reaffirm that Celltrion Group's chemical drug production capacity and technology met global demand and standards, and at the same time were competitive."
- Company
- Sales of SGLT-2 diabetes drugs surpassed 150 billion won
- by Ji Yong Jun Jan 24, 2022 05:56am
- Sales of SGLT-2 inhibitor-based diabetes treatments exceeded 150 billion won for the first time last year. The SGLT-2 inhibitor market, including Forxiga and Jardiance, continues to grow at double digits every year. ◆ Sales of SGLT-2 inhibitors have increased five times in the past five years According to UBIST, a pharmaceutical market research firm on the 21st, the total amount of outpatient prescriptions for SGLT-2 inhibitors last year was 150.1 billion won, up 17.2% from the previous year. Sales of SGLT-2 inhibitors in Korea, which amounted to 28.6 billion won in 2016, have more than tripled in the past five years. The market size of SGLT-2 inhibitors has grown year by year. It rose from 50.1 billion won in 2017 to 70.3 billion won (40%) in 2018, followed by 96.9 billion won (37.8%) in 2019. The following year, it achieved 127.9 billion won (32%) in 2020. This growth is expected to continue for the time being. Both Forxiga and Jardiance, SGLT-2 inhibitors, are likely to increase their prescription performance in the future as their indications expand to patients with full heart failure in addition to diabetes treatment. SGLT-2 plays a role in reabsorbing glucose from urine into blood. SGLT-2 inhibitors are mechanisms that inhibit this reabsorption action to prevent glucose from entering the bloodstream and release it into urine. ◆SGLT-2 inhibitors such as Forxiga and Jardiance lead the growth The leading items in the domestic SGLT-2 inhibitor market are AstraZeneca's Forxiga and Jardiance. Last year, Sales of AstraZeneca's Forxiga and Xigduo recorded 79.5 billion won. The domestic market share alone is 52.9%. By product, Forxiga's outpatient prescription amount was 42.6 billion won, up 12% from the previous year. During the same period, Xigduo recorded 36.9 billion won, up 21.3%. It is analyzed that AstraZeneca got the preemptive effect when it first introduced Forxiga in Korea in 2014. The joint sale with domestic companies from the beginning of entering the market is also believed to have affected the increase in performance. AstraZeneca started co-selling with CJ Healthcare (currently HK inno.N) from the beginning of its launch. Since March 2018, it has been jointly selling with Daewoong Pharmaceutical. Jardiance and Jardiance Duo of Beringer Ingelheim and Lilly are closely chasing Forxiga. Last year, Jardiance achieved 40.9 billion won in outpatient prescription performance, up 10.8%. During the same period, Jardiance Duo also rose 46.7% to 24.5 billion won. The performance of these two items is 65.3 billion won, with 43.5% market share. Jardiance was released in 2016, two years later than Forxiga in the domestic SGLT-2 inhibitor market. Although it is generic, it is evaluated that it is acting as a positive factor in expanding prescription performance by proving the effect of reducing cardiovascular mortality through clinical trials. Astellas' Suglat and MSD's Steglatro's prescription performance was poor. Suglat's outpatient prescription amount stood at 3.5 billion won last year, similar to the previous year. Suglat has been in charge of distribution, marketing, and sales since April 2018. At that time, a synergy effect was expected when Handok, which had diabetes treatments such as Tenelia, introduced Suglat, but its performance was not good. MSD's Steglatro rather reduced prescription performance. Last year, Steglatro's outpatient prescriptions fell 21.8% from the previous year.
