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- 2026-03-16 21:30:22
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- Ildong applies to change trial protocol after completion
- by Kim, Jin-Gu Sep 29, 2022 05:50am
- Ildong Pharmaceutical and Shionogi Pharmaceutical submitted an application to modify their clinical trial protocol after completing the Phase 3 trial for their COVID-19 treatment. The industry saw this as Shionogi Pharmaceutical’s intent to reinterpret the clinical trial results around the Omicron variant. On the 27th, Ildong Pharmaceutical publicly announced that it applied to modify the Phase 2/3 clinical trial protocol for its oral COVID-19 treatment candidate 'S-217622 (brand name: Xocova).’ According to the public announcement, the biggest change was made in Cohort A’s Phase III trial size that is being conducted on moderate-to-severe COVID-19 patients. Cohort A’s Phase 2b trial size had been 428, and Phase 3 1821. Through the modification, Ildong and Shionogi decided to increase the Phase 2b trial size for Cohort A to 435, and reduce the Phase 3 trial size to 780. The size of Phase 2b and Phase 3 trials for Cohort B, which are being conducted concurrently and enrolled asymptomatic and mild COVID-19 patients, will also be reduced from 605 to 495. However, the number of participants enrolled in Cohort A and Cohort B are not that different in Korea, 204 and 200, respectively. The reason why the modification application had been receiving interest was that the two companies had already completed the global Phase III trial for Xocova. The two companies completed observation of the final trial participant on August 14th and submitted the clinical trial completion report to regulatory authorities. This is why the industry analyzes the companies’ applied for the change to reinterpret the clinical trial results, focusing on the Omicron variant. When the clinical trial was first designed, the company enrolled COVID-19 patients infected with the original (Wuhan) strain and Omicron variant in Korea. However, as time went by, the Omicron variant became the dominant strain, which naturally shifted the treatment target to the Omicron variant as well. At the same time, some industry experts analyzed that the reinterpretation of clinical trial results was Shionogi’s strategy to raise the possibility of receiving Special Approval for Emergency in Japan. Shionogi submitted an application for the conditional approval of Xocova to Japan’s Ministry of Health, Labor and Welfare in February this year. After the bill for the Special Approval for Emergency was passed in Japan, emergency use of Xocova had been discussed by MHLW’s expert committee. However, the conclusion was for the agenda to be redeliberated by MHLW’s Pharmaceutical Affairs and Food Sanitation Council. Although a second discussion was made by the council in July, the council decided to further discuss the issue in the future. An official from Ildong Pharmaceutical said, “The application for modification that was submitted this time was led by Shionogi. The company is known to have filed the application to re-review the result around subjects affected by the Omicron variant in line with the current situation where the Omicron variant is the dominant strain.”
- Company
- FDA approved Celltrion's anticancer drug Avastin biosimilar
- by Chon, Seung-Hyun Sep 29, 2022 05:50am
- The 3.6 trillion won U.S. market has begun in earnest. Celltrion announced on the 27th that it has obtained a license from the Food and Drug Administration (FDA) to sell the Avastin biosimilar Vegzelma. Vegzelma has been approved for Avastin's indications, including metastatic direct bowel cancer, non-small cell lung cancer, metastatic renal cell cancer, cervical cancer, epithelial ovarian cancer, ovarian cancer, ovary cancer (uterine cancer), primary peritoneal cancer, and circulating glioblastoma. Since August, Celltrion has sequentially obtained sales licenses for Vegzelma from regulators in major global countries such as Europe, the United Kingdom, and Japan. According to IQVIA, a global pharmaceutical market research firm, Avastin's global market reached $6.43 billion last year. The U.S. market is about $2.62 billion, the largest in the world, on a single scale. Celltrion plans to quickly settle Vegzelma in the global market with cost competitiveness from its own drug development and production know-how. Celltrion completed a global patent agreement with Genentech, the developer of original drug Avastin, in May and laid the foundation for stable launch of Vegzelma in the global market. Celltrion Healthcare, which is in charge of selling and marketing Celltrion products, plans to launch Vegzelma in the global market sequentially, including major European countries in the second half of this year. An official from Celltrion explained, "We have obtained all the permits from major countries such as Europe, the United States, and Japan, and are ready to target Vegzelma's global market." He said, "We will do our best to settle in the global market as soon as possible with Vegzelma's cost competitiveness, and to proceed with clinical trials and permits of other biosimilar products currently being developed."
- Company
- Daewoong Pharmaceutical SGLT-2 Diabetes New Envlo
- by Kim, Jin-Gu Sep 28, 2022 06:06am
- Daewoong Pharmaceutical has registered a trademark of Enavogliflozin, which is being developed as a new drug for treating diabetes in the line of SGLT-2 inhibitors. Daewoong Pharmaceutical temporarily confirmed the name of the single, second, and third complex series centered on Enavogliflozin as Envlo, and began the last-minute work with the aim of approving items in the first half of next year. According to the pharmaceutical industry on the 28th, the Korean Intellectual Property Office recently decided to register the trademark Envlo applied for by Daewoong Pharmaceutical. Daewoong Pharmaceutical applied for this trademark late last year. At that time, Daewoong Pharmaceutical also applied for the brand ENAZIN, ENAVOX, and BENAVO at the same time. This year, it applied for additional trademarks such as Enaflo, Eaglex, Glucut, Imabec, Imatin, and Imatide. All of these trademarks are confirmed to have applied for "drugs for treating diabetes" as designated products No. 1. Among them, Daewoong Pharmaceutical finally decided to use the name Envlo after an internal review. The rest of the applied trademarks are expected to be used as the names of drugs with the same ingredients of related companies such as Daewoong Bio and Hanol Biopharma. Daewoong Pharmaceutical recently applied for the trademarks ENVLOMET and ENVLOJEM. It is interpreted that Daewoong Pharmaceutical is likely to be a strong brand name in that it is conducting clinical trials of Metformin combi and Metformin and Gemigliptin 3 combi drugs at the same time with Enavogliflozin. Daewoong Pharmaceutical plans to continue its plan to license items and release products after trademark registration. Daewoong Pharmaceutical applied for an item permit for Enavogliflozin in April. It then plans to release a single and complex system in the first half of next year after obtaining an item license in the second half of this year. Earlier, in the first quarter of this year, the results of the phase 3 clinical top-line for Enavogliflozin and combination therapy were announced, and statistical significance of the difference in HbA1c change in monotherapy and safety in combination therapy were confirmed.
- Company
- 4th JAKi Cibinqo makes a step towards reimbursement
- by Eo, Yun-Ho Sep 28, 2022 06:06am
- The 4th JAK inhibitor, Cibinqo, is nearing insurance reimbursement in Korea. According to industry sources, Pfizer Korea’s new Janus kinases (JAK) inhibitor ‘Cibinqo (abrocitinib)’ passed the review of the National Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee. The company applied for Cibinqo’s reimbursement in April. Its competitors -’ Lilly Korea’s ‘Olumiant (baricitinib)' and Abbvie’s ‘Rinvoq (upadacitinib)’ – have already been receiving reimbursement for the atopic dermatitis indication since May. Considering how the company made the strategic move to accept the weighted average price of its alternative drugs, its progress is not on the faster side. However, as the remaining steps to reimbursement can be accelerated with the will of the pharmaceutical company, Cibinqo’s may be launched with reimbursement within this year. Cibinqo is a JAK1 inhibitor that modulates multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP), etc. It is indicated for the treatment of adults and adolescents over the age of 12 with moderate-to-severe atopic dermatitis. Cibinqo demonstrated its efficacy through the Phase III trials JADE MONO-1, MONO-2, COMPARE, etc. The drug reduced the Eczema Area and Severity Index (EASI) by over 70% at Week 12 and demonstrated improvement in itch relief within 2 weeks after initiating treatment. Its pivotal study, JADE Mono-1, was designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo monotherapy vs placebo in randomly assigned patients 12 years of age and older with moderate-to-severe AD for 12 weeks. Results showed that 63% of the Cibinqo 200 mg administered group had achieved EASI-75 (improvement of at least 75% in lesion extent and severity) at week 12, which was a significant improvement compared to the 12% in the placebo group. Also, the rate of patients that achieved EASI-90 at week 12 had been 39% in the Cibinqo group, 5% higher than the placebo group
- Company
- MFDS allows academic marketing of EUA COVID-19 treatments
- by Sep 28, 2022 06:05am
- The Ministry of Food and Drug Safety gave an interpretation that allows academic marketing activities for oral COVID-19 treatments. As drugs approved under the Emergency Use Authorization are as validly approved as officially authorized drugs, such drugs that were left unattended by the Pharmaceutical Affairs Act can also be advertised within its approved indication. With this favorable interpretation, the healthcare professionals’ access to information that arose as a barrier in prescribing COVID-19 treatments will also gain momentum and be improved. During a phone interview with Dailypharm on the 26th, an official from the Ministry of Food and Drug Safety said, “The Korea Disease Control and Prevention Agency is in charge of the overall management of EUA drugs, from its use volume to distribution. Therefore, the KDCA needs to determine the need for the drugs’ advertisement, etc. Although academic marketing is not necessary for EUA drugs as they are not directly sold by individual pharmaceutical companies, the companies may jointly provide information with the KDCA for reasons such as raising the prescription rate, etc. The official added, “Applying the Pharmaceutical Affairs Act mutatis mutandis for such academic marketing activities mean that the companies that received EUAs for their drugs can advertise their products within their approved indications as the EUA is also a form of ‘authorization' subject to the mutatis mutandis application of the Pharmaceutical Affairs Act. It does not mean we are forbidding academic marketing activities of pharmaceutical companies.” Until now, advertising of EUA drugs had been left in the blind spot with no clear regulations. The EUA system was introduced under the Special Act on the Promotion of Development and Urgent Supply of Medical Products in Response to Public Health Crisis to promptly respond to the rise of new infectious diseases. The law does not have specific regulations set for the advertisement of EUA drugs. As no issues relevant to such had risen until recently, the MFDS had taken a principled position, saying that “no advertisement-related regulations are available under the Special Act, therefore the issues are applied mutatis mutandis to the Pharmaceutical Affairs Act.” Pharmaceutical companies had taken this as a “No advertising” stance, as EUA drugs are not subjects for advertisement under Article 68-5 of the Pharmaceutical Affairs Act. The article specifies that an imported pharmaceutical product’s name, manufacturing method, and efficacy cannot be advertised unless the drug product has been approved or reported according to Article 42-1 of the Pharmaceutical Affairs Act. If taken word by word, as drugs granted Emergency Use Authorization was not approved under Article 42-1 of the Pharmaceutical Affairs Act, such drugs are not allowed to conduct advertisements. Also, at the time of introductions, when pharmaceutical companies had asked the MFDS several times on what scope of information provision activities are allowed for their EUA drugs, the MFDS only responded that “It is difficult for the ministry to provide a definite answer due to lack of information in determining the necessity and validity of providing information." The pharmaceutical companies then received the response as a “Don’t.” This was why officials from pharmaceutical companies had been passive in conducting activities for their drugs, only responding when receiving inquiries from healthcare professionals. Unlike formally approved drugs, companies were unable to conduct educational or promotional activities such as directly explaining their drugs or delivering drug information to healthcare professionals. However, the Advisory Committee on Infectious Diseases deems the academic marketing activities of pharmaceutical companies necessary to raise the prescription rate. During a phone interview with Dailypharm, Gi-Seok Jeong, Director-General of Special Response of the Central Disaster and Safety Countermeasure Headquarters, said, “Despite the state’s efforts in encouraging the prescription of oral COVID-19, there are still many cases in which prescriptions are not available to patients who need them in the medical field. Adding pharmaceutical companies' information provision activities to the effort will help increase the prescription rate.” In other words, although the KDCA is in charge of training healthcare professionals and providing medication guidance to patients, etc., for the EUA drugs, it has been experiencing limitations with the expanded number of institutions that can prescribe oral COVID-19 treatments It was found that many medical staff and pharmacists have not yet received the prescription and medication guide, which is creating confusion in the medical field. This is analyzed to have also impacted the slow rise in the prescription rate of COVID-19 treatments. According to the 'Measures to Raise Prescriptions of Oral COVID-19 Treatments’ that had been reported by CDSCH last month, healthcare professionals were reluctant to prescribe oral COVID-19 treatments due to a large number of contraindicated drugs and lack of clinical information. Accordingly, the authorities are contemplating ways to increase accessibility to information by preparing educational materials and prescription guidelines. The MFDS said that there was a miscommunication in the course of interpreting the Pharmaceutical Affairs Act. Still, the MFDS is presumed to have had a negative stance on advertising activities of COVID-19 treatments in the earlier stages of introduction. It is believed as the KDCA is in charge of providing information, there is no reason for the company to conduct additional academic marketing. However, with the emphasis put on expanding access to information among healthcare professionals, it seems that the MFDS has broadened its scope of interpretation to “Companies may advertise if KDCA deems it necessary.” Furthermore, the MFDS has formalized its position that even drugs approved under EUA may conduct academic marketing activities just like drugs that have received official approval. An MFDS official said, "As KDCA is in charge of supplying and managing the EUA drugs, companies may of course cooperate with the agency when it needs support. When the KDCA requested on a similar note in the middle of this year, we answered that such activities can surely be conducted if the government deems it necessary.”
- Company
- Reduce steroid in long-term use of Dupixent in asthmatic pts
- by Sep 28, 2022 06:05am
- Sanofi's Dupixent was found to improve major symptoms in a three-year long-term follow-up of severe asthma patients while reducing the use of oral corticosteroids. The results of these studies were released at the 2022 ERS Annual Academic Conference held from the 4th to the 6th. Through this conference, Dupixent released a number of data and RWE data confirming the improvement effect of asthma symptoms related to type 2 inflammatory biomarkers to solidify the treatment effect and safety profile in type 2 inflammatory severe asthma. It proved that it is a treatment that reduces the frequency of deterioration of severe asthma and lowers the severity, thereby helping to reach the treatment goal of severe asthma. Post-analysis study data from VENTURE/TRAVERSE clinical trials once again suggested that Dupixent could be a treatment solution for severe asthma patients, including Steroid-dependent patients. According to published data, Dupixent reduced steroid use for three years while improving major symptoms of asthma, including severe annual exacerbation and lung function deterioration. The results of this post-analysis study were conducted on Steroid-dependent asthma patients who participated in the VENTURE study, the existing phase 3 clinical trial of Dupixent. Patients who were administered Dupixent 300 mg or placebo every two weeks in the existing VENTURE clinical trial received additional Dupixent for up to 96 weeks through TRAVERSE clinical trials. These patients were analyzed by dividing them into patients who used Steroids less than or equal to 10 mg per day. If the daily usage exceeds 10 mg, caution is needed as it can be exposed to steroid side effects such as diabetes and osteoporosis in the long run. According to the main results, Dupixent decreased the annual severe asthma exacerbation rate of patients regardless of Steroid use at 96 weeks from the end of the previous study, VEUNTURE. Among patients with daily Steroid use exceeding 10 mg, the placebo-administered group showed an improvement of more than 81% in the annual severe asthma exacerbation rate at 96 weeks of Dupixent administration. It was also found to have improved by more than 43% in the existing Dupixent administration group, confirming the effect of Dupixent in Steroid-dependent asthma patients. In the group of patients with daily steroid use of 10mg or less, it was found to have improved by more than 80% and 36%, respectively, compared to the baseline of the VENTURE study. Steroid use also decreased as asthma symptoms improved with Dupixent. Dupixent reduced Steroid use by more than 70% at 96 weeks of administration, regardless of both Dupixent/ placebo administration and Steroid use compared to the baseline of the VENTURE study. Patients with daily steroid use exceeding 10 mg also decreased by 83%, confirming the long-term treatment effect of Dupixent in Steroid-dependent patients. The data released on that day also included RWE data from the United States analyzed for severe asthma patients who received Dupixent. According to the data, Dupixent reduced the rate of emergency room visits related to asthma by up to 73.4%, and the rate of hospitalization by up to 66.7%. In addition, it has been confirmed that medical expenses related to asthma have been reduced by reducing the frequency of visits to internal medicine.
- Company
- MOHW's view of ‘few’ and ‘pediatric’ for PE exemptions
- by Eo, Yun-Ho Sep 27, 2022 05:51am
- Chang-Hyun Oh, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare Although yet to be finalized, the PE exemption criteria will not be amended' in the direction desired by pharmaceutical companies. In particular, companies are likely to have little room in utilizing the special exemption of the pharmacoeconomic evaluation system due to the restrictions set, such as treatments that are used by ‘few’ patients and those with ‘pediatric’ indications. The period for industry opinion collection still remains, with the deadline being the 30th. But as the government is determined to implement the amendments to the system, to what extent the opinions will be reflected remains to be seen. Chang-Hyun Oh, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare, said so regarding the “Measures to Improve Patient Access and Manage Reimbursement of High-Priced Severe Disease Treatments" at a recent meeting with the multinational pharmaceutical company press gallery. The ‘Few’ patients standard to be maintained at a 200-patient level The government's improvement plan raised industry concerns because it changes the major premise set for PE exemptions. The new change adds ‘few numbers of subject patients’ as a prerequisite for PE exemptions. Originally, the condition was a ‘OR’ clause included with other optional clauses such as ‘if a single-arm study was conducted,’ under Subparagraph 2(c) of Regulation for Drugs Subject to PE Exemptions. The ‘few’ was defined to be in the 200 range. Although the exact number has not been specified in the condition, the PE exemption evaluations has been made at that level. Therefore, there were many opinions in the industry that the number defined as a ‘few’ should be adjusted upward if the condition was to become a prerequisite. However, Director Oh said, “We don’t plan to change the standards we set to define the ‘few’ just because of the amendment. However, no specific number is universally applied to all drugs, therefore, the number may be flexibly adjusted to a small extent for each drug in the future." In other words, if the amendment is applied as is, all drugs that seek PE exemptions will first have to satisfy the 'few numbers of patient' (around 200) requirement, then receive recognition from the committee for their difficulty to generate PE data. What about drugs that have broader indications that are applied to pediatric to adult patients? The main point of the system improvement being made was to improve coverage for pediatric patients. The government had added the clause 'drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option, and demonstrates improvement in quality of life or is otherwise approved by the committee.' In essence, the added clause excluded the 'life-threatening disease' condition for PE exemptions just for pediatric patients. In other words, if drugs used for pediatric patients satisfy the remaining conditions, the PE exemption may be applied even if the condition is not life-threatening. On the surface, it seems like an encouraging improvement. However, there were wild speculations in the industry on what the scope of 'drugs used in pediatric patients' will be. The government had not specified whether the 'drugs used to treat pediatric patients' clause applies only to diseases that occur only in children, drugs that only have indications for children, or drugs that can be prescribed broadly to children and adults. However, it is likely that this clause will also not be widely applied. Director Oh said, “It is difficult to provide a clear answer on that part. However, the system was not intended to limit the indication of drugs that can be used for even the adults to only children so that they can take the PE exemption track."
- Company
- Daewoong Nabota is expected to take a global leap
- by Nho, Byung Chul Sep 27, 2022 05:51am
- As Daewoong Pharmaceutical's botulinum toxin product Nabota (Jubo·Jeubeau) is likely to surpass 100 billion won in sales this year, it is drawing attention as it is expanding its global scope as a representative K-toxin product. Nabota, which was launched in Korea in 2014, recorded 15.1 billion won in 2019 It achieved sales of 79.6 billion won last year after Quantum Jump, 233% sales of 50.4 billion won the following year. After the FDA approved the final item license in February 2019, it began to target the North American market in May of the same year. The U.S. occupies 50% of the global toxin market worth 6 trillion won, and Allergan Botox products are leading the treatment, beauty, and plastic surgery market. Europe is the second-largest market for toxin drugs, and Nabota is expected to be launched in the second half of this year. Item licenses in China, which are highly regarded for its rapid growth and potential market value, are also expected to be approved as early as this year, and full-fledged releases and profits are expected from next year. Evolus is in charge of the beauty business partners in the U.S., Europe, Australia, and Canada, while Ion Biopharma is in charge of the treatment business partners in the U.S. Currently, Nabota is in charge of production at the first plant of Hyangnam Pharmaceutical Complex, and when the second plant is completed in 2025, it is expected to become a global leading company as it can produce a total of 5 million vials per year. As of September 2022, Nabota's indications include eyelid wrinkles, eye wrinkles (abnormal beauty), improvement of upper extremity muscle stiffness after stroke, and eyelid cramps (abnormal treatment). As for the progress of additional indications, it is waiting for approval after submitting approval to the MFDS in April 2022 for the world's first item permission to add positive adiabatic hypertrophy (square jaw improvement). In addition, phase 2 clinical trials for chronic and inflammatory migraine and cervical muscle tension are underway in the United States, Canada, and Australia. A panoramic view of Nabota Chronic migraine headaches account for 40% of the total treatment market, and there is no competition other than Botox yet. If Nabota enters this field, it is expected to penetrate the market quickly based on price competitiveness.I t is also preparing clinical trials for gastric paralysis indications, which do not yet have a clear treatment. It is predicted that a new treatment paradigm can be provided in a unique way by injecting toxin directly into the upper and lower parts of the stomach through endoscopy. In addition to the three global toxin markets, plans to release them in niche markets such as Turkey, Chile, Peru, Saudi Arabia, Egypt, and Indonesia are also drawing attention. Nabota is a premium toxin brand based on high-pure technology patent technology. An official from Daewoong Pharmaceutical said, "Nabota is the only product in Asia that has been approved for sales in the United States, Europe, and Canada." "We plan to expand our markets in the U.S., Europe, and China through aggressive investment in the future," he said. Meanwhile, Nabota's ITC lawsuit disappeared in February last year when Daewoong Pharmaceutical's U.S. partner Evolus signed a three-way agreement with AbbVie and Medy Tox, and has since grown rapidly based on U.S. exports. Of Nabota's overseas sales in the second quarter, exports to the U.S. through Evolus amounted to 21.1 billion won, which doubled from the same period last year.
- Company
- 4 pharmaceutical companies challenge to add Vemlidy patents
- by Kim, Jin-Gu Sep 27, 2022 05:51am
- VemlidyGilead Sciences' patent for hepatitis B treatment Vemlidy (Tenofovir) is increasing. While Dong-A ST, Daewoong Pharmaceutical, Chong Kun Dang, and Jeil succeeded in avoiding patents for the first time in March this year, Samjin, Hutechs, DongKook, and Samil have challenged the same patent for the past two months in a row. According to the pharmaceutical industry on the 23rd, Samil recently requested a passive judgment on the scope of rights for the Gilead Vemlidy salt patent. Since Samjin challenged the same patent in July, a total of four companies, including Hutechs and DongKook, have joined patent disputes in the past two months. This patent has already been successfully avoided by Dong-AST, Daewoong, Chong Kun Dang, and Jeil in March this year. Samjin, Hutechs, DongKook, and Samil challenged the same patent as generics. The background of a series of generic challenges is that there is no impact on generic exclusivity. The drug is an upgraded version of Gilead's existing hepatitis B treatment Viread. However, since the main ingredient is Tenofovir, generic for Vemlidy is not given a separate opportunity to acquire generic exclusivity. Gilead developed a new Vemlidy in the form of pro-drug. Through this, drug resistance and renal toxicity side effects have been improved. Vemlidy is rapidly replacing the existing Viread in the hepatitis B treatment market. According to IQVIA, a pharmaceutical market research firm, sales of Vemlidy surged in four years from 500 million won in 2017, the first year of its launch, to 28 billion won last year. During the same period, Vemlidy's sales nearly halved from 129.3 billion won to 63.1 billion won.
- Company
- Praluent can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 26, 2022 06:08am
- PCSK9 inhibitor Praluent has settled on general hospitals. After registering insurance benefits in June 2021, the landing process is steadily underway. According to related industries, Sanofi-Aventis Korea's Praluent passed the Pharmaceutical Affairs Committee (DC), including Samsung Medical Center, Asan Medical Center, Sinchon Severance Hospital, Bundang Seoul National University Hospital, Chonnam National University Hospital, and Pusan National University Hospital. The drug was approved in Korea in January 2017, but was listed last year. Amgen Korea's Repatha, which was approved around the same time, was first registered as a Homozygous Family Hypercholesterolemia (HOFH) indication in August 2018. In other words, there were two PCSK9 inhibitors, but in fact, Repatha was the only option. Since last year's salary registration, Sanofi has carried out the landing process at general hospitals, and as it has shown results this year, the competition between the two drugs is expected to begin in earnest. In January 2020, Repatha succeeded in expanding the criteria for high-risk patients with atherosclerotic cardiovascular disease (ASCVD), heterozygous family hypercholesterolemia (HeFH), and non-heterozygous patients. It is believed that the actual battlefield between the two drugs will also be the ASCVD and HeFH regions. Praluent added a HoFH indication in the United States in April last year. Praluent has a tendency to reduce the risk of all-cause death, and it has the advantage of being able to select patient-specific doses by referring to patient status and LDL-C levels as two approved drugs, Praluent 75 mg and Praluent 150 mg. Meanwhile, MSD is currently developing oral PCSK9 inhibitor. MSD announced phase 1 clinical results of the candidate substance MK-0616 at the American Heart Association (AHA) conference last year. Studies have shown that up to MK-0616 300 mg was administered to healthy men, or LDL cholesterol was reduced without serious side effects or death when administered with Statins in men and women with high cholesterol.
