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- 2026-05-20 05:10:45
- Policy
- Nine out of 27 patients in Remdesivir improved
- by Kim, Jung-Ju Jul 14, 2020 06:12am
- Of the 27 COVID-19 patients in Korea who took Remdesivir, 9 cases improved out of 27 patients with severe change. The positive effect was about 30%, which is only a numerical example and is still under professional review. Deputy General Manager Kwon Joon-Wook, the Central Disease Control Headquarters of the KCDC (Director, Eun-kyeong Jung), briefly explained the current status of domestic medications for Remdesivir at the regular briefing session during the day. Currently, the Central Disease Control Headquarters sent a request for special import to the Gilead Korea branch, which is a holding company of Remdesivir, and requested urgent import of 360 people for emergency use and 5000 people for preparation for the pandemic. According to Deputy General Manager Kwon, there are a total of 42 COVID-19 patients currently receiving Remdesivir. A total of 27 patients were able to detect the change in severity because the comparison between the administration group and the non-administration group was not yet completed. Nine out of 27 cases improved. However, he explained, "It is not yet known whether this improvement is due to Remdesivir or the patient's own symptomatic therapy or immunity." It was found that 15 cases were hard to judge the effect or the condition did not change, and three cases were worse. Regarding this, he emphasized again, "This is only a numerical situation, and it is necessary to seek professional judgment from the central clinical committee for the effectiveness of the treatment." Meanwhile, the Central Disease Control Headquarters applied for Remdesivir to 23 hospitals for 42 seriously ill patients, and has now completed supply to all 42 patients.
- Company
- 14 new drugs approved from Jan to June with no Korean drug
- by Jul 14, 2020 06:12am
- Korea’s Ministry of Food and Drug Safety (MFDS) reported total 14 new drugs have been approved from Jan 1 to June 30 this year. While none of them were a Korean-made, the absence of Korean-made new drug has continued for two years now. Pfizer Pharmaceutical Korea, Astellas Pharma Korea and Bayer Korea received the highest number of new drug approvals with two products each, and Eisai Korea, Novartis Korea, AbbVie Korea, Bayer Korea, Roche Korea, Menarini Korea, MSD Korea, Daiichi Sankyo Korea and Handok respectively received one new drug approval as well. Source: Ministry of Food and Drug Safety Categorized by each month, January had the highest number of new drug approvals at four. From February to June, one, two, one, three and three new drugs were approved, respectively. By disease type, anticancer treatments (five products) had the highest number of approvals, and Janus kinase (JAK) inhibitors treating rheumatoid arthritis with two approvals came second. Early this year, Daiichi Sankyo’s peripheral neuropathic pain treatment Tarlige and Astellas Pharma’s rheumatoid arthritis treatment Smyraf were the first ones to receive approval. Pfizer Pharmaceutical’s antifungal Cresemba and MSD’s human immunodeficiency virus (HIV) treating combination drug Delstrigo followed the next. On Feb. 14, Pfizer Pharmaceutical won the health authority’s approval on second generation non-small cell lung cancer targeted therapy Vizimpro. In March, Xospata, a FMS-like tyrosine kinase 3 (FLT3) inhibitor indicated to treat acute myeloid leukemia by Astellas Pharma, and Ranexa, a novel angina treatment by Menarini were approved. In April, the Korean government green lit Roche’s anticancer treatment Rozlytrek that targets all solid tumors with neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Three new drugs were cleared in May—Handok’s paroxysmal nocturnal hemoglobinuria (PNH) treatment Ultomiris and Bayer’s two anticancer treatments (Nubeqa and Vitrakvi). Nubeqa is an oral androgen receptor inhibitor (ARi) indicated to treat non metastatic castration resistant prostate cancer (nmCRPC), and Vitrakvi is orally taken selective tropomyosin receptor kinase (TRK) inhibitor for targeted therapy. In June, AbbVie’s rheumatoid arthritis treatment Rinvoq, Novartis’ macular degeneration treatment Beovu and Eisai’s Parkinson’s disease treatment Equifina were approved in the order. Including Novartis’ Lutathera approved on July 9, the Korean health authority has cleared 15 new drugs so far this year. No Korean-made drug approved for two years, but expecting one within this year Continuing on from last year, none of the approved drugs were made in Korea this year. Although Handok owns the license over Ultomiris, the drug was originally developed by the U.S.-based company, Alexion. Similarly, all drugs sought after approval last year by Korean companies were licensed from other global companies. HK inno.N’s (formerly CJ Healthcare) potassium competitive acid blocker (P-CAB) K-CAB approved on July 5, 2018, was the last Korean-made drug. As an osteoarthritis gene therapy Invossa’s license was revoked in 2019 and Dong-A ST withdrew licenses on two types of Sivextro, three out of total 31 Korean-made drugs were removed from the market. Finally, however, a long-awaited new Korean-made drug is expected to get approved. Daewoong Pharmaceutical is seeking for an approval on its P-CAB Fexuprazan and the application has been submitted last November. Considering the review process takes approximately ten to 12 months until the final decision, the drug is expected to get passed within this year. But the novel coronavirus (COVID-19) delaying the approval review process could bring unexpected change to the estimated approval date.
- Policy
- Forxiga's pro-drug by Dong-A ST, conducted clinical trials
- by Lee, Tak-Sun Jul 14, 2020 06:11am
- Dong-A ST recently succeeded in overcoming a material patent, and SGLT-2 suppression-based diabetes treatment Forxiga by AstraZeneca is speeding up commercialization. IND has already been approved by the MFDS in April. According to the MFDS on the 10th, IND of Dong-A ST's 'DA-2811' was approved on April 16 to confirm its equivalence with Forxiga. According to the recently published plan, DA-2811 is tested with Forxiga 10 mg (Dapagliflozin), Comparator. and a clinical trial is conducted in 60 healthy adults in the month of July at Seoul National University Bundang Hospital. Clinical trials are conducted in a public, randomized, single dose, or cross-over manner to evaluate pharmacokinetic properties, safety, and tolerability compared to Forxiga. Dong-A ST's DA-2811 has no medicinal properties in itself, but when absorbed by the human body, it turns into an active ingredient and is known as a pro-drug. In a recent patent trial, Dong-A ST was the first domestic drug company to evade Forxiga's substance patent (expired on April 7, 2023) with this pro-drug. Accordingly, upon successful commercialization of the product, it laid the foundation for bringing the product to market. It is known that Forxiga's material patent specification does not include pro-drug in its scope of rights. Looking at the trial of the patent trial, Donga ST's product is a prodrug ester compound in the form of formic acid bound to the carbon at the glucose site in the Dapagliflozin molecule. It was named 'Dapagliflozin Formate' in the trial. In other words, when Dapagliflozin Formate is administered to the human body, Dapagliflozin is a drug that produces an active ingredient. Comparison of chemical formula between Forxiga (left, AZ) and prodrug (right, Dong-A ST) (Source: Patent trial decision)Because of this characteristic of the prodrug, securing the comparability with the original reference drug is interpreted as the key to commercialization. Animal model tests have been shown to demonstrate equivalence. Dong-A ST plans to successfully complete phase I clinical trials and apply for permission in the first half of next year. Dong-A ST, along with SGLT-2, possesses the DPP-4 inhibitor, Suganon, which is currently leading the diabetes treatment market, so it is likely that Forxiga's prodrug will be more competitive if it is released early.
- Company
- LG Chem launches filler's clinical trial in China
- by An, Kyung-Jin Jul 14, 2020 02:34am
- china's filler market share (Source: 2019 Samsung securities reasearch) LG Chem is launching a large-scale clinical trial in China with the new product of Yvoire, a hyaluronic acid filler brand. It is an ambition to secure the differentiation and expand the market share by preparing clinical data of Y-Solution, which was introduced as a premium line. LG Chem recently unveiled a new clinical trial plan for Yvoire Y-Solution on clinicaltrials.gov, a clinical trial registration site operated by the National Institutes of Health (NIH). This study is to check the effect and safety of the volume improvement of Y-Solution 720 for 238 subjects. The researchers decided to evaluate the effectiveness by confirming the MFVDS (Mid-Face Volume Deficit Scale) response rate, which is used as a measure of the volume recovery of the central part of the face, at week 26 after the injection of Y-Solution 720. The study begins in earnest from this month and is scheduled to proceed until July 2022. Professor Xiaojun Wang of Peking Union Medical College Hospital was appointed as the Principal Researcher (PI). Yvoire Y-Solution is a premium product among LG Chem's hyaluronic acid filler brand 'Yvoire'. LG Chem introduced Y-Solution series in 2018 to target the premium wrinkle improver market. According to the volume improvement effect, it is composed of three types: 'Y-Solution 360', 'Y-Solution 540', and 'Y-Solution 720'. According to the company, it is expected that the volume improvement effect will be further improved by supplementing the existing product 'Yvoire' with additional viscosity. It is interpreted as the will of LG Chem to actively target the overseas market with filler products. LG Chem started exporting to Russia in 2012 and has exported Yvoire to more than 30 countries including China, France, the UK, Italy and Mexico. China's filler market share (Source: 2019 Samsung securities report) In the case of the Chinese market, it has secured the initiative by introducing the existing Yvoire products early. According to the '2019 Healthcare Report' published by Samsung Securities, among the 7 companies that occupy the hyaluronic acid filler market in China, LG Chem and Humedix are included in Korean companies. LG Chem's 'Yvoire' market share is about 26%, and Elravie by Humedix is about 13%. It is judged that it is necessary to rapidly increase the penetration rate of the market through the launch of new products as China has rapidly emerged as a base for filler industries worldwide. LG Chem is conducting a clinical trial comparing 'Y-Solution 360' with Allergen’s Juvederm in Germany. An official from LG Chem said, "Yvoire has maintained the best selling fillers in the Chinese market by surpassing Chinese local brands and global brands for 4 consecutive years since 2016." "In the future, we plan to expand the sales of Yvre in the center of Europe and South America as a global brand" added him.
- Company
- DongKook & YuYu have challenged Dutasteride &Tadalafil
- by Kim, Jin-Gu Jul 13, 2020 06:13am
- The prostate hyperplasia & erectile dysfunction complex market competition is expected to become even hotter. Gugu tams sales by year (Unit: ₩100 million, Data: IQVIA)With only Hanmi's Gugu tams (Tamsulosin + Tadalafil ) released on the market, DongKook and YuYu Pharma have challenged. According to the pharmaceutical industry on the 13th, DongKook recently approved a clinical trial phase III IND for the development of a combination drug of prostate hyperplasia and erectile dysfunction. DongKook is developing a combination of Dutasteride-based prostate hyperplasia treatment and Tadalafil-based erectile dysfunction treatment. YuYu Pharma is slightly ahead of Dongkuk in the development situation. YuYu Pharma has started clinical trial phase III of the same combination of YY-201 in 2018. A clinical trial is underway in 942 patients with prostate hyperplasia at the Catholic University of Korea Seoul St. Mary's Hospital. If YuYu Pharma and Dongkuk succeed in developing the combination drug, three companies including Hanmi will compete. Gugu tams (Tamsulosin + Tadalafil)Hanmi is currently the only drug in the domestic market that has released 'Gugu tams' as the combined prostate hyperplasia and erectile dysfunction treatment. However, the ingredients are slightly different from the combination drugs that YuYu Pharma and Dongkuk are developing. The active ingredient for erectile dysfunction is same as Tadalafil, but the active ingredient for prostatic hyperplasia contains Tamsulosin, not Dutasteride. In the industry, synergy of prostate hyperplasia and erectile dysfunction is expected to be popular. This is because many patients suffer from both diseases at the same time. According to the Korean Prostate Society, 30-40% of erectile dysfunction patients in their 50s or older in Korea are accompanied by prostatic hyperplasia. According to the drug market research agency IQVIA, the annual sales of Gugu tams are ₩100 million in 2016, ₩1.1 billion in 2017, ₩1.5 billion in 2018, and ₩1.9 billion in 2019. Sales of ₩500 million were raised by the first quarter of this year. Gugu tams sales by year (Unit: ₩100 million, Data: IQVIA) Given that there are many generics in the erectile dysfunction market, this is not a bad outcome. In fact, Gugu tams ranked 11th in the treatment of erectile dysfunction in the first quarter of this year. In particular, in the first quarter of this year, the erectile dysfunction drug market decreased 4.8% year-on-year, and sales increased 5.4% YoY. For this reason, many pharmaceutical companies have developed prostate hyperplasia and erectile dysfunction in the past. Around 2015, along with Hanmi, Chong Kun Dang, Ildong, and Yungjin challenged the development of a Tamsulosin + Tadalafil combination. Yungjin started with YBH-1603 from April 2015, Chong Kun Dang with CKD-397 from June 2015, and Ildong with Double T from December 2015. They initiated Phase III clinical trials to develop a combination of Tamsulosin + Tadalafil combination. However, Hanmi is the only company that has successfully developed. The rest of the pharmaceutical companies have ended the clinical trial, but have not released it. It was reported that a drug company that entered the development at the time proved the effectiveness of Tadalafil, but did not demonstrate the efficacy of Tamsulosin.
- Company
- Eligibility for HPV vaccine Gardasil9 extends up to age 45 i
- by Eo, Yun-Ho Jul 13, 2020 06:12am
- A promotional image for prospective Gardasil9 recipients with expanded vaccination eligible age group Vaccination eligible age for the human papillomavirus (HPV) vaccine Gardasil9 has been extended up to age 45 in Korea. Pharmaceutical industry sources reported Ministry of Food and Drug Safety (MFDS) has approved MSD expanding the indication to vaccinate in female aged 27 to 45. Unlike the U.S., however, the Korean health authority excluded male from the eligible subject scope. The number of young patients with cervical cancer is surging in Korea. Health Insurance Review and Assessment Service (HIRA) reported the number of patients with cervical cancer in 2015 was at 54,603. But the figure soared by 15% in 2019 with 63,051 patients. In the same span of time, the number of patients in 20s and 30s skyrocketed by 47 percent, whereas the number in 40s and 50s was increased by 7 percent. Gardasil9 covers the most number of HPV types, in which it added five more types of HPV (Type 31, 33, 45, 52, 58) from the original Gardasil (Type 6, 11, 16, 18). In Korea, the vaccine is used in female and male aged from nine to 26 to prevent HPV-related cervical cancer, vulva cancer, vaginal cancer and anal cancer. Also the effectiveness of preventing precancerous cervical changes, dysplasia and genital warts has been recognized as well. The indication to vaccinate people aged from 27 to 45 was approved in the U.S. two years ago. In a clinical study on 3,200 women aged from 27 to 45, Gardasil9 demonstrated 88 percent prevention effect in HPV-induced cervical cancer. The study also confirmed the vaccine’s effect on male vaccine recipients. The Korean market supplier of Gardasil9, MSD Korea, is currently in a joint sales and marketing partnership with GC Pharma over the vaccine. The two companies have been in a close partnership since 2013 when they inked the shingles vaccine Zostavax co-sales deal.
- Policy
- NHIS expects avg 322 generic pricing negotiations per month
- by Lee, Hye-Kyung Jul 13, 2020 06:12am
- Korea’s National Health Insurance Service (NHIS) is to start negotiating with generics over healthcare reimbursement contracts from the second half of the year. At a press conference convened on July 7, NHIS Reimbursement Executive Director Kang Chung-hee stated, “For the pricing negotiation on generics to be conducted from August to September, the Drug Pricing System Improvement Division previously operated under one team of six staffs in one division would be expanded to two teams of nine staffs in one division.” According to the deliberations done by Health Insurance Policy Deliberation Committee (HIPDC) from last year January to last March, average 322 generic items would be negotiated for pricing every month. When NHIS initiates pricing negotiation with generic, pharmaceutical companies would have a preliminary consultation with NHIS regarding negotiation and contract compliance as they submit an application for reimbursement listing to Health Insurance Review and Assessment Service (HIRA). After HIRA calculates drug pricing, the pursuing company should engage in a pricing negotiation with NHIS for 60 days and a deliberation by HIPDC before the final announcement of listing and pricing is made. Director Kang said, “The negotiation process would be streamlined through preliminary consultation with pharmaceutical companies,” and “the contract would become the focal point of the generic supply and quality management.” For the process, NHIS held a meeting on July 8 with Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), Korea Biomedicine Industry Association (KoBIA) and Korean Research-based Pharmaceutical Industry Association (KRPIA). At the meeting, NHIS explained about detailed guidelines of revised ‘Regulations on National Health Insurance Reimbursement Criteria’ and ‘Pharmaceutical Decision and Adjustment Standards,’ which mandate a 60-day drug pricing negotiation on generics listed through authorized pricing calculation, instead of pricing negotiation. Answering the industry representatives’ concern on the pricing negotiation delaying the listing process, Director Kang said, “The Ministry of Health and Welfare would decide on the detailed guideline,” and “the delay would be minimized by conducting a preliminary consultation first.”
- Policy
- Clarifying the conditional approval target
- by Lee, Tak-Sun Jul 13, 2020 06:12am
- Chief Ho-sang Jeong (left) & team leader Jeong-won Oh (right), who conducted briefings with the reporters on the 7thThe MFDS strictly enforces the Advanced Bio Act (the Act on the “Safety and Support of Advanced Regenerative Medical and Advanced Biopharmaceuticals”), and said that concerns about safety are only a concern. However, the conditional approvals subject to the enacted legislation will maintain the previous conditions. Ho-sang Jeong, chief of the Cell Gene Therapy Products Division, and Jung-won Oh, leader of the permission team of the MFDS, who is in charge of the screening and licensing parts of the cell and gene therapy products, said in a press briefing on the 7th. On August 28, the MFDS issued an administrative notice by setting up 'Regulations for Permit and Examination of Items for Advanced Biologics' prior to the implementation of the Advanced Bio Act. Accordingly, advanced biopharmaceuticals such as cell therapies and gene therapies that have been applied to the existing the pharmaceutical affairs law will be subject to the new regulations within the framework of the new law. Although the number of licensed items for cell and gene therapies in Korea is small, it is a new kind of treatment, and there are many items developed by listed ventures, which is of interest. In addition, the necessity for strengthening the permit screening is being raised through the case of Invossa, a gene therapy product that has been canceled. Some are also raising concerns about whether drugs subject to expedited review or drugs subject to conditional approval, such as exemption of a phase III, will be screened with neglecting safety. In response, the MFDS explained that safety measures were faithfully reflected in the law to prevent safety problems. For example, a follow-up management system, such as a long-term follow-up survey, was established. ""In fact, even before the law was enforced in August, the screening system for cell and gene therapies was prepared similarly to the standards of developed countries," said Ho-sang Jeong. He said, "The Advanced Bio Act supports high-tech biopharmaceuticals while strengthening safety at the same time, and the rapid review regulations that existed at the public notice level have been enacted, so that the drugs subject to rapid review can be approved within a short period of time." In the meantime, "the criteria for rapid review or conditionally approved products have been clarified, so that there are no concerns about safety due to the misuse of conditionally licensed medicines at some point." He added, "The management became tighter while clarifying the measures for under-conditional items." The MFDS is also considering the input of screening personnel tailored to this. The conditional approval was mainly a system to conditionally phase III clinically and approve items in phase II completion. It was possible because there were no existing treatments, significant life-threatening diseases, or endpoints that could predict clinical benefit. However, these conditions were abstract, and there were few cases where conditionally approved drugs were actually used in patients. The MFDS recognized this problem and explained that the Advanced Bio Act clarified the requirements for conditional approval or expedited examination. Accordingly, it is expected that there will be fewer cases of disagreement over the conditional approvals with companies. The MFDS recently filed a lawsuit against Pharmicell for a conditional license for 'Cellgram-LC' and lost it. However, it is the policy that the conditional permits and pre-licensed items will maintain the previous conditions. The Advanced Bio Act states that licensed items must be re-applied within one year after promulgation. Accordingly, 16 items of cell therapy products must be re-applied. Some of these items are licensed under the condition of phase III. "The three items are conditionally approved under the premise of phase III clinical trials, and the items under phase III clinical trials are planned to maintain the existing license conditions until the re-application is made," said Jeong-won Oh. "On the 3rd, the information submitted to companies with re-permitted items was guided. Basically, safety and effectiveness data have similar requirements according to the pharmaceutical affairs law. They have to submit the data in CTD version," he explained.
- Policy
- Mixed responses on exempting PE for antibiotics
- by Eo, Yun-Ho Jul 10, 2020 06:14am
- The people are voicing both positive and negative reactions on the pharmacoeconomic evaluation (PE) exemption track opened to antibiotics. Considering the unique characteristic of the drug, expanding the coverage on antibiotics with the difficulty of conducting PE is an improvement. But there is a dispute brewing on the definition of antibiotics. In March, Korea’s Ministry of Health and Welfare (MOHW) and Health Insurance Review and Assessment Service (HIRA) preannounced the revised regulation of pharmaceutical healthcare reimbursement subject evaluation criteria and procedure, and started accepting relevant public opinion. The noticeable changes in the regulation related to PE exemption track is expanding the subject scope, currently limited to rare disease only, to include tuberculosis treatment, antibiotics, and emergency antidotes essential to promote public health. ◆A definition of antibiotics could cause confusion The controversial issue is in the definition of ‘antibiotics,’ which could get limited to ‘antibacterial.’ Apparently, the government has expressed intention to positively review the issue as raised by Korean Research-based Pharmaceutical Industry Association (KRPIA). As a medical term, antibiotics means ‘antimicrobial medicine’ functioning as ‘antibacterial (treating bacterial infection),’ ‘antifungal (treating fungal infection),’ and ‘antiviral (treating viral infection).’ And constant rise of antimicrobial resistance (AMR) has been addressed as the most alarming public health issue around the world. Usually, many people interchangeably use the term antibiotics as antibacterial or antimicrobial. But medically speaking, drugs used to impede growth of microbe, like bacteria, fungus and virus, are categorized as antimicrobial medicines. President Choi Jung Hyun (Infectious Disease Division of the Catholic University of Korea Eunpyeong St. Mary’s Hospital) of Korean Society for Antimicrobial Therapy (KSAT) said, “As PEs were conducted without full understanding of newly developed antibiotic and antifungal drugs targeting antibiotic-resistant bacteria, which cannot be treated with other existing options, the drugs were impossible to enter the Korean market. The sources of infectious diseases like bacteria, fungus and virus should be handled by taking in account of possible development of AMR during treatment. ◆The background of introducing PE exemption track on antibiotics The objective of revising the regulation is to revisit some of criteria in PE exemption track to include drugs, challenged to produce PE results but essential to public health improvement. The clinical trial on antibiotics tests non-inferiority against a reference drug. As antibiotics have to treat infectious disease, it is unethical to confirm superiority or to use a drug with developed AMR and diminished treatment effect as a reference drug to confirm superiority. Under such circumstances, PE has been pointed out as the cause of delay in listing antibiotics regardless of the high medical needs. The industry highly anticipates the revised PE exemption benefit would contribute in promptly and reliably supplying new antibiotic and antifungal drugs to Korean market. The U.S. Food and Drug Administration and the European Medicines Agency (EMA) also approve new antibacterial and antifungal drugs based on non-inferiority clinical trial results. President Choi stressed, “We would like to express our appreciation for the government’s effort to secure infectious disease treatment crucial in responding against severe infection seriously threatening the public health. The regulation revision would provide the foundation to have stable access to antibiotic and antifungal drugs to treat antibiotic-resistant bacteria. It would also be a great help for developing the antimicrobial stewardship and resistant bacteria practice guideline the academic society is leading.” Introduced in 2015, the PE exemption track, also known as ‘special PE benefit,’ excludes rare disease treatment or anticancer treatment from the PE data submission requirement, a part of pharmaceutical reimbursement review process. The drugs listed with PE exemption track are applied with expenditure cap type risk sharing agreement (RSA). However, the public has been constantly demanding for the PE exemption subject to expand as drug other than anticancer or rare disease treatment struggling to prove the cost-effectiveness. This marks the first revision made since the system was established in 2015.
- Policy
- Dongkuk's DKF-313 entered clinical trial phase III
- by Lee, Tak-Sun Jul 10, 2020 06:13am
- The prostate hyperplasia complex developed by DongKook Pharmaceutical enters Phase III clinical trials. YuYu Pharma is also developing the same prostate hyperplasia complex, which attracts interest in the competition between the two companies. On the 9th, the MFDS approved the clinical trial phase III trial (IND) for 'DKF-313', which DongKook Pharmaceutical applied for. DKF-313 is known as a combination of Dutasteride and Tadalafil currently used in prostatic hyperplasia. This trial is a multicentre, randomized, double-blind, double placebo, parallel group, phase III clinical trial to evaluate the efficacy and safety of DKF-313 in 654 patients with benign prostatic hyperplasia. The test will be conducted at Asan Medical Center. Dutasteride-Tadalafil combinations are currently not commercially available. It will be the first in the world If developed. YuYu Pharma was approved for a phase III clinical trial plan for 'YY-201,' a candidate for the same ingredient in March 2018. Therefore, it is noted who will succeed in commercialization first. The size of the domestic prostate hyperplasia treatment market is about ₩200 billion , and the original drugs of foreign pharmaceutical companies occupy most of the market share. Representative drugs include Harnal (Tamsulosin HCl, Astellas Korea), Avodart (Dutasteride, GSK), and Proscar (Finasteride, MSD). Tadalafil (Cialis, Lilly) is more famous for erectile dysfunction, but is also used for benign prostatic hyperplasia in low doses. For reference, Dutasteride is effective for prostate hyperplasia as well as hair loss. Therefore, if a combination drug is developed, it is expected that it will be spotlighted in patients with erectile dysfunction and hair loss accompanied by prostate hyperplasia. It seems to be the key to commercialization whether it is possible to increase the solubility of the two components in a single formulation in view of the fact that Dutasteride is a poorly soluble drug that is insoluble in water.
