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- 2026-04-12 05:55:21
- Company
- 2nd P-CAB Fexclu to be released into the 800 bil market
- by Chon, Seung-Hyun Jun 30, 2022 05:52am
- Daewoong Pharmaceutical’s new drug, ‘Fexclu’ will be released next month. The industry’s eyes are on whether the drug will raise a storm in the PPI class and P-CAB class antiulcer medication prescription market that is estimated to be worth over ₩800 billion. The industry is also eyeing competition between Fexclu and K-CAB abroad. ◆Fexclu to be applied reimbursement from next month… prepares to target the ₩800 billion PPI·P-CAB market According to industry sources on the 29th, Daewoong Pharmaceutical’s Fexclu will be listed for NHI reimbursement starting next month. With the reimbursement approval, the drug will be released in the market 6 months after it received approval on December 30th. Fexclu’s insurance price cap was set at ₩939, which is 27.8% cheaper than its same-class drug K-CAB (₩1,300) Fexclu is a P-CAB class drug that treats gastroesophageal reflux disease (GERD). The drug was approved for the indication of treating erosive gastroesophageal reflux disease (GERD). P-CAB class antiulcer drugs competitively bind to the proton pump and potassium ion located in the final stage of acid secretion from the stomach wall to inhibit gastric acid secretion. This class of drugs has quickly settled in the market since HK inno.N introduced its first P-CAB type of new drug ‘K-CAB’ in 2018. Fexclu will be mainly targeting the PPI class and P-CAB class antiulcer drug market, which raised ₩842.1 billion in prescriptions last year. The PPI class market made ₩732.5 billion and the P-CAB class market ₩109.6 billion last year. The industry sees a high possibility of Fexclu’s success in the market. K-CAB had already demonstrated the marketability of P-CAB class anticancer drugs during the past 3 years. According to UBIST, K-CAB had raised ₩109.6 billion in outpatient prescriptions 3 years into its release last year, which is the first time a single brand of a homegrown novel drug had made annual prescriptions exceeding ₩100 billion. K-CAB had created a sensation selling ₩30.9 billion in the first year of its release and has continued its rapid growth in 2020 and last year. K-CAB’s sales continued to grow due to its advantages - having a faster onset of action than PPIs, is allowed to be taken regardless of meal ingestion, demonstrating superior symptom improvement, and showing longer-lasting night-time gastric acid suppression. With HCPs and patients in the field already showing high satisfaction with P-CAB class antiulcer medications using K-CAB, Fexclu is expected to make a relatively easier way into the market. Also, Fexclu’s insurance cap, which was set 30% lower than that of K-CAB may act as an advantage in the prescription market. However, K-CAB owns a total of 4 indications, rendering it difficult for Fesclu to completely replace K-CAB in the market. In addition to the treatment for erosive and non-erosive GERD, K-CAB sequentially secured additional indications as a combination therapy with an antibiotic for Helicobacter pylori eradication in patients with peptic ulcer or chronic atrophic gastritis. Among the indications, insurance reimbursement is applied to K-CAB for the treatment of GERD and stomach ulcers. Fexclu will also be targeting PPI-class drugs that account for the largest amount of the antiulcer drug market, as a significant amount of K-CAB prescriptions arise from patients who have switched to K-CAB from PPIs. Last year, the amount of outpatient prescriptions for PPI class drugs recorded ₩732.5 billion. This is a twofold increase in 5 years from the ₩372.4 billion in 2016 and is continuing to record high growth. ◆Fexclu·K-CAB accelerates entry to overseas market… competition in overseas performance of the two drugs also a point of interest The overseas market competition between Fexclu and K-CAB is also a point of interest. Daewoong Pharmaceuticals had signed 6 export agreements with 15 countries in North America, Latin America, China, Middle East to export Fexclu. In 2020, the company signed a contract with the Mexican pharmaceutical company Moksha8 and Brazil's EMS for the local marketing and sales rights of Fexclu and paved the way for Fexclu’s entry into Central and South America. In March last year, the company signed a $384.5 billion contract with China's Shanghai Haini Pharmaceutical. Status of Fexclu export agreements (Source: Daewoong Pharmaceutical)) In June last year, the company made a technology transfer agreement with U.S. company Neurogastrx and handed over the development, authorization, and sales rights of Fexclu in the US and Canada. Through the agreement, Daewoong Pharmaceutical secured a 5% stake in Neurogastrx as an upfront, non-refundable fee, and was assured up to $430 million in development, regulatory, and sales milestone payments. It then signed 2 additional export contracts to enter 10 countries in Central and South America and the Middle East. In total, Daewoong secured up to ₩1.2 trillion through export agreements for Fexclu. K-CAB has entered the market of a total of 34 countries through technology or finished product exports. HK Inno.N had first signed a technology export agreement with the Chinese company Shandong Luoxin Pharmaceutical in 2015. The deal was to receive $18.5 million in upfront payments and clinical development, regulatory, and sales milestone payments. The company estimated that the agreement amount would rise to $95.29 million with royalties incurred after the local commercialization of K-CAB. Also, HK InnoN signed an export agreement for the finished K-CAB product with the Mexican pharmaceutical company Laboratorios Carnot in February 2019 to export K-CAB to 17 countries in Central and South America. Its export amount, including supply price, has amounted to $84 million over the past decade. Exports agreements have been more actively made after K-CAB was released in Korea. In September 2019, contracts were signed to supply the finished drugs to Indonesia, Thailand, and the Philippines, and in 2020, export agreements were made to export K-CAB to Mongolia and Singapore. Last year, the company also signed export contracts with companies in Vietnam, Malaysia, the US, and Canada.
- Policy
- SK Bioscience gets final approval for SKYCovione
- by Lee, Hye-Kyung Jun 30, 2022 05:52am
- Permission for the item COVID-19 Vaccine No. 1 developed and manufactured in Korea is imminent. As a result of discussing SKYCovione's safety and effectiveness, the Central Pharmaceutical Review Committee said that it was recognized for the purpose of preventing COVID-19 based on the immunogenic clinical results compared to Vaxzevria, which was already approved, and that the item could be approved. The MFDS (Director Oh Yoo-kyung) explained the progress of item approval for the COVID-19 vaccine SKYCovione (GBP510) developed and manufactured by SK Bioscience in Korea at 10 a.m. on the 27th. SK Bioscience applied for a preliminary review of quality data on April 15, and an application for item permission was received on April 29. A meeting of the Central Pharmaceutical Affairs Review Committee was held at 4 p.m. on the 26th to advise on the safety and effectiveness of SKYCovione. Based on the submitted data such as clinical trial data for SKYCovione, the committee acknowledged the safety and effectiveness of the drug and discussed whether the item permission was appropriate. In particular, experts' comprehensive opinions were exchanged on overall permits, such as overall views on the effectiveness and safety of vaccines and measures to secure safety after approval. As a result of discussing whether SKYCovione's safety and effectiveness were recognized, safety such as abnormal cases that occurred in clinical trials was judged to be acceptable. However, there was an opinion that the predicted adverse reactions in the local and systemic areas were more likely to be caused by vaccinations such as fatigue, muscle pain, headache, chills, fever, joint pain, nausea, vomiting, and diarrhea in adults younger than the first dose. Unforeseen adverse events related to vaccine administration (4 weeks after administration) occurred in about 13.3% (402/3029 patients) of the vaccine group, the main symptoms were injection site hyperplasia, dizziness, pain, etc., and the control group was about 14.6% (145/996). The serious abnormalities were similar to 0.5% (15 cases, 15 cases) in the vaccine group and 0.5% (5 cases, 9 cases) in the control group, and there was 1 rapid progressive glomerulonephritis, which cannot be excluded from vaccine administration, but it was recovering at the time of submission of clinical trial data. In the immunogenicity results comparing already approved Vaxzevria with a control vaccine, neutralization antibodies formed 2.93 times after 14 days of administration every four weeks over the age of 18, and serum conversion rate was 98.06% in the vaccine group and 87.30% in the control group. It was suggested that the overall safety security plan is appropriate, and it is reasonable to observe and evaluate abnormal cases of special interest similar to existing vaccines as a risk management plan after approval. The Ministry of Food and Drug Safety said, "When compiling the opinions of the committee, it was agreed that SKYCovione could be approved." The MFDS received advice from the COVID-19 treatment, vaccine safety, and effectiveness verification advisory group on June 21 to enhance the expertise and objectivity of the COVID-19 vaccine licensing review process. The effectiveness for permission is recognizable, and safety during clinical trials is acceptable, and abnormal cases of special interest should be observed and information should be collected after permission. The MFDS will review SKYCovione's submission data, comprehensively judge expert opinions, efficacy, effectiveness, dosage, and recommendations obtained from the advice of the COVID-19 vaccine safety and effectiveness committee, and hold a final inspection committee to make a final decision.
- Opinion
- [Reporter's view] Negotiation of Zolgensma
- by Jun 30, 2022 05:52am
- Attention is focused on negotiating the drug price of Zolgensma, a one-shot treatment and the most expensive drug in Korea. Conflicts are in full swing between the government to set the lowest price and pharmaceutical companies to be recognized as much as possible for new drugs. Zolgensma is a gene therapy approved in May last year. It is used for a severe and rare disease called SMA. This disease is causing muscles to gradually shrink. Based on the most serious type of SMN type 1, motor neurons are damaged more than 95% within six months of microtreatment, and 90% die before the age of two. Prior to Zolgensma, there were treatments for spinal muscular atrophy such as Spinraza and Evrysdi, but Zolgensma is special for patients. This is because unlike other treatments that require continuous medication, Zolgensma can fundamentally treat the disease with one dose. While existing treatments are involved in backup genes to increase SMN protein production, Zolgensma functionally replaces the deficient SMN1 gene so that protein can continue to be produced in one shot. The issue is the price of medicine. In the United States, the cost of administering Zolgensma amounts to about 2.5 billion won. Even in countries with low prices of Zolgensma, it is generally about1.9 billion won. There have been several drugs worth hundreds of millions of won so far, but Zolgensma is the first drug to exceed 2 billion won. Since Zolgensma is a single administration, the overall cost may be similar to other drugs that are multiple administrations. As ultra-high-priced drugs that need to be administered multiple times will continue to appear, it was time for the government to consider a new drug price model to be applied to ultra-high-priced drugs. As various discussions continued, Zolgensma was submitted to the HIRA about a year after applying for benefits through the patent linkage system and was recognized for its appropriateness. Earlier this month, it entered the drug price negotiation stage. The NHIS and Novartis Korea will hold two months of Zolgensma price negotiations until the 25th of next month. The government wants to set the price at the lowest level among major OECD countries. The standard that the government has in mind is known to be lower than 1.9 billion won in Japan. Pharmaceutical companies want to be recognized for the value of new drugs as much as possible. If negotiations are slow, it is the patients who are frustrated. Earlier this year, parents of SMA patients delivered their opinions to the National Assembly calling for Zolgensma. A parent who attended the meeting said, "My child has no muscles all over his body and can't eat anything with his mouth, so he lives on an oxygen respirator. Getting Zolgensma is only a hope. The longer the discussion, the more my child misses the golden time," he appealed. There are some people anxiously waiting for Zolgensma, which can be expected to be cured once administered. I hope that the two sides will not take the drug price negotiation extension for granted by only putting forward each other's positions, but will be determined to complete the negotiations within the deadline from the patient's point of view. After all, doesn't both the system and the new drug exist for patients?
- Company
- Opdivo reattempts reimb in first-line gastric cancer
- by Eo, Yun-Ho Jun 29, 2022 05:54am
- The cancer immunotherapy drug Opdivo is reattempting reimbursement as a first-line treatment once more. According to industry sources, Ono Pharma Korea and BMS Korea’s PD-1 inhibiting cancer immunotherapy Opdivo (nivolumab) will be deliberated by the Cancer Disease Deliberation Committee (CDDC) of the Health Insurance Review and Assessment Service on the 28th. In Korea, Opdivo was approved ‘as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma’ in June last year. With the added indication, the drug became the first and only domestically approved cancer immunotherapy for the first-line treatment of gastric cancer. Also, Opdivo’s unresectable malignant pleural mesothelioma indication will also be deliberated at the CDDC meeting. More specifically, Opdivo’s indications as ▲ first-line treatment of advanced or metastatic gastric adenocarcinoma, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with chemotherapy, and ▲ in combination with ‘Yervoy’ in unresectable malignant pleural mesothelioma will be deliberated at the CDDC meeting. In the CDDC meeting that was previously held in February, the committee decided not to set reimbursement standards for both indications. Therefore, whether Opdivo’s second attempt at reimbursement in gastric cancer will bear fruit remains to be seen. Gastric cancer is considered to be the field in most urgent need of extended reimbursement to immunotherapy drugs after lung cancer. As the most prevalent cancer and the fourth most common cause of cancer deaths in Korea, gastric cancer has a favorable survival rate when detected in its early stages but its relative survival rate drops to 5.9% with distant metastasis. In particular, the current stand of care for HER2-negative gastric cancer is chemotherapy due to the unavailability of new drugs approved for first-line treatment for the past decade. Opdivo has received attention as a viable alternative for these patients. Meanwhile, Opdivo’s efficacy in lung cancer was confirmed through the large-scale Phase III CheckMate-649 trial. The median overall survival (mOS) of patients was 13.8 months for all patients randomly assigned to receive Opdivo compared to the 11.6 months in the control group. In PD-L1 positive patients (CPS ≥ 5), the Opdivo combination group’s mOS was 14.4 months, which was a 29% reduction in risk compared to the 11.1 months of the control group. Also, Opdivo improved the overall response rate (ORR) by 12% in the all-randomized population, and by 15% in PD-L1 positive patients (CPS ≥ 5). The complete response (CR) rate was also higher for the Opdivo combination group in both the all-randomized population and PD-L1 positive patients.
- Policy
- ↑The cost of drugs for severe dz by ₩1.79 trillion
- by Lee, Tak-Sun Jun 29, 2022 05:53am
- The proportion of drug costs for four major serious diseases such as cancer and rare diseases is increasing significantly every year. Another reason is the increasing number of expensive new drugs that are listed. As the proportion of drug costs for these four major serious diseases increases, the need for efficient financial management measures is also expected to increase. According to the "2021 reimbursed drug claim status" published by the HIRA on the 27th, the cost of drugs for the four major diseases was 5.6 trillion won last year, accounting for 26.4% of the total drug cost of 21.2097 trillion won. The four major serious diseases refer to cancer, cerebrovascular, heart, and rare and symptomatic incurable diseases. Among them, most of them are cancer and drugs for rare and symptomatic incurable diseases. The cost of drugs for the four major serious diseases increased by 1.79 trillion won in four years from 3.8107 trillion won in 2017. The share of the total drug cost also increased significantly from 23.5% in 2017 to 26.4% in 2021. At this rate, it is expected to exceed 30% soon. Among the four major serious diseases, the proportion of cancer disease drug costs also increased from 12% in 2017 to 14.2% in 2021. In addition, the proportion of drugs for rare and symptomatic incurable diseases also increased from 10.8% to 11.6%. Analysts say that drug costs are also increasing as the health insurance coverage rate for the four major serious diseases is strengthened. However, analysts say that the pace of increase in drug costs will exceed expectations as new drugs targeting certain cancers or rare diseases are increasingly priced. Kymriah, which was recently registered, was listed for 3603 million won, Spinraza 92.35 million won, and Lutathera 22.1 million won. On top of that, the proportion of high-priced drugs for cancer and rare diseases is expected to increase as one-shot treatments worth more than 1 billion won, such as Zolgensma and Luxturna, are waiting for reimbursement one after another. Analysts say that the voluntary reduction in drug prices for MSD's diabetes drug Januvia as MSD Kymriah was listed as the primary drug for non-small cell lung cancer in February is also a case in point of view. The proportion of total drug costs in health insurance medical expenses has been stably managed. Last year, the proportion of drug costs was 24.06%, down from 25.09% in 2017.
- Policy
- Fexclu reimb at ₩939, Kadcyla reimb extended from July
- by Kim, Jung-Ju Jun 29, 2022 05:53am
- Four items including Daewoong Pharmaceutical’s Fexclu Tab (fexuprazan hydrochloride) will be listed at ₩939 per tablet starting next month as latecomers of the homegrown novel drug K-CAB indicated to treat erosive gastroesophageal reflux disease (GERD). Also, reimbursement of Kadcyla (trastuzumab emtansine), Roche Korea’s second-line treatment for breast cancer, will be extended to cover its treatment as ‘adjuvant treatment of patients with early breast cancer after surgery’, and will accordingly receive a new drug price. The Ministry of Health and Welfare held the 14th Health Insurance Policy Deliberation Committee meeting (Chair: 2nd Vice Minister of Health and Welfare, Ki-Il Lee) today (28th) and announced that the listing and reimbursement extension proposals for 2 new drugs and 1 previously listed drug have been passed after deliberation at the HIPDC meeting. The listing of 4 latecomer fexuprazan hydrochloride drugs including Fexclu Tab 40mg, and reimbursement extensions of two items - Kadcyla inj. 100mg and 160mg – passed deliberations and will be applied reimbursement starting July 1st. ◆4 items including Fexclu Tab. 40mg = Four fexuprazan hydrochloride latecomers used to treat erosive gastroesophageal reflux disease (GERD) will be concurrently listed for reimbursement. The 4 items are Daewoong Pharmaceutical’s Fexclu Tab, Hanall Biopharma’s Abcito Tab, Daewoong Bio’s We Cab Tab, and iN Therapeutics’ Veloxcab Tab. The companies had received marketing authorization from the Ministry of Food and Drug Safety for their respective drugs from December 30th last year to January 11th of this year and applied for reimbursement listing from December 27th last year to January 13th of this year. Upon receiving the reimbursement request, HIRA’s Drug Reimbursement Evaluation Committee reviewed the 4 drugs on the 12th of last month and passed the agenda on to the NHIS. During deliberations, DREC decided that the four drugs’ clinical benefit is non-inferior to K-CAB, and is adequate for reimbursement at ₩939, which is 90% of the weighted average of its alternatives. The NHIS then carried out negotiations on the expected claims amount of each item with the companies from May 25th to June 17th. The drug price has been set at ₩939 per each 40mg strength tablet. ◆ Kadcyla Inj 100mg and 160mg = Kadcyla Inj, Roche Korea’s treatment for locally advanced or metastatic breast cancer, had been listed for reimbursement since August 2017. This time, a reimbursement standard for Kadcyla to be administered ‘for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment’ will be added. The company had received additional approval for the above indication on August 8th, 2019 from the MFDS, and requested a reimbursement extension on the same day to HIRA. HIRA had deliberated on the agenda at the DREC meeting held on October 16th of the same year, on August 26th in 2020, and on February 10th. DREC had set the reimbursement standards for Kadcyla in consideration of the reimbursement evaluations made abroad and the additional fiscal sharing plan proposed by the company, after which the DREC members discussed whether the drug should submit pharmacoeconomic evaluation data and be evaluated for its cost-effectiveness. In the case of pharmacoeconomic evaluations, Kadcyla had significantly improved invasive disease-free survival compared to its alternative Herceptin (trastuzumab) and was required to demonstrate its cost-effectiveness. After PE evaluations, DREC decided that the drug’s ICER level was within an acceptable range and is therefore cost-effective. As a result, members at the DREC meeting passed Kadcyla in consideration of how its PE evaluation value was at an acceptable level compared with Herceptin and is listed for reimbursement in all A7 countries. The company thereafter agreed with the NHIS on applying the Utilization cap / Fixed cost per patient type of RSA for Kadcyla's reimbursement, under which the company is required to refund the excess amount used to the NHIS. The agreed price was set at ₩1,956,328 per vial for Kadcyla Inj 100mg, and at ₩2,930,920 for Kadcyla Inj 160mg.
- Company
- Celltrion Stops Developing Inhalation-type COVID Antibody Tx
- by Kim, Jin-Gu Jun 29, 2022 05:53am
- Celltrion announced on the 28th that it will suspend phase 3 clinical trials of inhalation-type antibody treatments that were being developed as COVID-19 treatments. Celltrion explained the reason for the clinical suspension that the business feasibility of the COVID-19 treatment will be insignificant due to the difficult global clinical environment. Celltrion judged that the business feasibility would be insignificant as the number of phase 3 clinical patients required by global regulators is larger than expected amid the rapid transition of coronavirus to endemic diseases due to the global spread of Omicron subvariations and expansion of vaccinations. According to Celltrion, global regulators are avoiding "fast-track" procedures such as emergency approval in line with full-fledged entry into Endemic. Regulatory agencies are reportedly increasing the threshold as several global pharmaceutical companies have recently failed to prove their effectiveness due to weakening pathology in clinical trials of COVID-19 treatments for standard risk groups, not high-risk groups. Celltrion has previously completed phase 1 clinical trial of inhalation-type antibody treatments and approved a global phase 3 clinical trial plan for inhalation-type cocktail COVID-19 treatments, which added CT-P63, a candidate substance for COVID-19 treatments. However, Celltrion plans to closely monitor the current status of the COVID-19 pandemic in the future and continue to manage and research on the pool of COVID-19-responding cocktail candidates that have been built since the beginning of the pandemic. It will continue to study the development platform of mRNA vaccines and oral COVID-19 treatments that can prepare for future pandemics. Celltrion is developing oral COVID-19 treatment products under generic licenses secured at the group level to expand access to treatments in low- and middle-income countries, and aims to supply them early next year. An official from Celltrion said, "Celltrion has actively contributed to overcoming the global pandemic by focusing on the development of antibody treatments for the first time in Korea and supplying them at home and abroad, but the clinical and licensing environment of COVID-19 treatments is changing." He added, "We will reorganize the direction of developing COVID-19 treatments by watching international environmental changes in the face of an endemic transition, and focus on developing various pipelines currently facing clinical and permission."
- Company
- Patent challenge for gastritis drug Rebamipide expanded
- by Kim, Jin-Gu Jun 29, 2022 05:53am
- 30 generic companies participated in the patent dispute for Yuhan's acute and chronic gastritis treatment "Recomid SR." According to the pharmaceutical industry on the 24th, 20 pharmaceutical companies, including Kyung Dong, recently requested a passive judgment on the scope of rights to Recomid SR's patent. Prior to them, 13 pharmaceutical companies, including Mother's, also challenged the same patent. However, Dongkwang, Samjin, and Huons, which previously requested a patent trial, voluntarily withdrew. As a result, a total of 30 companies are challenging Recomid SR patents. Mother's are the first companies to file a claim as well as Kyung Dong, Nexpharm, Daewoong Bio, Dahannupharm, Dongkook, Dongwha, Litepharmtech, Vivozon, Samil, SCD, Sinil, CMG, Arlico, Alvogen Korea, HLB, Aprgen, YS, Withus, Unimed, Reyonpharm, Ilhwa, Genuonesciences, Joonghun, GLPharma, Pharmgen Science, BNC Korea, Korea Pharma, Hutecs, and Hanlim. The reason why 30 generic companies challenged the patent is that Recomid SR grew rapidly in the pharmaceutical industry. The drug was jointly developed by Yuhan Corporation, GC Pharma, Daewoong Pharmaceutical, and Daewon Pharmaceutical. It received permission in December 2020 and released the product at the same time in March last year. Yuhan Corporation will entrust the production of the remaining three companies. Patents are also in Yuhan Corporation. Recomid SR is taken twice a day. According to the MFDS, the combined production performance of the four companies reached 15 billion won in the 10 months since its release in March last year. Sales of Yuhan's Recomid SR is 5.8 billion won, GC Pharma's Mucotect SR is 4 billion won, Daewon Pharmaceutical's Bidreba SR is 2.9 billion won, and Daewoongs Mucotra SR is 2.4 billion won. In contrast, the combined production performance of the four existing products was only 3.7 billion won. The original pharmaceutical company for Rebamipide is Otsuka. In 1991, Mucosta was granted permission. Production of tablets last year was 16.7 billion won. On top of that, Otsuka was approved for Mucosta SR in January last year and released the product a month later than Yuhan Corporation. SR Product's performance last year was 3.5 billion won.
- Policy
- Low strength Esomezole Plus Tab priced same as Eso Duo
- by Lee, Tak-Sun Jun 28, 2022 06:09am
- Hanmi Pharmaceutical has decided to set the ceiling price of its gastroesophageal reflux disease (GERD) treatment combo ‘Esomezole Plus (esomeprazole+ magnesium hydroxide)’ at the same level as Chong Kun Dang’s ‘Eso Duo (esomeprazole+sodium bicarbonate)’ to directly target Eso Duo in the market. Its lower strength formulation, in addition to its higher strength, is setting out to the market at the same price as Chong Kun Dang’s Eso Duo. According to the Ministry of Health and Welfare, Esomezole Plus 20/350mg Tab will be listed for insurance benefit at a ceiling price of ₩720 from the 1st of next month. This is the same price as Eso Duo 20/800mg Tab. Both products contain 20mg of esomeprazole. Hanmi Pharmaceutical had also listed Esomeprazole Plus 40/350mg Tab at the same price as Eso Duo 40/800mg Tab, at ₩920 in April this year. This is interpreted as a head-on challenge made by Hanmi against the current market-leading product, Eso Duo. Eso Duo, a combination of the PPI esomeprazole and an antacid ingredient, is the product that mainstreamed such combinations in the GERD treatment market. Esomeprazole, which is weak in stomach acid is complemented by an antacid to provide a quicker effect. The drug was released in 2018 and exceeded ₩10 billion in sales, the record set for blockbusters, in the year of its release. Last year, its outprescription sales amounted to ₩18.2 billion according to UBIST. In particular, its growth continued despite the release of dozens of Eso Duo generics last year. Although Hanmi has dominance over the GERD monotherapy market, it is a latecomer to the PPI+antacid combination market. Therefore, the company seems to be pushing to overthrow the current leader in the combination drug market, Eso Duo. Although 29 Eso Duo generics are currently listed in the market, no other drug has the same price set for their drugs higher and lower strength formulations as the original. In addition, Esomezole Plus contains a different antacid from Eso Duo. This means that Hanmi could have listed its drug for a higher price, in line with the highest price of esomeprazole, but had lowered its price to compete with the market leader Chong Kun Dang. Therefore, industry eyes are on who will seize victory among the two companies that have the best sales power in Korea. The pride is in line for the two companies, and whether Chong Kun Dang, the pioneer in the combination drug market will continue exerting its dominance in the market, or whether Hanmi, the sole leader of the monotherapy market will become a sensation in the combination drug market remains to be seen.
- Policy
- Phase 3 of Danicopan will be conducted in Korea
- by Lee, Hye-Kyung Jun 28, 2022 06:09am
- Phase 3 clinical trials of Danicopan (ALXN2040), which is called a competitive drug for rare drug Soliris, will be conducted in Korea. The MFDS recently approved a phase 3 clinical trial for patients with seizure night hemoglobinuria (PNH) who had previously been administered Danicopan in a clinical trial commissioned by IQVIA. This clinical trial is an additional therapy for C5i and is a long-term extension (LTE) test to characterize Danicopan's safety and effectiveness. It is conducted at Seoul St. Mary's Hospital, Sung Vincent Hospital, Severance Hospital, Chungnam National University Hospital, Seoul Asan Hospital, and Samsung Medical Center. Danicopan is a PO Factor D inhibitor as a candidate for complement-mediated rare disease treatment such as Paroxysmal nocturnal hemoglobinuria (PNH) and C3 glomerulopy (C3G). In a phase 2 clinical trial conducted in PNH patients, it was found that the average hemoglobin level was increased in combination with the monoclonal antibody drug Soliris binding to C5 complement protein, reducing the need for blood transfusion. Danicopan was designated as an innovative treatment by the US FDA in September 2019 after being designated by the US FDA as a rare drug for the treatment of paroxysmal night hemoglobinuria in 2017. Danicopan is a drug that is being developed for use with C5 protein monoclonal antibodies to treat paroxysmal night hemoglobinuria (PNH), which only exhibited sub-optimal responses when treated using only C5 protein inhibitors. The FDA decided to designate innovative treatments based on positive efficacy and safety data derived from phase 2 clinical PNH combined test of Danicopan.
