- LOGIN
- MemberShip
- 2026-04-10 23:49:13
- Company
- HK inno.N introduces biosimilar for Prolia & Xgeva
- by Lee, Seok-Jun Jan 27, 2023 05:51am
- HK inno.N announced on the 25th that it has signed an exclusive license contract for Denosumab biosimilar, a treatment for preventing osteoporosis and cancer-related skeletal complications in Mabxience, Spain. HK inno.N will receive an exclusive supply of two Denosumab biosimilars from Mabxience to apply for and sell domestic licenses. Denosumab is an antibody treatment that targets the RANKL protein, which is key to the survival and function of osteoblasts and exhibits a strong bone absorption inhibitory effect. The original is Prolia60mg, a cancer osteoporosis treatment, and Xgeva 120mg, which is used to prevent skeletal complications in patients with metastatic cancer and treat osteoporosis. Both products were released in Korea in 2016. Based on IQVIA, it recorded a total of 120 billion won in sales from October 2021 to September 2022 and is about to expire in 2025. HK inno.N aims to obtain a domestic license for Denosumab biosimilar in 2025, the expiration date of the original patent. Mabxience, which signed a contract with HK Innoen, was acquired by Fresenius Kabi in Germany last year as a company specializing in the development, production, and commercialization of biopharmaceuticals based in Spain. Mabxience is currently undergoing an original equivalence confirmation clinical trial with a Denosumab biosimilar.
- Policy
- Negotiating Erleada's price with the NHIS
- by Lee, Tak-Sun Jan 27, 2023 05:51am
- It has been confirmed that Erleada, Janssen Korea's prostate cancer treatment, is negotiating drug prices with the NHIS. This drug was conditionally passed at the deliberation of the HIRA Drug Benefit Evaluation Committee in December last year. According to industries on the 25th, it is negotiating Erleada's price with the NHIS. Erleada was passed at the 12th meeting of the Drug Benefit Evaluation Committee held in December last year on the condition that if the conditions for presenting the drug evaluation committee were accepted, it would be appropriate for benefit. The move to the stage of drug price negotiations is interpreted as meaning that Janssen Korea accepted the amount suggested by the Pharmaceutical Affairs Evaluation Committee. This drug is a hormone-responsive metastatic prostate cancer treatment and was approved in 2020. The efficacy and effect were approved as a combination therapy with androgen-blocking therapy, a treatment for hormonal-responsive metastatic prostate cancer patients. Phase 3 clinical trials (TITAN study) showed that the risk of imaging progression was reduced by 52% compared to the placebo group when frozen in patients with metastatic castration-sensitive prostate cancer, and the risk of death was reduced by 33% compared to the placebo group. At the time of approval by the U.S. FDA in February 2018, Janssen explained that Erleada would be an alternative option to delay metastasis when treating prostate cancer. Erleada is expected to be the next-generation treatment that connects Zytiga of Janssen and Xtandi of Astellas. If a smooth agreement is reached in the drug price negotiation with the NHIS, it will be applied after reporting to the Health Insurance Policy Review Committee of the Ministry of Health and Welfare. In the case of hormone-responsive metastatic prostate cancer, delaying metastasis is an important treatment goal, so if Erleada succeeds in entering the benefits range, the treatment effect will increase and the cost burden on patients will be greatly reduced.
- Company
- Flu activity rises...revives Tamiflu market
- by Jan 27, 2023 05:51am
- The influenza treatment market, which had virtually disappeared after the spread of COVID-19, has revived for the first time in 3 years. With the number of flu patients surging due to the flu epidemic, the number of quarterly prescriptions soared from less than KRW 100 million to KRW 10 billion. According to the market research institution UBIST on the 26th, outpatient prescriptions of oseltamivir in A4 last year had recorded KRW 10 billion. Oseltamivir is the most commonly used substance to treat influenza, and the original product is Roche's 'Tamiflu'. This is the first time since Q4 2018 that quarterly prescriptions of the substance recorded KRW 10 billion. By product, Roche Korea’s ‘Tamiflu’ occupied over half of the market, recording KRW 6 billion in sales. Hanmi Pharmaceutical’s ‘Hanmiflu’ followed, raising KRW 1.7 billion in sales. The flu treatment market had been dissolved after the spread of COVID-19 in 2020. With the breakout of the pandemic, personal hygiene management such as social distancing, the mandatory wearing of masks, and hand washing have been strengthened, resulting in a significant decrease in the incidence of infectious diseases, including the flu. The market, which raised prescriptions of KRW 7.8 billion in Q4 2019 and KRW 8.7 billion in Q1 2020, plunged 99.7% YoY to KRW 27 million in Q4 of 2020 after Corona 19 became prevalent. Since then, the market recorded less than KRW 100 million won in quarterly prescriptions for 9 consecutive quarters and then showed signs of a rebound in Q3 last year. The first flu epidemic warning in 12 years since 2010 was issued in Q3 last year. The Korea Disease Control and Prevention Agency issued a flu epidemic warning earlier than in previous years with the fraction of flu-like patients (patients with suspected flu symptoms) meeting the epidemic standards of 5.1 per 1,000 people from September 4 to 10 last year. Data: KDCA Weekly Report on Infectious Disease Sample Surveillance The number of flu patients really started to surge rapidly in the winter. The fraction of suspected patients, which was 13.2 in the 46th week of last year (November 6-12), increased by 130% to 30.3 a month later. In the 53rd week, the last week of last year, the fraction peaked to 60.7. This was a higher rate than that in the 2019-2020 season. Due to the surge in the number of patients and the limited quantity of treatments, a treatment shortage issue had also risen last year. In addition to the original oseltamivir, many generic versions have been approved for manufacture, but their manufacture was limited. Even before COVID-19, the majority of drugs other than Hanmi Pharmaceutical’s ‘Hanmiflu’, Yuhan Corp’s ‘Yuhan N Flu’, Kolon Pharmaceutical’s ‘Comyflu,’ and Vivozon Pharm’s ‘Seltaflu Flu,’ etc sold less than KRW 100 million per quarter. Also, many products withdrew their licenses in the aftermath of COVID-19. According to the Ministry of Food and Drug Safety, licenses of ▲Dong-A ST’s ‘Newraflu,’ ▲Ahngook New Pharm’s ‘New Flu,’ ▲Dongkoo Bio Pharm’s ‘Dongkoo Oseltamivir,’ ▲Samsung Pharm’s ‘Samsung Oselta,’ ▲Dae Han New Pharm’s ‘Enphiflu Cap,’ ▲Seoul Pharma’s ‘ OD Flu,’ ▲Yuyu Pharm’s ‘Yuyu Tami,’ ▲Inist ST’s ‘Inist ST Oseltamivir,’ ▲CTC Bio’s ‘Easy Flu Cap,’ ▲Genu Pharma’s ‘Genupharma Tamiro,’ ▲Kolon Pharmaceutical’s ‘Comiflu Suspension Powder,’ ▲GC Corp’s ‘Taminewra,’ ▲Hawon Pharm’s ‘Tami-One,’ ▲Roche Korea’s ‘Tamiflu Suspension Powder,’ ▲Aprogen Biologics ‘Tamflu,’ ▲Kwang-dong Pharm’s ‘Phenflu,’ ▲HK Inno,N’s ‘Flucle Cap,’ ▲Han Lim Pharm’s ‘Hanlim Oseltamivir,’ ▲ Hanmi Pharmaceutical’s ‘Hanmi Flu-S’ had automatically expired or voluntarily withdrawn during the COVID-19 pandemic. With many of the approved drugs not in circulation in the market, a shortage of flu treatments had risen last month. To address the shortage, the KDCA supplied 780,000 courses of flu treatments from the government stockpile to the market on the 9th. With the flu epidemic subsiding this year, the number of prescriptions is also expected to decrease slightly. According to KDCA, the fraction of suspected patients in the second week of January (8th to 14th) was 40.2, a 12.3 (23.4%) person decrease from 52.5 in the previous week.
- Policy
- The copyrights of Valcyte, Alvesco, & Bonviva changed
- by Lee, Tak-Sun Jan 27, 2023 05:50am
- As the domestic owners of major drugs such as Valcyte, Alvesco, and Bonviva changed, they were newly reflected in the salary list. All three items were previously copyrighted by the Korean branch of a global pharmaceutical company, but now domestic pharmaceutical companies are the owners. In the case of Valcyte 440mg, pharmaceutical companies will be changed from February 1st from Roche Korea to Chong Kun Dang. The transfer of permission rights has already been completed. The drug is used to treat CMV retinitis in adult AIDS patients. Roche has been copyrighted and sold in Korea in cooperation with Chong Kun Dang, but Chong Kun Dang will sell exclusively in the future. The global copyright of the drug has already been transferred from Roche to Cheplapharm. Chong Kun Dang acquired exclusive sales rights for Valcyte in Korea through a contract with Cheplapharm in March last year. The two asthma treatment Alvesco inhalants will also be changed from AstraZeneca Korea to SK Chemicals in February. As global copyrights moved, domestic copyrights were finally transferred to SK Chemicals. Along with this drug, SK Chemicals also acquired the domestic copyright of AstraZeneca's Omnaris nasal spray. Bonviva is changed from Handok to Jeil. Cheil Pharmaceutical announced last month that it will exclusively supply osteoporosis treatments Bonviva and Bonviva Plus in Korea. Bonviva was originally copyrighted by Roche Korea but later passed to Jeil via Handok. Currently, global copyright is held by the British pharmaceutical company Pharmanovia. Jeil signed an exclusive domestic sales contract for Pharmania and Bonviva, and began sales and marketing activities for hospitals and clinics. Only Bonviva pharmaceutical companies will be replaced in February, but Bonviva is also expected to revise its salary list soon as the license has been transferred to Jeil. Bonviva Plus is licensed by Alvogen Korea, which developed the drug, and Jeil is in charge of selling it. Drugs that are replaced by pharmaceutical companies this time do not change the upper limit.
- Company
- Will the 3 asthma biodrugs finally be reimbursed this year?
- by Eo, Yun-Ho Jan 27, 2023 05:50am
- Whether the 3 new biologics for asthma will be listed for insurance reimbursement in Korea is receiving attention. According to industry sources, treatments for severe asthma including GSK Korea’s Nucala (mepolizumab), Teva-Handok’s Cinqair (reslizumab), and AstraZeneca Korea’s Fasenra (benralizumab) are undergoing processes for reimbursement in Korea. As interleukin-5 antagonists, the drugs reduce levels of blood eosinophils, a type of white blood cell that is involved in the development of asthma exacerbation. At the time of their approval, the drugs received attention for being an effective treatment option that had not been available before. All 3 drugs have been approved for over 3 years in Korea. However, no other drug has been reimbursed since the reimbursement approval of Novartis Korea’s ‘Xolair (omalizumab)’ in 2020. At the time, the companies had foregone the listing process as they deemed it would be difficult to narrow the differences in opinion on setting the drug price with the government. However, at the end of last year, GSK, Teva-Handok, and AstraZeneca started discussing reimbursement listing again at about the same time. However, it remains to be seen whether the pharmaceutical companies will be able to derive positive results from cost-effectiveness discussions with the Health Insurance Review and Assessment Service under different their different situations. One of the main purposes of asthma management is to reduce the risk of asthma exacerbations Nucala, Cinqair, and Fasenra directly bind to the alpha subunit of the interleukin-5 receptor (IL-5Rα) to induce apoptosis. The drugs demonstrated efficacy in reducing asthma exacerbation and improving lung function.
- Company
- JAKi Cibinqo attempts reimb in both adolescents and adults
- by Eo, Yun-Ho Jan 26, 2023 06:06am
- Pfizer is attempting to receive approval to reimburse its JAK inhibitor ‘Cibinqo’ in atopic dermatitis (AD) for both adults and adolescents in Korea. According to industry sources, Pfizer Korea resubmitted an application for the reimbursement approval of its new janus kinases (JAK) inhibitor ‘Cibinqo (abrocitinib)’ at the end of last year. After the drug passed the review of the National Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee in August last year, no news had been heard of its deliberation by the Drug Reimbursement Evaluation Committee. This time, the company is attempting to receive reimbursement approval for the drug in adolescents aged 12 years or older as well as adults that the company had previously applied for. As a latecomer, Pfizer is seemingly attempting to receive reimbursement for its combined indication as its competitors, Lilly Korea’s ‘Olumiant (baricitinib),’ ‘Abbvie’s ‘Rinvoq (upadacitinib),’ has already been receiving reimbursement for the atopic dermatitis indication since May and Rinvoq is also attempting to extend its reimbursement to adolescents. As a result, competition among JAK inhibitors is expected to widen from the adult atopic dermatitis market to the adolescent market as well. Sanofi-Aventis Korea’s ‘Dupixent (dupilumab),’ which is of a different class, has also been receiving attention after its pediatric-adolescent AD indication passed DREC review. 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 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 that in the placebo group.
- Opinion
- [Reporter's view] There's no instability in supply & demand
- by Lee, Tak-Sun Jan 26, 2023 06:06am
- Last-minute discussions between the NHIS and the pharmaceutical industry are underway regarding PVA of cold medicines, which increased their use due to COVID-19 last year. The consultation began when the government decided to correct the usage instead when the pharmaceutical industry suggested that cold medicines, which have increased their usage due to COVID-19, should be excluded from the PVA. The issue is how far we look at a specific time when usage increased due to COVID-19 last year. This is because the longer the correction time, the more advantageous it is for the pharmaceutical industry, and the shorter the correction effect. The PVA of cold medicines, which are mostly generic drugs, compares the usage of last year and the year before and negotiates the level of drug price reduction according to the increase. Therefore, there is a possibility that it will be excluded from the negotiation, except for a specific time last year when the usage increased due to COVID-19. Since it is difficult to confirm whether it was used for COVID-19 patients one by one, the advantages and disadvantages of the pharmaceutical industry are expected to vary depending on how the two sides consult. The important point is that this PVA should not negatively affect the supply and demand of cold medicines. This is because pharmaceutical companies could lose production power if they are subject to drug price cuts just because of increased usage. It is also a decision against interest rates to raise the upper limit of acetaminophen in December to increase production, and on the contrary, to cut the upper limit to PVA. Therefore, it is important to accurately calculate the level of correction based on actual data, but political calculations are also needed in consideration of the risk of supply and demand instability in the future. We hope that NHIS and the pharmaceutical industry will engage in reasonable consultations without threatening the public health of the people.
- Company
- 54 billion won ⟵ 3.7 billion won in four years
- by Kim, Jin-Gu Jan 26, 2023 06:06am
- In the high blood pressure and hyperlipidemia complex market, the pace of generational replacement between the second and third complexes is accelerating. The size of outpatient prescriptions for the third-party complex of the ARB+CCB+statin combination has tripled in the past three years, expanding to the market of more than 50 billion won a year. The ARB+statin combination's second-generation complex market has been on the decline since its peak in 2021. In the case of last year, the market size fell below 90 billion won, down 7% year-on-year. ◆ Three-drug complex last year's prescription amount was 54 billion won, 3.4 times in three years According to UBIST, a pharmaceutical market research institute on the 25th, the outpatient prescription amount of the three-drug combination of hypertension and hyperlipidemia last year was 54 billion won. This market has exploded recently. The market size expanded from 3.7 billion won in 2018 to 15.7 billion won in 2019, 34.9 billion won in 2020, and 50.8 billion won in 2021. In other words, the size of the market has expanded 3.4 times in the past three years. The market was formed in October 2017 when Hanmi Pharmaceutical launched "AmosartanQ" in a combination of Amlodipine + Losartan + Rosuvastatin. The following year, Ildong Pharmaceutical, Jeil Pharmaceutical, Daewon Pharmaceutical, Celltrion Pharmaceutical, and Samjin Pharmaceutical introduced the third-generation complex to the market. In 2019, Yuhan, Hana, Daewoong, Ahngook Pharmaceutical, and HK inno.N launched their products, and in 2020, Boryeong, Myungmoon, Kyungdong Pharmaceutical, and Unimmed Pharmaceutical launched their products. Most of them are products that have improved their second-order composite. The market leader is Boryung Dukaro. Dukaro made a soft landing in the market with a prescription performance of 6.4 billion won in the first year of its launch in 2020. In 2021, it doubled to 12.7 billion won. At the same time, it surpassed Hanmi Pharmaceutical's AmosartanQ, which is the No. 1 product in the existing market, and took the lead in the market. Last year, prescription performance increased further to 14.1 billion won. Hanmi Pharmaceutical's "AmosartanQ" steadily increased to 2.7 billion won in 2018, 6.8 billion won in 2019, 10.5 billion won in 2020, and 11.4 billion won in 2021. Still, its growth seems to have slowed to 11.3 billion won last year. In addition, Daewoong Pharmaceutical's Ollomax (8.7 billion won), Ildong Pharmaceutical's Telostop Plus (4 billion won), Yuhan Duowell A (2.8 billion won), and HKinno.N Exone-R (2.8 billion won) produced more than 2 billion won last year. Since the success of the third-party complex, competition for the fourth-party complex is also in full swing. Likewise, Hanmi Pharmaceutical first pioneered the market and other companies entered the competition with drugs from the same combination of ingredients. Hanmi Pharmaceutical was approved for Amozaltan XQ in November 2020. The prescription amount of Amozaltan XQ increased 2.7 times from 2.3 billion won in 2021 to 6.4 billion won last year. Following Hanmi Pharmaceutical's Amozaltan XQ, Yuhan Duowell A Plus, GC Pharma Rozetelpine, Jeil Pharmaceutical's Telmican-Q, and Chong Kun Dang Nuvorozet were approved one after another. The pharmaceutical industry predicts that competition for the fourth-generation complex will take place in earnest this year. ◆2nd Compound Market Decreases to Less than 90 Billion won As the 3rd and 4th composite markets grow explosively, the pace of generational replacement with the existing 2nd composite is also accelerating. Last year, the market size of the ARB+Statin combination's second-generation complex was 89.6 billion won, down 7% from 2021. The second complex market has steadily expanded to 86.9 billion won in 2018, 90.4 billion won in 2019, 94.5 billion won in 2020, and 96.5 billion won in 2021, but it has been reduced for the first time last year. Most of the major products are also on the decline. Yuhan Duowell's prescription amount increased to 20 billion won in 2018 but has steadily decreased since then. Last year, prescriptions fell to 16.5 billion won. Hanmi Pharmaceutical's Rovelito also peaked at 22.7 billion won in 2018 and steadily decreased to 15 billion won last year. JW Pharmaceutical's Livaro V, LG Chem's Rovatitan, and Ildong Telostop also saw their prescriptions fall more than 10% year-on-year last year. The prescription performance of Akarb and Tuvero in Boryung increased. Akarb recorded a prescription amount of 7.4 billion won last year. It increased by 14% compared to 6.5 billion won in 2020. Tuvero, which combines fimasartan with Rosuvastatin, increased slightly from 6.4 billion won to 6.5 billion won.
- Policy
- MFDS preannounces temporary narcotics designation of 2 drugs
- by Lee, Hye-Kyung Jan 26, 2023 06:05am
- On January 20th, The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) preannounced the designation of two drugs including ‘Etazene’ that is being misused or abused as a narcotics substitute in Korea and abroad. Etazene is a synthetic opioid that has a similar structure and effect to Etonitazene, which has been designated as a narcotic drug, and is being controlled as a temporary-class narcotics drug in Japan. 6-Monoacetylmorphine, whose temporary narcotics designation expires on March 8th, will be redesignated as a Group 2 temporary narcotics drug. The temporary narcotics designation system is a system that manages and controls certain non-narcotics in the same manner as narcotics within a 3-year period due to concerns of such being misused or abused as an alternative to narcotics and posing risks to public health. Substances designated as temporary narcotics are handled and managed in the same manner as narcotic drugs from the date of the pre-announcement. Therefore, carrying, possessing, using, controlling, exporting, importing, manufacturing, trading, assisting in the trade of, giving, or receiving temporary narcotics will be completely banned, and relevant substances can be seized. Also, anyone who export, import, manufacture, trade, assist in the trade, give or receive Group 1 temporary narcotics after the pre-announcement on the list of temporary narcotics will be punished by imprisonment with labor for an indefinite term or not less than 5 years. Anyone who imports, exports, or manufactures Group 2 temporary narcotics shall be punished by imprisonment with labor for not more than 10 years or by a fine not exceeding KRW 100 million. Those who trade, assist in trade, give or receive Group 2 narcotics shall be punished by imprisonment with labor for not more than 5 years or by a fine not exceeding KRW 50 million. MFDS expressed hopes that the preannouncement will help block the distribution of new illicit drugs in advance and will cooperate with relevant prosecution, police, the Korea Customs Service, and other related agencies, and continue making efforts to protect public health from the harms inflicted by new and illicit narcotic drugs.
- Company
- Medytox in legal dispute with its Chinese partner
- by Kim, Jin-Gu Jan 25, 2023 06:08am
- Medytox has been embroiled in a 120 billion won legal dispute with its Chinese botulinum toxin partner. Medytox officially announced on the 20th that Gentix Ltd., a subsidiary of the Chinese company Bloomage Biotechnology, had filed a claim for damages against Medytox to the Singapore International Arbitration Centre (SIAC). Gentix had claimed that Medytox violated the contracted terms of their Chinese joint venture. In addition, Gentix requested SIAC to confirm the company’s right to terminate the agreement. The amount claimed for damages is HKD 750 million (approximately KRW 118.8 billion). Based on the end of the third quarter of last year, this is equivalent to 26.4% of Medytox's total capital of KRW 449.2 billion. Medytox established Medybloom China with Bloomage Biotechnology in 2015 to prepare for entry into the Chinese market. Medytox had planned to sell its botulinum toxin product to the Chinese market through the newly established company. However, the plan was put to a halt in July last year with Bloomage announcing intentions to terminate its cooperative relationship with Medytox. At the time, Bloomage is said to have pointed to how Medytox did not supply products for sale as the reason for termination. On this, Medytox said, "We believe that no violations of such that have been claimed by the other party has been made, and plan to actively respond with our legal representatives.”
