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- 2026-04-16 04:58:38
- Company
- Ilyang's leukemia treatment Supect, approved by Russian GMP
- by Oct 28, 2020 06:02am
- The factory that manufactures Ilyang's Supect has passed the GMP (Manufacturing, Processing, Packing or Holding of Drugs) due diligence conducted by the Russian government. According to the pharmaceutical industry on the 26th, the Ministry of Industry and Trade of Russia determined that Ilyang’s plant located in Jecheon-si, Chungcheongbuk-do on the 20th (local time) was suitable for manufacturing and quality control standards, and approved GMP compliance. This plant is where Ilyang manufactures Supect, which was completed in 2015. The validity period for GMP conformity approval is until September 25, 2023. The Russian government conducted due diligence on the Ilyang Biopharm’s plant from September 21 to 25. The due diligence was conducted by video conference due to COVID-19. This GMP due diligence was carried out by Ilyang for Supect's entry into Russia as a leukemia treatment, but as it is combined with the COVID-19 clinical trial, expectations of shareholders are growing together. Supect is a Korean new drug No. 18 developed by Ilyang. Ilyang initially attempted to advance Supect into Russia as a treatment for leukemia. Targeting leukemia, it was approved for Phase III clinical trials and conducted GMP due diligence. It has not yet entered the leukemia clinical trial. At the same time, Ilyang also explored the possibility of Supect as a treatment for COVID-19. Ilyang , which confirmed the inhibitory effect of the COVID-19 in an in vitro experiment in March, was approved by Russia on May 28 and is undergoing clinical trials. In the pandemic, the clinical progression of COVID-19 was faster than that of leukemia. The industry is speculating that it will be able to speed up commercialization with rapid production if only the effectiveness of COVID-19 treatment is proved in phase III as it has been approved for GMP compliance. It is predicted that the GMP due diligence will be exempted because the Corona 19 clinical trial is a drug repositioning method. However, Ilyang has expressed concern about the direct link between the GMP compliance approval and COVID-19 clinical trial. Another variable is that it is difficult for Ilyang to grasp the progress as the local pharmaceutical company 'R-Pharm' is entirely leading COVID-19 clinical trial. Ilyang has delegated all authority to R-Pharm for the Russian clinical trial of COVID-19. R-Pharm signed an export contract with Ilyang in December 2014 for Supect. R-Pharm is conducting clinical trials for 185 mild and severe COVID-19 confirmed patients at 29 institutions in Russia and Republic of Belarus. An official at Ilyang said, "This GMP due diligence was done on the manufacture of Supect as a leukemia treatment, and was planned from the beginning of this year." He added, "If Supect is commercialized as a treatment for COVID-19, there is a possibility that due diligence may be exempted, but this is something the Russian government will judge."
- Company
- Tecentriq as 1st reimbursed immunotherapy for TNBC and HC
- by Eo, Yun-Ho Oct 27, 2020 06:12am
- An immunotherapy Tecentriq (atezolizumab) is seeking for the National Health Insurance (NHI) reimbursement in treating patients with either triple-negative breast cancer (TNBC) or hepatocellular carcinoma. A pharmaceutical industry source reported Roche Korea has recently submitted an application to expand reimbursement for indication to treat patients with TNBC and also hepatocellular carcinoma. In early this year, Tecentriq, in combination with nanoparticle albumin-bound (nab) paclitaxel, won the health authority’s approval to treat patients with TNBC as a first-line treatment, and it also earned an approval to treat liver cancer as a first-line treatment through Avastin (bevacizumab) combination therapy. Once it successfully expands its coverage, Tecentriq would be the first immunotherapy option for the two cancer types. However, it is still unknown how long the listing procedure would take. Tecentriq’s first reimbursed indication, treating patients with non-small cell lung cancer (NSCLC) as a second-line treatment, was approved by the South Korean government as the company accepted the condition to cover the initial administration cost. However, Roche has not commented if it would take the same condition for the expanded coverage. Meanwhile, the two indications barely had any treatment option and an emerging option of an immunotherapy heightened the interest of medical academics. To this date, the needs for the treatment in patients specifically with TNBC—reacting negatively on all receptors (estrogen, progesterone and HER2)—have been unmet. In the IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone. In the same patient group, the Tecentriq combination therapy marked the median overall survival (mOS) at 25.0 months. Professor Im Seock-ah at the oncology department of Seoul National University Hospital said, “The Tecentriq combination therapy demonstrated a meaningful improvement in PFS and mOS longer than two years in patients with metastatic TNBC. We can anticipate the treatment option to be a crucial turning point in treating metastatic TNBC with high unmet medical needs.” The efficacy of Avastin combination therapy treating patients with hepatocellular carcinoma was confirmed in the IMbrave150 study. The result found the patient group using Tecentriq in combination with Avastin reduced the risk of disease worsening or death by 41 percent, compared with Nexavar (sorafenib) patient group. The Tecentriq plus Avastin therapy was also confirmed superior than Nexavar therapy as the combination therapy group’s mPFS marked 6.8 months, which was significantly longer than Nexavar group’s 4.3 months. The combination therapy has not reached the mOS, but the median value during the monitoring phase was at 8.6 months. Nexavar had mOS of 13.2 months. Also the combination therapy’s response rate at 27 percent doubled Nexavar therapy’s at 12 percent. Professor Kim Doyoung of Gastroenterology Department at Severance Hospital noted, “Beside the OS, the improvements in the response rate and PFS were positive findings. We are glad to have found an immunotherapy option in the liver cancer area that has no other alternative than Nexavar. Hopefully, the drug can meet the highly unmet medical needs in the future.”
- Policy
- Godex continues to monopolize the market
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- Annual sales of ₩60 billion in outpatient prescriptions Celltrion's liver disease treatment 'Godex capsule', which has grown to about ₩60 billion per year, was developed as tablet formulations rather than conventional capsule formulations and is pursuing product approval. Godex capsule has no competing generics, but as the patent expired in November last year. Accordingly, Celltrion has developed tablets preemptively to maintain its monopoly position and expand its market share. According to the industry on the 26th, Celltrion has completed the development of a so-called Godex tablet and has recently submitted the application to the MFDS. Godex capsule, licensed in 2000, is a complex improved drug combining Carnitine Orotate, Adenine HCl, Antitoxic Liver Ext, Biphenyl Dimethyl Dicarboxylate, Cyanocobalamin, Pyridoxine HCl, and Riboflavin. Transaminase (SGPT) is used in patients with elevated liver disease, and prescription results are steadily increasing in recent years. Together with Ursa, it is the most commonly prescribed drug for patients with liver disease, and the amount of outpatient prescription based on UBIST last year reached ₩59.3 billion. However, Godex capsule is also in a situation where it can compete for generics due to the expiration of its patent on November 8 last year. However, since it is a complex drug that combines seven main ingredients, it is difficult to prove the equivalence, so no pharmaceutical companies are developing generics. Accordingly, it will be able to achieve more than ₩60 billion, surpassing last year's performance. Celltrion has proactively developed IMD (Incrementally Modified Drugs) in line with the expiration of the patent for Godex capsule. In April of last year, CTP-JB02 was approved for Phase III clinical trials and went through a validation procedure. CTP-JB02 was known as 'Godex tablet'. Godex tablet, which is being promoted for commercialization, is slightly different in ingredients from the existing Godex capsule. Among the ingredients, the salts of Carnitine have changed. In Godex capsules, Orotate was used for Carnitine, while Godex tablets were known to use napadicylate for L-carnitine. Celltrion is said to have applied for a patent for such a pharmaceutical composition. Once a patent is registered, Godex's market monopoly is also guaranteed. Godex capsules should be taken 2-3 times a day, 2 capsules at a time. Therefore, it seems that Godex tablets will be an alternative to patients who do not prefer Godex capsules.
- Policy
- Kyongbo joins Galvus latecomer competition with IMD
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- Kyongbo Pharmaceutical joined the competition among the dipeptidyl peptidase-4 (DPP-4) inhibitor Galvus (vildagliptin) latecomers. The South Korean company has reportedly applied for the authority’s approval on its new incrementally modified drug (IMD). According to the Ministry of Food and Drug Safety (MFDS) and the pharmaceutical industry sources on Oct. 23, Kyongbo Pharmaceutical submitted an approval application on three doses of vildagliptin hydrochloride plus metformin hydrochloride on Sept. 28. Unlike the original Galvus, the IMD has hydrochloride base attached to the original active ingredient vildagliptin. As a result, now three South Korean companies—Ahn-gook Pharmaceutical, Hanmi Pharmaceutical and Kyongbo Pharmaceutical—have either applied for the government approval or received the approval for a Galvus follow-on drug. In November 2019, Ahn-gook Pharmaceutical won the authority’s approval on a vildagliptin latecomer, ‘Ahngook Vildagliptin 50 mg tablet,’ and became the first company to take on the market. As for Hanmi Pharmaceutical, the company received the approval on ‘Vildagle 50 mg tablet (vildagliptin hydrochloride),’ but it soon dropped the license as it lost the patent challenge trial to enter the market by breaking off indications. However, Hanmi Pharmaceutical submitted the applications on a single agent drug, sharing the same substance as Vildagle, and a combination agent drug with vildagliptin hydrochloride-metformin hydrochloride on Sept. 29 and on Oct. 16, respectively. Ahn-gook and Hanmi would be able to release their products from August next year at earliest, as they have succeeded in nullifying 187 days of Galvus patent term to be terminated in March 2022. But Novartis filed an appeal to cancel the Intellectual Property Trial and Appeal Board’s decision, which is expected to conclude on Oct. 29. If the two South Korean companies were to win the case at the Patent Court as well, their products would be available in the market by August next year. But the release date could be pushed to March 2022, if they were to lose the case. Ironically, Kyongbo Pharmaceutical is rooting for Ahn-gook and Hanmi, because it wants to release its product alongside the two companies after confirming the nullification of the Galvus patent extension term. When the original’s company loses the patent challenge, other follow-on drug companies are also allowed to take an action. Although Ahn-gook Pharmaceutical owns the preferential sales rights effective from August next year, Hanmi and Kyongbo can enter the market without sales ban as their products have different salt base from Ahn-gook’s. At the moment, Kyongbo is in process of seeking negative confirmation of Galvusmet substance patent (Sept. 25, 2026) scope filed in last January to evade the patent. As Ahn-gook Pharmaceutical, Hanmi Pharmaceutical and Korea United Pharm have already won the cases, Kyongbo is confident it would also evade the patent. As a Phase I clinical trial to confirm the equivalence with the original from last March was successful, Kyongbo Pharmaceutical was cleared to apply for approval with the third latecomer drug in the market. Only time would tell if Kyongbo Pharmaceutical can take over the vildagliptin market valued at 20 billion won in South Korea.
- Company
- Domestic supply of Nimbex has been discontinued
- by Oct 27, 2020 06:11am
- NimbexAccording to the distribution industry on the 23rd, 'Mitsubishi Tanabe, which is in charge of distribution and sales of Nimbex in Korea, sent an official letter to the wholesale industry and announced that Nimbex will cease distribution in Korea on November 3rd. Mitsubishi Tanabe said, "Due to internal circumstances such as the productivity problem of the manufacturer Aspen, there is no additional supply and demand plan since the imported volume in May." The company said that it can only be sold until November 3rd. Nimbex was changed once from GSK to Aspen. In June 2018, GSK transferred the Nimbex rights to South African pharmaceutical company Aspen, and the domestic seller was changed to Mitsubishi Tanabe. Mitsubishi Tanabe has been distributing the product for two years, but this time Aspen decided to stop supplying it. It is believed that there are no plans to resupply in the future. Nimbex's inventory is 1,542 cases for 10ml/5amp and 20 cases for 2.5ml/5amp. The validity period is December 1, 2021 and January 23, 2022, respectively. Nimbex is a drug with two or less identical ingredients (No. 3) among drugs with production and import records in the previous year, and a drug with a market share of 50% or more (No. 4) among product groups with the same ingredient. Mitsubishi Tanabe recently reported the discontinuation to the MFDS. MSD's Esmeron and Hana Pharm's Atra are mentioned as generics for Nimbex.
- Policy
- Continued administration of Remdesivir was recommended
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- COVID-19 treatment Domestic health authorities recommended that patients continue to administer 'Remdesivir', a treatment for COVID-19. Although the WHO announced that it was not effective, it was not the final clinical trial result, and the US clinical trial reliability, which was the basis for the approval, was highly regarded. The MFDS and the Korea Disease Control and Prevention Agency announced on the 23rd that it is recommended to continue administration under the judgment of medical staff in accordance with the approval of the product in relation to the results of the clinical trial of Remdesivir recently announced by the WHO. The WHO announced on the 15th that there was no difference between the control group and the test group of Remdesivir clinical trial results, mortality, and treatment duration. The research results have not gone through a peer review process in the academic paper publication procedure. The MFDS and the Korea Disease Control and Prevention Agency determined that additional data reviews such as review of the presentation contents, expert consultation results, administration timing, and subgroup analysis by severity were necessary. When the final results of The MFDS clinical trial are announced, the test methods and results such as the target patients registered for the trial and the local medical situation where the trial was conducted will be carefully reviewed, and discussions will be conducted with overseas regulatory authorities including expert advice. The MFDS approved Remdesivir on July 24 to use Remdesivir only for severe hospitalized patients who need supplemental oxygen based on the results of a clinical trial led by the NIAID for the treatment of Korean COVID-19 patients. In particular, the result that Remdesivir shortened the treatment period by 5 days in COVID-19 patients was judged to be clinically meaningful. Remdesivir has been approved and used in the United States, Europe, Japan, Taiwan, and Singapore. In addition, the MFDS’ COVID-19 Expert Committee and the Central Clinical Committee of Novel Infectious Diseases said that the U.S. NIAID used a highly reliable research method, and it was judged that there was a scientific basis for the effectiveness of the drug, so the use of Remdesivir as a treatment for COVID-19 should be maintained. Accordingly, the MFDS and the Korea Disease Control and Prevention Agency continue to monitor clinical trials and abnormal cases for COVID-19 treatments and vaccines, while introducing safe and effective drugs in Korea, so that Koreans can receive treatment opportunities. Remdesivir was approved by the U.S. Food and Drug Administration (FDA) as an official treatment for COVID-19 on the 22nd local time in the United States.
- Company
- Pfizer’s EGFR TKI Vizimpro to get listed by the year-end
- by Eo, Yun-Ho Oct 26, 2020 06:15am
- Pfizer’s epidermal growth factor receptor (EGRF) tyrosine kinase inhibitors (TKI) Vizimpro (dacomitini) is predicted to get listed for National Health Insurance (NHI) reimbursement within this year. The pharmaceutical industry sources reported the fifth ERGR TKI Vizimpro is to begin the pricing negotiation with National Health Insurance Service (NHIS) soon. As the negotiation is due within 60 days, the drug could receive reimbursement by the end of the year if the administration procedure is processed promptly. Currently, the first generation EGFR TKI ‘Iressa (gefitinib)’ by AstraZeneca and Tarceva (erlotinib) by Roche, and the second generation Giotrif and the third generation Tagrisso (osimertinib) by AstraZeneca are prescribed in South Korea. The key competition takes place in the non-small cell lung cancer (NSCLC)-treating indication. As the direct competitor Giotrif has already taken root in the market, Vizimpro decided to take the weighted average pricing as an alternative drug and took the fast-track review route. Without the burden of setting the upper limit pricing, the negotiation with NHIS is expected to cruise on without much of issue. Vizimpro’s efficacy has been confirmed in Phase III ARCHER 1050 trial. The study compared Vizimpro and the first-generation Iressa head-to-head with total 452 patients fighting against NSCLC. In the trial, the medicine reduced the risk of progression-free survival (PFS) by 41 percent compared to Iressa, as Vizimpro patient group’s median PFS was at 14.7 months and Iressa group’s was at 9.2 months. Nevertheless, Vizimpro showed worse cases of adverse reactions. In the Vizimpro group, the frequently demonstrated severe adverse reactions included dermatological issues with pimple (14 percent) and diarrhea (8 percent), whereas changes in liver enzymes (8 percent) were significant in the Iressa group. Around 60 percent of Vizimpro patient group had to adjust their medication dose due to adverse reaction. Vizimpro is a second-generation targeted therapy indicated to treat patients with EGRF-mutation-positive NSCLC. The U.S. Food and Drug Administration (FDA) approved the anticancer treatment in September 2018 after granting Priority Review in January same year. Currently, the drug is approved and used in the U.S., EU and Japan. In South Korea, the medication has been approved as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC, and it is also indicated to treat patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations, who have not been treated before.
- Policy
- Stribild was withdrawn in Korea
- by Lee, Tak-Sun Oct 26, 2020 06:15am
- Stribild, which once ran the No. 1 HIV treatment market with an annual sales of ₩20 billion, withdrew from the domestic market. It has been 7 years and 8 months since the approval in February 2013. Stribild has been on a roll as a drug that enhances the convenience of AIDS patients by containing four ingredients in one pill, but it was naturally replaced Genvoya with less side effects. According to the MFDS on the 25th, Gilead voluntarily withdrew Stribild's domestic license on the 23rd. It is a drug that competes with GSK’s Triumeq. Stribild is a combination of Cobicistat/Elvitegravir/Emtricitabine/Tenofovir disoproxil fumarate in the treatment of adult HIV-1 infection in one pill. It was released in February of the following year with domestic approval in February 2013. As soon as the sale started, it dominated the HIV market with its strong effect and convenience of taking it once a day. In 2016, sales based on IQVIA were ₩20 billion. In the second half of that year, it was overwhelmingly ranked first. However, with the release of 'Genboya', which improved the side effects of Stribild in 2017, sales began to gradually decline. Genvoya is a drug that uses Tenofovir alafenamide fumarate (TAF) instead of Stribild's Tenofovir disoproxyl fumarate (TDF). TAF shows equivalent viral suppression at a tenth dose compared to TDF, and improves side effects such as kidney toxicity and bone marrow toxicity. Genboya has replaced Stribild and is now the best item. Zenboya recorded ₩9.9 billion in sales in the first half of this year based on IQVIA, and Stribild has not been able to capture sales since the third quarter of last year. Stribild was completely replaced by Zenboya. There is no need to maintain licenses since Stribild has no track record. Gilead withdrew from the domestic market voluntarily.
- Company
- Whanin·Myung In successfully evaded patent for Fycompa
- by Kim, Jin-Gu Oct 26, 2020 06:15am
- Fycompa Myung In and Whanin succeeded in circumventing some of the patents of 'Fycompa (Perampanel anhydrous)', an epilepsy treatment. The two companies will be able to launch generics as early as October 2023. On the 21st, the Intellectual Property Trial and Appeal Board issued a trial decision for ``establishment of claim'' at the judgment on the passive scope of rights for crystal patent of Fycompa (October 14, 2026), which Myung In and Whanin claimed against Eisai. As a result, the two companies met two of the three requirements for the early release of generics (first request for trial and trial decision for claim establishment). One of the remaining requirements is 'application for approval for the first generic'. For now, it is very likely that both companies will achieve this requirement at the same time. The two companies are conducting bioequivalence tests for the generic for Fycompa. Whanin has started bioequivalence tests in May of this year and Myung In in July. Fycompa's PMS expires July 9, 2021. Considering that it is possible to apply for an item permission after the expiration of the PMS, this means that about 9 months will be given. It's time to end the bioequivalence test. Assuming that the two companies apply for product license at the same time, the generic release is expected to be on or after October 14, 2023. It is when Fycompa's material patent expires. The two companies did not file a separate patent trial for material patents. Fycompa is a new drug for epilepsy that was launched in Korea in February 2016. In particular, it can be used as a monotherapy for adolescents 12 years of age or older with partial epilepsy seizures, and prescription performance is increasing. According to UBIST, Fycompa's annual prescription amount increased more than three times in three years to ₩1.3 billion in 2016, ₩3 billion in 2017, ₩3.7 billion in 2018, and ₩4 billion in 2019. Fycompa's prescription amount was worth ₩3.2 billion until September this year.
- Policy
- Tagrisso is not an expensive drug
- by Kim, Jung-Ju Oct 26, 2020 06:15am
- While Tagrisso, a new lung cancer drug, is currently being paid for as a second-line treatment, the government responded that it was difficult to claim that it should further increase its coverage as a first-line treatment. This is because the government should apply the principle by reasonably setting the economic evaluation and ICER standard values for the government that needs to continue to release ultra-high-priced new drugs and improve patient access evenly, so there is a gap with the needs of the people. Minister of Health and Welfare Park Neung-hoo made such a statement on the arguments of Lee Yong-ho at the National Assembly Health and Welfare Committee's comprehensive national audit, which is being held from the morning of the 22nd. He pointed out the fact that Tagrisso, which costs ₩200,000 per tablet, is being given as a second-line treatment in Korea, which shows a remarkably effective drug when taken daily among patients. Lee said, "Even though Tagrisso is a priority in the international standard for cancer treatment, the price is very high because it is paid as a secondary treatment in Korea." He stressed that the ICER threshold for the economic evaluation of severe and rare diseases should be realized at a GDP of ₩20,000 and asked the minister for an answer. In response, Minister Park said, "From the government point of view, the price of Tagrisso is not as a very expensive drug." He added that the reason is that new drugs are released every day and there are a lot of very expensive drugs, but we will actively review Tagrisso.
