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- 2026-04-11 18:24:59
- Company
- Hanmi Poziotinib has greater patient benefits than risks
- by Nho, Byung Chul Sep 22, 2022 06:02am
- Regarding the opinion that Poziotinib's clinical results are not enough to support prompt approval in a briefing released by the U.S. FDA on the 20th (local time) ahead of the Oncology Drug Advisory Committee (ODAC), Hanmi Pharmaceutical said, "We will fully explain the usefulness of Poziotinib at the ODAC scheduled for the 22nd." Poziotinib is considered an innovative treatment that can play a sufficient role as one of various treatment options for patients with HER2 Exon20 mutated non-small cell lung cancer who do not have a suitable treatment so far. The adverse reactions reported so far are cases that appear in other drugs, and it is not only sufficiently manageable, but it is also observed that the benefit of Poziotinib to patients is clearly greater than the risk. Lung cancer is a disease with a higher fatality rate than other cancers, and it is widely believed in the medical community that various treatment options must be provided to patients. Not only can it be administered as a secondary or tertiary treatment to patients who do not respond to existing treatments, but also the usefulness of Poziotinib is clear in that it provides convenience to cancer patients because it is an oral formulation rather than an intravenous injection. "We will do our best to fully explain the usefulness of Poziotinib with our partner Spectrum so that positive recommendations for patients can be made," Hanmi Pharmaceutical said. "The recommendations made after ODAC discussions are not binding, so the FDA will review all situations including ODAC recommendations and decide whether to approve them by November 24."
- Company
- From Factive to Rolontis, commercial success or failure
- by Chon, Seung-Hyun Sep 22, 2022 06:01am
- Domestic development biosimilar and botulinum toxin drugs expand their influence in the U.S Hanmi Pharmaceutical's neutropenia treatment Rolvedon has succeeded in entering the U.S. market. Starting with LG Chem's Factual in 2003, a total of six new drugs made with domestic technology passed the U.S. licensing gate. However, it is evaluated that new domestic development drugs that have entered the U.S. so far have a long way to go to achieve commercial success. Although it is not a new drug, biosimilars and botulinum toxin drugs developed with domestic technologies are gradually expanding their market impact and writing a success story. ◆Hanmi Pharmaceutical's bio-new drug FDA's first approval, and domestic new drug's 6th commercial success is the key According to industries on the 13th, the U.S. Food and Drug Administration (FDA) finally approved Rolontis (U.S. product name Rolvedon), which Spectrum Pharmaceuticals applied for permission on the 10th (local time). Rolvedon is a new bio drug that Hanmi Pharmaceutical transferred technology to Spectrum Pharmaceuticals in 2012. It is administered to cancer patients subject to bone marrow-suppressing chemotherapy for the treatment or prevention of neutropenia. In Korea, it was approved by the Ministry of Food and Drug Safety as the 33rd domestic new drug in March last year. Rolvedon is produced at Hanmi Pharmaceutical's Pyeongtaek bioplant. It is the first bio-new drug in Korea to be produced at a domestic factory that has passed FDA due diligence and enter the U.S. market. Rolvedon is the sixth new drug developed with the technology of a domestic company to pass the FDA approval gate. In 2003, LG Chem's antibiotic Factive was the first to pass the U.S. FDA among domestic new drugs. In 2014, Factive, which was exported by Dong-A ST, obtained FDA approval. In 2016, SK Chemicals' hemophilia treatment Afstyla passed FDA approval. Afstyla is a genetically modified bio-new drug developed by SK Chemicals with its own technology. In 2019, two products developed by SK Biopharm passed the U.S. FDA. In March 2019, SK Biopharm's new sleep disorder drug Sunosi, which was exported by technology, approved the FDA's final permission. Sunosi is a product that SK Biopharm transferred its technology to Jazz Pharmaceuticals in 2011 after completing a phase 1 clinical trial after discovering candidate materials with its own technology. In November 2019, SK Biopharm received FDA approval for XCOPRI, a new drug for epilepsy. XCOPRI is the first new drug developed by a domestic company and carried out FDA approval directly. The industry is eagerly looking forward to the commercial success of domestic development new drugs in the United States. In Factive, its partner GSK suddenly took issue with clinical data, causing a setback in its overseas expansion. More than 300 billion won has been invested in the development of Factual, but sales in the U.S. are insignificant. Last year, Factive's domestic production performance was only 10.5 billion won. Sivextro, which was approved by the FDA in 2014, and Afstyla, which debuted in the U.S. market in 2016, say that commercial performance fell short of expectations. Sivextro disappeared from the market, withdrawing its permission due to low drug prices in Korea. Two new drugs to develop SK Biopharm, which were recently approved by the U.S., are gradually expanding their influence in the market. Sunosi made 25.3 billion won in profits to SK Biopharm last year, followed by 2.4 billion won in exports in the first half. XCOPRI recorded 300.7 billion won in exports last year and 13.7 billion won in the first half of this year. ◆ Domestic development biosimilar accelerates its entry into the U.S.. Although it is not classified as a new drug, biosimilars and botulinum toxin drugs developed by domestic companies are rapidly penetrating the U.S. market. In the case of biosimilars, Celltrion and Samsung Bioepis have been approved for a total of eight products in the United States. Celltrion was granted Remicade's biosimilar Inflectra in August 2016. Celltrion received U.S. permits from Truxima and Herzuma in 2018, respectively. Truxima is a biosimilar product of the anti-cancer drug Mabthera. Herzuma's original product is Herceptin. The biosimilar developed by Celltrion recorded more than 7 trillion won in cumulative exports. Celltrion Development's biosimilar posted 930.3 billion won in exports in the first half alone, with sales in the North American market accounting for 43% and 47% in the first and second quarters, respectively. Samsung Bioepis, which was launched in 2012, has been approved by Europe and the United States for biosimilars of five products, including Enbrel, Remicade, Humira, Avastin, and Lucentis. Since its launch, it has recorded sales of about 3.7968 trillion won until the first half of this year. Sales of 431.9 billion won were recorded in the first half alone, of which sales in the U.S. market account for 20-30%. Recently, Nabota, a botulinum toxin drug developed by Daewoong Pharmaceutical, is doing well in the U.S. market. According to Daewoong Pharmaceutical, Nabota's sales in the first half were 67.5 billion won, up 74.9% from the previous year. It recorded 52 billion won in export performance alone. If this trend continues, Nabota is expected to record more than 100 billion won in exports alone this year. Nabota has accumulated due to accumulation of experience in using the U.S., and export performance has begun to surge since the end of the Medy Tox and strain theft lawsuits conducted since 2019. In February last year, Medy Tox signed a three-way agreement with Daewoong Pharmaceutical's U.S. partners Evolus and AbbVie regarding the sale of Nabota (Jubo) to the U.S. The key to Medy Tox and AbbVie is to grant Jubo's continuous sales and distribution rights to Evolus in the United States and receive a certain amount of money. Earlier, at the end of 2020, the International Trade Commission (ITC) decided to ban Jubo from importing and selling in the U.S. for 21 months. With this agreement, Navota's hurdles for selling to the U.S. are gone. Of Nabota's overseas sales in the second quarter, exports to Evolus doubled from a year earlier to 21.1 billion won.
- Policy
- MOHW's advisory council to respond to US’s Bio initiative
- by Lee, Jeong-Hwan Sep 21, 2022 05:47am
- The government has organized a trade advisory council to address the trade issues that may arise from the National Biotechnology and Biomanufacturing Initiative that the Biden administration launched via an Executive Order. Through the council, the government plans to strengthen communication with the pharmaceutical and bio industry and promptly respond to rising issues. The advisory council, which consists of trade experts, will hold regular meetings every quarter and actively collect industry opinions to reflect on trade policies established in the healthcare and the pharmaceutical industry. Until a specific plan is set to regulate the pharmaceutical and bio industry by the US government, the Korean government will preemptively draw up a policy framework that reflects the difficulties expressed by the industry and establish an organic public-private consultative body. On the 20th, an MOHW official said, “We organized a trade consultative council with domestic industries including the pharmaceutical and bio industries, and held the first trade policy meeting on its regular operation.” Members of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Pharmaceutical Traders Association, Korea Medical Devices Industrial Cooperative Association, Korea Medical Devices Industry Association, Korea Cosmetics Association, and Korean Research-based Pharmaceutical Industry Association attended the policy meeting that was held at the Korea Chamber of Commerce and Industry (KCCI) office by the MOHW and the Korea Health Industry Development Institute (KHIDI). The MOHW recently evaluated that US’s Executive Order for the National Biotechnology and Biomanufacturing Initiative was made to protect its industries and reduce dependence on foreign countries such as China in the pharmaceutical and bio sectors, in addition to the measures it had previously made in the semiconductors and electric vehicles sector. Korean companies that heavily rely on exports to the US are expected to have a negative impact if the US promotes and reinforces domestic manufacturing, but MOHW believes its immediate impact will be limited due to its characteristics, being pharmaceuticals products. The MOHW plans to analyze the impact the Bio Executive Order will have on Korea’s pharmaceutical and bio markets from various angles and strengthen the role of domestic supply networks that have price and technological advantages. In addition, through external expansion of the advisory council by adding industry opinions, the government will enhance its response to trade frictions and regularize roundtable meetings between the government and the pharmaceutical and bio industry around the trade advisory council to respond promptly to trade issues that may arise. An MOHW official said, “The response to the US bio executive order will be decided through pan-ministerial discussions with not only the MOHW but also the Ministry of Trade, Industry, and Energy, etc. Starting with the trade advisory council that covers both the pharmaceutical and bio fields in healthcare, we plan to hold as many meetings with the industry as possible." The official added, “We will hold the first healthcare trade forum this October. Then, we plan to institutionalize, regularize, and activate this forum in the future. Then, we plan to regularly hold forums to share information and inform the industry of the government's direction of response in advance when trade issues arise for their rapid and efficient response.” At the trade meeting, a KHIDI official explained, “The meeting was held to explain the government’s course of direction regarding the difficulties that the pharmaceutical and bio industry may face with regards to the Biden administration’s Bio Executive Order. As it may be difficult for the associations and pharmaceutical and bio industries to take individual action, there was also a request for the government to take the lead in making such response.” The official added, “The trade support counter within KHIDI acts as a channel for communication that responds to questions and requests made by associations and companies for rising trade issues. It will act as part of a network that will be established to directly convey opinions of the Trade Advisory Council.”
- Company
- Enhertu lands in Korea...hopes rise for indication extension
- by Sep 21, 2022 05:47am
- The new breast cancer drug Enhertu (trastuzumab deruxtecan), which 50,000 people had petitioned for expedited approval, has finally landed in Korea. The Ministry of Food and Drug Safety announced on the 19th that it had granted marketing approval for Enhertu, the HER2-directed antibody-drug conjugate (ADC) that was jointly developed by AstraZeneca and Daiichi Sankyo. With the approval, Enhertu can be used in Korea for the treatment of ▲unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens (third-line or higher treatment) ▲locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior therapies including an anti-HER2-based regimen (third-line or higher treatment). 엔허투주 모식도(자료: Enhertu is an antibody-drug conjugate that combines ‘trastuzumab,’ a monoclonal antibody that binds to specific target proteins, and ‘deruxtecan,’ a strong cytotoxic agent, by a linker. Its selectivity on antibody targets and apoptosis of target tumor cells allows the drug to work selectively only on the tumor cells, increasing its therapeutic effect and minimizing side effects. In the Phase II DESTINY-Breast01 trial that enrolled 184 female patients with HER2-positive, metastatic breast cancer who had received two or more prior anti-HER2 therapies, patients treated with Entertu achieved a Confirmed Objective Response Rate (primary efficacy endpoint) of 60.9%. Its secondary efficacy endpoints, median Duration of Response (mDOR) and median Progression-Free Survival (mPFS), were 14.8 months and 16.4 months, respectively. In the confirmatory trial that the two companies conducted afterward, Enhertu satisfied all of its key efficacy endpoints including PFS and Overall Survival (OS). In the DESTINY-Gastric01 trial that enrolled HER2-positive gastric or gastroesophageal junction cancer patients, the ORR was 48.4%, mOS 12.5 months, mPFS 8.4 months for patients who received treatment with Entertu, which was a significant improvement compared to the 12.9%, 8.4 months, and 3.5% of the control group (that received chemotherapy). Various targeted therapies for HER2-positive breast cancer are already in use in Korea, such as Herceptin, Perjeta, Kadcyla, and Tykerb. Among the drugs, Kadcyla entered the market as the first ADC for HER2-positive breast cancer, just before Enhertu. However, Enhertu’s potential lies in its future indications to come. In the Phase III trial that was recently announced by the company, Enhertu demonstrated its efficacy as a second-line treatment in HER2-positive breast cancer. It had shown a 72% reduction in risk of disease progression or death and nearly a twice higher ORR compared to the first-generation ADC Kadcyla. Based on these results, the National Comprehensive Cancer Network (NCCN) recently recommended Enhertu as a “Category 1 preferred regimen” in the second-line treatment of HER2-positive breast cancer. Furthermore, the drug was acclaimed at the ASCO 2022 meeting held in June as the first treatment to demonstrate efficacy in HER2-low patients who had no other available treatment options. The study results showed that Enhertu reduced the risk of disease progression or death by nearly 50% compared with conventional chemotherapy, with an mOS of 23.4 months, which was a 6.6-month extension from the 16.8 months in the chemotherapy group. Based on these results, the US FDA had also approved Enhertu as the first targeted therapy for HER2-low breast cancer. Voices for Enhertu’s expedited approval had also been high in Korea. The petition for the expedited approval of the breast cancer treatment Enhertu that was uploaded to the National Assembly's petition for public consent was submitted to the National Assembly's Health and Welfare Committee on the 30th of last month after receiving over 50,000 signatures of consent from the public. In the petition, the petitioner implored for expedited approval of Enhertu, saying “My mother suffered through the difficult chemotherapy, but the existing chemotherapy was unable to get rid of her cancer. There are no more drugs available in Korea. Please speed up the domestic approval process so patients in dire need can use Enhertu in Korea.” Daiichi Sankyo and AstraZeneca said, “The approval of Enhertu will offer a new treatment option to patients with metastatic HER2-positive breast cancer. Also, gastric cancer patients that had a high unmet medical need will benefit from Enhertu’s approval as it will allow them to continue their HER2 targeted therapies, as no other therapies available other than trastuzumab had proven clinical significance in the area.” The two companies will be jointly marketing Enhertu in Korea.
- Policy
- Domestic authorization for the Quadrivial Adjuvant Flu Vac
- by Lee, Tak-Sun Sep 21, 2022 05:47am
- With the flu warning issued in September, the beginning of Autumn, an upgraded flu vaccine was also approved in Korea. It is a tetravalent Adjuvant vaccine that can be used for people aged 65 or older, and is a product of a pharmaceutical company called CSL Seqirus, which is still unfamiliar in Korea. The Ministry of Food and Drug Safety announced on the 19th that it has approved Meditip's Fluad Quadrivalent PFS (MF59 Adjuvant). Meditip, a pharmaceutical consulting firm, seems to have been granted the product on behalf of CSL Seqirus, which has not yet been licensed in Korea. CSL Seqirus is a vaccine company that combines the vaccine division of Australian pharmaceutical company CSL and the Novartis influenza division. CSL Seqirus established a domestic branch this year. The approved product is the Adjuvant flu vaccine. The Adjuvant flu vaccine has the advantage of improving the immune response of the elderly with a degraded immune system to increase the preventive effect. Recently, ACIP under the U.S. CDC recommended tetravalent high-performance vaccines, including Fluad Quadrivalent, which contains immune enhancers, for senior citizens aged 65 or older. Fluad Quadriental was licensed in Korea for the purpose of preventing two types of influenza A virus and two types of influenza B virus for the elderly aged 65 or older. In clinical trials, this product proved better preventive effect than existing trivalent products. Attention is focusing on whether CSL Seqirus, including Adjuvant-containing products, will become a new issue in the domestic flu vaccine market led by GC Pharma.
- Company
- RET-targeted anticancer drugs are being released in Korea
- by Whang, byung-woo Sep 21, 2022 05:47am
- By disease in patients, is a small but some hospitals were already prescribing patients ahead of the clinical site in anticipation that there is high. But now excluded from prescription for pay from entering that the burden of costs and likely to be consideration of the prescription side effects. According to the pharmaceutical industry on the 16th, RET (REarranged drug transmission) target treatments currently approved in Korea are Lilly's Retevmo and Roche's Gavreto. Retevmo is applied to adult patients with metastatic RET fusion-positive non-small cell lung cancer, adults with progressive or metastatic RET-mutant thyroid cancer and children over 12 years of age who are not compliant with radiation Iodine, have previous treatment experience with Sorafenib and/or Lenvatinib, and others requiring systemic therapy. Gavreto has been approved in Korea as a treatment for adult patients with RET fusion positive local progressive or metastatic non-small cell lung cancer and adult patients with RET mutation local progressive or metastatic medullary thyroid cancer that requires a strategy. However, since it is licensed around the same time as Retevmo, it is predicted that the release date will not show much difference. Currently, the indication that the two treatments are expected to be prescribed the most is non-small cell lung cancer. It is expected that only 1-2% of all patients have RET mutations, but compared to the thyroid gland, there will be more patients. However, it remains to be seen which of the two drugs will have the upper hand. This is because at the time of approval of the RET gene mutation target anticancer drug, experts also showed that there was no difference enough to choose. Experts say that the emergence of the two treatments is positive, given that chemotherapy is the only treatment option for patients with RET mutations so far. This is because at the time of approval of the RET gene mutation target anticancer drug, experts also showed that there was no difference enough to choose. As a result, experts predict that if the number of prescription options increases to two soon, side effects issues will play a greater role than effects. Hong Min-hee, a professor of oncology at Yonsei Cancer Hospital, said, "There is little difference in efficacy in choosing the two drugs and there is a difference in terms of adverse reactions." Professor Hong explained, "Retevmo seems to have more side effects of gastrointestinal relationships and Gavreto has more side effects of bone marrow suppression, so I think I will choose the patient group accordingly." In addition, Yoon Sung-hoon, a professor of respiratory medicine at Pusan National University in Yangsan, said, "Personally, only Retevmo has prescription experience in that Gavreto is not being used sympathetically due to drug supply and demand." Considering this, there is a possibility that experienced treatments that first appear in the market and enjoy the effect of preoccupying the market due to the characteristics of RET gene mutation target anticancer drugs with small patient groups. Since Gavreto is administered once a day, there is a view that it will be a little more advantageous for the younger patients who are relatively active in society. Retevmo and Gavreto are still not able to enter the benefit range, so cost issues are also expected to be hurdles for prescriptions. Retevmo failed to pass the cancer disease review committee, the first gateway to the standard review in May. Currently, Retevmo is known to cost about 7 million won a month. Professor A of oncology at advanced general hospital in Seoul said, "There are patients waiting for the use of RET gene mutation target anticancer drugs, but cost problems and periods vary from patient to patient." He went on to say, "I don't know if the patient group will be able to submit data necessary for the benefit standard, but I don't think it will be possible to enter the benefit when looking at NTRK mutant treatment." He added, "It may not be possible to enter the benefit right now, but we look forward to positive news in the future."
- Policy
- 23 items have been designated as Fast Tracks in 2yrs
- by Lee, Hye-Kyung Sep 21, 2022 05:47am
- Goal of completion of examination within 75% of general examination period. Over the past two years, 23 items of medicine have been designated as Fast track. Specifically, it appeared as 4 items in 2020, 11 items in 2021, and 8 items until July 2022, and the reason for the increase in Fast track designated drugs last year compared to the previous year is interpreted as the impact of the COVID-19 vaccine. The MFDS (Director Oh Yoo-kyung) published a "Fast Track Drug Review Report" on the 13th by launching the "Global Innovative Products on Fast Track (GIFT) Program" to support the development of innovative medical products in Korea. Since August 31, 2020, the Ministry of Food and Drug Safety has established a Fast Track department and has designated and reviewed Fast Track items for innovative products such as life-threatening diseases or treatments for rare and incurable diseases. The items designated as Fast Track for the first time in Korea were AstraZeneca's Selumetinib and Daewoong Pharmaceutical's DWP16001, an innovative pharmaceutical development new drug, applied simultaneously on October 23, 2020. The application for Fast Track designation requires active ingredients, mechanism of action, manufacturing method, preliminary clinical trial data to confirm clinical significance in the disease, and target indications, and the application for designation will be reviewed within 30 days. Over the past two years, a total of 17 items have been approved after the Fast Track designation, including 5 chemicals, 1 biopharmaceutical, 10 COVID-19 vaccines, and 1 biopharmaceutical, with the goal of completing the screening within 75% of the screening period. From August 31, 2020 to July 31, this year, a total of 25 applications for the designation of medical products Fast Track were designated, of which 23 were designated. One of the items applied for designation was not designated due to insufficient data to prove the effectiveness improvement compared to existing treatments, and one was voluntarily withdrawn. Among the Fast Track designated items, 12 treatments for life-threatening or serious diseases, 7 drugs for preventing or treating infectious diseases for public health hazards, and 4 new drugs for developing innovative pharmaceutical companies. By drug group, anti-malignant tumors were 56.5% (13 items), COVID-19 treatments and vaccines 30.4% (7 items), chemotherapy drugs 4.3% (1 item), circulatory mechanical drugs 4.3% (1 item), and diabetes solvents 4.3% (1 item). Of the 17 Fast Track item permits, COVID-19 vaccines accounted for a high proportion of 10 items and 5 items of anti-malignant tumor drugs. Eight of the designated items are currently undergoing screening, and one item has not applied for permission. The average number of fast track days for the COVID-19 vaccine was 26 working days, and the average number of items excluding the vaccine was 51 working days. 22 preliminary reviews have been conducted so far to shorten the period of approval before applying for item permits. In the case of occasional screening using the preliminary review system when performing Fast Track, COVID-19 vaccines such as AstraZeneca, Pfizer, and Janssen applied for the screening. The Ministry of Food and Drug Safety is planning to launch a GIFT program based on its Fast Track experience over the past two years. The GIFT program is a program that supports global innovative medical products from the beginning of development (clinical) to quickly commercialize them, and pharmaceutical companies review designations when applying for Fast Track targets and, if necessary, decide on GIFT targets after consulting the Fast Track expert council. The GIFTprogram targets will receive various support such as applying rolling reviews that examine the prepared data first, close communication between reviewers and developers, regulatory consulting, and clinical results for products with excellent innovation (improvement of safety and effectiveness), submission after market, and preemptive application of global screening standards such as ICH.
- Policy
- GOV engrossed in minimizing damage from US's Bio Initiative
- by Lee, Jeong-Hwan Sep 20, 2022 05:57am
- The Korean government is busy preparing measures to protect the Korean industry from the Executive Order signed in the US by President Biden to launch a National Biotechnology and Biomanufacturing Initiative that focuses on research and manufacturing of pharmaceuticals within the United States, As the US government has not yet finalized its direction in regulating other countries on bio-related matters, the Korean government has also not yet decided on specific measures other than to actively utilize the Korea-US dialogue channel. However, the authorities are planning to seek countermeasures by increasing the frequency of joint ministerial meetings after holding an industry inspection meeting in relevant ministries. On the 19th, the Ministry of Trade, Industry, and Energy announced plans to hold a joint meeting this week with the Ministry of Health and Welfare, Ministry of Food and Drug Safety, Ministry of Science and ITC, etc. to discuss countermeasures. The authorities that will be directly responding to the US's Initiative are MOTIE and MOHW. The MOTIE and MOHW have held individual review meetings with relevant industries and institutions upon US’s decision to launch the Executive Order to launch the Initiative (Bio Executive Order). The MOTIE had discussed countermeasures with KoreaBIO and bio companies, and the MOHW with pharmaceutical and bio companies including the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, based on which the ministries will be sharing results to establish future plans at the joint meeting. In particular, the MOTIE plans to convey the position of domestic pharmaceutical and bio companies at the scheduled ministerial-level dialogue with the US Secretary of Commerce. The Korean government is expected to first prepare measures to minimize the impact of the Bio Executive Order by utilizing all of the Korea-US dialogue channels in each ministry until the US government finalizes specific regulations. An MOTIE official said, “As only the broad framework of the biomanufacturing policy has been yet set by the US, we plan to continue holding joint ministerial and industry inspection meetings until a specific regulatory plan is announced. In order to maximize opportunities for Korean companies and minimize damage, we will discuss the issue through various dialogue channels including the ministerial-level Korea-U.S. supply chain and industry dialogue, etc.” he explained. The official added, “The executive order launched by the US this time has given more weight to promoting its own domestic industry rather than regulating industry of other companies. The MOTIE will be holding a joint meeting with the MOHW and other ministries based on the results of the review meeting it had held with KoreaBIO. As the case may be, the Executive Order may become an opportunity for domestic pharmaceutical and bio companies to advance into the US market.”
- Company
- Influenza alert in three years
- by Chon, Seung-Hyun Sep 20, 2022 05:57am
- The influenza (flu) alert, which disappeared after the spread of COVID-19, was issued. September 12 years after 2010, influenza alert has come. The pharmaceutical industry is Corona 19 that virtually died out after the spread of flu drug market to expect a revival of the atmosphere. According to the industry on the 19th, the Korea Centers for Disease Control and Prevention issued a flu epidemic warning nationwide on the 16th. The Korea Centers for Disease Control and Prevention issued a flu pandemic warning nationwide between September 4 and September 10 this year, with 5.1 suspected flu patients per 1,000 outpatients exceeding the epidemic standard (4.9). The number of suspected cases per 1,000 for the past 23 weeks, outpatient clinics, flu, the highest this year. 4.8 members leapt over the last 12 weeks. In previous years, the flu epidemic standard was set at 5.8 per 1,000 outpatients, but this year, COVID-19 and the flu are likely to spread at the same time. It is the first time in two years and six months that the number of suspected flu patients per 1,000 outpatients has exceeded five since the ninth week of 2020. It has never exceeded five since it recorded 6.3 in the ninth week of the first week of March 2020. This means that the flu has never been prevalent for more than two years. This is the aftermath of a significant decrease in the incidence of infectious diseases due to strengthening personal hygiene management such as hand washing and wearing masks after the spread of COVID-19. As social distancing was lifted this year, the number of flu patients gradually increased. In the last 24 weeks, the number of suspected flu patients per 1,000 outpatients was only 1.8 but tripled in three months. The pharmaceutical industry is expecting a rebound in flu treatments that have virtually disappeared since the spread of COVID-19. According to UBIST, a drug research institute, the amount of outpatient prescriptions for flu treatments in 2019 recorded 22.5 billion won. However, it fell to 8.8 billion won in 2020, and only reached 40 million won last year. In the past two years, the size of the flu treatment market has decreased by 99.8%. It was reduced by 99.9% in three years from 44.7 billion won in 2018. The flu treatment market recorded 8.4 billion won in the first quarter of 2020, but plunged 99.8% to around 10 million won in the second quarter when COVID-19 began to spread in earnest. The flu treatment market recorded less than 100 million won for nine consecutive quarters from the second quarter of 2020. In the first half of this year, the prescription for flu treatment was less than 100 million won. After the spread of COVID-19, the flu treatment market virtually disappeared as the number of flu patients decreased sharply due to strengthening personal hygiene management such as washing hands and wearing masks. The Oseltamivir market, which is most commonly used as a flu treatment, has virtually disappeared. Oseltamivir is the active ingredient of Tamiflu. In the first half of this year, Oseltamivir's out patient prescription market was only 92 million won. It was only 60 million won in the first quarter and 32 million won in the second quarter. The size of Oseltamivir prescription in 2019 recorded 22.4 billion won, falling to 8.7 billion won in 2020 and shrinking to 40 million won last year. Pharmaceutical companies expect the flu treatment market to rebound as the number of flu patients increases. An industry official said, "We will consider whether to expand the production and supply of treatments while looking at the trend of expanding flu patients in the future."
- Policy
- 37 Tenelia's generics will soon be listed
- by Lee, Tak-Sun Sep 20, 2022 05:57am
- Earlier this year, Tenelia's generics followed Galvus generics, and the generic drug market for DPP-4 diabetes treatments began in earnest. According to the industry on the 19th, the Ministry of Health and Welfare recently disclosed the registration of Tenelia's generics next month. Tenelia of material patent is expired on October 25th. A total of 37 items of next month to enter the generic market. DPP-4 inhibitor market has used a total of nine species of products had not been released, but a strong patent protection for markets are opening up generic. 18 current generic for Galvus are reimbursed. The DPP-4 generic market is expected to begin in earnest. As a result, it is analyzed that as competition among pharmaceutical companies intensifies, it will affect original drugs that maintained the existing monopoly. In particular, some analysts say that Galvus and Tenelia, which are allowed to compete generically, could weaken their competitiveness among the nine original DPP-4 types.
