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- 2025-12-24 21:46:20
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- Moderna releases first Omicron-specific vaccine, Spikevax-2
- by Sep 22, 2022 06:02am
- On the morning of September 21st, vaccine transport vehicle loaded with Moderna On the 21st, Moderna announced it will be releasing ‘Spikevax-2,’ its Omicron-containing bivalent booster vaccine. When released, the vaccine will be the first Omicron-specific vaccine to be released in Korea. Modern’s mRNA vaccine, Spikevax-2 (elasomeran/imelasomeran) has been approved by the Ministry of Food and Drug Safety on the 8th for use in people aged 18 years or older as a vaccine to prevent COVID-19. The approval was based on Phase II/III clinical trial that evaluated the efficacy of Spikevax-2 that compared Spikevax-2 with Moderna’s previous vaccine (Spikevax) in seronegative participants (participants who have never been infected with COVID-19). Results showed that the new vaccine met all major efficacy endpoints, including neutralizing antibody response to Omicron BA.1. Trial results also showed that additional vaccination with Spikevax-2 increased neutralizing antibodies against Omicron by 8 times in the seronegative group. Also, the new vaccine induced a stronger neutralizing antibody response than the previous vaccine against Omicron subvariants BA.4/5. Changes in the geometric mean functional relationship (GMFR) before/after vaccination showed that Spikevax-2 boosted neutralizing titers against BA.4/5 by 6.3-fold. Such results were shown in all participants regardless of prior COVID-19 infection history. Moderna is in close discussions with the Korea Disease Control and Prevention Agency (KDCA) on using Spikevax-2 as a booster dose from early October.
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- 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."
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- 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.
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- 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.
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- 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."
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- 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."
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- Patent term extensions for advanced biologicals under review
- by Kim, Jin-Gu Sep 20, 2022 05:56am
- The Korean Intellectual Property Office (KIPO) is pursuing a plan to apply the patent term extension system to advanced biological products that were left unattended within the system through law amendments. According to the pharmaceutical and biopharmaceutical industry on the 19th, KIPO prepared a systemic reform plan that contained the amendments above and is collecting industry opinion. Under the current Patent Act, the subjects eligible for the patent term extensions are stipulated in Article 7 of the Enforcement Decree of the Patent Act. However, the application of the regulation is limited to ‘drugs’ that are allowed marketing authorization under the Pharmaceutical Act or to ‘psychotropic substances’ under the Narcotics Control Act. When the Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals was separately enforced from the Pharmaceutical Affairs Act, it resulted in advanced biopharmaceuticals such as the latest gene and cell therapies being omitted from the extension list. In fact, Novartis had applied for two patent term extensions for Kymriah, which was approved as an advanced biopharmaceutical product, but its patent term extension is not being recognized due to the continued incomplete legislation. Industry concerns are rising over the confusion that would increase in the scene with more than 20 advanced biopharmaceuticals from pharmaceutical companies in Korea and abroad being approved one after another since Kymriah, including Novartis’s Zolgensma and Luxturna. To address this, KIPO is reviewing a plan to add ‘Advanced biopharmaceuticals approved under the Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ to subjects eligible for patent term extensions in Article 7 of the Enforcement Decree of the Patent Act This reform plan is expected to be discussed with the other reforms being prepared by KIPO, including ▲adjusting the number of patent rights that can be extended per item ▲introducing an upper limit on the duration of valid patent rights and ▲ introducing remedies after extension rejection decisions. However, unlike other reform plans, including advanced biopharmaceuticals in the patent term extension regulation, is expected to proceed more smoothly, as the position between the original and generic companies is not that different.
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- 41 were vaccinated in 11 days with K-COVID-19 vaccines
- by Sep 19, 2022 05:57am
- SK Bioscience’s COVID-19 vaccine is being released To address the low vaccination rate for Korea’s first homegrown COVID-19 vaccine, SKYCovione, the government has greatly expanded the eligibility for the vaccine. With the expansion, whether allowing the use of domestic vaccines to those who received their 1st to 3rd vaccinations will increase utilization of homegrown vaccines is gaining attention. However, the release of the Omicron-specific vaccine in Kores that is scheduled for next month is expected to act as a variable. During the opening remarks made by the first general coordinator of the Central Disaster and Safety Countermeasures Headquarters, Ki-Il Lee (2nd Vice Minister of Health and Welfare), during the CDSCH meeting held on the morning of the 16th, Lee said, “The CDSCH will expand the scope of vaccine eligibility for SKYCovione from the primary (1st and 2nd) vaccination to 3rd and 4th booster shots.” With the decision, people may reserve their 3rd and 4th vaccinations with SKYCovione through http://ncvr.kdca.go.kr or the call center, or receive same-day vaccinations at public health centers or some assigned medical institutions. The government explained that SKYCovione can be used as booster shots as its safety and efficacy of the SKYCovione have been demonstrated. Clinical trials for SKYCovione booster vaccinations, an investigator clinical trial led by KDCA, are currently in progress, and its results have not yet been released. According to the interim results of the trial, SKYCovione induced neutralizing antibody responses an average of 11 times higher in the original COVID-19 virus (Wuhan strain), 51.9 times higher for Omicron BA.1, and 28.2 times higher for Omicron BA.5 after vaccination with SKYCovione in 5 treatment groups. After the CDSCH meeting, Young-rae Sohn, Head of the Social Strategy Unit of the Central Disaster Management Headquarters, explained, “We first recommend mRNA vaccines for those who are receiving booster shots, however, those who do not wish to further receive vaccinations with mRNA vaccines for various reasons, such as discomfort after receiving primary and secondary vaccinations with mRNA vaccines, may receive additional vaccinations with SKYCovione.” In other words, Pfizer and Moderna’s mRNA vaccines are first recommended as boosters until formal approvals are granted to SKYCovione in that indication, but those aged 18 years or older who cannot or do not want to receive mRNA vaccines can receive SKYCovione as boosters. Such a decision has been deemed to be made despite the non-availability of clinical trial results for the indication as a preemptive measure to increase the utility of domestic vaccines. Although vaccinations started for SKYCovione on the 5th, the rate has been very low. According to the KDCA, the cumulative number of people that received vaccination with SKYCovione as of midnight on the 16th was 41 (1st vaccination), a mere 5.8 persons per day. This is less than 0.1% of the initial lot of 609,000 SKYCovione vaccines of the 10,000,000 vaccines purchased in advance by the government. This is because 97% of those eligible for primary vaccinations with SKYCovione have already received vaccinations. On the other hand, as the vaccination rate dropped greatly to reach 75.1%, for the 3rd vaccination and 16.5% for the 4th vaccination, allowing the use of SKYCovione as such booster shots are expected to greatly increase the use of SKYCovione. However, one variable that lies in its use is that foreign vaccines targeting the Omicron variant have already arrived in Korea and will begin vaccinations next month. On the 15th, 805,000 doses of the bivalent vaccine by Moderna that targets both the original strain (Wuhan strain) and the BA.1 subvariant arrived in Korea. 806,000 courses of the bivalent vaccine additionally arrived on the 17th. Pfizer’s bivalent vaccine is also being reviewed. The KDCA has recommended the new bivalent vaccine as a priority for high-risk groups, such as those aged 60 years or older, those hospitalized or serving in long-term care facilities, and those who are immunocompromised, and as a second priority for people in their 50s, those with underlying diseases, and healthcare workers. In addition, group facility officials and adults aged 18 to 49 are also allowed to receive vaccinations but were excluded from subject recommendations. Therefore, it is expected that demand for the Omicron-targeting vaccines will become higher than that for SKYCovione in October. The demand for SKYCovione may increase in groups who are not subject to the recommendations made for the bivalent vaccines, but whether this alone will increase the vaccination rate for SKYCovione remains in question, as the overall will to receive vaccinations in itself had dampened greatly. According to the ‘COVID-19 vaccine awareness survey’ published by Byung Chul Chun’s team of the Department of Preventive Medicine and Vaccine Innovation Center at Korea University College of Medicine, less than half –45.7%-- of the 1,500 adult survey respondents over the age of 19 responded that they are willing to receive COVID-19 vaccinations this winter. 30.5% responded that they have no will to receive COVID-19 vaccinations at all. In other words, 3 of 10 respondents said they would not receive vaccinations. Furthermore, with Moderna and Pfizer hastening the introduction of their bivalent vaccines that target Omicron subvariants (BA.4/5), their gap with domestic vaccines is expected to widen further. The authorities are discussing the possibility of receiving marketing authorization for its Omicron subvariant-targeting bivalent vaccines that were approved by the US on the 31st of last month.
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- Breast cancer drug Nerlynx can be prescribed
- by Eo, Yun-Ho Sep 19, 2022 05:56am
- Breast cancer drug Nerlynx can be prescribed in general hospitals. According to related industries, the oral tyrosine kinase inhibitor Nerlynx, which inhibits Bixink Therapy's HER2 protein, passed the Drug Committee (DC) of the Big 5 Advanced General Hospital, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital. However, as it is still a non-reimbursed drug, it is expected to take some time until the prescription is reimbursed. This drug was submitted to the Health Insurance Review and Assessment Service in February, but it was judged that the benefit standard was not set. Bixink Therapetics plans to submit it again in the second half of this year. HER2-positive early breast cancer has a 1.89 times higher tendency of brain metastasis than HER2-negative breast cancer. The high incidence of brain metastasis is interpreted to mean that it directly affects the survival rate. When comparing the 5-year survival rate of metastatic breast cancer in Korea, the 5-year survival rate of patients with cerebral metastasis is only 10.7%, which is a significant difference compared to the 34% of patients with metastatic breast cancer. Compared to the past, a number of HER2-positive early breast cancer target treatments have been developed. However, in the case of current standard therapy treatments, drugs that prevent brain metastasis or prove treatment effects are still insufficient. In a five-year long-term follow-up study, Nerlynx reduced the risk of recurrence or death in HER2-positive early breast cancer women by 42% and reduced the risk of developing or dying of brain metastasis by more than 59%. Nerlynx was originally a drug developed by Puma Biotechnology in the U.S., and was first approved by the U.S. FDA as an extended adjuvant therapy for early HER2 positive breast cancer patients in July 2017. In February 2020, the indication for the treatment of metastatic HER2 positive breast cancer was expanded. Bixink introduced Nerlynx in Korea in October last year, and the current indication is "extension adjuvant therapy for early breast cancer patients who are HER2 positive and hormone receptor positive within one year of the completion of Herceptin-based treatment after surgery."
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- Companies are ending a series of phase 3 of core R&D
- by Lee, Seok-Jun Sep 15, 2022 05:55am
- Samchundang ends phase 3 of Eylea biosimilar. Top line of Ildong's Zochova will be unveiled around November. Pharmaceutical companies' core R&D phase 3 is ending one after another. Corporate value is expected to change depending on the results. Some companies are seeking foreign permission using phase 3 data. DAE HWA recently completed an application for permission for Liporaxel, a gastric cancer drug containing Paclitaxel. The application for permission is based on Liporaxel efficacy and safety data. The clinical trial compared the efficacy and safety of Liporaxel and Paclitaxel injections Taxol as a secondary treatment for patients with advanced gastric cancer. Liporaxel, which was licensed in Korea in 2016, is the world's first PO Paclitaxel. Currently, Paclitaxel is being used as a single drug recommended by CSCO in China for secondary treatment of advanced gastric cancer. Samchundang also recently ended phase 3 of the Eylea biosimilar (SCD411). Phase 3 of SCD411 was conducted on 576 patients with macular degeneration in 15 countries, including the United States and Japan, starting with the first patient administration in September 2020. Comparative studies such as effectiveness and safety between SCD411 and Eylea were conducted. Samchundang expects to receive the final phase 3 clinical report of SCD411 in January 2024. The company is also pushing for partner contracts along with producing phase 3 results. Negotiating partners conducted a final due diligence in July this year to evaluate the production and quality management eligibility of SCD411. At the end of August, Ildong completed a phase 2/3 in Korea of Zochova (S-217622), a candidate for oral COVID-19 treatment. Topline results are expected to be produced around November. Ildong is co-developing Zochova with Shionogi, Japan. Ildong has been conducting phase 2b and phase 3 of Zochova for patients infected with mild, moderate, and asymptomatic COVID-19 in Korea. The size is 204. CTC Bio ended the administration of CDFR0812 phase 3 clinical trial patients at the end of April. Phase 3 of CDFR0812, which has been held since 2019, was conducted with 795 people. It is currently under statistical analysis and the results are expected to be released within this year. The substance is non-reimbursed and can be released immediately upon approval by the Ministry of Food and Drug Safety. CTC Bio has signed a business partnership with Dongkoo Pharmaceutical Co. for CDFR0812. Dongkoo owns about 5% of CTC Bio. A market official said, "As phase 3 of core R&D materials of pharmaceutical companies are terminated one after another, results are expected to be drawn soon. "Company value will fluctuate depending on when and when the data results are released," he analyzed.
