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- 2025-12-25 04:43:00
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- Sale of Atozet generics exceeds its orignial in 1 year
- by Kim, Jin-Gu Apr 29, 2022 05:42am
- The combination drug market for dyslipidemia treatment using the atorvastatin+ ezetimibe combination has increased twofold with the sudden growth of its generics. Moreover, the market share of the generics exceeded that of the original in Q1 of this year. The rapid expansion of the market last year is interpreted to be due to more than 100 companies joining in the competition after receiving approvals for their generics last year. ◆Atozet market increase twofold in 1 year due to entry of generics According to the market research institution UBIST on the 28th, outpatient prescriptions of atorvastatin+ ezetimibe combination drugs recorded ₩44 billion in Q1. This is a 109% increase from the ₩21.1 billion in Q1 last year. In other words, the market size had increased over twofold in just one year. The preference and prescriptions for the ‘statin+ezetimibe’ combination had been continuously increasing in the front line over the past few years. Sales of the original atorvastatin+ ezetimibe combination drug, Atozet, had also steadily increased during the period. Prescriptions of Atozet in Q1 recorded ₩21.4 billion, a 1% increase from the same period of the previous year (₩21.1 billion) The market has expanded rapidly since Q2 last year when generic products started entering the market in earnest. In fact, prescriptions of Atozet generics recorded ₩7.1 billion in Q2 last year, which surged to ₩15 billion in Q3 and ₩19.8 billion in Q4. In particular, sales of the generics recorded ₩22.7 billion in Q1 this year and exceeded that of the original (₩21.4 billion). A lot of Atozet generics entered the market after Q2 last year. Chong Kun Dang opened up the door for the entry of generics. Chong Kun Dang received approval for ‘Lipilouzet’, a combination drug that contains the same ingredients as Atozet in October 2020. In January of the following year, 21 companies received approval for their authorized generics of Lipilouzet. Authorized generics refer to already approved generic products with different packaging. Latecomer generics joined the competition in February. 89 companies received approval for Atozet generics then, and two more companies joined in June last year. In total, 113 companies currently own Atozet generics. Chong Kun Dang and other companies that were authorized to manufacture authorized generics of Lipilouzet released their products a month in advance. The companies had entered the market by listing their products on the reimbursement list in April last year. Other companies followed in May after receiving insurance reimbursement, totaling the number of competitors to 83. ◆Latecomers make rapid strides… authorized generics of Lipilouzet fail to preoccupy market Among the generics, Daewoong’s Litorvazet has made the most success. Litorvazet sold ₩3 billion in prescriptions in Q1. Following Litorvazet, Boryung’s L50 sold ₩2.1 billion, Jeil Pharm’s Lipitor Plus ₩2 billion, Yuhan Corp’s Atovamibe ₩1.9 billion, and HK.Inno.N’s Zepitor ₩1.4 billion. What’s interesting is that only 2 of the Top 5 generics – L50 and Zepitor- are Lipilouzet authorized generics. Even when broadening the scope to the top 10 generics, only 4 of the 10 items are Lipilouzet authorized generics. Among Atozet generics, the first generic Lipilouzet’s price is highest at ₩1,037, and Lipilouzet authorized generics are priced at ₩881, with other latecomers including Litorvazet set at ₩637 or lower. Lipilouzet received the highest price among generics at 53.55% of the original price by satisfying both the ‘direct bioequivalence testing’ and ‘Regulation on Registration of Drug Substances (DMF)’ requirements. Unable to satisfy the direct bioequivalence testing requirements, authorized generics received a price 15% lower than that Lipilouzet. Other latecomer generics had to receive a price even 15% lower. The stepped pricing system that was implemented in July 2020 requires the price of latecomer generics to be set 15% lower when over 20 products of the same item are already listed. In other words, the latecomer generics such as Litorvazet are showing good performance, increasing prescriptions by 61% compared to Lipilouzet Tab and by 71% compared to authorized generics of Lipilouzet Tab. When considering that Lipilouzet and the authorized generics have been released a month prior to the latecomer generics, the drugs enjoyed little market preoccupation effect. On the other hand, generic companies for authorized generics of Lipilouzet Tab had attempted to receive a pricing premium and preoccupy the market by paying an upfront payment to Chong Kun Dang but were unable to see as much profit as expected. The industry analyzed that consignees including Chong Kun Dang, Jinyang Pharm, Dongkoo Biopharma, Withus Pharm, and Dasan Pharmaceutical had made the most profit. Currently, Jinyang Pharm has the largest number of consignors. The company has been manufacturing and supplying Atozet generics to 26 companies including Daewoong Pharmaceutical. Chong Kun Dang is in charge of producing products for 21 companies including Boryung Pharmacuetical and HK Inno.N. Also, Dongkoo Biopharma (20 companies), Withus Pharm (15 companies), and Dasan Pharmaceutical (11 companies) also CMO generics for other companies.
- Company
- LG Chem will jointly sell Nesp & Regpara with Kyowa Kirin
- by Kim, Jin-Gu Apr 29, 2022 05:41am
- LG Chem announced on the 28th that it has signed a contract with Kyowa Kirin Korea to jointly sell two drugs, Nesp(Darbepoetin Alfa) and Regpara (Cinacalcet Hydrochloride)' in Korea. LG Chem is in charge of sales at the clinics level, and Kyowa Kirin Korea is in charge of sales at the general hospital level. Nesp is a continuous hematopoietic agent used to treat anemia in patients with chronic kidney disease. It is prescribed for hemodialysis or peritoneal dialysis patients or patients with chronic kidney disease before dialysis. LG Chem explains that treatment is highly convenient because it only needs to be administered once every one to two weeks. Since its release in South Korea in 2010, it has been steadily generating more than 20 billion won in sales. According to IQVIA, a pharmaceutical market research firm, Nesf's sales last year were 21.1 billion won. Regpara is a treatment for secondary parathyroidism in patients with chronic kidney disease. It can be treated with oral administration once a day. Secondary parathyroidism is a disease in which excessive production of parathyroid hormones continues due to decreased renal function and the size of parathyroid glands increases, and is known to be a progressive disease that intensifies as chronic kidney disease progresses. Regpara's revenue last year was 6.2 billion won. With the joint sales of Nesp and Legpara, LG Chem can expect about 27 billion won. LG Chem explained that the two drugs have the largest market share among drugs of the same family. Synergy with existing products is also expected. LG Chem has Espogen, the first-generation hematopoietic agent, and Nestykal, a treatment for hyperkalemia. Through this joint sale, the company plans to present expanded treatment options to medical staff with kidney disease. An official from LG Chem said, "We will continue to present various treatment options with customer value as the top priority. We will do our best to expand the market as soon as possible based on our strong national sales network and long business experience in the area of kidney disease." An official from Kyowa Kirin Korea said, "We expect that the joint sales partnership between Kyowa Kirin Korea and LG Chem will further increase the awareness of Nesp and Regpara to hospitals, clinics, and small and medium-sized hospitals. The two companies will make efforts to deliver higher levels of information and supply stable products to medical staff."
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- Immunotherapy Opdivo reattempts reimb in gastric cancer
- by Eo, Yun-Ho Apr 28, 2022 06:07am
- The cancer immunotherapy Opidvo is again attempting to receive insurance benefits for its gastric cancer indication. According to industry sources, ONO Pharma Korea and BMS Korea’s PD-1 inhibitor immunotherapy drug ‘Opdivo (nivolumab)’ will be presented for deliberation by the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service on the 18th of next month. In Korea, Opdivo was approved ‘as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma’ in June last year. With the added indication, the drug became the first and only domestically approved cancer immunotherapy for gastric cancer. However, Opdivo failed to receive reimbursement for the indication at the CDDC in February. At the time, the CDDC decided not to set reimbursement criteria for Opdivo in ▲ advanced or metastatic gastric adenocarcinoma, gastroesophageal junction cancer, and esophageal adenocarcinoma, and ▲ inoperable malignant pleural mesothelioma, Therefore, the industry’s eyes are on whether the company will be able to succeed in applying for reimbursement in gastric cancer this time. Gastric cancer is considered to be the most important field in need of extended reimbursement for immunotherapy drugs after lung cancer. Gastric cancer is the most prevalent cancer and the fourth most common cause of cancer deaths in Korea. Although gastric cancer has a favorable survival rate when detected in its early stages, the relative survival rate drops to 5.9% with distant metastasis. In particular, the current stand of care for HER2-negative gastric cancer is chemotherapy due to the unavailability of new drugs approved for first-line treatment for the past decade. Opdivo is expected to become a suitable alternative for these patients. Meanwhile, the efficacy of the combination therapy using Opdivo was demonstrated in the large-scale, Phase III CheckMate-649 trial. The median overall survival (mOS) of patients was 13.8 months for all patients randomly assigned to receive the Opdivo combination, a 20% reduction in risk compared to the 11.6 months in the control group. In PD-L1 positive patients (CPS ≥ 5), the Opdivo combination group’s mOS was 14.4 months, which was a 29% reduction in risk compared to the 11.1 months of the control group. Also, Opdivo improved the overall response rate (ORR) by 12% in the all-randomized population, and by 15% in PD-L1 positive patients (CPS ≥ 5). The complete response (CR) rate was also higher for the Opdivo combination group for both the all-randomized population and PD-L1 positive patients.
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- Sales of SGLT-2 diabetes drugs increased by 15%
- by Apr 28, 2022 06:06am
- The SGLT-2 inhibitor market, which surpassed 150 billion won in annual prescriptions last year, also grew 15% in the first quarter, surpassing 40 billion won in quarterly prescriptions. single and combination drugs have grown evenly. According to UBIST, a pharmaceutical market research firm, on the 28th, the total amount of outpatient prescriptions for SGLT-2 inhibitors in the first quarter was 40.2 billion won, up 15.0% from 34.8 billion won a year earlier. The quarterly prescription for SGLT-2 inhibitors, which was in the early 20 billion won in 2019, has nearly doubled in two years. The SGLT-2 inhibitor has been released as a type 2 diabetes treatment, expanding the disease group to the heart and kidneys, and indications are expanding. The SGLT-2 inhibitor is a mechanism that inhibits the reabsorption of glucose from the kidneys and releases glucose into the urine. This not only reduces blood sugar, but also reduces weight, kidney function, and blood pressure. This is why SGLT-2 inhibitors can also be used as heart and kidney drugs. Sales of AstraZeneca's Forxiga recorded the highest prescription amount of 11.6 billion won in the first quarter. This is an increase of 16.7% compared to 9.9 billion won a year earlier. Forxiga is leading the market with the most indications among competing drugs. It obtained indications of chronic heart failure in 2020 and expanded its scope to chronic kidney disease in August last year. All of them are the first of the SGLT-2 series. Beringer Ingelheim's Jardiance's prescription amounted to 10.3 billion won in the first quarter, up 5.2% from 9.8 billion won a year earlier. The gap with Forxiga widened in the first quarter of this year. In the first quarter of last year, Jardiance (9.8 billion won) had almost the same prescription as Forxiga (9.9 billion won), but it made a difference of 1.3 billion won. In November last year, chronic heart failure indications were added, and it is trying to expand its scope due to kidney disease. In particular, at HFpEF, Jardiance first released positive data. Handok's Suglat and MSD's Steglatro continue to perform poorly with quarterly prescriptions of less than 1 billion won. Prescription sales of Suglat and Steglatro in the first quarter were 900 million won and 400 million won, respectively. Compared to the same period last year, Suglat increased by 100 million won and Steglatro decreased by 100 million won. Unlike Forxiga and Jardiance, the two products are limited to type 2 diabetes, and clinical trials have not been conducted to expand their indications. They accounted for only 3.3% of the SGLT-2 inhibitor market. Xigduo achieved 10 billion won in prescription in the fourth quarter of last year. In the first quarter of this year, it also increased its prescription amount by 18.2% compared to the same period last year. During the same period, Jardiance Duo also increased its prescription amount from 5.4 billion won to 7 billion won, growing 28.5%. Jardiance Duo appeared in the market a year later than Xigduo, showing a difference of about 3 billion won. In the first quarter, prescriptions for SGLT-2 complex drugs amounted to 16.9 billion won, up 21.6% from 13.9 billion won a year earlier. Combination drugs have higher sales than single systems. In the first quarter of 2019, the prescription amount was 5.7 billion won, which was only one-third of the single system, and the quarterly prescription amount exceeded 10 billion won a year later, and 15 billion won last year. The gap between sales and single products has also narrowed significantly. Last quarter, the proportion of combination drugs and single drugs was 42:58.
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- Who will follow SK Bio with its homegrown COVID-19 vaccine?
- by Kim, Jin-Gu Apr 28, 2022 06:06am
- The marketing authorization for SK Bioscience’s homegrown COVID-19 vaccine 'GBP510' is nearing approval. If the drug is approved within the first half of the year as planned, GBP510 will become the first homegrown vaccine to be ever approved. With the developer of the first vaccine set, who will be the No.2 and No.3 in line is gaining attention. Currently, Eubiologics, Cellid, and Geneone Life Science are speeding up trials for their COVID-19 vaccines. The issue at hand is how the companies will secure a comparator vaccine for comparative trials. SK Bioscience had been able to quickly conduct a Phase III trial after securing the necessary comparator vaccines early on, other companies are having trouble securing comparator vaccines. ◆Eubiologics secures comparator vaccines and prepares to initiate global Phase III trial According to the pharmaceutical industry on the 27th, Eubiologics received approval to initiate its Phase III trial for ‘EuCorVac-19’ in three countries in Africa. Eubiologics’s COVID-19 vaccine in development is a synthetic antigen vaccine, the same as SK Bioscience’s GBP510 or Novavax’s Nuvaxovid. The company’s procurement of comparator vaccines played a decisive role in the initiation of the company’s Phase III trial in Africa. The latecomers in the COVID-19 vaccine development industry have been conducting Phase III trials by comparing the efficacy and safety of its vaccines with previously approved vaccines rather than with large-scale clinical trials. SK Bioscience had also conducted a Phase III trial by comparing its vaccine with AstraZeneca’s vaccine. The comparator vaccine secured by Eubiologics for the African trial is not one of the 5 vaccines (Pfizer, Moderna, AstraZeneca, Janssen, Novavax) that were approved in Korea. Eubiologics plans to conduct a clinical trial that compares the efficacy and safety of its vaccine with a comparator vaccine and expects to receive approval for a trial in the Philippines as well. An official from Eubiologics said, “The clinical trial will start at the local site within the month. If the Phase III trial is completed in Africa, it will be listed for Emergency Use Listing by the WHO, and then be supplied around low-income countries after obtaining export approval. ◆Have entered Phase III trials in Korea but have trouble securing ‘comparator vaccines’ Securing comparator vaccines is an issue in conducting Phase III trials in Korea as well, as Korea requires ‘vaccines approved in Korea’ to be used as comparators for domestic trials. A pharmaceutical industry official explained that although SK Bioscience was able to secure a comparator vaccine relatively easily because of its past CMO agreement with AstraZeneca, the situation is different for other vaccine developers. Global vaccine developers are showing a lukewarm reaction to being selected as a comparator vaccine for domestic companies due to concerns over technology leakage. However, if a comparator vaccine is not secured, the domestic companies’ concern is that it would take that much longer for the companies to develop their vaccines. An official from EUbiologics said, “If SK Bioscience receives approval for GBP510, we may use the vaccine as a comparator, but this is not our immediate plan as we would need to change our clinical trial protocol to enable this. We are working closely with the government to secure a comparator vaccine among those that are already approved in Korea.” ◆Companies change paths or give up development strategies due to difficulty securing comparatorvaccines Other companies are also having difficulty securing comparator vaccines. Companies are changing the development strategy or abandoning the development itself due to difficulty in securing comparators and the increased global vaccination rates and the smooth supply of vaccines already available in the market. Cellid received approval for a Phase IIb trial for 'AdCLD-CoV19-1' in Korea in January this year. If the Phase IIb trial is completed, the company would also need to secure a comparator vaccine for comparative trials. Its approval will depend on how well the company procures a comparator vaccine. Cellid had applied for the Phase IIb and III trials at the same time in November last year but was only approved for the Phase IIb trial due to the lack of a comparator vaccine. After failing to conduct the Phase III trial, Celid has developed a two-track strategy to continue clinical trials of the vaccine for primary inoculation that was in development while developing vaccines for booster shots (additional inoculation). Geneone Life Science changed its strategy from developing a vaccine for primary inoculation to developing a booster vaccine. Earlier this month, the company announced that the company completed the registration of subjects for the Phase IIa clinical trial of 'GLS-5310', which is being developed as a DNA vaccine. After confirming the safety and efficacy of clinical trials in a Phase IIa trial, the company plans to continue studying its vaccine through Phase IIb and III trials exclusively as a booster vaccine. HK Inno.N completed Phase I trials for its ‘IN-B009’ in development as a synthetic antigen vaccine. However, the company is pondering whether to proceed with Phase II trials. An official from HK Inno.N said, “We have completed Phase I trial for our vaccine but haven’t submitted a clinical trial protocol for Phase II trial plan yet. We haven’t decided on our direction from there.” Genexine withdrew its development. Genexine was the first among domestic companies to start the development of a COVID-19 vaccine in June 2020. Although it has completed the Phase IIa trial for 'GX-19N' in Korea, the company gave up proceeding with Phase II and Phase III trials last month. GX-19N was being developed through a DNA vaccine platform. No other vaccine approved around the world had adopted the use of this platform. As comparative clinical trials require the use of a control vaccine from similar platforms, it was virtually impossible to secure a control vaccine. For this reason, a large-scale Phase III clinical trial was inevitable for the company, which was why Genexine decided to stop the development of its vaccine determining that its business feasibility was low.
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- Novartis' anticancer drug/Rx division will be merged
- by Eo, Yun-Ho Apr 27, 2022 06:04am
- A change is expected in Novartis' subsidiary. Above all, the anticancer drug division and the Rx division, which have been operated independently, will be integrated. According to related industries, Novartis' Asia-Pacific Regional Headquarters has already been appointed as a representative of the integrated corporation. As a result, corporations such as Novartis Korea will also integrate their business units within this year. The anticancer drug division is led by CEO Shin Soo-hee, and the Rx division is led by CEO Yoo Byung-jae, who was appointed last year. The company consists of two business units, not only marketing and sales, but also support departments such as drug prices, rental, and permission. Therefore, if the integrated general manager is determined, manpower adjustment will be inevitable. Novartis' headquarters announced in April that it would introduce a new organizational structure and operating model designed to support innovation, growth and productivity goals as a pharmaceutical company looking forward to a new decade. As part of the reorganization, Novartis plans to merge its pharmaceutical and anti-cancer operations and create two independent commercial organizations, the U.S. Department of Innovative Medicine and the International Department of Innovative Medicine. Both organizations will have full profit and loss liability and customer experience, marketing, sales, sales ownership, and market access to each market across all treatment areas.
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- Additional formulations of Abbvie’s Skyrizi were approved
- by Eo, Yun-Ho Apr 27, 2022 06:04am
- The approval of an additional formulation of the IL-23 inhibitor ' Skyrizi' has increased the drug’s versatility in the field of plaque psoriasis. On the 22nd, Abbvie Korea announced that the Ministry of Food and Drug Safety additionally approved its Skyrizi Prefilled Syringe 150mg and Prefilled Pen 150mg formulations of its IL-23 inhibitor ' Skyrizi Prefilled Syringe Injection (risankizumab)’ for the treatment of adult patients with moderate-to-severe plaque psoriasis. With the approval, Skyrizi may additionally be administered 4 times a year as maintenance therapy in two formulations - Skyrizi Prefilled Syringe 150mg and Prefilled Pen 150mg. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the development and global sales of the drug. The 150mg formulation of Skyrizi is administered through a single shot of a 150mg injection. It is administered twice as a subcutaneous injection early on (at week 0, week 4), then every 12 weeks thereafter. The previously approved 75mg formulation was administered in two shots per visit. The approval of the new 150mg formulation would allow for the number of annual shots required by half. In other words, the newly approved dose of Skyrizi is 150mg (2 shots of 75mg prefilled syringe or 1 shot of Skyrizi Prefilled Syringe 150mg or Prefilled Pen 150mg) administered subcutaneously at week o and week 4, and every 12 weeks thereafter. Eun-Joo Park, Professor of Dermatology at Hallym University Sacred Heart Hospital said, “Skyrizi as a maintenance treatment demonstrated a consistent safety profile and a high skin improvement effect that can be maintained in the long-term with 4 doses a year in various clinical trials. The addition of the 150mg dose that allows for patients to receive the required dose with a single shot, would increase convenience among HCPs and patients as well as broaden their range of choices.” Skyrizi can be subcutaneously administered at hospitals or be administered at home after receiving training for subcutaneous injections. The new 150mg Prefilled Pen that was additionally approved was devised to improve the treatment experience for the patients. Abbvie explained that the additional approval of the new formulation was based on clinical results that demonstrated that a single shot of the Skyrizi Prefilled Syringe 150mg met the primary efficacy endpoint was bioequivalent to two shots of the existing 75mg formulation. The Prefilled Pen 150mg formulation also demonstrated its bioequivalence with the Prefilled Syringe 150mg. Skyrizi is an IL-23 inhibitor that selectively inhibits IL-23 by binding to its p19 subunit. IL-23 is involved in various chronic immune-mediated conditions including psoriasis. The 150mg formulation was approved by the European Commission in May 2021 to treat moderate to severe plaque psoriasis in adults after systemic or phototherapy. Phase III trials on Skyrizi in psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis are still ongoing. In Korea, the drug was approved in December 2019 as a treatment for adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy (including biological therapy). The drug then added the psoriatic arthritis indication on the 5th of last month. Skyrizi may be used to treat adult patients with active psoriatic arthritis who responded inadequately or were intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
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- Benefit of Pfizer's Cibinqo is applied
- by Eo, Yun-Ho Apr 26, 2022 06:12am
- Another JAK inhibitor aims to enter the atopic dermatitis insurance benefit right. According to related industries, Pfizer Korea recently submitted an application for benefits of Cibinqo, a new drug for JAK1. As Lilly's Olumiant and AbbVie's Rinvoq are expected to be applied in May. Cibinqo was approved in Korea in November last year when the listing process of Olumiant and Rinvoq was underway. There was an observation that Cibinqo would also hurry to apply for registration and proceed with the registration process together, but the timing of Pfizer's application was later than expected. This drug acts as a mechanism to control the levels of IL 4, 13, 31, and 22 and TSLP on the thymus substrate, which are involved in the pathophysiological characteristics of atopic dermatitis. The permitted indication is the treatment of symptomatic atopic dermatitis in moderate cases of adults and adolescents aged 12 or older. Cibinqo proved its effectiveness through phase 3 clinical studies such as JADEMONO-1, MONO-2, and COMPARE. In the 12th week, the eczema severity evaluation index was lowered by more than 70%, and the treatment effect was proved in indicators such as relieving itching within two weeks of treatment. Among them, the JADE Mono-1 study randomly assigned and analyzed oral Cibinqo 100 mg, Cibinqo 200 mg, or placebo administration groups once a day for 12 weeks for patients with severe-moderate atopic dermatitis over the age of 12. In the Cibinqo 200m group, 63% of patients achieved a 75% improvement in Eczema Severity Index (EASI) at 12 weeks of treatment, compared to 12% in the placebo group, and 90% improvement in Eczema Severity Index (EASI-90) at 39%.
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- RET targeted therapy Retevmo opens era of precision medicine
- by Apr 26, 2022 06:12am
- Lilly Korea’s RET targeted therapy Retevmo(selpercatinib) has landed in Korea. The drug is expected to become a new treatment option in RET fusion-positive patients with non-small-cell lung cancer and thyroid cancer. Lilly Korea held an online press conference to celebrate the approval of Retevmo on the 25th. Professor Min Hee Hong of Oncology at Yonsei Cancer Center and Professor Won Gu Kim of Endocrinology and Metabolism at Asan Medical Center attended the virtual event to explain the significance of Retevmo’s approval. Retevmo was approved by the Ministry of Food and Drug Safety in March last year as a treatment for RET fusion-positive NSCLC and thyroid cancer patients. More specifically, the drug is indicated for the treatment of▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. At the press conference, Professor Hong said, “Lung cancer patients with RET mutations are twice more likely to experience CNS metastasis, but had to be treated with chemotherapy, which is less effective and more prone to toxicity due to the lack of RET targeted therapies. Retevmo demonstrated significant response in the LIBRETTO-001 trial, as well as an 82% ORR in patients with CNS metastasis. 23% of these patients achieved complete response.” Kim added, “Although the survival rate for thyroid cancer is known to be high patients with RET point mutated medullary thyroid cancer have a poor prognosis and low survival rate. Also, patients with thyroid cancer who are refractory to radioactive iodine therapy have a low survival rate and life expectancy. Retevmo has shown a 79% and 69% ORR in the abovementioned patient groups, opening a new era of precision medicine.” RET mutations occur in 2 to 6 % of all NSCLC cases and are more often found in adenocarcinomas and younger patients under 60 years of age and non-smokers. In NSCLC, RET fusions occur more than RET mutations. In thyroid cancer, RET fusions are reported in up to 40% of the cases. RET fusions can be identified through rest such as NGS, FISH, RT-PCR, etc. Among the tests, NGS is known to be the most effective diagnostic method for identifying RET fusions. However, it takes around one month to receive results after NGS testing, and as ‘Keytruda,’ a reimbursed immunotherapy option already exists for NSCLC in the first line, it is highly likely that Retevmo will not be selected as a first-line treatment in these patients. Professor Hong said, “As RET fusion is not a common mutation, we cannot idly just wait for the test results, therefore it is likely that we will use immunotherapies first. However, using immunotherapies before Retevmo may reduce the response rate to Retevmo, this is why it is important for us to receive the NGS results as quickly as possible.”
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- President-elect Yoon visits SK Bioscience HQ
- by Kim, Jin-Gu Apr 26, 2022 06:12am
- President-elect Suk-yeol Yoon visited SK Bioscience headquarters in Seongnam, Gyeonggi-do, and promised “We will spare no effort in the development of vaccines so no one can say they could not develop vaccines due to lack of money.” Transition team chair Cheol-soo Ahn and members of the Social Welfare subcommittee of the transition team accompanied Yoon to the site, and Tae-won Chey, Chairman of SK Group, and Jae-Yong Ahn, CEO of SK Bioscience were also present at the site. According to SK Bioscience, president-elect Yoon observed the entire vaccine R&D process, from the extraction of animal cells used for vaccine development and production to culturing, fermentation, purification, and analysis. Yoon said, “I will visit more R&D sites in the future. Korea’s economy, security, and health all depend on this.” Yoon said, “In my administration, I plan to spare no support for companies that develop vaccines and treatments for the pandemic, including SK Bioscience. If companies ask for loosening of some regulations in the R&D process, I will actively review it and make sure that the companies are not inconvenienced." Jae-Yong Ahn, CEO of SK Bioscience, said, “We need steady support from the government to continue on our hard-earned vaccine development capabilities." Transition team chair Cheol-soo Ahn said, “The new virus is an important national crisis that requires continued management. Using this as an opportunity, it is the new administration’s task to create a data-driven disease control and prevention system. To SK Bioscience, transition team chair Cheol-soo Ahn said,” The NA had always deferred making decisions on vaccine-related budgets as a low priority agenda, but the new administration’s goal is to secure vaccine sovereignty in Korea by investing in vaccine development so Korea could gain vaccine development capabilities.” On the morning of the same day, SK Bioscience had announced that its own synthetic antigen COVID-19 vaccine candidate’GBP510’ had shown superior immune response to its comparator in a Phase III clinical trial. After securing safety data on GBP510 within the month, the company plans to apply for domestic and overseas approvals for its drug as a vaccine used for COVID-19 prevention after basic vaccination .
