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- 2026-04-14 05:09:10
- Company
- Y-Biologics has transferred anti-cancer drug technology
- by An, Kyung-Jin Jul 08, 2021 05:58am
- Y-Biologics announced on the 6th that it has signed a license agreement with French pharmaceutical group Pierre Fabre for antibody candidates. The deal is worth up to 116.4 billion won, including upfront fee and Milestone. Under the deal, Y-Biologics grants Pierre Fabre the right to exclusively develop and commercialize YBL-003, which has been developed for solid cancer treatment purposes worldwide. YBL-003 is a type of Checkpoint inhibitor that controls macrophage function and T-cell activity to reactivate the immune system of the tumor microenvironment and kill cancer cells. It is an early-stage leading material, and milestones can occur whenever the development of YBL-003, such as preclinical and clinical, proceeds and reaches commercialization goals. Technical fees for sales are guaranteed separately. However, detailed contract terms such as initial down payment were not disclosed. Industry sources say that the license contract for YBL-003, which is an early stage of development, could be concluded because the two companies maintained a close cooperative relationship while conducting joint research since last year. They have agreed to study three targets every year and jointly study and transfer up to 15 targets during the contract period. The joint research contract between the two companies is three years, and the contract can be extended for the next two years. YBL-003 is considered highly likely to be used as an immune anticancer drug for solid cancer targets as it can expand its adaptations to stomach, lung and breast cancer. Pierre Fabre plans to develop a new design drug optimized for tumor treatment through preclinical and clinical development after the introduction of YBL-003. This contract is the first of 15 targets, and there is a possibility that additional contracts will be made in the future. Pierre Fabre is the second largest pharmaceutical group in France. Last year's sales amounted to 2.3 billion euros. Recently, while adjusting R&D priorities, it has focused on apothecary fields such as targeted treatment and immuno-tumorology. In addition to colon cancer, breast cancer, lung cancer, and melanoma, it is known that there is a high interest in pre-cancer diseases such as photokeratosis. Y-Biologics is a bio-venture that specializes in developing antibody new drugs based on its own platform. It was founded in 2007 by Dr. Park Young-woo, who has been working on antibody new drugs for 20 years in LG Life Sciences. It is discovering and developing various pipelines based on original technologies such as more than 100 billion kinds of human antibody library "Ymax-ABL" and dual antibody platform "ALiCE". It is currently in the process of listing on KOSDAQ through technical specials within this year. Earlier this year, it passed the screening, receiving A ratings from two professional evaluation agencies designated by the Korea Exchange, and filed a preliminary review of KOSDAQ listing in May. Park Young-woo, CEO of Y-Biologics, said, "I am very happy to sign the first license agreement with Pierre Fabre. As joint research is underway on another innovative target, we expect cooperation between the two companies to further develop innovative immune tumor treatments targeting the tumor microenvironment."
- Company
- MFDS in a month-long silence regarding Champix issue
- by Jul 07, 2021 05:54am
- Confusion in the field continues as the impurity issue of the smoking cessation treatment ‘Champix(varenicline)’ remains unresolved. Contrary to the U.S. and Canada, where the authorities preemptively provided guidelines to patients and HCPs while notifying them of the product recall and the possibility of impurities, the Korean health authorities have kept their silence for over a month. The Ministry of Food and Drug Safety had ordered Champix manufacturer Pfizer and other domestic manufacturers to investigate the impurities earlier last month. However, this fact was not publicly announced by the authorities and was disclosed through Dailypharm’s report on the 14th of last month. Pfizer had first stopped the supply of Champix, however, confusion remains in the field. The official notice that Pfizer had sent to distributors on the 11th last month did not indicate any possibility of impurities. In the notice, Pfizer wrote, “The product is out of stock due to supply shortage. We are experiencing a shortage due to disruptions in global distribution. We expect to resume supply from mid-July (subject to change).” An official from the distributing industry said, “We became aware of the impurity issue through the news article. We are still unsure whether to sell or keep the current inventory, and whether resupply will be possible from mid-July. We asked Pfizer directly but didn’t get a clear answer.” On this, an official from Pfizer said, “(The reason for not specifying the possibility of impurities) We were focusing on notifying the distributors of the shortage in supply.” The official continued, “We are doing our best to address the situation, from inspecting for impurities to preparing follow-up measures.” However, a month has passed since the issue arose, and still no guideline has been issued for the prescription and intake of Champix to inform patients and HCPs. This is in stark contrast to how the U.S. and Canada provided guidelines while announcing the recall due to concerns over impurities. On the 8th and 30th of last month, Canadian health authorities had advised HCPs to “Not dispense the 5 lots of Champix that were affected due to the potential safety risk posed by long-term exposure to this impurity, and consider using available alternative products on the market,” while announcing the recall of Champix due to safety concerns. On the 2nd of this month, the U.S. FDA has also alerted people of the” voluntary recall of nine lots of Champix.” The FDA advised “healthcare professionals to consider other available treatment options for the patient’s medical condition,” and that “patients should continue taking their current medicine until their doctor or pharmacist gives you a replacement or a different treatment option.” In addition, the FDA recommended Pfizer revise its recall to the consumer level so that medical institutions and patients may request a refund for the Champix currently in the market.” However, Korea’s MFDS has not announced any official position on this matter. This lead to patients newly being prescribed the drug even after the issue rose to the surface. “I only became aware of the impurity concern in an article after being prescribed the drug. I am taking medications for hyperlipidemia, so I specifically asked my doctor about precautions when taking the drug, and the doctor assured me there was no issue. I believe the doctor wasn’t aware of this impurity issue either. With no guidelines set on this matter, I am not sure whether I should start taking the Champix I was prescribed or not,” said one patient. It is yet unclear at which stage the 'N-nitroso-varenicline' impurity detected in Champix occurred, and what the standards are. Also, whether the problem is limited to some lots (manufacturing unit), or is an issue for the formulation itself that contains varenicline is uncertain.
- Company
- [Reporter's view] Korean patients to name specific drugs
- by Eo, Yun-Ho Jul 07, 2021 05:54am
- A growing number of patients are looking for specific "Rx drugs." Patients who wanted certain OTC by visiting pharmacies are now finding a doctor and wanting certain Rx drugs. It is said that the demand for prescription, which was made in the past in the line of original and generics, is even spreading to the area of anticancer drugs. Times have changed. Patients or their families are now searching for new drugs or the clinical trial database (clinicaltrial.gov). When domestic licensed drugs are not covered by insurance benefits, complaints are poured out to the HIRA, the MOHW. Cheongwadae's petition is no exception. A professor at a university hospital said, "Patients already know the concept of reimbursement and non-reimbursement, and they demand a combination of prescriptions for the drugs. Of course, I try to reflect the patient's expression as much as possible, but sometimes I'm embarrassed by ridiculous demands." For example, diabetes patients who were taking Sulfonylurea are asking for DPP-4 inhibitors or hypertension patients who were taking ARB single drugs are actually asking for prescription of ARB+CCB complex drugs. But the right to prescribe Rx is a doctor's own right. The public has delegated them to doctors with expertise for their health. Even if the public's level of knowledge is high and there is distrust in the current medical society, the prescription of Rx drugs should be prioritized by professionals' medical judgment.
- Policy
- Generic prices are 41-54% more expensive than foreign ones
- by Lee, Hye-Kyung Jul 07, 2021 05:53am
- The level of generic prices in Korea is 41 to 54% higher than that of foreign generics. This leads to an interpretation that if domestic generics are replaced with foreign medicines, 41-54% of costs will be reduced if only tariffs and transportation costs are compared. The findings were recently published by The Korean Association of Health Economics and Policy in its "The Cross-National drug price computing on the methods" (Korea University's College of Pharmacy, Bae Eun-mi, Choi Sang-eun, Kang Daewon, and Kyungsun Shin). To investigate generic drug price levels in Korea, we conducted a cross-national drug price comparison. Also, it was investigated whether the price level could differ when the price comparison method was changed. Bilateral comparisons with 15 countries were conducted for the top 23 molecules based on health insurance claims data. As a result, the price level of generic drugs in Korea was slightly different depending on the method, but it was overall higher than that of comparison countries. The weighted average price of generics was similar to that of the brand, and none of the launch date, the market share, and the number of competing items appear to affect the drug price level. This study has demonstrated the sensitivity of cross-national drug price comparisons to the methods used, including comparison countries, weights, and price type. A total of 23 ingredients are included in this analysis, and the 2016 claims for these drugs are about ₩2 trillion. It accounted for 18.4% of all claimed medicines at ₩800 billion. According to the analysis, the price level of generics in 15 countries could be seen as 61% to 78% of Korea on average (simple average comparison basis), and the average of Group A, which has a higher economic level than Korea, was 77% to 88% of Korea's drug price level. When usage weights are applied, the level of drug prices in foreign countries is lower, indicating 41%-54% of the level of drug prices in Korea. In terms of the level of drug prices by country, Switzerland and Japan were the only countries that could be said to have higher generic prices than Korea. Some countries, such as the United Kingdom and Germany, had higher generic prices than Korea, but it was not known at what level the actual price (the country's weighted average price) was formed between the highest and lowest prices. The price level of brand drugs was formed slightly higher than the generic weighted average in Korea, and the weighted average of generic drugs in Korea was located at the top of the overall generic price range. Korea's upper limit price included wholesale distribution margins and VAT without a separate retail margin, and the average of 15 countries was similar to that of Korea (94-114%) compared to that of other countries. The drug price level by ingredient was overwhelming for systemic antibiotics, digestive systems, and metabolic medicines compared to brand drugs, but the price was similar to brand drugs. When listed in order of the amount of claims, the Korean generic price was higher than the foreign generic price in the ingredients with high claims. The earlier the initial notice date, the higher the proportion of generic drugs used, but the lower the price compared to brand and foreign generic prices. Although the generic share of ingredients with a large number of items was high, the price level was not lower than that of foreign countries, apart from the presence of competition. "Considering that most countries (excluding the UK) in the analysis use a reference pricing system and that there will be price competition between generics, it can be assumed that there will be more use of low-cost generics," the research team said.
- Product
- Consult with MD about controversy over Champix?
- by Jul 07, 2021 05:53am
- Concerns over the detection of carcinogens in the anti-smoking supplementary drug Champix (Varenicline), pharmacies are also making a series of inquiries. However, there are no clear guidelines for existing patients, adding to the confusion. As part of preemptive measures related to the impurity crisis, the domestic supply has been completely suspended and the investigation is underway at the global headquarters level, but no guidelines have been prepared for refunds or suspension. Therefore, pharmacists explain that it is difficult to respond to questions about whether pharmacies continue to take them. Pharmacist A said, "There have been more than a few recent inquiries from existing users asking if they can continue taking the medicine after hearing media reports." "There is a risk of cancer, so we are asking the pharmacy whether the dose continues or not," he said. Pharmacist B also had patients taking Champix asking the same question through the pharmacy, and he was confused when he asked Pfizer whether to take it continuously. The pharmacist asked the patient how to guide him in terms of safety, and the pharmaceutical company replied, "We can't give you advice that you can't take it steadily, so I have to discuss it with the doctor in charge." "It is sensitive to give accurate and clear answers because it is currently under investigation. As there are people who have already been prescribed and taken, we expect many inquiries from pharmacies." The pharmacist said, "It is absurd why they ask us to consult a doctor about impurities," and added, "There should be guidance from pharmaceutical companies on how to respond." The pharmacist actually asked the lawmaker, but the doctors also did not give a clear answer. He stressed the need to prepare guidelines for refunds and inquiries. The MFDS has launched an investigation into the impurities of the Sartan hypertension drug and the anti-smoking drug Varenicline. Regarding the guidelines, Pfizer explained, "We are currently investigating the possibility of Nitrosamine impurities, so we are guiding you to consult with a doctor about whether to take them. It is said that it is difficult for pharmaceutical companies to express their position on the suspension or recommendation of medication because they have not received additional recommendations from regulators other than the suspension of supply. The official predicted that follow-up guidelines will be prepared based on the results of the inspection. "The risk of exposure to Nitrosamine from taking Varenicline is very low," a Pfizer headquarters spokesman said. "The benefits of taking drugs are better than the risks," he said.
- Policy
- ‘Immunoglobulin inj’ is reimbursed for vaccine-related TTS
- by Lee, Hye-Kyung Jul 07, 2021 05:52am
- Human Immunoglobulin G may now be used with insurance benefits for the treatment of thrombosis thrombocytopenia syndrome (TTS), a known adverse event following COVID-19 vaccinations. Expansion of benefit standards for general drugs usually takes around 80 days, however, due to the specificity of the COVID-19 situation, the reimbursement standard was expanded in a single day. The Health Insurance Review and Assessment Service announced on the 1st that it has secured a safety net for the public against side effects that arise post-vaccination by reviewing the health insurance benefit standards in the shortest period ever. TTS is a rare condition, and only two TTS cases were confirmed in Korea as of now. Patients can fully recover when the condition is detected early by a doctor and treated approximately. Human Immunoglobulin G injections, which are necessary for treating TTS, had previously been covered by health insurance for a few conditions, but not for TTS. HIRA had promptly decided on expanding the reimbursement standards for the drug by reflecting the latest medical cases and the recommendation made by the Korea Disease Control and Prevention Agency. Kim Ae-Ryun, Director of HIRA’s Pharmaceutical Management Department said, “We have reviewed and set reimbursement standards for the drug in just one single day for the public’s safety. The process conventionally takes over 80 days, but we considered the current situation where COVID-19 vaccinations are increasing day by day. It is significant we have secured a safety net for the public, and when a vaccine's side effect that is of a public concern occurs, a treatment suitable for the patient's symptom may be administered in a timely manner in the field."
- Company
- The NPS bought shares in Samsung BioLogics & SK Bio
- by Kim, Jin-Gu Jul 06, 2021 05:51am
- The National Pension Service (NPS), the nation's largest institutional investor, significantly reduced its investment in the local stock market in the first half of last year. Investment in pharmaceutical bio stocks has rather increased. Investments in Samsung BioLogics, SK Bioscience, and SK Biopharm were significant. It sold more than ₩300 billion in shares of Celltrion. According to the KRX on the 5th, The NPS bought Samsung BioLogics shares worth ₩586.4 billion in the first half of this year. Not only pharmaceutical bio shares but also all stocks ranked first in net buying. The NPS' stake in Samsung BioLogics rose 0.12%p to 5.10% at the end of June from 4.98% at the end of last year. As of the end of June, Samsung BioLogics' stock valuation held by the NPS is close to ₩3 trillion as of the closing price of the 5th. In addition to Samsung BioLogics, four out of the top 10 net purchases of the NPS were pharmaceutical bio shares. SK Bioscience (3rd), SK Biopharm (6th), and Celltrion Healthcare (9th) ranked high. Net purchases of The NPS amounted to ₩259.1 billion from SK Bioscience, ₩157.6 billion from SK Biopharmaceutics, and ₩116.4 billion from Celltrion Healthcare. In addition, it sold ₩69.3 billion in GC LabCell shares, ₩49.5 billion in Hanmi Science, ₩45.2 billion in Daewoong Pharmaceutical, ₩41.6 billion in LegoChem Bioscience, ₩36 billion in Hugel, ₩35.5 billion in Medy Tox, ₩35.3 billion in ST PharmaReaserch, ₩26.2 billion in Celltrion, PharmaReaserch ₩17.5 billion in Pharmicell, ₩15.6 billion in Dong-A Socio Holdings, ₩15.2 billion in Alteogen, ₩13.4 billion in Daewoong, ₩12.5 billion in Macrogen, and ₩12 billion in Huons Global. The NPS' share of these companies has also increased. GC LabCell increased 1.12%p (4.99%→6.11%), Dewoong increased 1.05%p (5.09%→6.14%), and Hanmi increased 2.02%p (6.84%→8.86%). The NPS is said to have continued its all-time selling spree in the domestic stock market in the first half of this year. Net sales in first half of this year alone amount to ₩24.598 trillion. According to the fund management guidelines, the government decided to lower the portion of investment in domestic stocks to 16.8% by the end of this year, leading to large-scale net selling. As of the end of last year, it had a share of 21.2%. However, investment in pharmaceutical bio shares has increased even among large net sales. The cumulative net purchase amount of pharmaceutical bio shares by June is estimated at ₩836.7 billion. The NPS sold Celltrion shares the most. It bought ₩1.1447 trillion for six months and sold ₩1.507 trillion, reaching ₩362.3 billion in accumulated net sales. The NPS sold ₩182.8 billion in shares of SK Chemical, ₩85.5 billion in GC Pharma shares, ₩46 billion in Bukwang shares, ₩28.9 billion in JW-Lifescience shares, ₩28.4 billion in Chong Kun-dang shares, ₩24.5 billion in G-TreeBNT shares, ₩18.8 billion in Seegene shares and ₩15 billion in Shin Poong. Celltrion shares in the NPS fell 0.88%p to 7.48% at the end of June, compared with 8.36% at the end of last year. SK Chemical's shares fell 3.99%p from 10.13% at the end of last year to 6.14% at the end of June. In addition, shares of GC Pharma fell 0.04%p (9.12%→9.08%) and shares of Bukwang fell 1.12%p (8.18%→7.06%) respectively.
- Policy
- Benefit extended for Lipiodol, reduced for Imotun from 23rd
- by Kim, Jung-Ju Jul 06, 2021 05:50am
- Reimbursement benefit for Guerbet Korea’s liver cancer contrast medium Lipiodol Ultra-Fluid (iodised oil, 12.8g/10mL) will be extended to lymphangiography and sialography. On the other hand, reimbursement benefit for Chong Kun Dang Pharmaceutical’s avocado and soyabeam unsaponifiables, Imotun Cap., will be reduced in line with its reduced indication. The Ministry of Health and Welfare made a partial amendment and issued the ‘Details on the applied standards and methods of medical benefits (drugs)’ that contained the abovementioned changes. The changes will apply on different dates for each drug. First, the reimbursement benefit for the liver cancer contrast medium Lipiodol Ultra-Fluid will be extended to match the expanded efficacy and effect in its indication. Accordingly, reimbursement will be approved within the scope set under the ‘details on the standards and method for applying medical benefits to drugs prescribed and administered to cancer patients.’ All other medication costs will fully be borne by the individual patient. Specifically, Lipiodol may be used for lymphangiography, sialography, and transarterial chemoembolization (TACE) procedures in liver cancer. The extended reimbursement will be applied to Lipiodol that is used from today (July 6th). On the other hand, the scope of reimbursement for Imotun Cap. will be reduced in line with its reduced efficacy and effect. The change in efficacy and effect from its original developer, France, to ‘relief of symptoms of osteoarthritis of the knee in adults,’ had triggered follow-up measures by the Ministry of Food and Drug Safety in Korea as well. Through the reduction, the drug will be reimbursed for the relief of symptoms of osteoarthritis of the knee in adults. The government issued an MFDS letter of safety explaining that the scope of reimbursement standards will be clarified and set according to the reduced indication. The MOHW announced that the revision and issuance for the drug will be implemented from the 23rd of this month.
- Policy
- Cholib was eventually withdrawn from the domestic market
- by Lee, Tak-Sun Jul 06, 2021 05:50am
- Abbott's Cholib, the first combination of Fenofibrate-Simvastatin released in Korea, will be withdrawn from the Korean market. This is because the Statin-Fenofibrate market was lagging behind domestic pharmaceutical companies and administrative disposition by the MFDS was underway. According to industries on the 2nd, South Korea's Abbott informed distributors that it will stop supplying Cholib after October. Cholib has already been suspended due to administrative action by the MFDS. On the 10th of last month, the MFDS issued a six-month suspension of sales (June 24-Dec 23) due to the lack of the number of subjects required for the re-examination (PMS). The disposal period has increased due to the second violation. If proper re-examination data is not submitted during the disposal period, Cholib's item permit will be revoked. But Abbott withdrew Cholib without maintaining it. In an official letter to the distributor, Abbott stops selling both Cholib 145/20 mg and Cholib145/40 mg, and earlier for Cholib145/40 mg. The reason why it is suspending sales of Cholib is because it is having difficulties in competition wit pharmaceutical companies in Korea. The No. 1 item in this market is Yoo Young's Pravafenix, which recorded ₩21.6 billion in outpatient prescriptions last year. Cholib recorded ₩1.3 billion in outpatient prescriptions. Competition intensified as eight products of the Pitavastatin Calcium Hydrate-Fenofibrate complex were sold. Unlike other competitors, Cholib has the advantage of being able to take it regardless of meals, but it did not work with domestic pharmaceutical companies. It seems that it chose to withdraw from the market as it continued to dispose of the MFDS. When Cholib is withdrawn, the Statin-Fenofibrate complex will have only nine items left. All items are manufactured domestically except Pravafenix, an imported drug.
- Policy
- Domestic companies attempt at hemophilia treatment market
- by Moon, sung-ho Jul 06, 2021 05:50am
- Domestic pharmaceutical companies have thrown their hats into the domestic hemophilia treatment market, forewarning a change in the prescription market. The attempts will mainly target the large major hospitals that treat hemophilia, but the possibility of any significant change in the treatment market is considered low in the field. According to industry sources on the 2nd, SK Plasma was found to have started domestic sales and marketing activities for Afstyla (lonoctocog alfa) in large major hospitals as the drug started receiving reimbursement benefits as a hemophilia A treatment. SK Plasma is a spin-off of SK Chemical that specializes in blood products. Afstyla is based on SK Chemical’s original candidate substance NBP601 and was developed into the finished product after a technology export to CSL Behring in 2009. Contrary to existing hemophilia treatments that are composed of two separate protein chains, Afstyla’s single-chain molecule structure joins combines two protein chains into one to extend circulation time and improve safety. SK Plasma is the second company to throw a hat into the market following JW Pharma’s introduction of Chugai Pharmaceutical’s Hemlibra (emicizumab-kxwh) that made its way into the market in May last year after receiving reimbursement approval. In particular, expectations and interest is rising for Afstyla as Hemlibra is having trouble making its place in the treatment market. Recently, insurance cutbacks that were made on prescriptions for pediatric hemophilia patients aged 12 or younger had been in much dispute. Also, whether the drug can survive the competition in the ₩230 billion market dominated by GC Pharma is a key area of interest. In addition to their own products ‘GreenMono’ and ‘Greengene F,’ GC Pharma has also been jointly marketing Takeda’s ‘Advate’ and ‘Advonate,’ which, as a whole, accounts for over 60% of the hemophilia treatment market. Also, the industry is keen on whether Afstyla may survive the competition of similar-class drugs that are already in the market, including Sanofi’s ‘Eloctate’ and Takeda’s ‘Adynovate.’ The insured drug price set by NHI for these drugs is 675 won per 1IU. On this, Chuhl Joo Lyu, professor of Pediatric Hematology and Oncology at the Yonsei University Severance Hospital, said, “Large hospitals are currently using Eloctate and Adynovate, which have similar MOAs with Afstyla. However, even these are not prescribed much at hospitals because the dose and administration set under Korea’s reimbursement standards differ from those set overseas.” Lyu continued, “Basically, the drugs are approved abroad in higher doses but are restricted in Korea. To increase the dose and administration level to meet the standards overseas, the insurance fee setting process must be conducted again at a lower price.” In fact, the approved dose for Eloctate as routine prophylaxis is 25~65 IU/kg based on the patient’s clinical response. Pediatric patients under 12 years of age may require more frequent doses or a dose increase to 80 IU/kg Under the Health Insurance Review and Assessment Service’s reimbursement standards, a single dose of administration is 20-25 IU/kg, and for moderate or higher forms of bleeding, up to 30 IU/kg is allowed at the doctor’s discretion. The basic approved dose for severe conditions is twice weekly, 8 times every 4 weeks. For on-demand treatment of bleeding after administration, two injections per hospital visit are approved. Therefore, with Afstyla’s price set at the same level, unless the reimbursement criteria are improved, the drug will not have competitivity in the prescription market. A member of the Korean Society of Pediatric Hematology-Oncology who wished to remain anonymous said, “Afstyla’s efficacy is equivalent rather than superior to other long-acting agents. That was why its insurance fee was set at the same level as Eloctate and Adynovate. The price should be adjusted for the drug to have competitivity.”
