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- 2026-05-18 16:29:40
- InterView
- Leclaza’s ESMO data will determine FDA approval
- by An, Kyung-Jin Sep 15, 2021 06:11am
- Cho Byung Chul, a professor at Yonsei University "This data will be the basis for determining the approval of Leclaza combination therapy. Following Tagrisso, the world is paying attention to how much lung cancer patients who failed to treat platinum-based anticancer drugs will react. " Janssen, a partner of Yuhan, will announce new clinical data on combination therapy with Leclaza at the ESMO 2021 online academic event, which will open on the 16th (local time). It is the very combination that excited the society (ESMO 2020) a year ago with an incredible number of "OR 100%." In the meantime, Leclaza's combined drug, Rybrevant, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of non-small cell lung cancer accompanied by 20 insertion variations of epithelial cell growth factor (EGFR). What synergy effect will Leclaza and Ambantamab have this year? Cho Byung-chul, a professor of oncology at Yonsei University, emphasizes, "We should pay attention to the response rate (ORR) of Leclaza and Rybrevant combination therapy unveiled at ESMO 2021." According to the abstract list released by the society, the new data for Leclaza combination therapy this year is a clinical study of CHRYSALIS-2 (phase 1b). The phase CHRYSALIS-21b clinical cohort A study evaluates the OR of Leclaza and Librevant combination therapy in patients with EGFR targeted anticancer drug Tagrisso and EGFR mutant non-small cell lung cancer who do not respond to platinum-based anticancer drugs.It is a thoroughly designed study to obtain permission for Leclaza and Librevant combination therapy in patients with Tagrisso resistance. According to Professor Cho, Taxotere is the only drug that can be used for patients under the current conditions. Taxotere is a cytotoxic anticancer drug that causes severe adverse reactions. Nevertheless, the reaction rate is close to zero (0%). In other words, they try because there are no other options, but it is virtually the same as there is no cure. It is predicted that early market sales will be possible through Breakthrough Therapy Design and acceleration approval. Considering the case of Librevant, which obtained the FDA acceleration review in May, it is judged that the possibility is sufficient. Recently, the American Society of Clinical Oncology (ASCO 2021), a combination therapy with Leclaza, also reproduced 36% OR in patients with resistance after Tagrisso treatment. Professor Cho said, "Lung cancer specialists who face patients in desperate situations in the clinic every day need a new treatment. This is why the world is paying attention to the ESMO announcement data, he explained. We are looking forward to the release of a treatment that can be used instead of 'Taxotere' as soon as possible, he said. Professor Cho is in charge of CHRYSALIS-1 multinational clinical trials, led by Janssen, evaluating Rybrevant alone and combined therapy. An intermediary study on the anti-tumor mechanism of Rybrevant in Exxon 20 mutant lung cancer was conducted to reveal the mechanism of anti-tumor effectiveness. Recently, it is evaluated as the leading player in leading the final FDA approval while leading the clinical development of Rybrevant. Rybrevant has not yet been approved in Korea, but it is conducting a program for patients with EGFR Exon 20 mutant lung cancer.
- Policy
- Controversy over the price of COVID PO of ₩900,000
- by Lee, Jeong-Hwan Sep 15, 2021 06:11am
- While the government, which judged that oral treatments are needed to shift the COVID-19 phase, is negotiating pre-purchase with global pharmaceutical companies, it is pointed out that drug prices will reach ₩900,000. The government also acknowledges that the price of oral COVID-19 treatment is expensive, but if they have a therapeutic effect, they are more advantageous than hospitalization costs due to COVID-19 and loss costs due to economic activity. When the host asked about the price of oral treatments during MBC Radio's Kim Jong-bae's attention on the 10th, Bae Kyung-taek, a planning coordinator at the KDCA, replied, "It is difficult to tell you everything at the current stage of signing the contract." He said, "From the government's point of view, the price seems to be high," adding, "We need to compare and evaluate the direct cost of hospitalization or going to a life treatment center because they don't take the treatment." Regarding treatments being developed by domestic pharmaceutical companies, he said, "Celltrion treatments are injections, not PO," adding, "Oral treatments can be observed after taking them at home. If this happens, the COVID-19 situation will change a lot." "The pharmaceutical industry explains that it is not easy to produce the same effect by administering medicine to blood vessels with injections and putting it into the digestive system," he said. "This seems to delay the development of medicines compared to global companies."
- Company
- Who is the winner of the domestic toxin in the US market?
- by Nho, Byung Chul Sep 14, 2021 05:55am
- As Medy Tox received the rights of the improved botulinum toxin candidate MT10109L from AbbVie on the 8th, competition in the U.S. market for domestic Toxin companies is expected to intensify. The size of the US botulinum toxin market is about 2 trillion won, the largest sales in the world. For Korean companies, the United States is an essential country to expand global sales. Currently, Daewoong's Nabota (Jubo) is the only domestic product that is officially distributed. Hugel also submitted an application for an item license for Letybo 50 and 100 units to the U.S. Food and Drug Administration (FDA) in April this year, making it visible to enter the U.S. market directly through Hugel America. Hugel and Daewoong are entering the U.S. market. On the 8th, Medy Tox rights return and license contract for the neurotoxin candidate MT10109L signed with Allergan was terminated. With the contract signed in 2013, Allergan (AbbVie) will transfer all rights, including clinical data conducted by Allergan, to Medy Tox. Shinhan Financial Investment announced on the 9th that Medy Tox is likely to proceed with its own licensing process, and that it is also possible to sell botulinum toxin products by Medy Tox through Evolution. In fact, Medy Tox is currently the largest shareholder with a 13.7% stake in Evolus. Daewoong said in a statement on the 10th, "The possibility of selling Evolus in a report issued by Shinhan Financial Investment on the 9th is clearly false," adding, "Evolus can never handle competitors other than Nabota under a botulinum toxin exclusive license contract with Daewoong." All of these are disclosed in the disclosure data." In July, USPTO PTAB sided with Galderma, a Swiss pharmaceutical company, in 2019 regarding the long lasting effect of new botulinum toxin formulations patent registered in the U.S. by Medy Tox in 2018. Medy Tox said in a statement at the time, "The results of the first trial on Galderma's patent objection have been released, and we are considering applying for a review to maintain the patent." It has nothing to do with the production or sale of our products developed with the technology, he said. However, in the same month, Revance Therapheutics, a U.S. botulinum toxin company, also raised the issue of Patent No. 9480731, which includes the long lasting effect of new botulinum toxin formulations, to USPTO PTAB. An official from the pharmaceutical industry said, "Repeated lawsuits related to text between domestic companies in the global market, including Korea, can only provide opportunities to competing multinational companies. In particular, this method should be avoided to prevent negative perceptions of Korean healthcare companies in the global market."
- Policy
- Sama Pharm’s ‘Daxas’ generic approved
- by Lee, Tak-Sun Sep 14, 2021 05:55am
- Sama Pharm received approval for the first generic of the COPD treatment ‘Daxas (roflumilast, AstraZeneca Korea)'. As Sama was the only company that succeeded in avoiding the composition patent of Daxas, if the generic is released immediately, the company will be able to preoccupy and monopolize the market for the time being. The Ministry of Food and Drug Safety approved Sama Pharm’s ‘Samaloflu 500mg microgram tablets’ on the 13th. The drug is a generic drug of Daxas 500 micrograms tablets, and the first generic of its kind to be approved in Korea. The drug may be used as add-on therapy to bronchodilator treatment or as maintenance treatment of severe chronic obstructive pulmonary disease (COPD) is associated with chronic bronchitis in patients with a history of symptom exacerbations. Patients over the age of 18 may take a single tablet of the drug once daily with or without meals. Daxas, which was developed by Takeda pharmaceuticals in Japan, was approved in Korea in May 2011. AstraZeneca Korea, while acquiring Takeda’s respiratory treatment division, had acquired the domestic marketing authorization for Daxas in Korea as well. Daxas, which is a PDE4 inhibitor that inhibits factors related to the progression of COPD, has been received with positive reviews for its convenient single table, once-daily dosed regimen According to IQVIA the company sold around ₩1.6 billion in sales last year. Sama pharm had attempted to avoid Daxas’ composition patent since 2019. In the May of 2019, the company filed a defensive confirmation trial for the scope of rights to avoid Daxas’s patent, which was received by the Intellectual Property Trial Appeal Board in the March of the following year. The original developer did not file a suit to protect its patent, and Sama’s patent avoidance was confirmed in May of the same year. 2 years later, the company was finally approved the marketing authorization for its product. Other companies have also challenged Daxas’s patent but failed. Dong-A ST among other pharmaceutical companies had filed for patent invalidation but were all rejected. Accordingly, other pharmaceutical companies that joined in the suits also dropped their claims. As a result, Sama became the only pharmaceutical company to succeed in challenging Daxas’s patent. With Sama’s sales in action for respiratory disease treatment, the approval of Daxas’s first generic from Sama Pharm is expected to raise the market competitiveness of the company. In a clinical trial conducted on 33 healthy adults, the bioequivalence of Simaloflu in comparison to Daxas was demonstrated with a confidence interval of 90%, within the log 0.8 - 1.25 range.
- Policy
- Moon "Invest ₩2.2 trillion in 5 years for vaccines"
- by Lee, Tak-Sun Sep 14, 2021 05:55am
- President Moon Jae-in President Moon Jae-in announced that South Korea will “invest ₩2.2 trillion to increase its vaccine competency over the next 5 years.” On September 13th, President Moon expressed such plans in a recorded welcome address for the 'Global Bio Conference' that is being held at the Grand Intercontinental Parnas Hotel in Seoul. Moon said, "Korea aims to become one of the global vaccine production hubs that could lead the response to the rise of infectious diseases in the future. Moon added, “Biopharmaceuticals have provided new hope to mankind’s fight against COVID-19. The typical development period for vaccines, which used take more than 10 years, have now been reduced by 1/10, and pharma companies have successfully developed various vaccines and drugs.” Such achievement was only possible with close cooperation of global biopharma experts and businesses across borders, Moon reckoned. Moon also indicated that “The Korean government also is continuing its attempt to find different solutions to supply a steady flow of vaccines. Contract manufacturing and technology transfers have increased, and competing pharma companies have joined forces to co-produce vaccines. South Korea also has begun contract manufacturing of four vaccine products to aid the global vaccine supply." "Such collaborations between the industry, academia, and research organizations as well as emerging industries like artificial intelligence and big data, will be what brings the current biopharmaceutical industry to the next level. The minister of Food and Drug Safety Kang-rip Kim is giving a opening address The Minister of Food and Drug Safety (MFDS) Gang-Rip Kim, who gave the opening address, said that “This conference seeks to discuss new roles of the industry, the academia, and the government in the new normal, the 'With-COVID-19' era. During the pandemic, MFDS has not only served as a regulatory agency but also stepped up to become an active cooperator in the research, development, production, import and export, and international diplomacy of biopharmaceuticals." He added, “The conference will solidify MFDS’s new role in the ‘new normal,’ and be the opportunity to take the scope of regulatory science to the next level.” Meanwhile, the 7th GBC this year will be conducted for 3 days under the theme, ‘A New Normal: A Leap Towards Newly-Found Future of Biopharmaceuticals.’ Biopharmaceutical experts, pharmaceutical companies, and regulatory reviewers from companies had participated in the event.
- Company
- Pharmaceutical companies lost the impurity valsartan lawsuit
- by Kim, Jin-Gu Sep 14, 2021 05:55am
- The government won a lawsuit filed by the government and the pharmaceutical industry over the cost-responsibility issue of follow-up measures for impurity drugs. On the 9th, the Civil Affairs Division 21 of the Seoul Central District Court sided with the NHIS in a lawsuit filed by Daewon Pharmaceutical and 35 other companies against the NHIS. Pharmaceutical companies participating in the lawsuit must pay each reimbursement claimed by the NHIS unless they appeal separately. In addition, pharmaceutical companies must pay for the litigation. The case originated when the NHIS claimed reimbursement from 69 pharmaceutical companies in October 2019. The total amount of compensation was 2.03 billion won. The plan is to return health insurance finances paid as follow-up measures during the 2018 Valsartan crisis from pharmaceutical companies. The NHIS was working on exchanging impurity drugs prescribed to existing patients with new drugs. Pharmaceutical companies that protested the NHIS measure filed a lawsuit. Pharmaceutical companies claimed that unexpected impurities have become newly recognized with the development of science, and that it is excessive to pay indemnity as they were manufactured in a legitimate process. The lawsuit drew keen attention from the pharmaceutical industry in that impurities were detected in Ranitidine, Metformin, Losartan, and Irbesartan after the Valsartan crisis. This is because the outcome of the lawsuit is likely to determine the responsibility for the impurity crisis in the future.
- Company
- K-mRNA Consortium support group to gain momentum
- by Nho, Byung Chul Sep 13, 2021 05:57am
- The research and development move of the K-mRNA Consortium formed to develop the next-generation COVID-19 vaccine is expected to gain further momentum. The consortium consisting of Hanmi, ST Pharm, GC Pharma and KIMCo announced on the 9th that Dong-A ST, a major pharmaceutical company in the development and production of specialized drugs in Korea, and E-Cell, a company specializing in bio-original materials, participated in the consortium. Since the launch of the consortium in June, the progress of the project has accelerated, and material companies and others seem to be joining as partners. Dong-A ST is one of the representative pharmaceutical R&D companies in the domestic pharmaceutical bio industry, and will actively support the consortium's future application for approval of mRNA vaccines, clinical development, and licensing based on its rich experience and capabilities. E-Cell is Korea's first leading bio-materials, parts, and equipment company that developed disposable bio-processing equipment and consumables such as disposable cell culture devices and disposable mixer bags. At the time of launch, the consortium, which announced that it would expand additional participation from raw and subsidiary materials companies, universities, and research institutes, plans to open the door to companies that can play a role in the rapid implementation of the successful model of the entire cycle. Currently, the consortium is developing the COVID-19 mRNA vaccine candidate STP2104 with the aim of entering phase 1 clinical trial within the year and commercializing it following conditional permission in the first half of next year. The consortium is managing its schedule without a hitch, such as regularly sharing information and consulting with the MFDS every month for rapid clinical implementation. In addition, it is preparing to establish a production system of 100 million doses of mRNA vaccine, which is the national vaccination volume, by the end of 2022. In addition, a separate COVID-19 vaccine is being developed to respond to the delta mutation virus. In this regard, ST Pharm, which is in charge of the consortium's clinical part, is conducting a preclinical efficacy evaluation after selecting an additional mRNA vaccine candidate, STP2130.
- Company
- Pharma companies speed up delivery of urology combo drugs
- by Kim, Jin-Gu Sep 13, 2021 05:56am
- Korean pharmaceutical companies have been rushing to develop combination treatments for various urologic diseases, such as those for prostatic hypertrophy+erectile dysfunction or benign prostatic hyperplasia+overactive bladder. Many patients with urogenital disorders suffer various conditions at once, including enlarged prostate, erectile dysfunction, overactive bladder, etc. The market size for the single-therapy agents that treat each separate condition is considerable. With no other combination therapy than Hanmi’s ‘Gugutams’ authorized in Korea, the industry’s interest in the combo drug market has been rising. Pic of Hanmi Pharm As of the 13th, the only drug approved as a combination therapy for hypertrophy+erectile dysfunction in Korea by the Ministry of Food and Drug Safety is Hanmi Pharmaceutical's ‘Gugutams.’ Gugutams is a combination of the prostate treatment ‘tamsulosin’ and erectile dysfunction treatment ‘tadalafil.’ At the time of its release in 2016, Gugutam’s performance did not meet expectations, due to low awareness of the urogenital disease in general. However, with increased awareness, the product became a steady seller, reaching ₩2.1 billion in sales last year. On this, Dongkook Pharmaceutical and Yuyu Pharma have jumped in to compete in the combination treatment market for benign prostatic hyperplasia+erectile dysfunction that combines tadalafil with ‘dutasteride,’ which is another ingredient used for benign prostatic hyperplasia. No combination treatment has yet been approved for this combination in Korea. Dongkook Pharmaceutical has started Phase III clinical trials on its dutasteride+tadalfil combo, ‘DKF-313,’ earlier this month at the Seoul Asan Medical Center. The company expects the Phase III trials to be complete by the end of next year. Yuyu Pharma is also developing a combination therapy using the same two ingredients. The company received approval for the Phase III trial in 2018, however, before starting the Phase III trial, a need to change the formulation was raised, and the company decided to start over from Phase I. Also, the development of combination treatments for benign prostatic hyperplasia+overactive bladder is actively underway. KyungDong Pharm and Dongkoo Bio&Pharma are competing to develop the combo treatment. In March this year, KyungDong Pharm received approval to start Phase III trials for its ‘KDF1905,’ which combines the benign prostatic treatment tamsulosin with overactive bladder treatment ‘mirabegron.’ Dongkoo Bio&Pharma had also previously received approval for the Phase III trial of its tamsulosin+mirabegron combination in January last year. Ildong Pharmaceutical and Jeil Pharmaceutical had also developed combinations using tamsulosin and another overactive bladder treatment ‘solifenacin.’ The two companies have completed Phase III trials for their combinations. However, Ildong Pharmaceutical decided to discontinue the development of its drug last year. Jeil Pharmaceutical had not applied for the marketing authorization of its drug for over 2 years since the completion of its Phase III trial. Also, CTC Bio’s development of its combination treatment for premature ejaculation+ erectile dysfunction is in its final stages. It is a combination of the premature ejaculation treatment ‘clomipramine’ and the erectile dysfunction treatment sildenafil. The company plans to apply for marketing authorization of its combination drug after completing its Phase III trial within this year.
- Opinion
- [Reporter's view] A manual has been established
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- The recovery of hypertension treatments containing excess impurity Sartans is significant in that it has established a new manual for drug recovery. All items were banned and recovered, making it difficult for manufacturing, sellers, and medical institutions to do additional work due to collection. However, since only excess Sartan items have been recovered this time, the loss of pharmaceutical companies is expected to be minimized, and the inconvenience caused by the recovery of medical institutions such as pharmacies is expected to be reduced. All of these measures were not perfect. In particular, the MFDS explained that the risk of impurity-containing drugs is low, but that patients with health concerns can be exchanged for normal products. In order for consumers to exchange them for normal products, pharmacies must exchange medicines to open pt's medicine packet. The question was who should pay the additional fees and additional work costs incurred by this. The government wants pharmaceutical companies to pay health insurance premiums, saying it is difficult to pay. Pharmacies are also not willing to volunteer for free. In this situation, the MFDS mediated to discuss settlement issues between pharmaceutical companies and pharmacists. The consultation was satisfactory. Two pharmaceutical companies have agreed to pay 110% of the existing formulation, which has become a guideline for other pharmaceutical companies. As the recovery has been delayed for more than a week, there is no separate suspension of sales, so the response is too late. Another problem is that it is not easy for consumers to put it into practice. Since this recovery only applies to the product number in question, consumers need to know the product name and manufacturing number to request an exchange. However, most patients often do not know the name. It is not easy for many elderly people to know this through the internet. Most patients do not know about this recovery. Therefore, it is necessary to establish a system so that minimal information can be delivered, even if it is difficult to actively communicate the recall to consumers, as in the case of automobile recall. With this voluntary recovery, the government should create a manual and take measures to enable consumers to actually recover so that they do not suffer damage.
- Policy
- Hanmi pushes for Champix follow-on despite hardships
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- One pharmaceutical company is determined to develop a follow-on of the smoking cessation drug, ‘Champix’ (Pfizer, varenicline tartrate), and it is Hanmi Pharmaceuticals. Hanmi Pharmaceuticals had succeeded in the early release of its drug as a salt-modified drug, but had lost the patent challenge failed to enter the market. After the original's patent expiry, the company had attempted to set foot in the market again with a CMO product but faced hardships due to an impurity issue. On the 7th, the company voluntarily recalled its products due to an excess amount of N-nitroso-varenicline (NNV) impurities. With perseverance, Hanmi Pharmaceuticals attempted once more with a self-developed salt-modified drug. This is the company’s third attempt at a varenicline product. According to industry sources on the 9th, Hanmi Pharmaceuticals had recently applied for the approval of its smoking cessation treatment, ‘varenicline oxalate hydrate,’ to the Ministry of Food and Drug Safety. Industry experts observed that the product was prepared to replace the ‘Nokotine S tablet' that was partially recalled due to excess NNV detection. ▲ Smoking cessation treatment being sold by Hanmi Pharmaceuticals, Nokotine S is a Varenicline salicylate substance that is being produced on consignment by CTC Bio. The drug was released by Hanmi Pharmaceuticals after the original Champix’s substance patent was expired in July last year. Hanmi Pharmaceuticals had released a varenicline product before Nokotine S called ‘Nokotine,’ a varenicline oxalate hydrate that was originally developed by Hanmi Pharmaceuticals. However, the item was withdrawn after the company lost the patent challenge. Hanmi Pharmaceuticals had released Nokotine in November 2018 before the original's substance patent expiry, using the logic that the extended substance patent duration does not apply to salt-modified drugs. The claim, which was accepted by the Intellectual Property Trial and Appeal Board, was then rejected at the Patent Court. Due to the ruling, the product was taken off the market. To make matters worse, the Ministry of Food and Drug Safety revoked the license of ‘Nokotine’ with the reason of its sale before patent expiry. This was why the company had released the CMO product ‘Nokotine S,’ as an alternative. But the impurity issue put a hold on Hanmi’s path. Excess amounts of N-nitroso-varenicline were detected in products produced by Hanmi’s CMO, CTC Bio. The company recalled 16 lots of Nokotine S that was produced by CTC Bio. The fact that Hanmi Pharmaceuticals, whose credibility had suffered due to the impurity issue, was preparing a new product was found last month. The company filed an application to revive the canceled license for the varenicline oxalate hydrate product. In fact, many pharmaceutical companies have been wrapping up their Champix’s follow-on business due to the downtrend of the smoking cessation treatment market. Based on IQVIA, Champix sold ₩8.8 billion and NoKotine sold ₩715 million in the second half of last year. However still, Hanmi Pharmaceuticals is still intent on making it in the market. The company had entered the smoking cessation treatment market with ‘Nicopion,’ which was rare using bupropion products., and also lead the patent challenge against Champix after the development of its salt-modified drug. The company had filed for an invalidation trial of a patent after its appeal had failed. The company also runs a smoking cessation program involving all of its employees every time it launched a new product. Will the company be able to reap the rewards for its sincere efforts some day? Whether Hanmi Pharmaceuticals’ new smoking cessation treatment market will be able to break the sole lead held by Pfizer is gaining attention.
