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- 2026-03-18 05:51:34
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- “Reimburse Vyndamax, the only hope for amyloidosis”
- by Eo, Yun-Ho Jul 13, 2021 05:59am
- The hATTR Patients Association came forward to call for the reimbursement approval of ‘Vyndamax’ The patient group recently delivered a ‘Statement for the insurance benefit of Vyndamax' to the Ministry of Health and Welfare and the National Health Insurance Services. The move arose among patients with the reimbursement discussions being delayed on Vyndamax (Tafamidis 61mg), which is virtually the only drug approved for the treatment of ATTR-CM (ATTR amyloidosis with cardiomyopathy). After failing to receive the essential drug designation for Vyndamzx, Pfizer, its developer, conducted a PE evaluation on its drug and applied for reimbursement again in April this year. The company hopes to receive reimbursement benefits through the Risk Sharing Agreement (RSA) scheme. However, no solid discussion or progress has been made for the drug yet. And the patients are the ones most pressed for time. ATTR-CM is a life-threatening condition with a poor treatment outcome due to a lack of treatment and is often mistaken for simple heart failure. If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. In the Phase III ATTR-ACT study, Vyndamax had reduced cardiovascular events in ATTR-CM patients and improved their functional athletic ability in the six-minute walk test, demonstrating the drug's benefit in the area with a dire need. Based on such findings, healthcare professionals in Korea are also stressing the need to prescribe Vyndamax. In the statement, the patient group said, “We ask the government to show determination for improving the treatment environment for ATTR-CM. Please help us and establish an environment where we can devote ourselves to treatment." In the ATTR-ACT study, 441 patients were randomly assigned in a 2:1:2 ratio to receive the tafamidis 80 mg dose, tafamidis 20 mg dose, or placebo, respectively. The primary endpoint of the study was the hierarchical combination of all-cause mortality and frequency of cardiovascular-related hospitalizations. The key secondary endpoints were the change from baseline to month 30 for the 6-minute walk test and the score on the Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS), in which higher scores indicate better health status. Study results showed that the tafamidis demonstrated a statistically significant reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo.
- Company
- Takeda's innovation in Korea
- by Eo, Yun-Ho Jul 12, 2021 06:20pm
- Moon Hee-seok, CEO of Takeda Korea Takeda Korea, which sold off OTC division & DM division, which was the company's symbol. On the occasion of the 10th anniversary of the corporation's launch, constraints have once again confirmed their commitment to pursuing innovation. Marking the 240th anniversary of Takeda Pharmaceutical's headquarters and Korea Takeda's 10th Anniversary, 'Takeda has achieved innovative growth for patients,' it held an online press conference. At this press conference, Take Korea is in line with four key treatment areas: anti-cancer, gastrointestinal disease, nervous system disease, and rare diseases.The general managers of the four major pharmaceutical businesses announced major portfolios and core strategies of each business unit. Takeda Pharmaceutical sold its DM division and OTC division to Celltrion, a South Korean company, last year. The company's Actos is a representative TZD-based drug that survived the Avandia crisis, and Whituben and Albothyl are brand OTCs that everyone knows. Takeda Pharmaceutical has prepared in advance for this change. Takeda conducted four mergers and acquisitions, including Millenium Pharmaceutical in 2008, Nycomed in 2012, ARIAD Pharmaceuticals in 2017, and Shire in 2018. Through this process, it has been strengthening major pipelines in areas such as anticancer drugs, rare diseases, and gastrointestinal diseases. It quickly responded to rapidly changing market conditions. At the press conference, Takeda announced that she would focus on the specialty care sector in line with her global strategy, signaling a more innovative drug launch.It presented a vision for the future of pharmaceuticals. Kim Jung-hun, the first speaker, introduced the "3P (Patient, People, Product)" strategy under the title "Oncology Division's 3P Strategy for Domestic Cancer Patients." The oncology division introduced solid cancer treatments Alunbrig(Brigatinib) and Zejula(Niraparib) as notable products, saying they are generating various results by prioritizing patients first. Under the theme of "Focus on Inflammatory Bowel Diseases and Fire Extinguisher Division," Kim Tae-hoon then introduced the major portfolios of the division, Kynteles(Vedolizumab) and Mezavant (Mesalazine), and he expressed his ambition to continue activities to raise awareness of the disease in the domestic market, where competition is intensifying, and to become a company specializing in treating inflammatory bowel diseases. Under the title of "Korea's Rare Genetic Disease Treatment Partnership, Genetic Disease Division," Ji Chang-deok introduced Fabri's disease treatment drugs "Replagal (Agalsidase Alfa)" and Gaucher's disease treatment "Vpriv (Velaglucerase Alfa)" to improve treatment environment in Korea. Finally, General Manager Kim Na-kyung introduced hemophilia treatments such as Adavate(Blood Coagulation Factor Ⅷ) & Adynovate(Rurioctocog Alfa Pegol) under the theme of "Pioneer in improving the domestic hemophilia treatment environment, Hemophilia treatment division." Moon Hee-seok, CEO of Takeda, said, "Takeda for the past 240 years has worked on creating an environment that can change patients' lives as treatment partners around the world with a series of passionate challenges and dedication to patients. The company, which marks the 10th anniversary of its launch in Korea this year, will once again move forward, preparing for another 10 years through patient-centered realization and innovative treatments." Takeda celebrated its 240th anniversary on June 11th. Pharmaceuticals entered the top 10 multinational pharmaceutical companies in terms of total sales in 2019 and has become a leading global bio pharmaceutical company through intensive strategies and value-based research and development for specialty care.
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- Byfavo can be prescribed in general hospitals
- by Eo, Yun-Ho Jul 12, 2021 06:19pm
- The anesthetic drug Byfavo can be prescribed at a general hospital. According to related industries, Hana Pharm's Byfavo (Remimazolam Besylate) passed DC of Big 5 general hospitals, including Seoul National University Hospital and Asan Medical Center, and will also be able to be prescribed it at major advanced general hospitals this month. Byfavo is a new anesthetic drug released more than 30 years after the approval of the general anesthetic Propofol. Launched in March, Byfavo secured manufacturing rights and exclusive sales rights from German company Paion in 2013. It has completed phase 3 of clinical trials for 198 subjects that will carry out general anesthesia in South Korea since 2018. The main indication is the induction and maintenance of general anesthesia in adults. Byfavo is a anesthetic drug that does not cause pain, and has the pharmacological advantages of conventional general anesthesia such as Propofol and Midazolam. Hana Pharm's the new Hagil plant is under construction, and expected to operate in 2023, equipped with German-made freeze-drying facilities and designed to supply Byfavo to advanced markets. The company acquired additional rights from six Southeast Asian countries to Byfavo from the original developer Germany Paion, and completed internal work to receive permission documents from these countries. Hana Pharm CEO Lee Yoon-ha said, "We are doing our best to secure supply rights in Korea and Southeast Asia, as well as in advanced markets in the future." "We are implementing strategies to enter markets by countries with a focus on partnership structure that can be supplied with expensive finished products as mid- to long-term tasks."
- Company
- Huons has secured domestic rights to Sputnik Light
- by Lee, Seok-Jun Jul 11, 2021 07:03pm
- Huons said on the 7th that it has secured exclusive rights to domestic licenses and sales of Russia's one-shot vaccine Sputnik Light. Sputnik Light will be produced from Huons Global Consortium starting from second half of this year. It was developed by Gamaleya Research Institute of Epidemiology and Microbiology. It is a one-shot vaccine that was approved for use in Russia in May. It uses the same adenovirus as Sputnik V, a double inoculation method, as a vector (transmitter. However, only one type of vector (adenovirus type 26) needs to be inoculated once. The prevention effect is 79.4% and the immune system is known to last 3 to 4 months. Since the end of February, phase III has been underway for about 7,000 people in countries such as Russia, the United Arab Emirates and Ghana. Huons is considering Emergency Use Authorization for quick domestic approval.
- Company
- Researchers find COVID-19 Txs more effective than remdesivir
- by Kim, Jin-Gu Jul 09, 2021 05:56am
- A Korean research team of the Korea Advanced Institute of Science and Technology (KAIST) discovered new drug candidates for the treatment of COVID-19. Some of the candidates are expected to have a better effect than the currently approved remdesivir (product name: Veklury). On the 8th, the joint research team of Sang-yup Lee, Distinguished Professor of Chemical & Biomolecular Engineering at KAIST, and Dr. Seung-taek Kim, researcher of Institut Pasteur Korea (IPK)’s Zoonotic Virus Laboratory announced that they have discovered potential candidates for treating COVID-19 using their virtual screening technology. The team opted for a drug repurposing strategy using virtual screening. In other words, the team sought to find substances that may help treat COVID-19 among drugs with verified efficacy and safety. The researchers first built a virtual library on 6,218 drugs that are FDA-approved or in clinical trials, and then applied their newly developed virtual screening technology. The accuracy of the system was improved by adding structural similarity and interaction similarity analysis modules to the existing docking simulation-based virtual screening technology. Summary of the COVID-19 treatment development process using virtual drug screening technology (source: KAIST) Using the platform, the team selected 38 candidate compounds that inhibit the protease and RNA-dependent RNA polymerase needed for the replication and proliferation of the COVID-19 virus. Then, the efficacy of the candidates was verified by the Institut Pasteur Korea. Testing was conducted using a monkey’s kidney cells infected with COVID-19. Of the 38 candidates, 7 compounds showed antiviral activity. The 7 compounds that showed promise were further verified on human lung cells to be narrowed down to three: omipalisib, and tipifarnib, and emodin. Among these, omipalisib was found to have an antiviral activity that is over 200 times higher than that of remdesivir. Antiviral activity of tipifarnib was found to be similar to remdesivir. Omipalisib is currently being studied in a clinical trial as a treatment for cancer and pulmonary fibrosis. Tipifarnib is being studied in a clinical as a treatment for and progeria, and emodin, which is derived from plants, is being studied in a clinical trial as an anticancer drug. The research team is planning a preclinical trial on these 3 candidate substances. In the preclinical trial, the team aims to minimize toxicity and reach the effective concentration for treating COVID-19. Regarding the findings, Professor Sang-yup Lee said, ”With the research, we were able to prepare a base technology to promptly respond to new emerging viruses. We will continue our research to develop technologies applicable to new infectious viruses as well as variants of the coronavirus.”
- Company
- Jeil's anti-cancer drug business is doing well
- by Nho, Byung Chul Jul 08, 2021 05:59am
- It is noteworthy that Jeil is investing in expanding the lineup of anticancer drugs and research and development in related fields. Jeil, who entered his 33rd year of anti-cancer drug business, has a strategic relationship with Kyowa Kirin and Taiho in Japan and is making efforts to distribute original anti-cancer drugs. When the new anti-cancer drugs were introduced in the late 1980s, Jeil established a separate anti-cancer sales and marketing team to strengthen its professional capabilities and make communication between doctors and salespeople a top priority. The most likely anti-cancer drugs are Grasin300 PFS (Kyowa Kirin), Neulasta PFS(Kyowa Kirin), UFT(Taiho), Ts-1(Taiho), and Lonsurf (Taiho). The first anti-cancer drug introduced by Jeil was UFT(Tegafur·Uracil), which was first released in Korea in 1989. It is effective in relieving symptoms such as head and neck cancer, stomach cancer, rectal cancer, liver cancer, lung cancer, prostate cancer, uterine cervical cancer, and breast cancer, etc. UFT has capsule formulations and granules, which are usually administered three to six capsules a day, and the granules are taken in two to three doses of 300 to 600 mg. In 1993, Grasin300 PFS (Filgrastim) was released. The drug, which is a granulocyte colony-stimulating factor (GCSF) preparation, has indications of neutrophilosis, bone marrow dysplasia, regenerative anemia, congenital and idiopathic neutrophilia (HIV) infections. In 2004, the company launched a treatment called Ts-1(Gimeracil, Oteracil Potassium,Tegafur) for stomach, head and neck cancer, pancreatic cancer, and non-small cell lung cancer, providing a variety of treatment options for domestic patients. In 2014, it released Neulasta (Pegfilgrastim), the second generation G-CSF and co-sold it in Korea with Kyowa Kirin. Last year, Lonsurf (Tipiracil+Trifluridine) was introduced to provide new options for colon cancer treatment, and has continued its long sales experience in the domestic anticancer drug market. Lonsurf passed DC of 50 hospitals nationwide, including Seoul National University Hospital, Samsung Medical Center, Asan Medical Center, and Severance Hospital in the first year of its launch. Based on UBIST, it ranks first in sales in the field of oral anticancer drugs newly approved in 2020, and is recognized for its efficacy. Lonsurf is expanding its share of the colon cancer market using a specialised sales network. Attention is also focusing on Onconic therapeutics, which was established last year to improve its position in the anti-cancer drug R&D field. Bio company Onconic therapeutics is a subsidiary 100% invested by Jeil and is expected to grow as an organization focused on the development of immune and targeted anti-cancer drugs. A year after its establishment, the company announced the results of Phase 1 for PARP (Poly ADP-ribose Polymerase) and JPI-547 at ASCO, drawing attention from Big Pharma. Phase I of the clinical trial evaluated the medicinal efficacy, safety of JPI-547 in patients with terminal solid cancer, according to Lim Seok-ah, a professor of hemato-oncology at Seoul National University Hospital, announced at the poster session. It is encouraging to identify the potential as a new treatment for ovarian cancer that does not respond to existing PARP treatments. Based on the results of this Effects are expected in HRD and PARP inhibitor resistant patients, including BRCA. "Based on the 30-year history of introducing anti-cancer drugs, we are continuously expanding our specialized sales network in related fields." said a representative of Jeil. "We will strengthen the pipeline of new items and improve our long-term research and development capabilities in the anticancer drugs market through open collaboration with Onconic Therapheutics."
- Company
- Chong Kun Dang loses 1st substance patient suit on ‘Xarelto
- by Kim, Jin-Gu Jul 08, 2021 05:58am
- Pic. of Xarelto Chong Kun Dang has lost its first trial targeting the substance patent of Bayer’s new oral anticoagulant (NOAC) ‘Xarelto(rivaroxaban).’ Whether Chong Kun Dang will modify its strategy to preoccupy the market through a release of its generic before substance patent expiry due to this ruling is gaining attention. On the 6th, the Intellectual Property Trial and Appeal Board (IPTAB) has ruled in favor of the original manufacturer Bayer, in a trial to confirm the passive scope of rights for Xarelto’s substance patent that was filed by Chong Kun Dang. Chong Kun Dang had solely challenged Xarelto’s substance patent in December last year. This was interpreted as a strategy made to overtake SK Chemicals and Hanmi Pharmaceutical that is currently leading the Xarelto generic market. SK Chemicals and Hanmi Pharmaceutical were the first to succeed in avoiding Xarelto’s formulation patent. The two companies finally won in December last year after the case went up to the Supreme Court, and secured exclusive marketing approval for Xarelto's 2.5mg formulation. However, both companies were unable to overcome the substance patent, and are unable to release the generic version until Xarelto’s substance patent expires in October this year. Chong Kun Dang made the bid for victory by challenging Xarelto’s substance patent. Then, in May, the company released its Xarelto generic 'Riroxia Tab.' 15mg and 20mg' in the market, before Xarelto’s substance patent expires. This was an attempt to preoccupy the market alone by avoiding the substance patent. Chong Kun Dang’s bold attempt was considered a risky game - if the company wins the case, the early release of its generic will not have constituted a patent infringement, but if it oses, it could bring serious repercussions from patent infringement. However, Chong Kun Dang lost the first trial. Based on the current situation, it has been analyzed that Chong Kun Dang's risky attempt is highly likely to fail and that Chong Kun Dang will have to bear the burden of patent infringement. For now, Chong Kun Dang is highly likely to appeal the case, as the higher courts may decide otherwise. Some industry officials also believe that even if Chong Kun Dang loses in the end, the end results will not be bad in terms of profit or loss. An official explained, “From Chong Kun Dang’s view, the profit gained by preoccupying the market while the patent suit is reviewed by higher courts may be greater than the compensation for damages that the company will owe to Bayer from the patent infringement."
- Company
- GC Pharma, the most likely company to produce Covivak
- by Nho, Byung Chul Jul 08, 2021 05:58am
- Chumakov Institute recently visited Andong Animal Cell Verification Support Center. Russia's Covivak is likely to be produced in domestic CMOs. According to industries, MPC, which is a South Korean corporation to introduce Covivak, recently signed a contract with Pharm Bio-tech, a Russian company that has rights to produce and publish in Russia, to acquire shares (37.5%). Among the domestic companies that invested in securing the stake, Wellbiotec, HumanN, and Nexton Bio became Pharm Bio-tech shareholders. MPC is also expected to establish a joint venture for Pharm Bio-tech and Covivak production, sales, and distribution in Korea to run vaccine businesses for ASEAN countries. The fact that it has become the second largest shareholder of Pharm Bio-tech, which has Covivak production and copyright, is interpreted as including technology transfer conditions, not just CMO production. It can also secure dividends based on sales performance of vaccine exports. This is in contrast to Samsung Biologics' production of Moderna COVID-19 vaccine CMO, which has yet to be confirmed whether or not the technology will be transferred. GC Pharma and Andong Animal Cell Demonstration Support Center are among the CMO and CDMO pharmaceutical bio companies that will produce Covivak. According to industry estimates, it takes about two months for the technology transfer of the Chumakov Institute researchers at the Russian Federal Academy of Sciences, and is likely to be completed by September at the latest. It is expected that production of Covivak will be possible around October. MPC, which is in charge of South Korea's Covivak business, said, "It is difficult to answer questions related to consignment production, consignment development and production." "However, all companies that are interacting agree that South Korea should become a global outpost for producing COVID-19 vaccines, and we will be able to produce positive results."
- 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.
