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- 2026-05-19 23:56:48
- Company
- Which company signed the CMO deal? Rumors rampant
- by Kim, Jin-Gu May 13, 2021 05:57am
- Rumors on CMO production of COVID-19 vaccines by domestic companies continue. Rumors are rife on which company would be producing which vaccine. Repeatedly, a specific company is mentioned by some, then the rumor is denied by that company. On the 12th, Samsung Biologics publically announced that the reports that it will produce Pfizer’s COVID-19 vaccine through a CMO deal are “not true.” Earlier that day, a media had quoted a high-level government official to report that Samsung Biologics will be producing Pfizer’s COVID-19 vaccine from coming August under a CMO deal. According to the report, Samsung Biologics was revamping production lines at its Incheon Songdo plant to produce up to 1 billion doses of the vaccine per year. Samsung Biologics immediately drew the line. Through a public announcement on clarification of the rumors and reports, the company said that the reports were “not true.” Despite the company’s denial, the rumors have not ceased to exist. After Samsung Biologics publicly denied the report, another media reported that ‘Samsung Biologics is in discussions about producing Pfizer’s vaccine under a CMO deal.’ Only the wording had changed, from ‘signed a CMO deal,’ to ‘discussing a CMO deal,' with its context still intact. Regarding the issue, Pfizer Korea’s position is the same as Samsung Biologic’s. An official from Pfizer Korea said that “(The CMO deal) is not true.” ◆Rumors rife after the government’s announcement of a “domestic CMO producing vaccines in August” The unceasing rumors about COVID-19 vaccine production by domestic companies have been on the increase since the government made the remark of a ‘Korean CMO’s production of COVID-19 vaccines from August.” On the 15th of last month, Young-Ha Baek, head of vaccine procurement at the pan-government vaccine procurement task force, said that “A Korean pharmaceutical company is currently working on a contract manufacturing organization (CMO) deal to produce a COVID-19 vaccine that has been developed abroad. The vaccine will be manufactured in Korea from August.” The remark had aroused a great amount of interest. The report also coincided with Moderna’s announcement of its plan to establish a Korean subsidiary. This immediately brought up several companies as potential candidates. Among the companies, ST Pharm received the most attention. The rumor gained strength as the company had been working to develop an mRNA technology of its own since last year. ST Pharm denied the rumors, however still, this led to an incident where the stock prices of ST Pharm and other mRNA R&D companies surged. The next day, speculations on whether the company and vaccine mentioned by the government were Huons and the Russian vaccine Sputnik V rose as Huons Global announced that it had formed a consortium with Prestige Biopharma, Humedix, etc. and signed a technology transfer deal to produce the global supply of the Sputnik V vaccine. As the rumor spread as if it was an established fact, the government stepped up to correct the rumor. Young-rae Son, director of the Central Disaster Management Headquarters (CDMH) strategy and planning team said, “We cannot disclose which vaccine was commissioned for production, but it is not Sputnik V.” On April 16th, Young-rae Son, director of the Central Disaster Management Headquarters (CDMH) strategy and planning team, is explaining that the commissioned vaccine to be developed in August is not Sputnik V. And earlier this month, Moderna’s progress in establishing its Korean subsidiary once again stirred up rumors on the CMO production of vaccines in August. Officials from Moderna had visited a Korean pharmaceutical company prior to the establishment of its subsidiary, which gave leeway for speculations on which companies may be candidates of the CMO deal. More recently, not Moerna’s or Pfizer’s, but another vaccine also entered the discussion. This new vaccine was jointly produced by GSK and CureVac. CureVac had submitted an application for the authorization of its mRNA vaccine to the European Medicine Agency (EMA) after completing the Phase III trial. With the approval of a third mRNA vaccine imminent in Europe, some had raised the prospect that this vaccine is the one that will be produced under a CMO deal in Korea. However, whether speculations on CureVac’s production in Korea is true or not has not been determined yet. An industry official said, “You hear rumors about the CMO deal all day. Investors are immensely interested in which company will be producing the COVID-19 vaccines. As the rumors started due to the government’s announcement, I believe the government needs to sort out its position to some extent, to reduce confusion."
- Company
- It's not far from conquering lung cancer
- by An, Kyung-Jin May 13, 2021 05:56am
- Lim Sun-min, professor of oncology at Yonsei Cancer HospitalChoi, a woman in her 50s who lives in Seongbuk-gu, Seoul, was diagnosed with stage 4 lung cancer last year and was disappointed. At the time of diagnosis, metastases had occurred in various organs, including the brain, eyeballs, and bones, so it was impossible to participate in clinical research as well as surgery. Fortunately, EGFR targeted anti-cancer drugs were available. The condition began to miraculously improve when the primary treatment began with "Tagrisso," which has the highest penetration rate of brain war among EGFR targeted anti-cancer drugs on the market. The size of the cancer has also decreased noticeably. However, she has been unable to quit her job for seven months due to her continued high-priced anti-cancer treatment. The price of "Tagrisso," which is not covered by insurance during primary treatment, exceeds ₩6 million a month. Even that is burdensome to pay at once, so she visited Yonsei Cancer Hospital three times a week and take medicine for several days. Lim Sun-min, a professor of oncology at Yonsei Cancer Hospital, said, "Many lung cancer patients, who are not covered by health insurance, are suffering from difficult treatment due to the burden of drug prices. "Even if various clinical studies are underway, participation is not possible if they do not meet the recruitment criteria," she said. "Although they have improved a lot, the unfulfilled demand at the medical site is still high." It has been 70 years since mankind has fought cancer with weapons such as anticancer drugs and radiation therapy. Lung cancer is a deadly disease that ranks first among many cancers. Target anti-cancer drugs are considered to be one of the biggest contributors to the goal of conquering lung cancer, which seemed impossible. Epithelial cell growth factor receptor (EGFR) mutations, found in about 30 to 40% of non-small cell lung cancer patients, have significantly improved their survival rate with the emergence of EGFR tyrosynkinase (TKI). Tagriso (Osimertinib), a third-generation targeted anti-cancer drug developed by AstraZeneca, expanded the lung adaptation to secondary treatment and postoperative lung cancer in patients with T790M resistance metamorphosis after first-generation drugs such as "Iressa" (Gefitinib) and "Erlotinib. Nevertheless, the development of a third-generation EGFR targeted anti-cancer drug, which acts as a mechanism similar to ``Tagrisso,'' is in full swing because of the real restrictions. Professor Lim said, "It has been about five years since Tagrisso became the primary standard treatment for EGFR-positive non-small cell lung cancer, but many countries, including Korea, have not been insured." "Except for the U.S., accessibility is significantly reduced due to financial burdens," she said. "There is a high thirst for new drugs that can replace Tagrisso at the medical site." Tagrisso is obviously a good drug, but it means that more competitive drugs are needed in terms of cost-effectiveness. Even the third-generation drug Tagriso poses a risk of developing immunity.Combination therapy is actively being tried to overcome the problem of targeted anti-cancer drugs. It is a great pleasure for clinicians to see the results of third-generation EGFR-TKI research pouring in in Asian countries with high rates of EGFR mutations, including Korea, China and Japan. A review paper published in the latest issue of the Journal of Thoracic Oncology published by the International Association for Lung Cancer Research (IASLC) shows the active three-phase clinical progress of third-generation EGFR-TKI, including Almonertinib, Alflutinib, Abvertinib and Lazertinib. Professor Lim was also asked to participate as an author as "Leclaza," developed by Yuhan, produced commercialization results earlier this year. This shows international interest in Korean new drug "Leclaza." Professor Lim hinted, "Leclaza has proven its efficacy and safety comparable to Tagriso in its initial clinical trials and has shown excellent response rates in patients with cerebral palsy." Janssen is also showing an active willingness to develop MARIPOSA phase III clinical trial, which evaluates the primary treatment effectiveness of double anti-cancer antibodies "Amivantamab" and "Leclaza". "Overcoming resistance to targeted anti-cancer drugs is a difficult task," Professor Lim said. "It's a pity when patients don't get the right medication due to financial problems or when we meet patients who are struggling to continue treatment." Nevertheless, it is not far from overcoming lung cancer in that third-generation EGFR-TKI development is actively taking place, led by the domestic new drug "Leclaza," and various combined research is underway. "Lung cancer is a scary disease with the highest mortality rate, but various lung cancer treatments are being developed, so I hope patients don't give up and get active treatment with a positive mind," Professor Lim said. "We will focus on researching new drugs to provide benefits."
- Company
- Celltrion Exports COVID-19 treatments to Pakistan
- by Chon, Seung-Hyun May 13, 2021 05:55am
- Regkirona, COVID-19 antibody treatment developed by Celltrion, will be sold overseas. Celltrion Healthcare announced on the 10th that it plans to sign a contract for 100,000 vials of Regkirona with a subsidiary of Pakistan's largest order factories (POF) under the Ministry of National Defense and ship the contract. "Regkirona has been approved for emergency use by certain groups before obtaining official permission from Pakistani health authorities," the company said. Regkirona, which will be sold as the first batch, will be administered to confirmed COVID-19 patients among Pakistani soldiers and ordinary people. 100,000 vials with contracts can be administered to about 30,000 people. Celltrion Healthcare plans to send medical personnel to Pakistan to provide education to local medical personnel who will be in charge of taking Regkirona. Pakistan has the world's fifth largest population of 216.6 million, with an average of about 4,000 new confirmed cases of COVID-19 recently, and the cumulative number of confirmed cases has exceeded 850,000 people. The cumulative death toll from COVID-19 also amounts to 18,000. The situation caused by COVID-19 is getting worse, with the daily average death toll, which was maintained at 50-60 earlier this year, surpassing 150 as of the end of March. "Regkirona, which will be sold this time, will help Pakistan's COVID-19 quarantine policy," Celltrion Healthcare said. Regkirona has been prescribed to more than 2,700 patients since it obtained conditional approval from the MFDS in February for patients with high-risk minor and secondary diseases. Recently, a total of 1,300 global clinical phase III patients have been recruited and administered in 13 countries, including Korea, the United States, Spain and Romania, and data analysis is currently underway. An official from Celltrion Group said, "We are currently discussing Regkirona exports with a number of countries as well as Pakistan. "Considering the limited production capacity of antibody treatments, we plan to focus our support on countries that need help from the international community."
- Company
- Chong Kun Dang challenges New Biologics
- by An, Kyung-Jin May 13, 2021 05:55am
- Chong Kun Dang is a new drug developer and challenges to overcome lung cancer tolerance with a dual anti-cancer antibody that simultaneously inhibits hepatocellular growth factor receptor (cMET) and epithelial cell growth factor receptor (EGFR). It is planning to achieve both business performance and R&D performance with bio-new drugs that it is going to challenge for the first time. Park Kyu-jin, director of Chong Kun Dang, presented the theme of "cMET/EGFR dual antibody development for lung cancer patients" at the 5th Forum on Medical Innovation online event held by the Foundation for Medical Innovation on the 7th. Foundation for Medical Innovation is a non-profit corporation under the Ministry of Science and ICT established in 2016 by Professor Kim Hyo-soo of Seoul National University Hospital, who is considered an expert in cardiovascular, stem cell, and biology. Director Park introduced the main research results of the bio-new drug "CKD-702," which is being developed by Chong Kun Dang, at the forum on the theme of "the latest trends and visions of next-generation bio-innovation technologies." CKD-702 is a dual anti-cancer antibody that simultaneously inhibits c-Met and EGFR, which are essential for cancer growth and proliferation. By binding to each receptor to induce endocytosis and decomposition, the expression of the two receptors is reduced and cancer cell proliferation is suppressed by blocking related sub-signals. It is the first bio-new drug to be challenged by Chong Kun Dang since its foundation. Since launching the development of "CKD-702" in 2013, Chong Kun Dang has completed preclinical verification with the support of the pan-ministry new drug development project. According to the announcement, a preclinical study of CKD-702 exclusively administered to non-small cell lung cancer animal models confirmed that CKD-702 was resistant to EGFR tyrosinase inhibitors (TKI), such as "Giotrip" (Apartmentinib) and "Tagrisso" (Osimertinib). The MET exon 14 skipping mutation or MET gene amplification model, known as one of the major carcinogenes in non-small cell lung cancer, was also shown to significantly inhibit tumor growth only with CKD-702 alone. The results suggest that targeted anti-cancer drugs, which are currently actively prescribed at medical sites, may be overcome. Park Kyu-jin, director of Chong Kun Dang, is introducing the CKD-702 action mechanism at the forum Based on such preclinical data, Chong Kun Dang has been conducting phase 1 clinical tests in Korea since last year for patients with non-small cell lung cancer. It is exploring the possibility of subsequent development by administering CKD-702 solo therapy to those who express specific mutant findings among patients with non-small cell lung cancer. According to Director Park, "CKD-702" has a low binding power to EGFR, which has a low risk of developing skin toxicity, which was considered a side effect of EGFR targeted anti-cancer drugs. On the other hand, cancer cell proliferation ability is better than c-MET target anti-cancer drug and EGFR target anti-cancer drug combined. If preclinical results are reproduced at the clinical stage, the potential is sufficient as the best-in-class in the family, even if it is not the world's first-in-class. Director Park said, "We are targeting non-small cell lung cancer, which mainly expresses c-MET and EGFR, as the first indication. "We are in the process of comprehensively reviewing the possibility of global technology exports or internal development," he said. "We plan to push for global clinical trials by expanding our coverage to stomach cancer and head and neck cancer in the future."
- Company
- HER2-directed ADC ‘Enhertu’ in process of seeking approval
- by Eo, Yun-Ho May 12, 2021 04:43pm
- A HER2-directed antibody-drug conjugate (ADC) is looking to enter the Korean market. According to industry officials, AstraZeneca Korea and Daiichi Sankyo Korea are preparing the application process for the approval of their human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) ‘Enhertu (trastuzumab deruxtecan).’ Enhertu, which has indications for breast and gastric cancer, was jointly developed by AstraZeneca and Daiichi Sankyo and was first approved for the treatment of recurrent metastatic HER-positive breast cancer in the U.S. in 2019. Last year, Enhertu was additionally approved in the U.S. for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have received prior standard treatment with ‘Herceptin(trastuzumab).’ The drug was granted the Breakthrough Therapy Designation (BTD) in the U.S. As Roche’s ADC ‘Kadcyla (trastuzumab emtansine)’ failed to demonstrate its efficacy in gastric cancer, expectations are rising in the field on the possibility of prescribing Enhertu in gastric cancer. Although HER2 protein expression is generally found in breast cancer, it can also be found in other types of cancer. One out of five gastric cancer patients in the U.S. is diagnosed with advanced HER2-positive gastric cancer. The efficacy of Enhertu in gastric cancer was demonstrated through the Phase II DESTINY-Gastric01 trial. In the trial, 25 patients were randomly assigned to receive Enhertu or the investigator’s choice of chemotherapy (paclitaxel or irinotecan) administered by intravenous infusion every 3 weeks. The patients had HER2-positive, locally advanced or metastatic gastric or gastroesophageal junction cancer that had progressed after the patient had received at least two previous regimens, which included Enhertu and fluoropyrimidine-based chemotherapy. Results showed that median overall survival (OS) in the Enhertu group was 12.5 months, which was superior compared to the 8.4 months in the patient group that received the investigator’s choice of therapy. The objective response rate (ORR) was 40.5% in the Enhertu group and 11.3% in the paclitaxel or irinotecan group. Also, the median duration of confirmed objective response was 11.3 months in the Enhertu group, as compared with 3.9 months in the group that received the investigator’s choice of therapy. Also, Enhertu demonstrated efficacy and safety in breast cancer in the Phase II DESTINY-Breast01 trial. Results showed that Enhertu treated group met the primary efficacy outcome measures with an objective response rate (ORR) of 60.9%. The progression-free survival (PFS) was 16.4 months, and Enhertu also showed encouraging duration of response (DoR) and 1-year survival rate outcomes.
- Company
- Can steroid ointment be used for dermatitis?
- by May 12, 2021 05:58am
- Bayer Korea recently released a Pharm drama on the 12th, which consists of cases of chronic dermatitis, atopic dermatitis, and contact dermatitis patients and pharmacists in the form of a drama. The Pharm drama(View Video) is designed to provide guidelines for Bepanthen so that skin inflammation can be safely taken care of without worrying about steroid side effects. Pharmacist Lee Seung-hee, who runs Chunsa Pharmacy, appeared to introduce three cases of skin lesions and conducted an interview on the use of the correct ointment. The three mentioned cases include patients in their 30s suffering from chronic dermatitis due to steroid drug use, infants suffering from atopic dermatitis, and patients in their 30s suffering from contact dermatitis due to wearing masks. The pharmacist first mentioned cases of patients in their 30s suffering from chronic dermatitis, stressing the risk of side effects of steroid drugs. It is explained that stopping after applying steroid drugs for a long time can lead to rebound, which is one of the side effects. Due to the characteristics of steroids, which are immunosuppressants, steroids only improve skin symptoms that are immediately visible, and toxins and heat accumulate steadily in the body. Steroids can be used appropriately depending on the circumstances, but long-term use should be avoided, and it is recommended that the steroid-free ointment be chosen as much as possible. Moisturizing and skin regeneration are needed to alleviate symptoms of atopic dermatitis and contact dermatitis. In particular, Bayer Korea recommended Bepanthen (Dexpanthenol 5%) as an external solvent with these conditions and stressed that it should be treated steadily. Bayer Korea expects the video to help pharmacists consult on medication as more and more patients have skin problems due to wearing masks. In fact, Korean researchers recently announced a study that continued wearing of face masks due to COVID-19 causes skin trouble. It has been confirmed that significant changes in biochemical indicators of the skin are caused by long-term wear of face masks. Wearing a mask for a long time creates a humid environment inside, and skin irritation can occur frequently, causing inflammation, and frequent hand washing and use of sanitizers can also cause skin drying and itching. Chronic dermatitis symptoms such as atopic dermatitis can worsen as the dry and daily temperature range severe weather unique to the change of seasons continues. Pharmacist Lee Seung-hee said, "Bepanthen is an ointment that can be used exclusively for mild skin diseases and can be recommended for those who overuse steroid drugs. It is OTC drug that actually works well for dermatitis." Bepanthen is a non-steroidal ointment that features the effects of skin moisturizers, skin barrier restorants, and wound healing promoters, and ranked No. 1 OTC in the dermatitis treatment category.
- Company
- Will P-CABs take over PPIs in GERD treatment market?
- by Whang, byung-woo May 12, 2021 05:58am
- With HK Inno.N’s K-Cab increasing its influence in the potassium-competitive acid blocker (P-CAB) market, the introduction of new P-CAB products raises the question of whether the products may increase the P-CABs' share in the market. In addition to Daewoong Pharmaceutical’s Fexuprazan, which is expected to be approved in Korea within this year, there are expectations that the already-approved Takeda Pharmaceuticals Korea’s Vocinty (vonoprazan) may also be released this year. Since its introduction, P-CABs were regarded as the next-generation drug that would replace proton pump inhibitors (PPIs) in the market. P-CABs have been known to have resolved most of PPIs' limitations, including the slow onset of action, varied effect according to mealtime, inter-individual variability according to CYP2C19 genotype, and drug interaction concerns. In particular, HK Inno.N’s K-Cab is the world's first P-CAB that received approval for all major indications of gastric acid blockers including erosive and non-erosive Gastroesophageal reflux disease (GERD), It has 4 indications in total. Although reimbursement is not applied to all four indications yet, K-Cab has shown clear growth every year after preoccupying Korea’s P-CAB market. According to the pharmaceutical market data research firm UBIST, since recording 29.8 billion won in sales in 2019, K-Cab’s sales have more than doubled last year to record 72.6 billion won. Also, just in the first quarter of 2021, it already recorded sales of 22.5 billion won. Simple calculations show that if K-Cab’s sales continue at a similar level, the company may surpass 100 billion won in sales this year. However, the industry's prevailing view is that it will take more time to see a shift in the overall market, given that the sales of PPIs are still record around 200 billion won. This is why some predict that if Daewoong Pharmaceutical’s Fexuprazan is approved and released in Korea in the current environment, the rivalry between the two products may actually expand the P-CAB market. An official from A Pharmaceuticals said, “It seems that HK Inno.N’s also knows that the overall share of the pie, the market share of P-CABs in general needs to be expanded to shift the market trend from PPIs to P-CABs. Just like how the PPI market grew due to the introduction of many products in its class, Daewoong Pharmaceutical’s entry into the P-CAB market with its strong sales power will certainly make some waves in the current market situation.” In other words, the rivalry between HK Inno.N and Daewoong’s products may bring synergy in their market. Another product receiving attention in this context is Takeda Pharmaceuticals Korea’s Vocinty. Vocinty, known as the originator of this class of next-gen GERD treatment, was approved in March 2019, but no clear news on its release has been shared yet. An official from Takeda Pharmaceuticals Korea said, “We are working to provide innovative medicines to patients according to our decision-making priorities. However, we cannot disclose specifics on whether or not and when certain products will be released." However, with K-Cab looking to sell over 100 billion won this year and Daewoong Pharmaceutical’s entry imminent in Korea, the industry expects that Takeda may not be able to postpone the launch of Vocinty any longer. However, one obstacle for Vocinty, which is sold under the name Takecab in Japan, is its price. In Japan, the 10mg Vocinty tab. is sold at 130.3 yen (1,339 Korean won) and the 20mg Vocinty tab. is sold at 195.5 yen (2,005 Korean won). This is more expensive than the 50mg K-Cab tab that is currently sold at 1,300 won in Korea. On this, an official from B Pharmaceuticals said, “Many considerations need to be made for a product’s release including the adjustment of its price. However, the company may be able to contemplate much longer, considering the increased P-CAB market in Korea. In addition to Vocinty, which verified its competitivity in Japan, the introduction of Daewoong’s Fexuprazan in the market may trigger a three-way race in the P-CAB market."
- Policy
- The preventive effect of Moderna vaccine is 94%
- by Lee, Tak-Sun May 12, 2021 05:58am
- The MFDS' verification advisory group, consisting of outside experts, has recognized the prevention effect of Moderna COVID-19 vaccine for permission. The Central Pharmaceutical Affairs Review Committee, a court advisory body, will seek permission advice on the Moderna COVID-19 vaccine on Wednesday. COVID-19 vaccine safety and effectiveness verification advisory group by the MFDS held a meeting on the 9th and made this decision. The meeting of the verification advisory group is one of the procedures in which the MFDS collects advice from experts in various fields, including clinical, non-clinical, and quality, prior to consulting the Central Pharmaceutical Affairs Review Committee. At the meeting, the verification advisory group judged on the effectiveness of the Moderna vaccine, "The submitted data confirmed the effectiveness 14 days after the second dose of 18 years of age or older, so preventive effects for permission can be recognized." In addition, safety profiles were judged to be acceptable in clinical trials. They also said that it is reasonable to additionally observe abnormal cases that occurred during clinical trials through the "risk management plan" to secure safety after permission, and collect and evaluate information. In clinical trials, the Moderna vaccine was evaluated for its preventive effectiveness in 28,207 people (14,134 in vaccine groups and 14,073 in control group) who did not contract COVID-19 before administering a vaccine or control drug (0.9% in physiological saline). Since the 14th day of the second dose of the vaccine, 11 people have been confirmed with COVID-19 and 185 controls, showing 94.1% prevention effect, and more than 86% prevention effect regardless of age or presence of underlying disease. In addition, there were 31 cases of severe death due to COVID-19 in the control group (30 confirmed severe cases and 1 death) and none in the vaccine group. In the case of "Neutralizing antibodies," which can be combined on the surface of the COVID-19 virus particle to neutralize the infection of the virus, the "seroconversion rate," which means the proportion of people who have more than quadrupled since the second dose, was 100%. Of the 33,351 people eligible for clinical trials, 1.0% (147 people) of the vaccine group and 1.0% (153 people) of the control group reported "significant abnormal cases." There were nine cases of significant drug-abnormal reactions (including facial welling, nausea, vomiting, rheumatoid arthritis, autonomic nervous system imbalance, peripheral oedema, dyspnoea, and small B-cell lymphoma). However, most of them were recovering at the time of submitting clinical trial data. The MFDS plans to hold a Central Pharmaceutical Affairs Review Committee on the 13th to receive permission advice. The results are expected to be released later in the day.
- Policy
- Koselugo is about to be approved in Korea
- by Lee, Tak-Sun May 12, 2021 05:57am
- Koselugo (Selumetinib) is the FIRST and ONLY FDA-approved prescription medicine that is used to treat children 2 years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cannot be completely removed by surgery. It is not known if Koselugo is safe and effective in children under 2 years of age. And, it is about to be approved in Korea. The FDS last year supported the drug by designating it as an "Expanded Review target for Expedited Review". According to industries on the 7th, the MFDS recently completed a safety and validity examination of AstraZeneca's Koselugo. Koselugo is a new drug used in the treatment of type 1 neurofibromatosis, which is inoperable in children over the age of three. In October last year, the MFDS designated the drug as an Expedited Review target, saying that it is life-threatening and constitutes a serious disease treatment. "If designated as an Expedited Review target, we can receive a Priority Review compared to other medicines. The screening period will be shortened to up to 90 days. Koselugo was quickly reviewed by the FDA and approved in April last year after six months. Neurofibromatosis Type I is a genetic nervous system disorder in which tumors proliferate in the nerve region, showing the characteristics of tumors destroying normal cells such as faces. Therefore, it causes skin discoloration, damage to the nervous and skeletal system, and risk of developing benign and malignant tumors. There has been no fundamental treatment method, so symptomatic treatments such as medication and lesion resection have been carried out depending on symptoms. Koselugo's release is expected to make patient care much easier. Clinical trials used Koselugo every 28 days to compare tumor size changes and tumor-related mortality. As a result, the objective response rate (ORR) of the Koselugo treatment group was 66%, and patients with 82% ORR continued to respond for more than 12 months. As the MFDS' review has been completed, it is expected to be approved as soon as possible unless there are other supplements.
- Company
- Trials to suspend refund negotiations for CA drugs fail
- by Chon, Seung-Hyun May 11, 2021 06:00am
- Once again, the pharmaceutical companies have failed to suspend the execution of negotiations for the retrieval of insurance that has been paid for 'choline alfoscerate.' Both of the trials that were filed by two groups of pharmaceutical companies against the health authorities in Korea were dismissed by the court. According to industry officials, the Seoul High Court 1-1 ruled to dismiss the appeal by 28 companies including Chong Kun Dang filed to suspend the execution of negotiations on the retrieval of insurance. After the Seoul Administrative Court rejected the claim for the suspension of execution on January 29th, Chong Kun Dang and the other companies immediately appealed, but to no avail. The court of the second trial also dismissed the case. The law firm Kim & Shin is in charge of the lawsuit. At the end of last year, the Ministry of Food and Drug Safety (MFDS) ordered the National Health Insurance Service (NHIS) to make refunding deals for 230 choline alfoscerate products. The deal, which contains the condition 'If the trial fails, the whole amount of insurance paid for choline alfoscerate drugs that are prescribed from the date the clinical trial protocol is submitted to its the product's deletion from the benefits list shall be paid back in full by the company,' meant the deal was a 'negotiation for the retrieval of insurance.' In other words, the ministry intends to make a contract with the pharmaceutical companies so that when the clinical re-evaluation for choline alfoscerate that is being conducted on order by MFDS fails, the companies would have to pay back all of the insurance received for every prescribed choline alfoscerate drug from the date the clinical trial protocol was submitted to the date their license is revoked. Pharmaceutical companies have unanimously filed an administrative suit and complaint to suspend the execution of the order to pay back the insurance for choline alfoscerate drugs. The companies divided into two groups for the lawsuit. Lee&Ko is in charge of the suit for the 28 companies including Daewoong Bio, and Kim & Shin is in charge of the suit for the 28 companies including Chong Kun Dang. Daewoong Bio and the other companies have filed for the suspension of execution on December 30th of last year, but the first and second trials were both dismissed. The second trial was turned down on February 4th, a month after the case was filed, and the case is currently pending in the Supreme Court. Chong Kun Dang. and the other companies filed their complaint to suspend execution on January 8th of this year and received the dismissal ruling on January 29th. Chong Kun Dang and the companies appealed, but the case was again dismissed in the second trial recently. The administrative suit on choline alfoscerate has not been ruled yet. The Daewoong Bio's group and the Chong Kun Dang's group have both filed suits to the Seoul Administrative Court to cancel the negotiation order and notification, against the MFDS and NHIS separately. The cases of the two groups are to be merged for review, and the first proceedings are scheduled in July. Recently, NHIS failed to reach an agreement with pharmaceutical companies regarding the reimbursement of their choline alfoscerate products. NHIS and the companies were unable to reach an agreement after extending the negotiation period two times. As a result, the MFDS will have to delete the products from the benefits list or order renegotiations.
