- LOGIN
- MemberShip
- 2026-05-12 09:41:38
- Company
- Amgen won the second trial of 'Enbrel' patent
- by Kim, Jin-Gu Jul 09, 2020 06:26am
- Samsung Bioepis, Benepali in Europe, and Eticovo in US Samsung Bioepis' Enbrel biosimilar 'Eticovo' (Etanercept) is expected to postpone the US debut. A patent lawsuit was conducted that could affect the Eticovo's early launch strategy, but the US court sided with the original company. According to the pharmaceutical industry on the 6th, the U.S. Federal Court of Appeals earlier this month has sided with the original company in a patent lawsuit between Enbrel's patentee, Immunex and biosimilar maker Sandoz. Immunex is a subsidiary of Amgen. This is the same result as the first trial made by the New Jersey District Court. The court respected the original trial that Sandoz company's failure to provide sufficient grounds to prove Amgen's patent invalidity. As a result, Amgen succeeded in maintaining and defending Enbrel's patent until 2029. However, the possibility of reversal remains. Immediately after the second trial was announced, Sandoz announced its intention to appeal the third trial. The reason that Sandoz and Amgen's litigation has attracted attention is that this ruling also affects Samsung Bioepis' Eticovo. Sandoz and Samsung Bioepis are actually in a patent dispute with Amgen. Enbrel biosimilar ‘Erelzi’ by Sandoz was approved by the U.S. Food and Drug Administration (FDA) in 2016. Eticovo by Samsung Bioepis was approved in April 2019. However, the two companies are unable to release products to the US market. They have the challenge of overcoming Amgen's patent. It is analyzed that Eticovo’s case is likely to follow the results of Erelzi’s case. It means that it is also determined whether Eticovo will be launched early according to the results of the patent lawsuit between Sandoz and Amgen, which will be judged by the US Supreme Court. Samsung Bioepis is actually watching the lawsuits between Sandoz and Amgen. It is said that there is no full-scale pleading after the lawsuit under the licensed patent linkage system began in April of last year. An official from Samsung Bioepis said, "We are watching the results of the lawsuit between Sandoz and Amgen." Samsung Bioepis currently has four biosimilars in the United States. Eticovo, Remicade biosimilar 'Renflexis', Humira biosimilar 'Hadlima', and Herceptin biosimilar 'Ontruzant', etc. Of these, Renflexis and Ontruzant are currently on sale. Eticovo & Hadlima have been postponed due to patent. However, Hadlima can be released after 2023 according to an agreement with the original company, AbbVie.
- Company
- Phase III clinical trial plan for Rimatil has been submitted
- by Nho, Byung Chul Jul 08, 2020 09:14am
- Chong Kun Dang added a clinical pipeline for COVID-19 treatment following Nafabeltan. On the 18th of last month, Chong Kun Dang began the development of a COVID-19 treatment (clinical phase II) for its anticoagulant and acute pancreatitis treatment drug Nafabeltan (Nafamostat) on the 18th of last month. It is estimated that the mechanism of Nafamostat inhibits protease TMPRSS2, which is known to play a major role in the cell invasion process of COVID-19, and shows several hundred times more antiviral efficacy in human lung cell experiments compared to Remdesivir. On the 30th, IND application for Rimatil (Bucillamine) which is marketed as a rheumatoid arthritis treatment was submitted to the FDA. The Phase III clinical trial for Bucillamine is not directly controlled by Chong Kun Dang, but is hosted by the Canadian pharmaceutical bio company Revive Therapeutics. Rimatil is a safe drug that has been sold in East Asian countries for over 30 years, and is a licensed-introduced drug from Santen company, Japan. If the clinical trial phase III of Bucillamine is successful, Chong Kun Dang, which has exclusive domestic sales rights, will obtain COVID-19 treatment indication. Bucillamine reported that N-Acetyl-L-cysteine significantly alleviates the symptoms of respiratory viral infections and produces significantly positive results in small-scale clinical trials in preclinical and COVID-19 mild patients. According to Revive Therapeutics, the FDA has recommended the clinical phase III of COVID-19 treatment, Bucillamine, and will begin a full-scale clinical trial in the third quarter of this year. The clinical trial is conducted in a double-blind manner in 800 patients with mild COVID-19. Clinical participants receive Bucillamine 100 mg and 200 mg three times a day. The median result is 28 days after the first dose, which is the time when the dose for 210 patients is completed.
- Company
- “Liver cancer option expands, but needs further evidence”
- by Eo, Yun-Ho Jul 08, 2020 05:38am
- Professor Kim Doyoung When a new drug development in a specific area is sluggish, there are two prominent reasons why; either the disease area has low marketability or the drug development itself for the disease is very difficult. In the latter case, a new drug gets an obvious spotlight when it is released to the market. Liver cancer (hepatocellular carcinoma) would be a good example. For over a decade, Nexavar (sorafenib) was technically the only option to be used on liver cancer patients. But now, the disease specialists have heightened anticipation on other options to come. Stivarga (regorafenib) entered the market as a second-line treatment, and Lenvima (lenvatinib) was added as another first-line treatment option at the same level as Nexavar. In the U.S., Tecentriq (atezolizumab) and Avastin (bevacizumab) were approved as a combination therapy recently, which newly added an immunotherapy as an option. The situation in Korea is also taking a step at a time. Early this year, the healthcare reimbursement standard on Nexavar has been adjusted to grant the benefit on patients in Child-Pugh scoring of class B7, a severe case of the disease. The change raised the usability of the pharmaceutical treatment in liver cancer. Daily Pharm interviewed Professor Kim Doyoung of Gastroenterology Department at Severance Hospital and spoke of the hepatocellular carcinoma treatment strategy with more options available now. -First of all, what does expanded coverage on Nexavar mean for a healthcare provider? The patients in Child-Pugh class B7 were considered somewhat of ‘grey area.’ The patient’s liver function level is comparatively close to normal state, but they have risk of developing ascites or jaundice. The patients stuck in the middle did not have a clear answer to choose as a treatment option. These patients need treatment without building liver toxicity. And Nexavar, as proved in various evidences, demonstrates less liver toxicity. Basically, the liver cancer patients hopeless without a proper treatment option can now be treated with Nexavar. -What are some points to consider—like dosage control or administration suspension—when prescribing Nexavar on patients in Child-Pugh class B7? There are no specific precautions to consider. In the GIDEON study that produced global real-world data (RWD) from over 3,000 intent-to-treat participants, Nexavar barely showed much difference between patient groups in Child-Pugh class B7 and Child-Pugh class A. Regardless of class A6 or class B7, normal dosage is recommended but reduced dosage is recommended for patients showing adverse reaction. The dosage does not have to be adjusted from the beginning. -Would the transarterial chemoembolization (TACE) have some changes as Nexavar is now reimbursed and the systemic anticancer therapy option has expanded? Would it be safe to assume this is the period when healthcare providers are trying to reach a consensus on the recommended frequency of TACE and treatment ceasing point? Due to the coverage expansion, some may think of using Nexavar when the patient’s Child-Pugh scoring gets worse after repeated TACE. But the patient’s survival rate would worsen if the Nexavar administration timing is delayed and liver function starts failing according to Child-Pugh scoring. In fact, the talk of when to use systemic anticancer therapy on patients with failed attempt of TACE or refractory condition has continued for over a decade. Although some of the consensus among the healthcare providers has been documented, but it would take a while for the medical practice environment to accept the change and apply it. After practicing TACE for many times, I can see whether or not the patients either should continue on with TACE. Many healthcare providers would agree with me. The decision to continue with TACE should be made promptly but carefully, and switch to another option, if need be. At some point, there was a talk on how beneficial it is to quickly switch to systemic anticancer therapy after TACE. But the argument lacks sufficient evidence in improving the survival rate. -Does that mean, in some cases, there is a concerning factor when following up promptly with a systemic anticancer therapy after TACE? In the past, when Nexavar was the only option of systemic therapy for treating liver cancer, the healthcare providers regarded switching to a systemic anticancer therapy after TACE as a ‘last resort.’ So the treatment switch was not fast enough and it was worrying. But now the healthcare providers seem to agree more that a systemic anticancer therapy is not a ‘last resort,’ as Nexavar is prescribed to patients with comparatively good functioning liver, and also because a follow-on drug Stivarga is commercialized. -As Nexavar is the only systemic anticancer therapy with coverage for patients in Child-Pugh class B7. These patients do not have a choice in later-line treatment with coverage Stivarga’s global REFINE study conducted in a real-world practice conditions in 1,000 patients, diagnosed with unresectable hepatocellular carcinoma, included many of patients in Child-Pugh class B and other more severe cases. Regardless, the study confirmed improved efficacy against Stivarga in global Phase III RESOURCE trial. Based on these findings, Stivarga’s coverage should be expanded to patients in Child-Pugh class B7 for them to resume treatment after Nexavar. -Recently, a combination of immunotherapies was passed by the U.S. health authority. What is your expectation on it? I expect that the prospective competitor of Nexavar to be the combination of immunotherapies. To be honest, I had a great expectation on Opdivo (nivolumab) for treating patients with hepatocellular carcinoma, because its clinical trial had two patients who demonstrated complete response (CR). But using it in the actual practice, the response rate was not as good as I expected. And apparently, Tecentriq combination has exhibited improved result than Nexavar, and it looks ‘good’ at face value. But we need to watch if the combination therapy can show better efficacy in uncontrolled real-world practice conditions. There is also the catch—the patients have to frequently visit the hospital to receive the injection. And of course, the biggest problem of expensive price is still unresolved.
- Company
- Pfizer seeks for coverage on EGFR TKI to launch this year
- by Eo, Yun-Ho Jul 07, 2020 06:13am
- Pfizer Pharmaceutical Korea is quickly taking steps to join the competition in epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) market. According to the pharmaceutical industry sources, Pfizer is in process of listing EGFR TKI Vizimpro (dacomitinib) for healthcare reimbursement. Vizimpro took the pricing negotiation exemption track by accepting the weighted average pricing as an alternative option, taking into account that first generation Iressa (gefitinib), Tarceva (Erlotinib) and directly competing second generation Giotrif (afatinib) have already settled in the market. The drug would be able to launch with reimbursement in the second half of the year. The dacomitinib drug seeking for the reimbursement is a targeted therapy treating patients with non-small cell lung cancer (NSCLC), who have confirmed EGFR gene deletion in exon 19 or 21 L858R substitution mutations. The efficacy of Vizimpro was confirmed in Phase III trial ‘ARCHER 1050.’ The clinical trial compared dacomitinib’s efficacy head-to-head against AstraZeneca’s first generation EGFR TKI Iressa. Total 452 NSCLC patients have registered for the trial. The study reported Vizimpro lowered the risk of progression or death by 41 percent against Iressa, and the median progression-free survival (PFS) was 14.7 months in the Vizimpro group and 9.2 months in the Iressa group. However, Vizimpro demonstrated more adverse reactions. Frequently reported grade 3 events in Vizimpro group were dermatitis acneiform (14 percent) and diarrhea (8 percent), whereas over 8 percent of the Iressa group was reported with abnormal level of liver enzyme. As a result, 60 percent of the dacomitinib group had to adjust the dosage due to the adverse events. Meanwhile, Vizimpro has received marketing approval on three doses (15 mg, 30 mg and 45 mg) from Ministry of Food and Drug Safety (MFDS) in last February.
- Company
- GC Pharma has signed a contract to supply Pfizer's Rapamune
- by Jul 06, 2020 06:15am
- GC Pharma is launching a sale of Rapamune (Sirolimus), an immunosuppressive agent of Pfizer Korea. PfizerAccording to the distribution industry on the 3rd, GC Pharma signed a supply contract with Pfizer Korea for supply of Rapamune 0.5·1·2mg on the 19th of last month and began selling on the 1st of this month. Rapamune is an immunosuppressive drug released by Pfizer Korea with a domestic license in March 2006. It is used to prevent long-term rejection of patients with kidney disease and to treat patients with lymphangioleiomyomatosis (LAM). Rapamune's annual prescription amount is low at ₩2 billion. According to IQVIA, the annual sales from 2015 to 2019 were ₩2.4 billion. In the case of Rapamune 1 & 2mg, the drug price is expected to drop slightly from this year, and sales are expected to fall further. As a result, Rapamune has not released generics for 5 years after the patent expires in 2013. Only in August 2018, Chong Kun Dang was the first Korean pharmaceutical company to receive a generic named Raparobell. The generic got listed this year. With the drug price cut and generics, the impact of GC Pharma's sales of Rapamune is expected to be minimal. Nevertheless, the reason for choosing Rapamune is considered to reflect the company's willingness to empower the rare disease field. GC Pharma has a rare disease team and provides treatment for many rare diseases such as Hunter syndrome, hemophilia, and Fabry disease. An official in the pharmaceutical industry said, "As GC Pharma is focusing on the rare disease field, it seems to be a choice to increase the market influence by expanding the related pharmaceutical items rather than sales."
- Company
- Hanmi appealed patent lawsuit of Galvus
- by Kim, Jin-Gu Jul 06, 2020 06:14am
- GalvusAs soon as the Patent Judge sidede with the original company in the patent dispute of Galvus (Vildagliptin), a DPP-4 inhibitor-based diabetes treatment agent, Hanmi immediately announced its appeal. An official from Hanmi said in a call with Dailypharm on the 2nd, "We will appeal immediately and receive a trial for the scope of the patent once again." Earlier, on the 1st, the Intellectual Property Trial And Appeal Board made a decision to raise the hand of the original company in the patent dispute surrounding Galvus. The patent dispute was triggered when Hanmi and Korea United Pharm filed a claim against Novartis to confirm the passive scope of rights. About this trial, Hanmi evaluated that it was a meaningful patent challenge to overcome the high patent barrier of multinational pharmaceutical companies. Hanmi Pharm attempted a new patent evasion strategy to develop Galvus’ generic. Based on four indications (1, 2, 4, and 5 indications) except for one of the five indications applied to Galvus, the marketing authorisation of the MFDS was recently obtained. Galvus 5 indications of Galvus. Hanmi has obtained the marketing authorisation from the MFDS based on the four indications except for the third indication. However, the Intellectual Property Trial And Appeal Board ruled that four indications in addition to one indication excluded by Hanmi have an extended patent. It was the intention that the five indications correspond to a treatment regimen belonging to the same disease group (type II DM). Accordingly, Hanmi decided to appeal immediately and decide the patent court. Separately, Hanmi won the trial of invalidation of the extension of the duration of the patent for a substance at the existing patent tribunal. It was decided that the extended patent period of 187 days was invalid. Novartis appealed to the patent court. The second trial is scheduled for August 13th. An official from Hanmi said, “We expect that Hanmi's action will stimulate the drastic patent challenge of domestic pharmaceutical companies against multinational pharmaceutical companies. we will go to the strong pharmaceutical country based on our own innovation strategy.”
- Company
- Hanmi loses first trial in patent dispute over Galvus
- by Kim, Jin-Gu Jul 06, 2020 06:14am
- GalvusNovartis won the patent dispute between Hanmi and Novartis over the DPP-4 inhibitor-based diabetes treatment agent Galvus (Vildagliptin). The Intellectual Property Trial And Appeal Board made a decision to dismiss the passive right scope verification trial requested by Hanmi on the 1st. Hanmi has filed a total of eight trials for Galvus patent, but the Board has dismissed it. On the same day, Korea United Pharm also lost. It is expected that the trial will have a significant impact on Novartis' application to the Seoul Central District Court for a prohibition of sales disposition, a lawsuit for patent infringement claim, and a lawsuit to cancel an item license. ◆Hanmi's new strategy, Patent challenge by dividing indications In July 2018, Hanmi filed a judgment against Novartis to confirm the passive scope of rights for Galvus and Galvusmet's material patents. In the following year, Hanmi applied for permission of Vildagle, salt-changing generic for Galvus. Hanmi applied for a product license except one of the five indications of the original drug, Galvus. It was Hanmi's new patent avoidance strategy. Hanmi unveiled the logic that Novartis' patent is limited to only 3 out of 1-5 indications applied to Galvus. The indication is said that it is used dual oral therapy in combination with Metformin, Sulfonylurea, thiazolidinedione in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy. Galvus In other words, Hanmi asserted that since the validity of Galvus’ patent right only affects the indication #3 and not the rest of indication #1, #2, #4, and #5, Vildagle also does not infringe patent of Galvus. Novartis refuted this. In fact, the claims of Hanmi made an unreasonable demand because indications were included in the same scope (type II DMtreatment). The MFDS approved the application for Hanmi in January this year. In April, insurance benefits were decided. However, Hanmi has not yet released the product. As the Intellectual Property Trial And Appeal Board decided to take Novartis side on the 1st, the challenge of Hanmi has been put on hold. Vildagle's release schedule has been postponed indefinitely. ◆Dutasteride was applied, but why is it not Vildagliptin This patent dispute is of great interest in the industry. It is because expectations are raising whether the challenge of Hanmi will be a new path to generic's patent evasion strategy. It is said that Hanmi got a hint from patent dispute of Dutasteride in 2015. Patent dispute of Dutasteride was similar to Galvus, but proceeded with another issue. At that time, Generic company claimed that the patent for the substance was extended because original company's Dutasteride (Brand name: Avodart) was limited to the permission for prostate hyperplasia. In other words, it was argued that the patent right has no effect in the case of 'hair loss', another indication of Dutasteride. Based on these claims, the MFDS approved it because Generic company applied only one indication for hair loss. The generic company won the patent dispute. The Intellectual Property Trial And Appeal Board judged that the effective right of Dutasteride patent was limited to prostate hyperplasia and did not affect hair loss. Generic succeeded in launching a hair loss indication and before the patent expired. ◆Pharmaceutical industry expects new patent avoidance strategy The Judge's decision has not been released. However, in the industry, it is persuasive to argue that the case of Dutasteride and Galvus is different. In the case of the Dutasteride dispute, the indications of prostatic hyperplasia and hair loss are markedly different, whereas the Galvus dispute is virtually the same indication and cannot be regarded as the same case. Generic companies was expecting the result. A domestic patent official said, "It is true that we thought about whether to challenge patent evasion in the same way as Hanmi, but the possibility of success did not seem so high, so we were waiting for the result of this dispute." He added that there is no plan to file a referee with this strategy, the Intellectual Property Trial And Appeal Board did not accept the claim that it should judge the identity of medical use based on the individual indication. Another official in the pharmaceutical industry said, "If Hanmi leads the case with an appeal, it is unlikely that the trial will be overturned." The trial is expected to have a significant impact on other lawsuits between Novartis and Hanmi. Three related lawsuits are in progress. Novartis has filed a lawsuit against the Seoul Central District Court for infringement and prohibition of sale and filed a lawsuit against the Seoul Administrative Court to cancel the item permission, which is the main lawsuit of the provisional injunction. Three cases are currently pending. If the court accepts the provisional disposition, it is expected that Vildagle will not be available for the time being.
- Company
- AML treatment Rydapt can be prescribed in general hospitals
- by Eo, Yun-Ho Jul 03, 2020 06:18am
- Novartis' new acute myelogenous leukemia drug 'Rydapt' can be prescribed in general hospitals. According to the related industry, acute myeloid leukemia (AML) treatment, Rydapt (Midostaurin) has passed the pharmaceutical committee (DC, drug commitee) of Big 5 Hospitals, such as Seoul National University Hospital and AMC. It was approved as an orphan drug in Korea last year as a FLT3 inhibitor and can be prescribed for ▲combination of high-dose Cytarabine with standard Cytarabine or Daunorubicin induction therapy for new AML patients with positive FLT3 mutation ▲Aggressive systemic mastocytosis, systemic mastocytosis with hematologic neoplasm, mast cell leukemia. FLT3 inhibitors are also well known as 'HM43239', Hanmi’s candidate. The effectiveness of Rydapt has been demonstrated through ATIFY studies. The study was the largest of all clinical trials involving 3,277 AML patients with specific gene mutations. Patients treated with Rydapt in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy experienced significant improvement in overall survival (OS) with a 22% reduction in the risk of death compared with chemotherapy plus placebo. In patients in the Rydapt arm, OS was 74.7 months vs. 25.6 months in the placebo arm. AML is the most common form of leukemia, accounting for about 65% of adult acute leukemias. The incidence increases with age. AML is primarily treated by administering 2 to 3 drugs such as Anthracycline in combination. The problem is that after the first chemotherapy, up to 50% of cases of recurrence of leukemia cells fall below 5%, even if the degree of 'complete remission' reaches 50 to 70%. Official from Society of Hematology said, “It is important to reduce the number of cancer cells in the early stages of AML. We are looking forward to the emergence of an option that can be prescribed to patients who are not able to apply induction techniques, which is an important issue.”
- Company
- Lee Heeseung to oversee MA-GA-PR at MSD Korea
- by Eo, Yun-Ho Jul 02, 2020 06:09am
- A former senior director at Novartis Korea, Lee Heeseung is to be appointed as a leader of the External Affairs department at MSD Korea. According to the pharmaceutical industry sources told the latest personnel decision by MSD Korea. Lee Heeseung would take over the position of External Affairs Lead from July 15. Three teams including Market Access (MA), Government Affairs (GA), and Public Relations (PR) are operating under the umbrella of the External Affairs department at MSD Korea. The soon-to-be Lead would oversee all three teams. Lead Kim So Eun, who has been in charge of the External Affairs so far, is newly appointed as a Translation Leader for MSD spin-off Organon. A new CEO would be appointed for the full-fledged spin-off company. MSD Korea insiders are speculating the latest personnel decision was made to appoint Kim as the CEO of Organon Korea. Lee Heeseung started her career from a PR agency Edelman Korea and joined Novartis Korea in 2016 managing the PR operation. In 2019, she worked at Visa Korea to manage marketing in Korea and Mongolia.
- Company
- Nicetile's Rx has decreased by 40% over the past year
- by Chon, Seung-Hyun Jul 02, 2020 06:08am
- Sales of 'Acetyl-L-Carnitine (ALC)', a brain function improving agent, fell sharply. As a result of clinical re-evaluation, the market size has decreased by 40% in one year as indications have been reduced. The market for 'Choline alfoscerate', which is predicted for clinical re-evaluation, is also expected to change depending on the results. According to UBIST, a pharmaceutical research institute on the 28th, the outpatient prescription amount of ALC in the first quarter was ₩11.7 billion, a 37.9% decrease from the same period last year. Dong-A ST's ALC, generic for Nicetile, is approved for use in 'primary degenerative diseases' or 'secondary degenerative diseases caused by cerebrovascular diseases'. However, as a result of the clinical reevaluation ordered by the MFDS in 2015, the indication was deleted in July as it was unable to prove the efficacy of the 'primary degenerative disease'. Quarterly Rx amounts of ALC (Unit: ₩1 million, Source: UBIST) Acetyl-L-Carnitine (ALC) formulations have steadily formed a market size of nearly ₩20 billion every quarter. In the first quarter and the second quarter of last year, the prescription results were ₩18.9 billion and ₩17.9 billion respectively. However, the scale of prescriptions has dropped significantly since the reduction of indications. In the third quarter of last year, it fell 26.8% from the previous year to ₩13.5 billion, and in the fourth quarter of last year, it decreased by 38.0% compared to the previous year to ₩12.1 billion. This year, This trend has accelerated. It is analyzed that the prescription avoidance phenomenon has spread due to the reduction in indications according to the reevaluation results. The market for ALC products has been slower since the recent spread of COVID-19. In April and May last year, the prescription amounts of ALC were recorded at ₩6.5 billion and ₩6.4 billion, respectively. The ALC based products had a large reduction in prescription sales amount. Major ALC outpatients prescription amount (Unit: ₩ 1 million, %, Source: UBIST) Hanmi's 'Carnitil', which is currently in the top position in the market, has a 32.8% decrease in prescription performance in the first quarter to ₩3.7 billion. Dong-A ST's 'Nicetile ' decreased 29.4% from ₩2.7 billion in the first quarter of last year to ₩1.9 billion in the first quarter of this year. Daewoong Bio, Samik, and Myungmoon, all of which have the highest prescriptions, have significantly reduced their prescription amounts from last year. As a result of re-evaluation of the Choline alfoscerate, which has recently been decided on a clinical re-evaluation policy, such as Acetyl-L-Carnitine, it is predicted that prescription reduction will be inevitable if some indications are deleted. Choline alfoscerate is a drug that has three indications: ▲secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral stromal psychological syndrome ▲emotional and behavioral changes ▲senile pseudoplastic depression. It recorded a total of ₩352.5 billion in prescriptions last year, and has established itself as a new source of revenue for pharmaceutical companies. The MFDS approved an item renewal for Choline alfoscerate in 2018, but announced that it would conduct a clinical re-evaluation of Choline alfoscerate on the 23rd as the efficacy controversy continued. The MFDS ordered 255 items from 134 companies to submit domestic clinical trial results. When conducting a clinical trial, it was instructed to submit IND by December 23.
