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- 2026-05-17 11:17:55
- Policy
- Entry of FDA-approved new Chinese blood cancer drug imminent
- by Lee, Tak-Sun Dec 28, 2021 05:51am
- A new blood cancer treatment that was developed by a Chinese pharmaceutical company and approved by the US FDA will be soon introduced to Korea. The drug awaiting entry is BeiGene Korea’s ‘Brukinsa.’ If approved, Brukinsa will be the second new drug approved by a Chinese pharmaceutical company following Antengene’s ‘Xpovio tab 20mg.’ According to the industry on the 27th, the Ministry of Food and Drug Safety completed the safety and efficacy review of BeiGene Korea’s ‘Brukinsa,’ and the countdown for its marketing authorization has started. Brukinsa is a Bruton's Tyrosine Kinase inhibitor used in patients with B-cell primary central nervous system lymphoma. A BTK inhibitor is a targeted anticancer therapy that suppresses the survival and proliferation of malignant B-cells by blocking Bruton's tyrosine kinase protein, a signal that affects the survival and growth of B-cells. Other BTK inhibitors approved in Korea include Janssen’s ‘Imbruvica,’ AstraZeneca’s ‘Calquence,’ and ONO’s ‘Velexbru.’ Brukinsa is also famous as the first drug that was approved by the FDA based on a clinical trial conducted in China by a Chinese pharmaceutical company. It received FDA approval in November 2019. In the same year, the global pharmaceutical company Amgen acquired 20.5% of BeiGene’s shares. In particular, Beigine’s new innovative drug is being received with anticipation in Korea with the news that the company sells its drug at a reasonable price. Beigine had established its Korean subsidiary and prepared entry into the domestic market since October 2019. In addition to Brukinsa, the company has also been working to commercialize its immuno-oncology drug ‘tislelizumab.’ Antengene’s ‘Xpovio Tab. 20mg (Selinexor),' the first new drug developed by a Chinese pharmaceutical company to be approved in Korea, was introduced in July this year. It was approved in Korea for the treatment of refractory multiple myeloma and refractory diffuse large B-cell lymphoma and marked the start of the Chinese pharmaceutical companies’ entry into the Korean market. In addition to Beigine Korea that is working to receive marketing authorization for its new drug, Dizal Pharmaceutical is also conducting a clinical trial for a non-small cell lung cancer treatment, driving the entry of Chinese pharmaceutical companies into the Korean market in earnest.
- Policy
- MFDS approves emergency use of Pfizer’s oral COVID-19 drug
- by Lee, Tak-Sun Dec 28, 2021 05:50am
- Pfizer’s oral COVID-19 treatment ‘Paxlovid’ received emergency use authorization in Korea as well. Authorities plan to use the drug to treat adults and pediatric patients over the age of 12 with mild-to-moderate COVID-19 at high risk of progressing to severe disease. Pharmacies will be supplying the pills for patients treated from their homes. On the 27th, the Ministry of Food and Drug Safety announced that it had authorized the emergency use of ‘Paxlovid,’ an oral COVID-19 treatment developed by the US company Pfizer. The decision was made after a comprehensive deliberation into the need to introduce oral treatment options that patients can self—administer amid the growing number of confirmed severe/critical COVID-19 cases and the MFDS’s safety/efficacy review results, as well as expert advisory meeting results at the ‘Public Health Crisis Response Medical Product Safety Management and Supply Committee.’ ‘Paxlovid’ is the first oral treatment to be introduced to Korea. The government said that it plans to diversify treatment options that may be used by patients in addition to the shot-type treatment used in the field and expect the addition of Paxlovid to support the prevention of patients treated at residential treatment centers and home from progressing to severe diseases. Paxlovid Paxlovid inhibits a proteolytic enzyme (3CL protease) to prevent the production of proteins needed for virus replication and virus proliferation. In a clinical trial that enrolled 2,246 non-hospitalized, mild-to-moderate COVID-19 patients at high risk of progressing to severe disease, the drug reduced COVID-19 hospitalization or death by 88% in patients who took the pill within 5 days of symptom onset. In particular, the drug also showed the same effect in a clinical trial that enrolled around 300 Asians, including 19 Koreans. The drug may be administered on adult patients and pediatric patients (12 and older weighing at least 40 kg) with mild-to-moderate COVID-19 that are at high risk of progressing to severe COVID-19 due to age, underlying disease, etc. Paxlovid is administered as ‘three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally, twice daily for five days, and should be initiated as soon as possible after the diagnosis of COVID-19 and within five days of symptom onset. The Korea Disease Control and Prevention Agency (KDCA) has requested a priority review of ‘Paxlovid’ on the 22nd to the MFDS due to the rising need to introduce oral COVID-19 treatments that patients can take on their own in the process of returning to normal. The MFDS has been conducting a preliminary review on the quality, clinical, and nonclinical data of ‘Paxlovid’ from November 10th before the KDCA requested a review for the emergency use approval. Also, the ministry had received advice from external experts (9 people) in various fields including infectious diseases, respiratory medicine, toxicology, and virology. As a result, experts agreed on the need to grant emergency use approval for ‘Paxlovid’ in consideration of the COVID-19 pandemic situation and the nonclinical and clinical trial results, and the feasibility of the subject patient population as proposed by the MFDS. The MFDS said it will continue its efforts after granting the emergency use approval to collect information on adverse events that may arise in the process of using ‘Paxlovid’ while preparing further safety measures. In addition, the authorities will request the company that imports Paxlovid to actively collect and report safety information on the drug and has improved related systems so that medical experts, as well as patients receiving treatment at residential treatment centers and homes, may report their side effects. Also, through continuous analysis·assessment of safety information on Paxlovid in Korea and abroad, the authorities will make the safety measures necessary including precautions, discontinuations, and recalls. With patient safety as a top priority, the authorities plan to take measures such as compensating for damages after evaluating the causality of the side effects that may occur. An MFDS official said, “The drug may be used with doctors’ prescriptions. However, as it is an oral pill rather than a shot, it will be distributed through pharmacies and supplied to patients that receive treatments at home.” Meanwhile, Paxlovid received emergency use authorization from the US FDA on the 22nd.
- Company
- ST Pharm has applied for phase 1 of the COVID-19 vaccine
- by Kim, Jin-Gu Dec 28, 2021 05:50am
- ST Pharm will join the ranks of COVID-19 vaccine development. It introduced mRNA vaccine platforms such as Pfizer and Moderna vaccines. ST Pharm announced on the 24th that it has applied for a phase 1 clinical trial plan for the mRNA-based COVID-19 prevention vaccine STP-2104 to the MFDS. Clinical trials were planned in stages of capacity increase, multisystem, and disclosure to evaluate the safety and immunogenicity of the COVID-19 vaccine STP-2104 for healthy adults aged 19 to 55. The clinical scale is at least 30, and the subjects will be divided into two groups, and STP2104 will be administered twice with doses of 25㎍ and 50㎍, respectively, to confirm safety and immunogenicity. According to ST Pharm, STP2104 contains mRNA designed based on modified nucleosides. 5-Capping Agent (SMARTCAP) technology developed by itself was used to improve the capping and transcription effects. In addition, lipid nanoparticles (LNPs) that have already been proven to be safe through global clinical trials are used as mRNA carriers. ST Pharm said, "If we confirm the safety and immunogenicity of STP2104 targeting delta mutations, we expect to be able to respond quickly by changing only the mRNA sequence to new corona mutations such as omicrons." ST Pharm said, "We plan to conduct follow-up clinical trials at home and abroad through the K-mRNA consortium in the future," adding, "We will then seek commercialization in Korea and ASEAN countries with conditional approval for use and sales." Currently, there are nine companies and institutions in Korea that have been approved for COVID-19 clinical trials. SK Bioscience, Genexine, Cellid, Geneone, EuBiologics, Curitas, HK inno.N, Eyegene, and International Vacuum Institute are challenging the development of vaccines. Among them, SK Bioscience is the only one to enter phase 3. By vaccine platform, there are three genetically recombinant vaccines (SK Bioscience, EuBiologics, HK inno.N), three DNA vaccines (Genexine, Geneone, International Vaccine Institute), one virus vector vaccine (Cellid), and two mRNA vaccines (Quaratis, Eyegene).
- Company
- Ildong's new DM GLP-1 analog has acquired a new patent
- by Dec 28, 2021 05:49am
- Ildong (CEO Yoon Woong-seop) announced on the 24th that it has obtained a patent for domestic substances for ID110521156, a new drug candidate for type 2 diabetes treatment under development. ID110521156 is a drug in the GLP-1 receptor agonist family that acts as a analog to the Glucagon-like peptide-1 (GLP-1) hormone that regulates blood sugar levels by inducing insulin secretion. GLP-1 hormones are produced and secreted in β cells of the pancreas and are known to be involved in the secretion and blood sugar control of insulin in the body, digestive organ exercise, and appetite suppression. ID110521156 has the same function as GLP-1 hormone and has a low molecular weight compound structure, so it is expected to be developed as an oral drug that is advantageous in terms of marketability and convenience of administration. Earlier, Ildong Pharmaceutical confirmed safety not only in excellent pharmacological activity but also in the effect on cardiovascular relations as a GLP-1 receptor agonist through ID110521156 study. Currently, the company is conducting nonclinical research to develop an oral type 2 diabetes treatment.
- Policy
- AstraZeneca Xigduo’s latecomers consecutively approved
- by Lee, Tak-Sun Dec 27, 2021 05:57am
- AstraZeneca’s SGLT-2 inhibitor diabetes combination, Latecomers of AstraZeneca’s SGLR-2 antidiabetic combination therapy ‘Xigduo XR (dapagliflozin propanediol/metformin) are receiving approval. Due to the patent period set for the original’s substance patent, the latecomers will only be available for sale from April 2023, however, due to its commerciality and patent issues, companies are racing to commercialize their latecomers. According to the industry on the 24th, four companies including KyungDong Pharm have recently received approval for their Xigduo latecomers. The approved drugs are fixed combinations of dapagliflozin L-proline and metformin hydrochloride. The latecomers contain a different active ingredient solvate from the original Xigduo XR tab. With the addition of the 4 companies, a total of 24 companies have now received approval for Xigduo XR latecomers. However, only three companies will be manufacturing the drugs. Richwood Pharmaceutical, the first company to receive approval in October, Chong Kun Dang that completed independent development in November, and KyungDong Pharm will be manufacturing the latecomers. Richwood Pharmaceutical’s latecomer is a combination of dapagliflozin citric acid and metformin hydrochloride and Chong Kun Dang’s is a combination of dapagliflozin and metformin hydrochloride, all of which use a different solvate from the original drug. The drugs decided to use a different solvate to evade the solvate patent. The patent was set to expire on June 21st, 2027, but the invalidation claims filed by latecomers in Korea have been accepted and therefore invalidated. Latecomer companies have also filed and won the first and second trials to invalidate Xigduo’s second substance patent that is to expire on January 8th, 2024. Therefore, the possibility of invalidating the patent is rising, raising the probability of latecomers being sold from April 7th, 2023 after the expiry of the first substance patent. Even if this becomes a reality, around 2 years are still left until the companies may release the latecomers. However, the companies have initiated their development early as Xigduo’s outpatient prescription last year amounted to 28.6 billion won (UBIST), and the PMS expiry date for latecomers was due November 26th, 2019. If some companies obtain generic exclusivity, the release date of the other companies' products could be further delayed. At the time of development, there were no restrictions regarding consigned bioequivalence studies, therefore many companies have made CMO agreements to outsource their products. Richwood Pharmaceutical has orders from18 companies and KyungDong Pharm from 3 companies to produce Xigduo latecomers.
- Company
- The development of Kcav's Mucovac is in full swing
- by Dec 27, 2021 05:57am
- A spray-type COVID-19 vaccine sprayed on the nose, not on injections, is being developed by domestic company. Amid the trend of muscle injection, attention is focused on claims that mucosal immunity is more effective in defending the COVID-19 virus. Kcav (CEO Song Chang-seon) announced on the 27th that Mucovac, a COVID-19 mucosal vaccine candidate that is jointly researching with Konkuk University and Bionote, has succeeded in entering the second stage of the "Bio Medical Technology Support Project" supported by Ministry of Science and ICT and National Research Foundation of Korea. Accordingly, Kcav will receive 2 billion won in research funds for non-clinical trials and clinical sample production necessary for submitting the clinical trial plan (IND) of the COVID-19 mucosal vaccine Mucovac. Mucovac, which is being developed by Kcav, is a candidate substance for the COVID-19 mucosal vaccine derived by combining the ECSL immune enhancer, which signed a contract with Eubiologics in March, with a new antigen developed by Bionote. Mucovac confirmed that nasal administration using hACE2 TG Mice and Ferret animal Model enhances body fluidizing antibody and cellular immunity (IFN-r ELISPOT) to the COVID-19 virus. In addition, as a result of conducting attack vaccination tests using Wuhan and Delta, the Mucovac vaccine group showed a 100% survival rate. In particular, Kcav is planning to analyze Mucovac's ▲MoA-related analysis ▲ Evaluation of defense ability through attack inoculation after the sale of Omicron mutant and ▲ Boostershot application test (existing muscle vaccination + Mucovac inoculation). Since many pathogens, including COVID-19, invade through mucous membranes, mucosal vaccines can be said to serve as the first defense mission against pathogens invading from the outside. Since injection needles are not used, they can be administered safely and easily. It has been argued that vaccines using nasal cavity are more effective against COVID-19 than through veins and muscles. Currently, there are about 100 vaccines being developed worldwide, of which seven are vaccines using nasal cavity. This is why the Korean government desperately needs support for the success of commercialization of Mucovac while global efforts are underway to overcome the COVID-19 pandemic situation. An official from Kcav said, "The mucous membrane vaccine currently under development is a spray-type vaccine sprayed on the nose, not a conventional injection vaccine." He explained, "When applied with booster shots to existing vaccinations, it induces not only systemic immunity but also mucosal immunity." "We expect Mucovac to increase the ability to prevent infection through the respiratory tract of COVID-19 and respond to various mutant viruses," he said. "We have already confirmed our defense against delta mutant as well as Wuhan." Kcav has already confirmed its ability to defend against the SARS-Cov-2 virus of COVID-19 mucosal vaccine candidates using ECLS immunostrengthening agents by receiving research funding from the Global Health Technology Research Fund "RIGHTFUND," co-invested by the Bill & Melinda Gates Foundation, and eight domestic life science companies in 2020. Meanwhile, Kcav was established in 2014 by Professor Song Chang-sun of Veterinary Science College as the first subsidiary of Konkuk University's technology holding company. It has secured a variety of vaccine pipelines for animals and humans using core platforms such as Live attenuated vaccines and Newcastle Disease vector vaccines.
- Policy
- Roche applies for approval of its new drug faricimab
- by Lee, Tak-Sun Dec 27, 2021 05:56am
- The global pharmaceutical company Roche has applied for the approval of its newly developed treatment for macular degeneration, ‘faricimab.’ The company had submitted an application for faricimab in the US, Europe, and Japan. If approved, the drug will be competing with Bayer’s ‘Eylea (aflibercept)’ and Novartis’ ‘Beovu (brolucizumab-dbl)’ in the next-generation treatment market for macular degeneration. According to the industry on the 24th, Roche applied for the marketing authorization of ‘faricimab’ to the Ministry of Food and Drug Safety. Faricimab was registered under the brand name ‘Bavismo inj.’ in Korea. Faricimab is the first bispecific antibody treatment developed for ophthalmologic diseases. It simultaneously blocks both pathways involving the Ang-2 that causes various retina conditions and VEGF-A and promotes vascular stability and improves the vision outcome of patients in the long term. A Phase III study that was disclosed earlier this year showed that faricimab was well tolerated with a consistent safety profile in four studies that assessed faricimab on age-related macular degeneration (nAMD) and diabetic macular edema (DME) under a dosing schedule that administers the drug at a maximum of 48 weeks apart. Macular degeneration is a major cause of vision loss in adults over the age of 60. With the aging society, the size of the treatment market has also been growing exponentially. Last year, the market size recorded 37 billion won, with the global market recording 13 trillion won. According to global data announced by a market research institution, the market size of the macular degeneration market is expected to spike to record 21 trillion won by 2028. The market is currently led by ‘Eylea (aflibercept)’ and ‘Lucentis (ranibizumab ).’ Also, the development of biosimilars for the two drugs is speeding up upon the imminent expiry of Eylea and Lucentis’s patents. Novartis has released Beovu in preparation for the Lucentis biosimilars. The prefilled syringe formulation of Beovu was approved in Korea last year, and reimbursed and sold since April this year. Beovu’s strengths lay in the improved patient convenience and compliance provided with its 12-weekly dosing schedule. On the other hand, Lucentis is administered every 4 weeks. Faricimab is administered every 16 weeks at most and therefore is expected to further improve patients’ convenience in administration. Roche had completed applying for the marketing euroization of farcical in Japan in June, and in Europe and the US in July, and is awaiting authorization from the respective authorities.
- Policy
- The suspension of execution for Legalon has been extended
- by Kim, Jung-Ju Dec 27, 2021 05:56am
- It is an extension of the grace period for deleting insurance drug benefits due to prolonged lawsuits. Abbott's Cholib, which item license has been revoked by the licensing authority, is automatically removed from the list according to the company's decision to withdraw from the market. The MOHW announced the court's decision to extend the suspension of execution of the drugs currently being sued and follow-up measures on insurance drugs following the cancellation of the MFDS' item license.12th division of the Seoul Administrative Court decided to extend the deadline for suspension of the execution of Bukwang Pharmaceutical, which was scheduled for the 17th, as the lawsuit was prolonged. The government previously conducted a re-evaluation of this year's benefit for a total of five ingredients, Vitis Vinifera, Avocado-Soya, Ginko X, Bilberry Gunjo X, and Silymarin. Milk-thistle Fruit Dry Extract, to which Bukwang Pharmaceutical products belong, was confirmed to be withdrawn, and the government deleted the list after three months of action (deferred). Accordingly, the company decided to file a lawsuit and applied for a suspension of execution to the court at the same time, and the suspension was extended this time. The period of suspension of execution is 30 days from the date of the sentence of the judgment, and during this period, the deletion of benefits is suspended. However, since the government suspended it for three months at the time of the announcement, medical institutions are not expected to undergo significant changes in prices for the time being. The insurance price of Legalon cap 70 is 137 won per capsule and 242 won per capsule for Legalon cap 140. Abbott's Cholib 145/20 mg and 145/40 mg products are removed from thel list according to the withdrawal of the company's market. Earlier on June 10, the MFDS suspended sales for six months (June 24th to December 23rd) due to a lack of the number of survey subjects required for the reexamination PMS. The disposition period has been extended due to the second violation, and if the reexamination data is not submitted again, the item permission will be automatically revoked. As a result, the insurance drug benefit list will also be deleted. The deletion period is on the 24th.
- Company
- To introduce a phase 3 clinical drug preferential policy
- by Nho, Byung Chul Dec 27, 2021 05:56am
- Attention is focusing on whether the industry, the National Assembly, and the MOHW will be able to derive a reasonable and efficient institutional direction in relation to the "policy for preferential treatment of new drugs in phase 3 clinical trials for Koreans." According to related industries on the 23rd, after the drug preferential regulations for innovative pharmaceutical companies were deleted during the 2018 Korea-US FTA negotiations, Article 17-2 of the Pharmaceutical Industry Promotion Act was introduced, but the legislation process seems urgent. Generic, which is released by innovative pharmaceutical companies, can get additional drug prices if it meets certain items of drug decision and adjustment standards, while there is no incentive for new drugs developed by all domestic and foreign pharmaceutical companies, that is, new drugs that have conducted clinical trials in Korea. As the global innovative drug preferential system was virtually stranded due to trade friction such as WTO and FTA three years ago, drug preferences such as 10% of the highest price of alternative drugs to encourage innovative pharmaceutical companies to develop new drugs and application of similar drugs (adjusted lowest price) in A7 countries have disappeared. With the outbreak of the COVID-19 Pandemic, public opinion on the formation of public opinion on the independence of vaccines and treatments and the government's justification for establishing pharmaceutical sovereignty is also gaining momentum. As Big Pharma such as Pfizer, Moderna, AstraZeneca, and MSD exclusively develop vaccines and treatments, other countries may suffer supply and demand difficulties at any time, as well as the fact that they are not the main clinical subjects. The "Phase 3 Clinical New Drug Treatment for Koreans" is a system that benefits 5-10% of alternative drugs when domestic and foreign pharmaceutical companies conduct clinical trials (300-1000 people) or higher in Korea when developing innovative drugs. In order to prevent international trade problems such as negotiations on the revision of the Korea-US FTA in 2018, there is an international obligation to introduce a drug price system within the scope of compliance with the agreement. The regulations in question in the FTA agreement at the time allow drug and medical device registration or procedures, rules, standards, and guidelines applied to establishing benefits for medicines and medical devices to apply for benefit based on evidence of safety. The phase 3 clinical drug preferential treatment for Koreans is a system that provides common benefits not only to domestic companies but also to foreign companies, so there is no concern about trade friction. In the case of new drugs that have proven that there is no difference in safety and effectiveness of drugs due to ethnic factors, they have the advantage of creating customized drug therapy, providing appropriate treatment, and securing clinical data while maintaining the maximum drug effect. The revision of the HIRA's drug adjustment standards can achieve the desired results, preventing waste of time and unnecessary costs due to the preparation of new bills such as legislation of the National Assembly and government. According to Article 7 (7) of the Drug Adjustment Standard, the cost of medical care benefits for drugs that omit drug price negotiations is 90% of the weighted average price of alternative drugs, but exceptionally 100% for new drugs, biopharmaceuticals, and rare diseases. An industry official said, "As a result of reviewing 122 drugs registered over the past six years, 4·13 domestic and foreign drugs will be applied to the preferential treatment of phase 3 clinical drugs in Korea." This can benefit in common from domestic and foreign pharmaceutical companies through various legal review, so there is no concern about trade friction due to the application of special cases, he said. In addition, he predicted, "Multinational pharmaceutical companies' drugs are unlikely to be subject to the revision as they are exempted from submitting Bridge study data due to anticancer drugs and rare drugs, and biological drugs will need to be given 100% of the average drug price."
- Policy
- What are the variables for the release of Forxiga+ Januvia?
- by Lee, Tak-Sun Dec 24, 2021 05:49am
- MSD Januvia and AZ Forxiga Daewon Pharmaceutical and Dongkoo Bio's combination of Dapagliflozin (Forxiga) and Sitaglipin (Januvia) is approved. Since both ingredients are widely used in the diabetes treatment market, attention is being paid to whether there will be a change in the market due to the emergence of complex drugs. However, there are still steps to overcome, such as patents and benefits. On the 21st, Daewon Pharmaceutical was approved for "Dapacombi 10/100mg," a combination that combines Dapagliplozin and Sitaglipin. On the 23rd, Dongkoo was then approved for Sitagliptin 10/100mg, which combines Papaglipozin and Sitagliptin. The salt and solubilizing materials are slightly different, but the active ingredients are the same. Both drugs are administered as supplements to diet and exercise therapy to improve blood sugar control in patients with type 2 diabetes whose combined administration of Sitagliptin and Dapagliplozin is suitable. The original brands of Sitagliptin and Dabagliplozin are leading the domestic diabetes treatment market. According to UBIST's outpatient prescriptions, MSD's Januvia recorded 21.2 billion won in the first half of this year and AZ Forxiga recorded 18.3 billion won. It was also known that the proportion of combined prescriptions for the two drugs was also high. Therefore, it is analyzed that the emergence of a Forxiga+Januvia complex with convenience of use will have significant market value. However, the Forxiga+Januvia complex developed by a domestic pharmaceutical company has to wait until next year to be released in Korea. This is because Januvia's material patent will not end until September 1, 2023. Forxiga's material patent expires on April 7, 2023, ahead of that. Along with this, it is a variable for applying benefits. This is because the SGLT-2+DPP-4 complex, which was approved in Korea before the Forxiga+Januvia complex, has not yet obtained insurance benefits. Domestic approved SGLT-2+DPP-4 complexes are AZ "Qtern" (Dapagliflozin+Saxagliptin), Beringer Ingelheim Esglito (Empagliflozin+Linaglipin), and MSD "Stegluzan(Ertugliflozin L-pyroglutamic acid). Qtern was first released in November as a non-reimbursment. Recently, insurance authorities are discussing the improvement of benefit standards for the combined prescription of SGLT-2 and DPP-4 drugs. A growing number of domestic pharmaceutical companies are also developing SGLT-2+DPP-4 combination due to the possibility of entering the reimbursed market. Recently, SK Chemicas, Donghwa, and GL Pharm Tech have begun clinical trials for Dapagliflozin+Sitaglipin combinations.
