- LOGIN
- MemberShip
- 2025-12-23 19:12:32
- Company
- Seven times stricter standards
- by Chon, Seung-Hyun May 25, 2023 05:46am
- Panoramic view of the Ministry of Food and Drug Safety Health authorities have prepared new standards for managing impurities in Januvia, a diabetes treatment. Prior to the release of Januvia generics, pharmaceutical companies were requested to only ship products within the newly set standard. Pharmaceutical companies are busy with quality control by presenting a standard that is seven times stricter than the temporary acceptance standard applied at the time of the recall of Januvia impurity products. According to the industry on the 25th, the Ministry of Food and Drug Safety recently sent an official letter to pharmaceutical companies with instructions on safety measures and information on nitrosamine impurities in drugs containing ‘sitagliptin’. The MFDS determined that the nitrating agent among the additives of Sitagliptin generated the impurity NTTP during the manufacturing or storage process of the finished drug. It means that it has a chemical structure in which impurities are generated during the manufacturing process of sitagliptin. It suggested the permissible daily intake of Sitagliptin NTTP as 37ng and instructed pharmaceutical companies to implement safety measures. The MFDS ordered, “We will conduct an NTTP test and inspection for impurities and only ship products within the permissible daily intake (37ng/day), and if impurities are detected as a result of the test, we will take step-by-step measures according to the level of detection.” The MFDS ordered pharmaceutical companies to conduct stability tests so that the NTTP can be managed at 30% or less of the acceptable standard during the period of use of the finished product of sitagliptin. In case the standard is exceeded or there is a concern, it is instructed to immediately report it to the Ministry of Food and Drug Safety. Sitagliptin is a DPP-4 inhibitory diabetes treatment, and MSD's Januvia is the original drug. Recently, Chong Kun Dang acquired the domestic sales rights of Januvia. After Januvia's patent expires in September, domestic pharmaceutical companies are preparing to release generics. In other words, the Ministry of Food and Drug Safety presented the impurity control standard before the release of Januvia generics and started a preliminary inspection. The danger of impurities in Januvia was raised last year. In August of last year, the European Medicines Agency (EMA) instructed Januvia to investigate the possibility of detecting a new NTTP impurity. As a result of MSD's impurity analysis at the time, NTTP was found, but it was not detected above the standard level, so it did not lead to a recall action. In Korea, in March, MSD Korea voluntarily recalled two lot numbers (U010253, U012914) of ‘Januvia 50mg’. At the time, MSD Korea said, "The NTTP level detected in Januvia slightly exceeds the temporary release standard (maximum 246.7ng/day)." The Ministry of Food and Drug Safety suggested 246.7ng/day as the standard for the temporary release of Januvia, and Januvia exceeded this standard and voluntarily recalled it. The limit for sitagliptin impurities set by the Ministry of Food and Drug Safety this time is 37 ng/day, which is one-seventh of the temporary release standard applied at the time of Januvia recovery. This means that the standard was set seven times stricter than the temporary release standard. If Januvia's recalled product was detected with NTTP at the temporary release standard level, it means that it exceeded the standard set by the Ministry of Food and Drug Safety by about 7 times. An official from the Ministry of Food and Drug Safety said, “The temporary acceptance standard is a standard that is applied when there is a concern about the supply disruption of the drug.” Explained. This means that the NTTP standard for sitagliptin has been set based on the same standard as other medicines because there is no problem with drug supply and demand even if impurities problems arise in some products when Januvia generics are poured out. It is known that many pharmaceutical companies conducted sitagliptin NTTP quality control based on temporary release standards. However, as the standard proposed by the Ministry of Food and Drug Safety is seven times stronger than the temporary acceptance standard, pharmaceutical companies are forced to conduct NTTP inspections according to more stringent standards. Since impurities in Sitagliptin preparations must be controlled within 30% of the allowable limit during the period of use, pharmaceutical companies complain that the quality control standards have become too strict. Some companies have begun adjusting their impurity quality control plans as the Ministry of Food and Drug Safety presents stricter standards than those set by itself. According to the Ministry of Food and Drug Safety, 100 domestic pharmaceutical companies have approved 715 products containing Sitagliptin and are waiting for the release date. According to UBIST, a pharmaceutical research institute, a total of 109.4 billion won in outpatient prescriptions for sitagliptin-containing drugs was jointly made last year. Januvia and Janumet raised 40.5 billion won and 68.9 billion won, respectively. As Januvia is forming a large market, domestic pharmaceutical companies are preparing to enter the generic market indiscriminately.
- Company
- Leading companies in developing new PO microbiome drugs
- by Nho, Byung Chul May 24, 2023 08:28pm
- The next-generation microbiome, Akkermansia muciniphila, was observed under an electron microscope (photo by Enterobiome) Recently, the world's first oral microbiome treatment obtained approval from the US Food and Drug Administration (FDA). VOWST from Seres Therapeutics in the U.S. is a drug that prevents re-infection after antibacterial treatment for CDI bacteria for people over 18 years of age. As a new microbiome drug, it is the second after Rebyota of Ferring Pharmaceuticals of Switzerland, but if the treatment was an anal-administered drug, VOWST is significant in that it is the first oral formulation treatment of a related drug. As microbiome new drugs are approved one after another, domestic microbiome companies are also accelerating the development of new drugs for various indications based on each company's microbial strain pipeline. The microbiome is a combination of microbe and biome and refers to various microorganisms living in the human body and their genes. Microbiome treatment is one of the fields that many biopharmaceutical companies are challenging because it is based on microorganisms and has the advantage of higher safety than other treatments. Genome & Company's GEN-001 is a microbiome-based immuno-anticancer drug made in an oral formulation by improving a single strain of Lactococcus lactis isolated from the intestine of a healthy person and has currently obtained a domestic patent. GEN-001 acts as a mechanism to activate the body's immunity and is currently conducting phase 2 clinical trials for gastric cancer in combination with Bavencio, an immuno-oncology drug from Merck and Pfizer. In the case of MSD's phase 2 clinical trial of Keytruda, an anticancer drug for biliary tract cancer, it is currently applying for approval to change its IND (clinical trial plan) to the Ministry of Food and Drug Safety, and patients are scheduled to be administered in the second half of this year. KoBioLabs' KBL697 is a Lactobacillus gasseri monostrain substance with an anti-inflammatory immunomodulatory mechanism and is currently patented in the US. The strain is undergoing global phase 2 clinical trials in the US and Australia, targeting psoriasis (KBLP-001) and ulcerative colitis (KBLP-007) caused by an excessive immune response. KBLP-007 recently received IND approval from the Ministry of Food and Drug Safety, which includes Korea for phase 2 clinical trials and is about to proceed with domestic clinical trials. Some companies are developing microbiome treatments using new strains that have not been registered with the Ministry of Food and Drug Safety in Korea. Enterobiome's EB-AMDK19 is Akkermansia muciniphila, a non-notified strain of Akkermansia muciniphila that is non-cultivable and extremely anaerobic that lives in the intestinal mucosa of the body and shows efficacy in diseases such as metabolic and immune diseases. Akkermansia muciniphila, also known as next-generation probiotics, is an extremely anaerobic bacterium that is extremely sensitive to oxygen and requires advanced culture technology because it is difficult to isolate, identify, and culture. Enterobiome has completed the registration of a 'patent for high-yield cultivation technology of anaerobic bacteria' in the United States, Australia, India, and Canada, starting with Korea, and holds six patents related to the EB-AMDK19 strain. The strain has completed the GLP non-clinical toxicity test and is currently scheduled to apply for an IND targeting atopic skin disease in the first half of next year.
- Company
- Pharma industry on alert over business risks in China
- by Lee, Seok-Jun May 24, 2023 05:32am
- Business risks related to China have been rising in Korea’s pharmaceutical industry. There are many causes, including the termination of the contract for supplying medicines (or cosmetics), liquidation of Chinese subsidiaries, and claims for damages, etc. Most of them are due to the failure of their Chinese partners in fulfilling their promises. On the 22nd, Ahn-Gook Pharmaceutical publicly announced that it had requested the termination of its supply contract to the Chinese company (Sichuan Wanhe Chinese Medicinal Decocting Pieces PLC) it had signed a supply contract with for its ‘Anycough Cap’. The original contract term was 10 years from when the company receives the Import Drug License for Anycough Cap. However, the Import Drug License was not approved due to the other party's non-fulfillment of the contract, which was the grounds for the termination. The contract was worth KRW 26.9 billion at the time of its signature. Il-Yang Pharmaceutical is liquidating its key OTC Chinese subsidiary. On the 15th, Il-Yang Pharmaceutical publicly announced that it had decided to dissolute and liquidate its subsidiary 'Tonghwa Ilyang Health Products Co., Ltd.’ to increase management efficiency. The industry pointed to the company’s conflict with its partner as the cause. The company announced that it was unable to settle the dissolution by agreement, and plans to proceed with the dissolution procedure with the competent court. By shares, Tonghwa Il-Yang is 45.9% owned by Il-Yang Pharmaceutical, 19.4% by Il-Yang Pharmaceutical’s owner family Do-eon Jeong and affiliates, and 34% by Tonghua City in China. The dissolution was decided upon due to a conflict with the Chinese city. Tonghwa Ilyang was a profit-raising company that posted sales of KRW 40.4 billion and an operating profit of KRW 19 billion last year. Its good profitability also played a positive role in the consolidated performance of Il-Yang Pharmaceutical In addition, Dong Sung Bio Pharm terminated its overseas distributor contract for Rannce brand products in early May. The termination will be worth KRW 8.5 billion, excluding the KRW 6.5 billion payment made for contract fulfillment from the original contract’s worth, which was KRW 15 billion. The other party, Artface had planned to supply the Rannce brand to China and other countries. However, the contract was terminated due to the other party’s non-compliance with the minimum performance amount in the contract. Korea United Pharm also announced the termination of the supply contract for Clanza CR tablets worth KRW 40.9 billion in December last year. This is a measure following China's JJK's failure to fulfill its contract. Also, Medytox’s Chinese joint venture is on the verge of dissolution. Its partner, Gentix sued Medytox earlier this year for contract violation. The company also filed a claim for damages worth KRW 118.8 billion, claiming that there was a problem with the terms of the JV contract. Medytox had established the joint venture, MedyBloom China, with Bloomage Biotechnology in 2016 with a 50:50 stake. Medytox, which invested KRW 7.2 billion, judged that there was no violation of the contract on its side and is responding through legal representation. As risks arise in the Korean pharmaceutical industry's business with China, the feasibility of the contracts made by other pharmaceutical companies in China is also drawing attention. In June 2017, Seoul Pharmaceutical signed a KRW 111.1 billion contract with a Chinese company to sell and supply orally disintegrating strips for the treatment of erectile dysfunction. The amount of KRW 111.1 billion was set as the supply price based on US dollars for the quantity agreed upon by the two companies for a total of 10 years after the drug’s approval by the CFDA in China. This is a conditional amount that can only be generated if the drug is approved in China. However, no separate announcement has been made so far on its approval. A market insider pointed out, "There are many cases where businesses in China fall apart due to the partners' failure to fulfill contracts. This is why business is often delayed and contracts are broken."
- Company
- Leclaza posts sales of KRW 25 bil in 2 years in Korea
- by Chon, Seung-Hyun May 24, 2023 05:32am
- Yuhan Corp’s anticancer drug ‘Leclaza’ is making good sales in the Korean market, and raised sales of KRW 5.1 billion in Q1 alone. Its efficacy and safety were confirmed in the real world in actual patients at the time of treatment, and the drug is gradually expanding its market influence ahead of its approval as a first-line treatment. According to the market research institution IQVIA on the 23rd, Leclaza’s sales were KRW 5.1 billion in Q1, up 57.4% YoY. It is also a 12.9% increase from the KRW 4.5 billion made in the previous quarter. Leclaza is an NSCLC treatment that was approved as the 31st homegrown novel drug in January last year. It is a 3rd generation EGFR TKI that inhibits the proliferation and growth of lung cancer cells. It is currently approved as a treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs. The drug entered the market in earnest after being listed for reimbursement in the National Health Insurance Service in July 2021. The drug recorded sales of KRW 1.5 billion and KRW 2.6 billion in Q3 and Q4, respectively. Last year, its quarterly sales had risen to the KRW 4 billion range, and continued growing this year. Cumulative sales made during the 2 years since the release of Leclaza totaled KRW 25.2 billion. Leclaza Leclaza posted sales of KRW 16.1 billion last year, breaking the sales record made by homegrown new anticancer drugs in Korea. Other homegrown new anticancer drugs that were approved before Leclaza include Il-Yang Pharmaceuticals’ Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita. None of the products have exceeded annual sales of KRW 10 billion. At the current rate, Leclaza may likely exceed annual sales of KRW 20 billion this year. Leclaza is considered to have made a smooth start in the market. Anticancer drugs that are usually used in large medical institutions, can only be prescribed after the drug passes each institution’s drug committee, therefore, it takes a considerable amount of time before sales are generated after the initial stage of release. With the added pressure of having to directly compete with outstanding new drug products from multinational pharmaceutical companies, it is not easy for new anticancer drugs developed in Korea to achieve commercial results. Leclaza passed the drug committee of major large medical intuitions in Korea and is accelerating its market penetration efforts. The drug is expected to expand further into the market if it receives approval in the first line. In March, Yuhan Corp applied for approval of Leclaza as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation to the Ministry of Food and Drug Safety. Leclaza demonstrated its efficacy over existing treatments in a global Phase III trial (LASER 301) that was conducted on 393 locally advanced or metastatic NSCLC patients with EGFR mutations. The trial results had been presented at the European Society for Medical Oncology Congress that was held last year in Singapore. The company has also been accumulating evidence of its efficacy and effect in the real world. Lim Sun Min, Professor of Oncology at Yonsei Cancer Center, and Beung-Chul Ahn, Professor of Oncology at the National Cancer Center, recently published real-world data (RWD) on how Leclaza confirmed its safety and efficacy in practice in the journal, Lung Cancer. This was the first-ever real-world study results announced since Leclaza’s approval, The research team conducted a retrospective study on 103 patients with EGFR T790M mutation-positive NSCLC patients who developed resistance after being previously treated with EGFR-TKI that received Leclaza from January 2021 to August 2022 at Yonsei Cancer Center and the National Cancer Center. 90 of the 103 patients received Leclaza as a second or third-line treatment. The patients’ primary efficacy endpoint in the study, median progression-free survival (mPFS), was 13.9 months. This was consistent with the mPFS of 11.1 months confirmed in LASER201, the study that became the basis of Leclaza’s approval. The objective response rate (ORR) was 62.1%, slightly higher than the 55.3% observed in the LASER201 study. In terms of safety, the drug was also well-tolerated, similar to previous studies. The research team explained, “ The real-world study reaffirmed the consistent effect and efficacy of Leanza as a second-line treatment for EGFR T790M mutation-positive NSCLC patients in practice.” Yuhan Corp has invested a total of KRW 93 billion in the Phase III trial for Leclaza. According to the Financial Supervisory Service, as of the end of the first quarter, Yuhan Corp reflected KRW 93 billion of Leclaza’s development cost as intangible assets. In 2019, the Financial Supervisory Service set a standard that only R&D projects that have technical feasibility, including those for new drugs, shall be accepted as accounting assets. The FSS suggested that R&D costs can be turned into assets after initiating Phase III trials for new drugs and receiving approval for its Phase I trial for biosimilars. As for generic drugs, they can be capitalized after their bioequivalence test plan is approved. Under such standards, Leclaza’s development costs of KRW 32.6 billion were first recognized as intangible assets in Q4 2020. Its development costs were reflected as intangible assets after its Phase III trial began in earnest. Leclaza’s development cost intangible asset increased to KRW 61.4 billion by the end of 2021, and then rose to KRW 88 billion last year, with the added KRW 26.6 billion last year. In Q1 this year, an additional KRW 5 billion was invested as clinical expense.
- Company
- Merck retrieves rights to PD-L1 antibody Bavencio in Korea
- by Eo, Yun-Ho May 23, 2023 05:54am
- The long-standing collaboration that had existed between the Korean subsidiaries of Merck and Pfizer Korea for the immunotherapy ‘Bavencio’ has come to a close. According to industry sources, the companies are in the process of handling the rights for the PD-L1-inhibiting immunotherapy Bavencio (avelumab) in Korea as Merck retrieved the global rights for the drug. As a result, Pfizer Korea’s Bavencio-related personnel (marketing, sales) will also be reassigned to different posts. The two companies have jointly developed and marketed Bavencio after forging a partnership in 2014. Also, the ongoing processes for expanding reimbursement to the first-line in urothelial cell cancer will be carried out by Merck Korea alone from now on. Currently, Bavencio passed the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee review in April last year, but no news has yet been heard on its deliberation by the Drug Reimbursement Evaluation Committee. Bavencio was first approved in Korea as a monotherapy to treat adult patients with metastatic Merkel cell carcinoma (mMCC) in 2019. The indication was granted insurance reimbursement in October 2020. Since then, the drug has additionally been approved as a first-line maintenance monotherapy in August 2021 for patients with locally advanced or metastatic urothelial carcinoma who have not progressed after using platinum-based chemotherapy. Pfizer, which let go of its rights for Bavencio, announced its plans to acquire the anticancer drug company Seagen. This merger between Pfizer and Seagen, which was officially announced in March, is worth USD 43 billion (about KRW 56 trillion) and is considered to be the largest among global pharMaceutical and bio-industry M&A transactions this year. Known for its global expertise in antibody-drug conjugates (ADC), Seagen is considered a leader in the new drug development industry. Its oncology pipeline has 4 anticancer drugs: Adcetris, Padcev, Tivdak, and Tukysa. Pfizer expects the merger to bring sales growth through royalties and collaboration related to the development of ADC anticancer drugs.
- Company
- RWD results reaffirm Leclaza’s efficacy in practice
- by Chon, Seung-Hyun May 23, 2023 05:54am
- Professor Lim Sun Min (right) and Professor Beung-Chul Ahn (left) are presenting Leclaza study results Study results that confirm the efficacy and safety of Yuhan Corp's new anticancer drug ‘Leclaza’ in the real world has been released. Lim Sun Min, Professor of Oncology at Yonsei Cancer Center, and Beung-Chul Ahn, Professor of Oncology at the National Cancer Center, met with reporters at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association head office in Seocho-gu, Seoul on the 22nd to introduce the real-world data (RWD) that confirms the efficacy and safety of Leclaza in practice. This was the first-ever real-world study results announced since Leclaza’s approval, and was published in the journal, Lung Cancer. Leclaza is an NSCLC treatment that was approved as the 31st homegrown novel drug in January last year. It is a 3rd generation EGFR TKI that inhibits the proliferation and growth of lung cancer cells. It is currently approved as a treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs. The research team conducted a retrospective study on 103 patients with EGFR T790M mutation-positive NSCLC patients who developed resistance after being previously treated with EGFR-TKI that received Leclaza from January 2021 to August 2022 at Yonsei Cancer Center and the National Cancer Center. 90 of the 103 patients received Leclaza as a second- or third-line treatment. The patients’ primary efficacy endpoint in the study, median progression-free survival (mPFS), was 13.9 months. This was consistent with the mPFS of 11.1 months confirmed in LASER201, the study that became the basis of Leclaza’s approval. The objective response rate (ORR) was 62.1%, slightly higher than the 55.3% observed in the LASER201 study. In terms of safety, the drug was also well-tolerated, similar to previous studies. The research team explained, “ The real-world study reaffirmed the consistent effect and efficacy of Leanza as a second-line treatment for EGFR T790M mutation-positive NSCLC patients in practice.” Leclaza also showed similar efficacy in patients with the Exon19 deletion mutation (Exon19del) and the L858R substitution mutations (L858R), and the team saw no decrease in efficacy in patients whose dose was reduced. Professor Lim said, “The study holds significance for being results from the first real-world study that confirmed the efficacy and safety profile of Leclaza in NSCLC patients in Korea’s actual prescription environment.“ Lim added, “Study results showed consistent data with LASER201, the trial that was conducted for Leclaza’s approval. Along with other clinical data, these RWD results will be actively used as grounds for prescribing Leclaza to patients in practice.” In the study, Leclaza’s treatment effect was also significant in patients with brain metastasis as in the LASER201 study. The mlPFS (median intracranial progression-free survival) was 17.1 months, and ORR was 57.6%. Professor Ahn said, “Brain metastasis is found in about 25% of NSCLC patients upon diagnosis, and the condition is so common that 50% of patients eventually experience brain metastases as the condition progresses. This is why a drug’s effect in NSCLC with brain metastasis is a very important consideration in prescribing drugs for NSCLC in the field.” Professor Ahn added, "In the real-world study, Leclaza has consistently demonstrated its antitumor effect in NSCLC patients with brain metastases, and we are thus accumulating evidence to further prescribe Leclaza for those patients in Korea.”
- Company
- SGLT2 lowers BP, but more evidence is needed to use it alone
- by Hwang, Jin-joon May 23, 2023 05:50am
- Professor Cho Ik-Seong of Severance Hospital is giving a presentation (photo by Dailypharm) There was an opinion that there is still insufficient evidence for the use of the sodium-glucose cotransporter-2 (SGLT-2) inhibitor, a treatment for type 2 diabetes and heart failure, for the treatment of hypertension. It can be expected to lower blood pressure in patients with heart failure or diabetes, but it is difficult to use it alone for the treatment of hypertension. Professor Cho Ik-Seong of Severance Hospital held a hypertension drug treatment update session at the '2023 Korean Society of Hypertension Spring Conference' held at EXCO in Daegu on the 20th and said, "SGLT-2 inhibitors are a drug that is attracting attention in the field of diabetes and heart failure. · For patients suffering from high blood pressure, it can act as a weak blood pressure drug," he said, "but more data are needed to use it only for high blood pressure." Famous drugs for SGLT-2 inhibitors include AstraZeneca's 'Forxiga' and Eli Lilly/Boehringer Ingelheim's 'Jardiance'. Recently, Daewoong Pharmaceutical's 'Envlo', Donga ST's 'Sugadapa', LG Chem's Zemidapa, and Chong Kun Dang's Exiglu M have been released, causing a sensation in the diabetes treatment market. SGLT-2 inhibitor drugs are evaluated as next-generation treatments globally because they have not only blood sugar-lowering effects but also cardiovascular disease prevention, weight loss, and blood pressure-lowering effects. According to the 2021 Diabetes Guidelines, in the case of type 2 diabetes accompanied by heart failure, treatment with proven cardiovascular benefit is considered first. Even in the presence of atherosclerotic cardiovascular disease, SGLT-2 inhibitors are used in combination therapy. The Korean Heart Failure Association completely revised the guidelines last year and recommended the administration of SGLT-2 inhibitors to reduce hospitalizations or cardiovascular deaths due to heart failure, regardless of diabetes mellitus. The fact that SGLT-2 inhibitors have the effect of lowering blood pressure can be confirmed through various studies. According to the 'phase 3 study on the blood pressure and blood sugar lowering effect of dapagliflozin versus placebo on antihypertensive combination therapy in patients with type 2 diabetes' published in the international journal The Lancet, the SGLT-2 inhibitor Dapagliflozin-administered group had lower blood pressure than the placebo control group. The Hypertension Society also acknowledges that SGLT-2 inhibitors lower blood pressure. In the hypertension treatment guidelines, SGLT-2 inhibitors have a blood pressure-lowering effect, so care should be taken to see if the dose of antihypertensive drugs needs to be adjusted. Professor Ik-Sung Cho explained, "In patients without heart failure but with diabetes and high blood pressure, the use of SGLT-2 inhibitors lowered SBP by about 8 compared to placebo." Professor Cho continued, "Looking at the results of studies on patients suffering from both diabetes and heart failure, SGLT-2 inhibitors can lower SBP by 4 to 7 and diastolic blood pressure (DBP) by 1.5 to 2." -2 inhibitors are effective in lowering blood pressure, but it seems difficult to use them only for hypertension.”
- Company
- AZ runs a neurofibromatosis disease awareness campaign
- by Jung, Sae-Im May 22, 2023 05:42am
- AstraZeneca Korea announced on the 18th that it had conducted the 'Twinkling a Light for NF-1 Campaign' for its executives and employees to support domestic neurofibromatosis patients in celebration of 'World Neurofibromatosis Awareness Day'. The Children's Cancer Foundation designated May 17 every year as World Neurofibromatosis Awareness Day to raise social interest in neurofibromatosis. Worldwide, various activities are conducted every year to increase treatment access for patients with neurofibromatosis and support their overcoming disease. AstraZeneca Korea held in-house lectures, disease infographic exhibitions, etc. to better understand pediatric patients with neurofibromatosis in Korea, and executives and employees carried out a campaign to deliver messages of hope and commitment to improve the domestic treatment environment. Neurofibromatosis is a rare disease that causes developmental abnormalities in the nervous system, bones, and skin due to genetic mutations. The cafe-au-lait-spot is characteristic, and axillary/inguinal spots and Leish nodules, which are small hamartomas, appear on the iris. Accurate clinical diagnosis of neurofibromatosis type 1 can usually be made before the age of 10, and symptoms tend to intensify with age. About 20 to 50% of patients with type 1 neurofibromatosis experience plexiform neurofibroma, which can occur anywhere in the body except for the brain and spinal cord. Depending on where it occurs, it causes pain as well as various body deformities or damage to vision, hearing, and cognitive abilities. Surgical resection was the only fundamental treatment for neurofibromatosis. In the case of plexiform neurofibroma, it appears in various irregular shapes and is difficult to completely remove, leaving the risk of tumor recurrence even after surgery. AstraZeneca Korea received approval for Koselugo, the first type 1 neurofibromatosis treatment in Korea, in May 2021. Koselugo, the only treatment for neurofibromatosis type 1 to date, reduced the tumor size by more than 20% in 68% (34 out of 50) of patients administered in global clinical studies, and among them, 82% (28 patients) showed a response of more than 12 months. showed lasting results. Cheol-Woong Kim, Executive Director of AstraZeneca Korea's Rare Disease Division, said, "Through the Neurofibromatosis Awareness Day event, it was an opportunity to properly understand neurofibromatosis disease and think about what AstraZeneca Korea executives and employees can do for patients." said.
- Company
- Hana Pharm, signed a sub-license agreement for Byfav
- by Lee, Seok-Jun May 22, 2023 05:42am
- Hana Pharm announced on the 18th that it had signed a sub-license contract with Hyphens Pharma of Singapore for the exclusive rights to Byfavo 20mg, an anesthetic new drug. This contract is the first achievement of local partnering while Hana Pharm received licenses for six Southeast Asian countries from German PiON in 2020 and was in the process of obtaining licenses for each country. Byfavo 20mg has indications for surgical sedation that can be used for endoscopic sedation in addition to induction and maintenance of general anesthesia, which is the indication for 50mg. Hyphens Pharma of Singapore is a major pharmaceutical company in Singapore with branches in five major Southeast Asian countries and about 500 employees. Choi Tae-hong, CEO of Hana Pharm, said, "Partnering was made with Hyphens Pharma, which has excellent capabilities in the gastroenterology market in Singapore. We will accelerate the timing of approval and release in Singapore as much as possible and use it as a bridgehead to enter the Southeast Asian endoscopic sedation market."
- Company
- New formulations for schizophrenia are being commercialized
- by Eo, Yun-Ho May 22, 2023 05:42am
- According to related industries, new long-acting formulations of existing schizophrenia treatment drugs, such as Abilify and Invega, are being released one after another. Lundbeck and Otsuka Pharmaceutical obtained US FDA approval for Abilify Asimtufii, which is administered once every two months, last month. Abilify Asimtufii confirmed its efficacy through a clinical study comparing 266 patients with schizophrenia to Abilify Maintena. In pharmacokinetic analysis, Abilify Asimtufii induced plasma aripiprazole concentrations similar to those of once-monthly Abilify Maintena. Janssen's Invega Hafyera is a 6-month long-acting drug that is commercialized more quickly. After obtaining US FDA approval in 2021, the drug was approved in Korea in 2022, and insurance benefits were applied from this month. Invega Hafyera is eligible for reimbursement only when patients have been treated with Invega sustenna for at least 4 months or with Invega Trinza for at least one cycle. Invega Hafyera, which is administered every six months, has confirmed its safety and tolerability profile through PSY3015 clinical trials. Professor Kim Se-hyeon of the Department of Psychiatry at Seoul National University Hospital said, "We expect that patients with schizophrenia will be able to enjoy the benefits of returning to society and restoring confidence in life by continuing treatment with stable drug compliance and convenience through long-acting injections." said.
