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- 2026-03-17 02:03:10
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- Yuhan Leclaza's first-quarter sales were 3.2 billion won
- by Chon, Seung-Hyun May 24, 2022 05:55am
- Yuhan's new anticancer drug Leclaza posted sales of 3 billion won in the first quarter. It has continued to rise since it entered the domestic market in earnest in the second half of last year. It is expected to surpass 10 billion won in annual sales for the first time among new anti-cancer drugs developed in Korea. According to IQVIA, on the 23rd, Leclaza recorded 3.2 billion won in sales in the first quarter. Leclaza is a non-small cell lung cancer treatment approved as the 31st new drug developed in Korea in January last year. Patients with local progressive or metastatic non-small cell lung cancer who developed T790M resistance after administration of the first and second generation epithelial cell growth factor receptor (EGFR) tyrosin kinase inhibitor (TKI) are eligible for administration. It acts as a mechanism to suppress the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth. Leclaza made its market debut in July last year with the listing of health insurance benefits. Leclaza made 4.1 billion won in sales in the second half of last year alone. The first sales of 1.5 billion won occurred in the third quarter of last year and 2.6 billion won worth of sales were sold in the fourth quarter. Cumulative sales have been estimated at 7.3 billion won since the third quarter of last year. Since anticancer drugs usually used in large medical institutions can be prescribed after the passage of the drug committee, it takes a considerable amount of time for sales to occur at the beginning of the release. Leclaza can be prescribed at more than 30 medical institutions, including Seoul National University Hospital, Sinchon Severance Hospital, Samsung Medical Center, and Asan Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Hwasun Chonnam National University Hospital, Chilgok Kyungpook National University Hospital, and Pusan National University Hospital. At this rate, it seems likely that annual sales will surpass 10 billion won in the second year of its release. None of the new anticancer drugs developed by domestic pharmaceutical companies has yet exceeded 10 billion won in annual sales. Domestic developed anticancer drugs licensed before Leclaza include Supect of Ilyang Pharmaceutical, Chong Kun Dang's Camtobell, Samsung's Riavax, and Hanmi's Oilta. Among them, Supect recorded 7.4 billion won in sales last year. Sales in the first quarter of this year are 1.9 billion won. Supect, which was approved as the 18th new drug developed in Korea in January 2012, is a drug used as a treatment for chronic myeloid leukemia. However, compared to the anticancer drugs of multinational pharmaceutical companies used for similar purposes to Leclaza, there are hurdles to overcome in the future. EGFR targeted anticancer drugs approved for use in Korea before the release of Leclaza include Iressa and Tarceva, the first-generation drugs, Giotrip and Vizimpro, and Tagrisso. Tagrisso posted 26.4 billion won in sales in the first quarter, up 8.0% from a year earlier. Tagrisso is a secondary treatment prescribed for non-small cell lung cancer (NSCLC) patients who developed resistance after administration of existing EGFR tyrosin kinase (TKI), such as Iressa, Tarceva, and Giotrif. It is called the same third-generation drug as Leclaza in that it overcomes the resistance of existing EGFR-TKI. Tagrisso, which received domestic permission in 2016, saw its sales increase significantly after applying health insurance benefits in December 2017. Tagrisso surpassed 10 billion won in sales in the third quarter of 2018 and has been recording 20 billion won in sales since the second quarter of 2019. It recorded sales of about 100 billion won for two consecutive years in 2020 and last year. Beringer Ingelheim's Geotrip, which is classified as a second-generation EGFR target anticancer drug, recorded 5.8 billion won in sales in the first quarter, up 13.2% from the previous year. Iressa and Tarceva, the first-generation drugs, showed sales of 3.4 billion won and 1 billion won in the first quarter, respectively. Yuhan Corporation has secured a total of $150 million in technology fees with Leclaza. Yuhan Corporation exported Leclaza to Janssen Biotech in November 2018. At this time, he received a deposit of $50 million without obligation to return it. Yuhan Corporation received $35 million in milestone from Janssen in April 2020. Janssen paid additional milestones to Yuhan Corporation when he began clinical trials of combination therapy with Amivantamab and Leclaza at the time. In November 2020, Janssen paid an additional $65 million to Yuhan Corporation when it began recruiting subjects for this clinical trial.
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- Duodart may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho May 24, 2022 05:55am
- The combination drug ‘Duodart’ that contains ‘dutasteride’ and ‘tamsulosin’ may be prescribed in general hospitals in Korea. According to industry sources, Duodart, GSK Korea’s fixed-dose combination drug for benign prostatic hyperplasia (BPH), has recently passed the drug committee (DC) review of Sinchon Severance Hospital and is undergoing landing procedures at major medical institutions across the country. The drug was granted insurance benefits starting in March this year. Duodart is reimbursed for ?? patients with ‘benign prostatic hyperplasia (BPH)’ who satisfy both of the following conditions: International Prostate Symptom Score (IPSS) of 8 or higher and ▲ Ultrasonography shows a prostate size of 30ml or larger, or Digital rectal examination shows moderate or higher BPH or the patient’s prostate-specific antigen (PSA) level is 1.5ng/ml or higher. Duodart is the first fixed-dose combination of dutasteride and tamsulosin introduced for BPH in Korea and can be administered orally once daily in a capsule form to treat moderate-to-severe symptoms of BPH. The drug was approved by the EU and the US FDA in 2010 and approved in May last year in Korea. The combination of the 5α-reductase inhibitor (dutasteride) and antagonist of α1a-adrenoreceptors (tamsulosin hydrochloride) is recommended in global clinical practice guidelines. Rapid symptom improvement and long-term disease progression control were expected through the combination of the two drugs with complementary mechanisms of action. In real-world data, patients using Duodart showed statistically significantly higher compliance compared with those using 5α-reductase inhibitor/ Alpha1-adrenergic antagonist free-combination therapy. The European Association of Urology (EAU) currently recommends introducing the 5α-reductase inhibitor (5-ARI) and Alpha1-adrenergic antagonist combination therapy in the early stages of treatment in patients with BPH with accompanying lower urinary tract symptoms (LUTS). The American Urological Association (AUA) also recommends using combination therapy in the early stages of BPH treatment. According to the CombAT study, the clinical trial that became the basis for Duodart’s approval, patients in the dutasteride-tamsulosin combination therapy group showed rapid symptom improvement at Month 3 like the tamsulosin monotherapy group. Also, the combination demonstrated superior symptom improvement over either monotherapy from Month 9, which lasted until Month 48. In addition, the combination therapy reduced the risk of BPH symptom progression and risk of AUR-related surgery than either monotherapy.
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- Janssen makes first bid into lung cancer mkt with Rybrevant
- by May 24, 2022 05:55am
- “We will work to make Rybrevant, which had been first approved to treat EGFR exon 20 insertion mutations, the No.1 option for lung cancer patients in Korea.” Janssen Korea expressed so at the press conference that was held on the 23rd to celebrate the launch of Rybrevant in Korea. Rybrevant (amivantamab) received marketing authorization from the Ministry of Food and Drug Safety in February and was officially released this month. As the first and only dual inhibitor that targets both the EGFR exon 20 insertion mutation and MET, the drug is approved for use in patients whose disease has progressed during or after platinum-based chemotherapy treatment. According to the CHRYSALIS trial that became the basis of Rybrevant’s approval, the overall response rate (ORR) of the Rybrevant monotherapy-treated group was 40%. 4% of the participants achieved a complete response (CR), and 36% achieved a partial response (PR). The median duration of response (DOR) was 11.1 months. Based on such results, the National Comprehensive Cancer Network guidelines recommend Rybrevant as a treatment option for patients with EGFR exon 20 insertion mutation NSCLC after platinum-based chemotherapy treatment. Professor Byoung-Chul Cho, Chief of Yonsei Cancer Center (Professor, Division of Medical Oncology, Yonsei Severance Hospital) who first identified the potential of Rybrevant in exon 20 insertion mutations, said, “While conducting a Phase I trial on lung cancer patients with Rybrevant, we found that the drug showed a dramatic effect in patients with exon 20 insertion mutations. After identifying its potential through various preclinical trials, we quickly initiated the CHRYSALIS study to come up with results.” Exon 20 insertion mutations are present in around 10% of all patients with EGFR mutations. Due to its various subtypes, patients with the mutation are unable to achieve desired results with existing EGFR-targeted cancer therapies. Compared to the PFS of patients with common EGFR mutations (Exon 19 deletion, L868R) which was 11 months, the PFS of patients with Exon 20 insertion mutations was a mere 3 months. The 5-year survival rate of patients with common EGFR mutations is 19%, but only 8% in patients with Exon 20 insertion mutations. This was why the need for a new targeted therapy had been rising for the specific mutation. Professor Cho believes that Rybrevant has a high potential to expand to other indications as it simultaneously targets both the EGFR and MET mutations and has a unique mechanism of action that activates immunity by engaging NK cells, monocytes, and macrophages. Cho said, "Exon 20 insertion mutation presents in various subtypes. Subgroup analysis results of the CHRYSALIS study showed that Rybrevant showed an even response across various subtypes. Also, Rybrevant is promising as it has an immunological mechanism in addition to the target inhibition effect held by targeted therapies." Janssen Korea is also conducting various clinical trials to test the expandability of Rybrevant. A Phase III trial in combination with chemotherapy and a Phase I study of Rybrevant monotherapy on MET exon 14 skipping mutation is underway. The most anticipated combination is its combination with Leclaza (lazertinib) to target common EGFR mutations. The company is conducting 3 clinical trials using the Rybrevant+Leclaza combination. Two of the trials are Phase III trials, MARIPOSA-2, which identifies the potential of Rybrevant+Leclaza+chemotherapy as a treatment used after Tagrisso, and the MARIPOSA trial which directly compares Rybrevant+Leclaza to Tagrisso, is underway. Also, Janssen Korea is exploring Rybrevant’s potential in various solid cancers including breast cancer and ovarian cancer. Professor Cho said, “EGFR and MET are key targets that are commonly present in various other solid cancers as well. The fact that Rybrevant is a bispecific antibody that inhibits both at the same time holds immense potential, and with the various clinical trials in progress, we may expect the drug to expand to other indications in the future.”
- Company
- Alvogen, 1 in 3 failed patent attempts for Avastin
- by Kim, Jin-Gu May 24, 2022 05:55am
- Alvogen Korea failed to cross the last hurdle in the Roche anticancer drug Avastin patent challenge. It challenged three patents, but succeeded in overcoming only two and failed one. The Korean Intellectual Property Tribunal recently dismissed the Avastin patent invalidation trial filed by Alvogen Korea against Roche. As a result, the original company Roche succeeded in defending one out of three related patents in the first trial. Roche has registered a total of four patents in Avastin. It is one patent for substance and three patents for use. One patent for substances registered in Korea has already expired in April 2018. In August last year, Alvogen filed a series of invalidation trials for the three patents. The results of the first trial related to this began to come out last month. In the case of two use patents that expire in February 2031, Alvogen succeeded in invalidating them last month and early this month. In the case of a patent for use that expires in February 2033, the Korean Intellectual Property Tribunal sided with the original company. Alvogen's plan to develop Avastin biosimilar while overcoming related patents has also become inevitable. As a result, the pharmaceutical industry predicts that Alvogen will continue the patent dispute through the patent court appeal. Avastin is a blockbuster anticancer drug developed by Roche and is used for treatment of non-small cell lung cancer, metastatic direct bowel cancer, metastatic breast cancer, and glioblastoma. According to IQVIA, a pharmaceutical market research firm, Avastin's domestic sales reached 112.3 billion won last year.
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- Ilaris reattempts reimb for its 13 patients in Korea
- by Eo, Yun-Ho May 23, 2022 06:06am
- ‘Ilaris,’ an ultra-orphan drug indicated for only 13 patients in Korea, is reattempting to be listed for insurance benefit. According to industry sources, Novartis Korea recently submitted an application to receive insurance benefits for its hereditary periodic fever syndrome treatment ‘Ilaris (canakinumab). This is the first attempt made by the company since it was denied reimbursement by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in 2017. Among the various Hereditary Periodic Fever Syndrome conditions, the drug was approved in 2015 in Korea for the treatment of ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS), and ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and ▲Familial Mediterranean Fever (FMF) in patients who are unable to use colchicine (due to contraindication, intolerance or lack of efficacy). The drug demonstrated an improvement in quality of life and convenience in administration in CAPS patients (a type of Hereditary Periodic Fever Syndrome) with 6 doses a year but was unable to prove its cost-efficiency, being a drug for an ultra-rare disease. In fact, Novartis had first applied for its reimbursement in 2017 after the drug was approved in 2015, and the company did not make any further attempts at listing until now. With this delay, the dire need for a reimbursed treatment option has intensified among patients. An alternative option exists, but just for one phenotype of the Hereditary Periodic Fever Syndrome - the chronic infantile neurological, cutaneous and articular (CINCA) syndrome – that patients can receive through the Korea Orphan & Essential Drug Center. With expectations rising on increased coverage for severe and rare disease drugs with the inauguration of the new administration, whether Ilaris will see different results this time remains to be seen. Dae Chul Jeong, Professor of Pediatrics at Seoul St. Mary's Hospital, said, “We need to improve accessibility to rare disease treatments so that Hereditary Periodic Fever Syndrome patients are guaranteed the same treatment benefits as other rare disease patients in Korea.” He added, “We also need to provide social attention and support so that patients diagnosed with Hereditary Periodic Fever Syndrome could continue on their difficult treatment journey while maintaining the quality of life with their families.”
- Company
- Keytruda became a new breakthrough in the tx
- by May 23, 2022 06:06am
- MSD's Keytruda succeeded in applying Hodgkin's lymphoma benefit for the second time as an immuno-cancer drug. Takeda is considered the best option for Hodgkin's lymphoma treatment. It is evaluated as suitable as a new option by proving superiority through comparative clinical trials with Takeda's Adcetris. As of March 1, Keytruda was reimbursed as a second or more treatment if it recurred or progressed after self-hematopoietic stem cell transplantation (ASCT) in typical Hodgkin lymphoma, and a third or more treatment if self-hematopoietic stem cell transplantation is impossible. Yoon Deok-hyun, a professor of oncology at Asan Medical Center in Seoul, commented on the expansion of the benefit, "Keytruda showed superior effect than Adcetris in most Hodgkin lymphoma patients, so Keytruda will be used first unless it is an exception." Hodgkin's lymphoma is mostly young patients, with people in their 20s and 30s accounting for 80% of the total. Lymphoma can occur in T lymphocytes, which play an important role in regulating the immune system and fighting viral infections, and in B lymphocytes, which produce antibodies essential to fighting some infections. Hodgkin's lymphoma is a type of lymphoma that is believed to have originated from B lymphocytes. In Korea, it accounts for about 5% of all lymphoma. Hodgkin's lymphoma has a high cure rate. In the case of local weapons, more than 95% of them are completely cured. However, about half of the high-risk groups of advanced stage patients suffer recurrence. Overall, it shows a recurrence rate of more than 20%. Patients who recur or fail to comply with treatment with cocktail therapy represented by ABVD consider autologous hematopoietic stem cell transplantation. The cure rate during transplantation is reported to be about 50%. However, the treatment of patients who cannot be transplanted or recur after transplantation still remains a homework. Professor Yoon said, "Self-hematopoietic stem cell transplantation is like high-dose chemotherapy, so patients who do not respond to chemotherapy cannot try it. This is one in three. In addition, about 20% of all patients are elderly or in poor systemic condition, so they cannot withstand transplants. The homework was how to treat these patients and those who recur after transplantation. Adcetris is the drug that contributed to improving their survival rate. It was a drug that combined strong anticancer drugs with antibodies targeting cancer, and it was effective not only in recurrent patients, but also in post-transplantation maintenance therapy and first-line treatment in high-risk groups." Although Adcetris has become the most effective drug for treating recurrence patients, many patients still experience recurrence with a 5-year progression-free survival rate of 20%, Professor Yoon said. At this time, Keytruda emerged as a new option by expanding the indication to Hodgkin's lymphoma. In particular, Keytruda first demonstrated superiority through a direct head-to-head comparison with Adcetris in phase 3 KEYNOTE-204. In this clinical trial, the risk of disease progression and death in the Keytruda group was 35% lower than that of the Adcetris group, and the median duration of progression-free survival was 13.2 months, showing a significant improvement compared to the control group (8.3 months). The objective reaction rate of the Keytruda group was 65.6%, and one in four showed complete remission. The median value and quality of life of the reaction duration were also significantly improved compared to the Adcetris group. Professor Yoon said, "When I used Keytruda at the treatment site, the quality of life of the patient increased due to its resistance, and it was convenient for patients as they only had to come once every three weeks without hospitalization. There was little hematological toxicity, he said. "Keytruda recorded a progression-free survival rate of 30-40% at the time of three years, which was higher than any other treatment." Since March, Keytruda benefits have been applied to Hodgkin's lymphoma, and treatment patterns at the treatment site have also changed. Professor Yoon said, "Based on the comparative clinical results, Keytruda can be considered first in almost all patients. If it is not an exceptional case, such as accompanying autoimmune diseases, we will use Keytruda first, he said. "Keytruda can be an important breakthrough in recurrent patients." Of course, Keytruda is not the perfect solution. Due to clinical design, Keytruda treatment is difficult to exceed two years. The reaction rate is high, but the rate of complete remission is 25%, which is also limited to achieving the goal of "complete recovery." However, Professor Yoon highly predicted the possibility of immuno-cancer drugs in Hodgkin's lymphoma, given that various clinical trials are underway beyond the effects of existing treatments. He said, "It is clear that immuno-cancer drugs will play a more role in the future as several clinical trials are currently underway in Hodgkin's lymphoma, including post-transplantation maintenance therapy and primary treatment therapy, including Keytruda."
- Company
- Keytruda leads sales for the 9th consecutive quarter
- by Chon, Seung-Hyun May 23, 2022 06:06am
- MDS’s cancer immunotherapy Keytruda has again topped the rank in pharmaceutical sales this year. Its increase in sales has been reduced somewhat due to the price cut disposition that followed Keytruda's reimbursement expansion, still, the drug was able to maintain its lead for the 9th consecutive quarter. Also, new drugs from multinational pharmaceutical companies, such as Plavix, Opdivo, Prolia, and Dupixent showed strength this quarter. According to the market research institution IQVIA on the 20th, Keytruda made the most among pharmaceuticals in Korea in the first quarter of this year, recording sales of ₩40.4 billion. Although the amount has decreased 8.4% YoY, still, the drug was able to maintain its overall lead. Keytruda is an immune checkpoint inhibitor that inhibits PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activating the immune system to treat cancer. The drug, which was first released in March 2015, is currently approved for 18 indications in 14 cancer types in Korea, including melanoma, lung cancer, and head and neck cancer. Keytruda’s sales had first remained in the ₩3 billion range but started soaring after the drug was approved for insurance benefit as a second-line treatment for non-small cell lung cancer. Its sales exceeded ₩10 billion in Q1 2018 and then exceeded ₩30 billion in Q2 2019. In Q1 2020, the drug outsold the then-lead Lipitor and rose to the top that it maintained for 9 consecutive quarters until now. The reduction in sales of Keytruda this year is considered to be due to Keytruda’s price cut. Keytruda’s insurance ceiling price had fallen 25.6% with its reimbursement expansion to first-line treatment of NSCLC in March this year. Although sales had reduced somewhat due to the price cut, its rise in sales is expected to continue to surge due to the expanded scope of reimbursement. Sales of the hyperlipidemia treatment Lipitor recorded 2nd place with ₩38.5 billion in Q1 this year, making a 9.7% YoY increase. The sales gap between Keytruda and Lipitor had been nearly ₩9 billion in Q1 last year, but this gap was reduced to ₩1.9 billion with the slower rise in Keytruda’s overall sales this year. Lipitor (atorvastatin) is a hyperlipidemia treatment that was released by Pfizer Korea in 1999. Although its insurance price fell to half after patent expiry and the fierce competition created by the 100 or more generics, the drug continues to exert its strong influence in the prescription drug market. Viatris Korea, which was launched in November 2020 through a merger between Global Pfizer’s business division Upjohn and the global healthcare company Mylan, is in charge of its sales. Sanofi’s antiplatelet Plavix recorded 3rd place with its sales increasing 37.7% YoY to record ₩26.8 billion in Q1 this year. Plavix’s patent had also expired in 2007, despite the 100 or more generics that entered its market in the past decade, the drug is still recording high growth. Also, new drugs released by multinational pharmaceutical companies have made the ranks and have shown high growth. Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 77.0% YoY to record ₩23.9 billion in Q1 this year and newly entered the Top 10. Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with prescription topical therapies or cannot use topical therapies. It selectively inhibits interleukin-3 and interleukin-4 proteins, which are known causes of adult atopic dermatitis. Sanofi Genzyme received marketing authorization for Dupixent in March 2018 for the treatment of moderate-to-severe atopic dermatitis in adults and released the drug in August of the same year. Although its initial performance was not up to par, its sales surged with its reimbursement approval for severe atopic dermatitis in January 2020. Dupixent’s sales, which had been only ₩3.3 billion in Q1 2020, increased over fourfold in a single year to record ₩13.5 billion in Q1 last year and exceeded quarterly sales of ₩10 billion. The drug has been recording sales in the ₩20 billion range since Q3 last year. Sales of Ono Pharmaceutical’s cancer immunotherapy Opdivo (nivolumab) also increased 43.5% YoY to record ₩25.1 billion in Q1 this year. Amgen’s osteoporosis treatment Prolia and MSD’s HPV vaccine Gardasil 9 also showed high growth with a 25.9% and 39.2% respective YoY increase in sales. Among new homegrown drugs, HK Inno.N’s gastroesophageal reflux disease (GERD) drug K-CAB’s sales rose 25.2% YoY to record 25.1 billion in Q1 this year and ranked 5th among the most-sold prescription drugs in Korea this quarter.
- Company
- The global competitiveness of new drugs depends on
- by Nho, Byung Chul May 23, 2022 06:06am
- Public opinion on the realization of the preference for new drugs developed in Korea is rising ahead of the announcement of the results of research services on drug prices support policies for innovative pharmaceutical companies in line with the international trade order. The research service, which took place for five months from December last year to this month, is handled by Professor Park Mi-hye of Sungkyunkwan University with the order of the KHIDI, and is scheduled to be published as a report in June and July. The background of the research is due to the feasibility review of the MOHW's written inquiry of last year's parliamentary audit in the absence of subordinate laws due to trade issues, although the Pharmaceutical Industry Promotion Act was revised ('18.12). While positive results are expected, the core background and contents of the research service are expected to present support measures consistent with pharmaceutical company innovation and insurance finances, establish enforcement ordinances related to Article 17-2 of the Pharmaceutical Industry Promotion Act, and raise and resolve trade issues. New drug price preferential treatment at the new drug registration evaluation stage As a preference for drug prices for innovative pharmaceutical companies that can avoid trade issues demanded by the industry, first, a new drug price preference target (a new drug performed in phase 3 clinical trials in Korea) is established at the new drug registration evaluation stage. In the negotiation stage, innovative pharmaceutical companies are raising the current weighted average price of 90% to 100% for new drugs developed through phase 3 clinical trials in Korea, focusing on promoting R&D will and securing predictable marketability. Other preferential measures include improving the selection criteria for alternative drugs (excluding patent expired drugs from alternative drugs), accumulating a discount on drug prices during the patent period (deferred application), applying it after patent expiration, and reflecting the cost data of innovative pharmaceutical companies in Korea at the negotiation stage. The global innovative drug preferential treatment system was introduced temporarily between 2016 and 2018, and K-Cab and Olita have benefited from the suspension of development, but it has been virtually private due to the issue of non-compliance. Preferential conditions were the world's first domestic licensed or domestic production, joint development or social contribution between domestic and foreign companies, domestic clinical performance (phase 1), innovative pharmaceutical companies, or equivalent companies. Since 2018, all five requirements such as proving clinical usefulness, such as new mechanisms or substances, alternative treatments, extension of survival, rapid licensing in the United States or Europe, and rare disease treatments or anticancer drugs have been met, causing reverse discrimination against domestic history. Therefore, the industry believes that if innovative pharmaceutical companies omit ▲ economic evaluation, the highest A7 adjustment price or the highest alternative drug price will be reasonable, ▲ ICER when submitting PE data, and ▲ if PE data are not submitted, the maximum price of alternative drugs will be added by 10%. For new drugs similar to clinical usefulness, the lower of the amount between the weighted average price of substitute drugs and the weighted average price of substitute drugs × (100/53.55) (but in the case of new drugs, the highest price of substitute drugs can be recognized). The KPBMA said, "We plan to adopt the Pharmaceutical Bio Innovation Committee's policy, which will be established in the future, to encourage R&D, as well as secure new drug powerhouses and global entry points."
- Company
- COVID-19 exports to Australia↑123 times in a year
- by Kim, Jin-Gu May 23, 2022 06:06am
- In the January-April period, exports of medicines to Australia surged more than 100 times compared to the same period last year-on-year. In the pharmaceutical bio industry, it is interpreted that the moderna vaccine produced by Samsung BioLogics was exported to Australia in earnest, leading to an increase in total exports. Exports to Germany, which was previously the largest exporter, fell by one-fifth in a year. Exports to China and Japan also fell sharply. As the COVID-19 crisis enters a calming phase, analysts say changes are coming to major drug exporters. ◆Export to Australia 3.4 billion → 420 billion won in a year, 95% of them are vaccines According to the Korea Customs Service on the 17th, exports of medicines from Korea to Australia from January to April this year were 325.1 million dollars. Compared to $2.65 million (about 3.4 billion won) between January and April last year, it increased 123 times in a year. Until the middle of last year, Korea did not export much medicine to Australia. Before August last year, it was around 2 million dollars per month. It was in September last year that there were signs of full-fledged change. It exported 6.5 million dollars (about 8.3 billion won), more than three times more than usual. In November, it increased further to $12.74 million (approximately 16.3 billion won) in November. From December last year to February this year, it recorded more than 90 million dollars per month. In particular, in March, it reached its highest point by exporting 130.21 million dollars over a month. Exports in March were higher than annual exports of $126 million last year. Monthly exports in April have fallen again to $349 million. The pharmaceutical bio industry is paying attention to the fact that exports of medicines to Australia are concentrated in vaccines. Exports of vaccines (HS code 3002.41) to Australia from January to April amounted to $314.36 million, accounting for 97% of all drug exports to Australia. For the rest, it is maintained at the previous year's. It is explained that Moderna vaccines produced by Samsung BioLogics were exported to Australia. Yeonsu-gu, Incheon, is the only region in the country where vaccine exports have soared during this period. It is the area where Samsung BioLogics is located. ◆81% of Germany, the largest pharmaceutical export country in the past. "The base effect of panic buying" Exports of medicines to Germany plunged by one-fifth compared to the same period last year. In the January-April period of this year, exports of medicines to Germany amounted to 192.91 million dollars, down 81% from 1.010.27 billion dollars during the same period last year. Until last year, Germany was Korea's largest exporter of medicines for the past three years. Last year alone, 1.76922 billion dollars of medicines were exported to Germany. The pharmaceutical industry interprets that the rapid spread of COVID-19 in Europe has led to a decrease in drug exports to Germany. In the early days of the spread of COVID-19, exports of medicines increased as Germany and other European countries competed to stock up on essential drugs, and the opposite situation is taking place this year when COVID-19 calms down. Exports of medicines to Germany, which were $521.31 million in 2019, increased 3.5 times to $1.856.97 billion in 2020, the first year of COVID-19. Last year, it recorded a slight decrease of $1.76922 billion. In the process, the proportion of drug exports to Germany also increased significantly. Germany accounted for 14.1% of all drug exports in 2019, but soared to 26.9% in 2020. It decreased slightly to 21.8% last year, and fell to 8.8% from January to April this year. ◆47% decrease in China and 15% decrease in Japan In addition to Germany, exports of medicines to China and Japan also decreased significantly in a year. In the January-April period, exports of medicines to China amounted to $45.31 million, nearly half of $84.77 million in the same period last year. Exports to Japan also fell 15.2% from 161.25 million dollars to 136.68 million dollars in a year. In the case of the two countries, it is analyzed that the decrease in local demand for medicines has affected the decrease in exports.
- Company
- The standard of Xospata is very disappointing
- by Eo, Yun-Ho May 19, 2022 05:51am
- Insurance benefits for the new leukemia drug Xospata have been applied, but clinics are expressing regret. Acute Myeloid Leukemia (AML) treatment Xospata has been reimbursed since March. Looking at the benefit criteria of this drug, remission-induction therapy is recognized in patients with FLT3 mutant acute myeloid leukemia who are refractory to conventional treatment or can transplant homologous hematopoietic stem cells. Considering the preparation period for the transplantation of homologous hematopoietic stem cells, additional administration of 2 cycles is required only if the transplantation of homologous hematopoietic stem cells is approved in advance. Xospata's administration is limited to up to 4 cycles. In general, when the drug administration cycle is limited in the benefit standard, it is based on the design of clinical research of the drug or authoritative overseas guidelines. Blood cancer treatments such as Besponsa and Blincyto have limitations on benefit administration, all of which are based on evidence. In the case of Xospata, there is no specific reason to limit the dosage cycle. According to Xospata's ADMIRAL study, it was designed without any limitation on the administration period, and the NCCN guidelines recommend it as "Category 1" without any limitation on the period. Lee Je-hwan, chairman of the Korean Society of Hematology, said, "I'm not sure why the four-cycle restriction was made. Currently, Xospata benefits are recognized in A7 countries such as the United States and the United Kingdom and Canada without restrictions on the treatment cycle, he said. In addition, "targeted treatments such as Xospata are virtually difficult to prescribe unless they are reimbursed." If the treatment period is limited, it will have a great adverse effect on the patient's treatment," he stressed.
