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- 2025-12-24 13:49:19
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- When will Xocova be approved in Korea?
- by Nho, Byung Chul Nov 30, 2022 05:53am
- With the new oral COVID-19 treatment Xocova starting prescriptions in Japan after obtaining emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW), attention is rising on whether it will be approved in Korea as well. In Korea, the Korea Disease Control and Prevention Agency determines the need and grants Emergency Use Authorizations to drugs after expedited review, rather than choosing among companies that submitted applications. Although no news has been heard on whether Xocova is being officially undergoing approval processes yet, news has been heard that the government will start a review, and Ildong Pharmaceutical has started preparations for Emergency Use Approval. Xocova is an oral antiviral that contains ensitrelvir that selectively inhibits the viral 3CL protease and suppresses SARS-CoV-2 replication. Xocova demonstrated clinical symptomatic efficacy through a Phase II/III trial that was conducted in Japan and Korea. Trial results showed that the mean time to initial relief of COVID-19 symptoms in patients that received Xocova was 167.9 hours, a significant reduction from the 192.2 hours in the placebo group. Xocova also met its secondary endpoint — reduction in viral RNA — in the trial. Reduction in viral RNA on day 4 following the third dose in the ensitrelvir-treated group was 1.4 log10copies/ml more than that in the placebo group. Regarding its safety, no serious adverse events or deaths have occurred from the use of ensitrelvir, and was also found to be well tolerated. Its convenience in intake has also been regarded as an advantage. Unlike conventional treatments that are administered for 5 days, twice a day, and three tablets per administration, patients only need to take Xocova once daily for 5 days as a single tablet. With the opinion that the drug has shown a positive effect in Japanese hospitals after starting prescriptions, local healthcare professionals have been welcoming the diversification of COVID-19 treatment options. The fact that Xocova can be manufactured locally in Korea if it is granted marketing authorization in Korea is also an added advantage. Ildong Pharmaceutical had previously signed an agreement with Shionogi to jointly conduct Xocova’s clinical trial. After successful development, Ildong Pharmaceutical will directly be in charge of the local manufacturing and distribution of Xocova. In other words, Xocova will be locally manufactured. However, it is true that other treatments have been previously developed and imported and the need for COVID-19 treatments is not as urgent as before. But with more than 70,000 people still being confirmed as of the 1st, and further resurgences to come, many have stressed the need to establish treatment sovereignty by securing a treatment that can be manufactured in Korea. An industry official said, “A new COVID-19 treatment option is needed as there are considerable limitations on the use of existing treatments. In particular, if we can locally manufacture a COVID-19 treatment, it will be of great support in stably supplying treatments in cases of emergency.”
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- Doveprella, the first new tuberculosis drug in 50 years,
- by Eo, Yun-Ho Nov 30, 2022 05:52am
- Doveprella, a new tuberculosis drug that appeared 50 years, is expected to be listed on the insurance benefit list. According to related industries, Viatris' multidrug-resistant tuberculosis treatment Doveprella recently concluded a drug price negotiation with the NHIS. After passing the HIRA's Drug Benefit Evaluation Committee in September, the negotiation process began as soon as possible, drawing positive results. As a result, if only the Health Insurance Policy Review Committee passes, the benefit will be applied without any major problems. Doveprella, which was approved domestically in October last year after U.S. approval in September 2019, can be used as a combination of Bedaquiline and Linezolid in adult patients with extensive drug-resistant pulmonary tuberculosis, treatment intolerance, or non-reactive multidrug-resistant pulmonary tuberculosis. This drug is the first new treatment in more than 50 years. The tuberculosis treatment market has been shunned by front-line pharmaceutical companies for its poor drug economy. In fact, Doveprella is a drug created through a collaboration between Viatris and a non-profit organization called TB Alliance. Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis that is resistant to two or more tuberculosis treatments, including Isoniazid and Rifampin, which are the two most effective anti-tuberculosis drugs for the treatment of tuberculosis. The causes of the outbreak are divided into primary and acquired resistance, which is infected with tuberculosis bacteria, which are resistant from the beginning, and acquired resistance during the treatment process due to discontinuation of drug use and irregular administration. MDR-TB has only a 50% treatment success rate, so treatment efficiency is low and secondary drugs used for treatment have more side effects than primary drugs. The treatment period is also long, ranging from 18 to 24 months, so the cost is high, and in some cases, the lesion should be removed through surgery. The combined treatment of seven drugs, including Bdq, which is currently used for standard treatment of MDR-TB, is not well used in Korea due to high drug resistance, and the treatment period is still long at 9-12 months, making it difficult for patients to manage medication and high treatment failure rates. Doveprella proved its validity through a phase 3 clinical Nix-TB study. Doveprella confirmed its potential as a new short-term combination therapy, with a successful treatment effect of 92% in MDR-TB patients and 89% in a broad range of drug-resistant pulmonary tuberculosis patients in 6 months with Bedaquiline and Linezolid. The existing treatment period of 18 to 24 months was shortened to 6 months, and almost all extensive drug-resistant pulmonary tuberculosis and sputum culture-negative of MDR-TB patients were confirmed within 16 weeks. BPaL therapy was the first ready-to-use combination therapy consisting only of oral agents and showed complete data in about 90% of patients with extensively drug-resistant tuberculosis at 6 months of treatment.
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- Oluminant's sales are higher than Xeljanz's
- by Kim, Jin-Gu Nov 30, 2022 05:52am
- (From left) Oluminant, Rinvoq, Xeljanz.Xeljanz lost its market lead by falling sales by 13% due to safety issues. The market for JAK inhibitors, an oral autoimmune disease treatment drug, is fluctuating. While long-time market leader Pfizer Xeljanz faltered, Lilly's Oluminant took the lead. On top of that, Abbvie Rinvoq quickly expanded its sales, signaling fierce competition. ◆↑ Olumiant 30% of sales According to IQVIA, a pharmaceutical market research firm, Oluminant's cumulative sales in the third quarter of this year were 11.7 billion won. It increased by 30% compared to the cumulative 9 billion won in the third quarter of last year. Oluminant is a drug used for autoimmune diseases such as rheumatoid arthritis and atopic dermatitis. In December 2017, it was approved in Korea as the second JAK inhibitor after Xeljanz. Sales have steadily increased since November 2018 when salaries were applied as a treatment for rheumatoid arthritis. In May last year, the scope was expanded due to atopic dermatitis. In the fourth quarter of last year, it surpassed the sales of Xeljanz, an existing market-leading product. Since then, it has consistently recorded higher sales than Xeljanz. The third JAK inhibitor, Rinvoq, has a steeper growth rate. Cumulative sales in the third quarter of this year were 8 billion won, up about six times in a year from the cumulative 1.4 billion won in the third quarter of last year. Domestic permits were the latest in June 2020, compared to competing drugs, but sales have risen vertically since benefits were applied as a treatment for atopic dermatitis in May last year with Oluminant. In the third quarter of this year, quarterly sales exceeded 3 billion won for the first time. The gap with Oluminant, the No. 1 product in the market, has narrowed to 700 million won. ◆ Oluminant·Rinvoq Rising, Additional Effects of Atopic Dermatitis Indication The growth of Oluminant and Rinvoq is interpreted as a result of active indication expansion. In particular, it is analyzed that it led to sales growth by securing atopic dermatitis, which is not in Xeljanz, as an indication. Oluminant was first licensed as a treatment for rheumatoid arthritis. In May last year, atopic dermatitis was added as an indication. Oluminant is seeking to expand the indication even with hair loss. Lilly applied for the expansion of the indication with severe circular hair loss last month. Rinvoq was also approved for rheumatoid arthritis, and in October last year, additional indications for ▲ psoriatic arthritis ▲ ankylosing spondylitis ▲ atopic dermatitis were approved. Ulcerative colitis was added this year. Rinvoq currently has the most indications of JAK inhibitors. ◆ Xeljanz sales dropped 13% in a year Xeljanz's cumulative sales in the third quarter of this year were 10.2 billion won, down 13% from 11.7 billion won a year earlier. After being released in March 2015, Xeljanz expanded its influence as the only oral autoimmune disease treatment until 2018. From 2019, sales of around 4 billion won were maintained every quarter. Sales plunged 16% year-on-year in the fourth quarter of last year. Since then, it has been maintaining quarterly sales in the early 3 billion won range. It is analyzed that safety issues affected the decline in sales in the fourth quarter of last year. Based on the results of a large-scale random safety study in September last year, the U.S. Food and Drug Administration (FDA) added a black box warning, saying that JAK inhibitors, including Xeljanz, increase the risk of heart attack, stroke, cancer, and death. The Ministry of Food and Drug Safety distributed the same safety letter. In October this year, the standards were changed to be limited to patients aged 65 or older, patients in high-risk groups in ▲ the cardiovascular system, and patients at risk of ▲ malignant tumors. Pfizer plans to once again expand its influence in the JAK inhibitor market through Xeljanz's follow-up drug, Cibinqo. Like Oluminq and Rinvoq, Cibinqo is targeting atopic dermatitis. It was approved in Korea in November last year and is currently being prescribed non-reimbursed. In August, it passed the HIRA and approached the application.
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- Boryung, start patent challenge for liver cancer drug Lenvim
- by Kim, Jin-Gu Nov 30, 2022 05:52am
- Boryung challenged Eisai's patent for Lenvima, a liver cancer treatment. It is interpreted as a strategy to spur the anti-cancer drug business, which has been strongly driving since 2020. According to the pharmaceutical industry on the 29th, Boryung recently filed a passive judgment on the scope of rights and a judgment on invalidity in three Lenvima patents at the same time. Lenvima is a treatment for liver cancer in Eisai. It is used in the primary treatment of liver cancer along with Nexavar and Tecentriq+Avastin. According to IQVIA, a pharmaceutical market research firm, Lenvima's sales last year were 15.8 billion won. It has increased by 30% compared to 12.2 billion won in 2020. This year, it posted 11.1 billion won in sales until the third quarter. Lenvima is protected by a total of four patents. They include material patents that expire in April 2025, usage patents that expire in March 2028, salt and crystalline patents that expire in June 2028, and pharmaceutical patents that expire in March 2031. Boryung requested a trial for invalidation of a patent for use except for a material patent, and a trial for confirming the scope of passive rights to salt and crystalline patent and a formulation patent, respectively. If Boryung succeeds in targeting three patents, it will be eligible to release generic after 2025, when the material patent expires. Boryㅕng plans to further expand its anti-cancer drug portfolio by targeting Lenvima patents. Boryung's all-around anti-cancer drug patent challenge began in earnest after the independence of the "ONCO (anti-cancer) sector" in May 2020. Boryung has filed a patent trial for five original anticancer drugs in the past two years, including Lenvima. The number of patents amounts to 13. In May this year, Novartis filed a trial on four patents for Tasigna, a leukemia treatment. Prior to this, a patent trial was filed with Ibsen's liver cancer treatment Cabometyx in April this year, Pfizer's breast cancer treatment Ibrance in March, and BMS' acute lymphocytic leukemia treatment Sprycel in December last year.
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- Samsung Bioepis occupies 25% of Avastin mkt 1yr since launch
- by Nov 30, 2022 05:52am
- Samsung Bioepis’s Avastin (bevacizumab) biosimilar ‘Onbevzi’ is enjoying its market preoccupation effect. In only one year since its release, the share of its similar reached nearly 25% in the market. With Alvogen and Celltrion’s biosimilars succeeding to be released with reimbursement from the next month, the competition between biosimilars is expected to intensify further. Onbevzi enjoys ‘first mover’ benefit... original’s sales reduced 35% Pic of Avastin On the 29th, according to the market research institution IQVIA, Samsung Bioepis’s Onbevzi raised sales of KRW 6.4 billion in Q3 this year. Such sales have been made only 1 year since its release. Onbevzi quickly took over the market as the only bevacizumab biosimilar for 1 year since its release. Onbevzi, which had been released in September last year, raised sales of KRW 1.8 billion in Q1. In Q2, its sales surged to KRW 4.1 billion. Its sales exceeded KRW 10 billion only 1 year after its release. Onbevzi is a biosimilar of Roche’s anticancer drug Avastin. Avastin, which is the first VEGF inhibitor ever introduced, is used in various cancer types including colorectal cancer, breast cancer, lung cancer, ovarian cancer, and renal cell carcinoma. Its annual sales last year reached KRW 112.3 billion. In Q3 this year, Onbevzi accounted for 24.2 % of the market. Samsung Bioepis’ Onbevzi has been enjoying the ‘first mover’ effect as the ‘first biosimilar.’ Onbevzi, which was released with reimbursement in September last year, has rapidly increased its share of the market with support from Boryung Pharmacuetical. Boryung Pharmacuetical, which opted to partner with Samsung Bioepis, is a company that is demonstrating its potential, achieving sales of KRW 100 billion in the second year of the establishment of its ONCO (oncology) division. Data: IQVIA Onbevzi’s lack of ovarian cancer indication had been pointed to as its weakness. However, after making an agreement with Genetech, Avastin’s original developer, Samsung Bioepis was able to obtain an additional indication for ovarian cancer last month. The delay in the reimbursement listing of the second biosimilar also worked as a favor for Onbevzi. However, sales of the original Avastin have remained stagnant since the introduction of the biosimilar. The biggest issue was in how sales of the original drug is cut by 30% ex-officio after the listing of generics or biosimilars. Since then, Avastin’s price was reduced further by 5% with its reimbursement extended to be used in combination with Tecentriq in May. Avastin’s current ceiling price is set at KRW 218.782 (0.1g/4mL) and KRW 712,093 (0.4g/16mL). Avastin's sales had seemed to gain momentum after being granted reimbursement as first-line treatment for liver cancer. However, the momentum was offset by further price cuts and has been analyzed to have made no significant changes to Avastin sales. In terms of its quarterly sales, Avastin’s sales had only increased slightly from KRW 19.3 billion in Q1, KRW 18.8 billion in Q2, then to KRW 20 billion in Q3. Alvogen·Celltrion succeeds in reimbursement listing...sparks 4-way race With Alvogen and Celltrion’s biosimilar being listed for reimbursement, competition between the original and its biosimilars is expected to intensify further in the bevacizumab market. Alvogen has succeeded in listing its Avastin biosimilar ‘Alymsis’ with reimbursement in October. Alymsis, which was approved in January, has canceled its reimbursement application once due to patent litigations. This was one reason why Onbevzi’s sole reign in the market had been extended. Alymsis was listed for reimbursement after deleting the ovarian cancer indication whose patent the company had not been able to overcome. Its ceiling price had been set at the same price as Onbevzi. Alvogen selected Daewoong Pharmaceutical as its local partner. Daewoong Pharmaceutical is selling, ‘Ogivri,’ its biosimilar of the breast cancer drug Herceptin. Adding Daewoong Pharmaceutical’s sales power, the company plans to rapidly increase Alymsis’s sales in the market. Celltrion will also jump into competition in the market in December. Celltrion succeeded in receiving reimbursement for the Avastin similar ‘Vegzelma’ on the 26th. Its price is set the same as Onbevzi and Alymsis. Celltrion plans to start its sales in earnest in December after it receives reimbursement.
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- Rolontis and Leclaza make their place in Korea
- by Chon, Seung-Hyun Nov 29, 2022 05:54am
- Leclaza and Rolontis, the homegrown drugs that have gained attention as promising new global drugs, have made a smooth start in the domestic market. Yuhan Corp’s Leclaza’s annual sales exceeded KRW 10 billion in the second year of release, and Hanmi Pharmaceutical’s Rolontis has also started making sales in earnest in the Korean market. ◆Yuhan’s Leclaza’s sales exceed KRW 10 billion in only 3 quarters... nears FDA approval According to the market research institution IQVIA on the 28th, Leclaza’s sales in Q3 were KRW 4.6 billion, a threefold increase from the KRW 1.5 billion in the same period of the previous year. Leclaza is the 31st novel drug to be developed in Korea. It received approval as a non-small-cell lung cancer treatment for patients with EGFR T790M mutation-positive, locally advanced or metastatic NSCLC who were previously treated with an EGFR-TKI. It inhibits the signal transduction that is involved in lung cancer cell proliferation and growth to inhibit the proliferation and growth of lung cancer cells. Leclaza entered the Korean prescription market in earnest with its reimbursement listing in July last year. It first made sales of KRW 1.5 billion in Q3 last year and then sold KRW 2.6 billion in Q4. Its sales continued to rise further this year. In Q1 and Q2 this year, it raised sales of KRW 3.2 billion and KRW 3.7 billion and continued its growth in Q3. Leclaza recorded cumulative sales of KRW 11.5 billion in Q3 this year and then exceeded KRW 10 billion in its second year of release. Among new anticancer drugs developed in Korea, Leclaza is the first to raise annual sales that exceed KRW 10 billion. 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. In the early stages of its release, Leclaza is evaluated to have made a smooth start. As anticancer drugs are usually used in large medical institutions, they are only allowed to make prescriptions only after passing drug committee reviews in their respective institutions. Also, as the new drugs need to directly compete with promising new drugs from multinational pharmaceutical companies, it is not easy for local homegrown new anticancer drugs to achieve commercial results. Leclaza passed reviews in drugs committees of major large-scale medical institutions in Korea and started speeding up market penetration. Leclaza is also speeding up entry to the US market. Yuhan Corp made a licensing deal with Janssen biotech in November 2018. Since then, Janssen has been developing the drug in combination with its own EGFR-MET bispecific antibody ‘amivantamab.’ The CHRYSALIS trial which had been the first trial initiated after the agreement was signed, has been now expanded to study its combination with other platinum-based anticancer therapies including ‘carboplatin,’ ‘pemetrexed.’ Janssen is also expected to apply for FDA approval for such combinations within the year at the earliest. The global Phase III trial for the first-line therapy is also in smooth progress. According to a phase III trial recently announced by Yuhan Corp, Leclaza reduce the risk of disease progression or death by 55% compared to Iressa and statistically significantly improved progression-free survival, the primary endpoint. PFS is an important evaluation index used to confirm the efficacy of anticancer drugs and refers to the period that a patient lives with the disease without progression or death. The Phase III trial has been conducted on 393 treatment-naive patients with EGFR-positive locally advanced or metastatic non-small-cell lung cancer. Yuhan Corp received approval to conduct the clinical trial in December 2019 from the Ministry of Food and Drug Safety, and 119 institutions in 13 countries participated in the trial. Based on the trial results, the company plans to apply for its use as a first-line treatment. ◆Hanmi’s Rolontis first makes KRW 1.5 billion this year... starts sales in the US market Hanmi Pharmaceutical’s Rolontis which recently entered the US market started to raise sales in earnest in Korea. 2 Rolontis recorded KRW 1 billion in the Korean market in Q3. It made sales for the first time in Q1 this year and then sold KRW 0.4 billion in Q2. As of Q3, its cumulative sales reached KRW 1.5 billion. Rolontis is a new biological drug that Hanmi Pharmaceutical transferred the technology to Spectrum in 2012. It is administered to prevent or treat neutropenia in cancer patients that receive myelosuppressive chemotherapy. The drug has a similar mechanism of action to Amgen’s blockbuster drug ‘Neulasta (pegfilgrastim),’ by increasing the G-CSF receptor to stimulate neutrophil production. The drug was approved as the 33rd homegrown new drug in March and started to be sold in Korea after receiving reimbursement in November last year. Rolontis was approved under the brand name Rolvedon by the US FDA in September this year and succeeded in commercialization 10 years after its technology transfer. Rolvedon is now recorded as the 6th product to pass FDA review among new drugs developed with a Korean company’s technology. LG Chem’s Factive was the first among homegrown new drugs to pass the US gates in 2003. Then, Sivextro that Dong-A ST licensed out was approved by the FDA in 2014. Then, in 2016, SK Chemical’s hemophilia drug Abstyla received FDA approval. In 2019, SK Biopharmaceutical’s narcolepsy drug Sunosi and new epilepsy drug Xcopri received FDA approval. Rolontis is the first drug to receive marekting approval from the FDA among Hanmi Pharmaceutical’s products. It is the first new drug to be produced in the US market and produced at a domestic plant (Pyeongtaek Bio Plant) that has received on-site inspections from the FDA. It is the first new drug to be produced in the U.S. market and produced at a domestic plant (Pyeongtaek Bio Plant) that has received an on-site FDA inspection. Rolontis started selling in the US market in earnest last month. The US neutropenia treatment market is worth KRW 3 trillion a year. With Spectrum failing to introduce another anticancer drug it brought in from Hanmi Pharmaceutical, poziotinib, to the US, the company has expressed aims to focus on the commercial success of Rolontis. After failing to receive approval for poziotinib, Spectrum planned to start restructuring, including a 75% reduction in R&D personnel by the end of the year, and concentrate the saved operating funds on Rolontis.
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- Keytruda has booked high sales in the domestic market
- by Chon, Seung-Hyun Nov 29, 2022 05:53am
- Keytruda, an immuno-cancer drug, has reserved a leading position in the domestic pharmaceutical market for 3 consecutive years. New drug products recently released by multinational pharmaceutical companies such as Gardasil 9 and Dupixent continued to be high. According to IQVIA, a pharmaceutical research firm, MSD Keytruda posted 161.6 billion won in sales in the first three quarters of this year, the largest among all medicines. Compared to the same period last year, it increased by 11.1%, firmly maintaining its leading position. Keytruda's sales in the first quarter were 40.4 billion won, down 8.4% from the previous year. At that time, the decline in sales was blamed for the drug price cut. Keytruda's insurance upper limit was lowered by 25.6% in March as the scope of health insurance benefits was expanded to primary treatment for non-small cell lung cancer. However, Keytruda recovered its upward trend from the second quarter. Sales in the second quarter rose 9.7% year-on-year to 53.9 billion won, and sales in the third quarter rose 28.8% to 67.2 billion won. It is analyzed that Keytruda's primary treatment benefit application effect occurred in earnest. In the case of sales in the third quarter, considering the drug price cut rate, it is calculated that usage increased by more than 60% compared to the same period last year. Keytruda, released in Korea in 2015, is an immune checkpoint inhibitor that treats cancer by inhibiting PD-1 protein on the surface of immune cell T cells to prevent binding to PD-L1 receptors and activate immune cells. In Korea, 21 indications were granted in 16 carcinomas, including melanoma, lung cancer, and head and neck cancer. Currently, the cancers that can use Keytruda have reached ▲ lung cancer, ▲ head and neck cancer, ▲ Hodgkin lymphoma, ▲ urinary epithelial cancer (Bladder cancer), ▲ esophageal cancer, ▲ melanoma, ▲ renal cell cancer, ▲ endometrial cancer, ▲ gastric cancer, ▲ small intestine cancer, ▲ pancreatic cancer, ▲ biliary cancer, ▲ cervical cancer 16, ▲ cervical cancer. It can be used in the largest number of cancer types among immuno-cancer drugs licensed in Korea. Keytruda's sales began to rise rapidly after insurance benefits were applied as a secondary treatment for non-small cell lung cancer in August 2017. Sales exceeded 10 billion won in the first quarter of 2018 and 30 billion won in the second quarter of 2019. In the first quarter of 2020, Lippito was brought down to the second place and ranked first overall, and since then, he has maintained the lead for 11 consecutive quarters. New drug products recently released by multinational pharmaceutical companies were strong at the top of drug sales. MSD's cervical cancer vaccine Gardasil 9 ranked third overall, with cumulative sales of 85.3 billion won in the third quarter, up 68.0% from the same period last year. Gardasil 9 saw its sales rise 39.2% year-on-year to 24.3 billion won in the first quarter, while sales in the second and third quarters grew 98.9% and 66.1% year-on-year, respectively. Gardasil 9 is an HPV (human papillomavirus) vaccine product that adds five serum types (31, 33, 45, 52, 58) to four serum types (6, 11, 16, and 18 types) owned by Gardasil. It includes most HPV types of cervical cancer vaccines. In addition to cervical cancer, the number of male vaccinations is also increasing every year due to word of mouth that Gardasil 9 can prevent HPV-related diseases such as anal cancer, reproductive demons, and precancerous lesions. Since July 2020, the recommended age for vaccination has expanded from 9 to 26 years old women to 27 to 45 years old women, and the rate of re-vaccination of adults who have previously been vaccinated against cervical cancer has also increased significantly. Sanofi's atopic dermatitis treatment Dupixent recorded 75.9 billion won in cumulative sales until the third quarter, up 45.2% from the previous year. Sales in the first and second quarters increased 77.0% and 47.6% year-on-year, respectively, while sales in the third quarter increased 23.8% from the previous year. Dupixent is the first targeted biological drug developed for the treatment of moderate to severe atopic dermatitis, where topical treatments are not recommended or symptoms are not properly controlled. It acts as a mechanism that selectively suppresses the signal transmission of interleukin-4 and interleukin-13, which are known to be the causes of atopic dermatitis. Dupixent, which received domestic permission in March 2018, has seen its sales expand rapidly since January 2020 when it was covered by salaries for severe atopic dermatitis. Dupixent's sales were only 3.3 billion won in the first quarter of 2020, but quadrupled to 13.5 billion won in the first quarter of last year. It has recorded sales of 20 billion won since the third quarter of last year. Ono's immuno-cancer drug Opdivo's cumulative sales in the third quarter were 79.8 billion won, up 32.6% from the previous year. Opdivo, which was licensed in 2015, began to see a significant increase in sales after it was listed as an insurance benefit in 2017. Opdivo surpassed 10 billion won in quarterly sales for the first time in the first quarter of 2018 and has recorded sales of 20 billion won since the third quarter of last year. Amgen's Prolia ranked fourth overall, with sales rising 28.6% from the previous year to 83.8 billion won in the first and third quarters. Released in Korea in November 2016, Prolia is a biomedical osteoporosis treatment that targets the protein RANKL, which is essential for the formation, activation, and survival of bone-destroying osteoporosis. Prolia began to see an upward trend in sales after salaries were applied only to secondary treatment therapy in 2017. Since April 2019, Prolia's sales have exploded as insurance benefits have been recognized in primary treatment. Among the new drugs developed by Korean companies, HK inno.N's anti-ulcer drug K-CAB ranked seventh overall with sales of 77.9 billion won in the third quarter, up 20.1% from the previous year. K-CAB, released in March 2019, is a new mechanism of action that inhibits gastric acid secretion by competitively combining proton pumps and potassium ions located in the final stage of acid secretion.
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- First targeted PIK3CA Piqray reapplies for reimb
- by Eo, Yun-Ho Nov 28, 2022 05:51am
- An anticancer drug that targets the PIK3CA gene will once again attempt reimbursement listing in Korea. According to industry sources, Novartis Korea submitted a reimbursement application for the reimbursement of its breast cancer treatment Piqray (alpelisib) recently. The drug was unable to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in February this year. Piqray, which was approved in Korea in May last year, is a 'PIK3Caα-inhibitor that blocks the overactivation of the PI3K enzyme which, when overactivated because of a mutation in the PIK3CA gene, stimulates cancer cells to divide and grow in an uncontrolled fashion. The targeted cancer therapy is prescribed in combination with Faslodex (fulvestrant) to treat metastatic and advanced-stage, hormone-receptor-positive/ HER2-negative breast cancer in patients who failed previous treatment. Piqray’s safety and efficacy were demonstrated in the SOLAR-1 trial, which was conducted on 572 postmenopausal women, and men, with HR+, HER2- advanced (locoregionally recurrent or metastatic) breast cancer whose disease had progressed or recurred on or after an aromatase-inhibitor-based treatment (with or without CDK4/6 combination) Results showed when used in combination with Faslodex, Piqray improved the median PFS (Progression- Free survival) of cancer patients with the PIK3CA mutation from 5.7 months to 11 months. The Objective Response Rate (ORR), which indicates the proportion of patients whose tumor size was reduced by over 30%, was 35.7% for the combination therapy group, which is twice more than the 16.2% in the fulvestrant monotherapy group. The secondary endpoint, Overall Survival (OS) in patients with PIK3CA mutations, was 39.3 months in the combination therapy group. This was 8 months longer than the 31.4 months in the fulvestrant monotherapy group but did not have statistical significance.
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- K-similars compete for Canada's ₩31 tril market
- by Nov 25, 2022 06:05am
- Biosimilars manufactured by domestic bio companies are targeting Canada, the world's 10th largest pharmaceutical market With an increasing number of provinces in Canada actively implementing policies to mandate the use of biosimilars, usage of biosimilars in the country, which had been in the 10% range, is expected to increase significantly. According to industry sources on the 25th, Samsung Bioepis launched its oncology drug ‘Avastin’ biosimilar ‘Aybintio’ through its partner company Organon. Aybintio is a VEGF inhibitor prescribed for metastatic colorectal cancer, metastatic or recurrent non-small-cell lung cancer, platinum-sensitive recurrent ovarian cancer, etc. With the approval, a total of 5 Samsung Bioepis biosimilar products have been released in Canada as of this month. When including the 4 Celltrion biosimilars, a total of 9 biosimilars from Korea are now in the Canadian market. Starting with its Enbrel biosimilar ‘Brenzys’ in 2016, Samsung Bioepis received approval for 6 biosimilars including its Remicade biosimilar ‘Renflxis’ in 2017, Humira biosimilar ‘Hadlima’ in 2018, Avastin biosimilar ‘Aybintio’ in 2021, Herceptin biosimilar ‘Ontruzant’ and Lucentis biosimilar ‘Byooviz’ in 2022. Among the products, Byooviz has not been released to the market yet due to patent issues. In the case of Celltrion, it received approval and has marketed 4 biosimilars including its Remicade biosimilar ‘Remsima,' Rituxan biosimilar ‘Truxima,’ and Herceptin biosimilar ‘Herzuma’ in 2014, and Humira biosimilar ‘Yuflyma’ in 2021. Among the 50 biosimilar products approved by the health authorities in Canada, 10 are Korean products. ◆Canada ranks 10th in the global market...receives attention for its policy pro-biosimilar policy The Canadian pharmaceutical market is worth UDS 23.8 billion (KRW 31.58 trillion) based on IQVIA in 2020, and is the 10th largest market in the world. The country has been pointed to as the ‘land of opportunity' by domestic biopharmaceutical companies with the government’s recent implementation of biosimilar-friendly policies in provinces to reduce the cost of prescription drugs. The Province of British Columbia after implemented a policy three years ago that only allows the use of biosimilars for certain diseases, with exceptions, to raise the usage of biosimilars that remained at the 8% level at the time. British Columbia has mandated that prescriptions be switched to biosimilars, except in exceptional cases for indications for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, and Crohn's disease. Some provinces in Canada have a policy that mandates the use of biosimilars instead of originals for certain diseases. (Source: Northwest Territories website) The unconventional policy significantly increased the use of biosimilars in the province. As of the end of last year, the share of biosimilars in the private biopharmaceutical market, which had been 12% in other provinces, had reached 65% in the Province of British Columbia. From December last year to this year, other provinces including Alberta, New Brunswick, Quebec, Nova Scotia, Northwest Territory, and Saskatchewan also adopted policies to encourage the use of biosimilars, therefore, the biosimilar market is expected to grow further. The number of biosimilar approvals has also increased. Since approving 9 biosimilars last year, Health Canada additionally approved 7 products by November this year. In total, 50 biosimilars have now been approved in Canada so far, which is more than the 39 approved in the US. The Canadian government projects that it will be able to save about KRW 1 trillion (USD 768.7 million) a year with the implementation of the pro-biosimilar policy. An official from Samsung Bioepis said, “We have established a diverse product portfolio in Canada, the world's 10th largest pharmaceutical market, and plan to work more closely with our partners to expand their sales in the North American market."
- Company
- Janssen Korea to reduce workforce...conducts VSP
- by Eo, Yun-Ho Nov 25, 2022 06:05am
- Janssen Korea plans to restructure its labor force. According to industry sources, Janssen finalized its decision to conduct a Volunteer Separate Program (VSP) in its town hall meeting. The company will receive applications for VSP until the 30th of this month and does not have a fixed number of reductions planned. The specific terms of compensation for the VSP have not been disclosed. While conducting the VSP in 2015, the company had proposed ‘'years of service X2+2 months (average wage)+2 months (normal wage)' as compensation for early retirement. Also, Janssen’s VSP will exclude those in charge of market access (MA) and regulatory affairs (RA). Other multinational pharmaceutical companies including Novartis Korea, GSK Korea, and Sanofi Korea have also implemented early retirement programs in the second half of this year.
