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- 2026-03-14 08:36:26
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- Lucentis sales fell 34%
- by Chon, Seung-Hyun May 26, 2023 06:47am
- Humira, Avastin, Herceptin, and Mabthera also saw drug prices cut after entering the market for similar drugs. Domestic sales of Lucentis, an eye disease treatment, fell by more than 30%. As Chong Kun Dang and Samsung Bioepis launched biosimilars, drug prices went down and sales took a direct hit. New drugs from multinational pharmaceutical companies, such as Remicade, Enbrel, Herceptin, Mabthera, Humira, and Avastin, are experiencing repeated sales declines due to drug price cuts after the introduction of domestically developed biosimilars. It is evaluated that a virtuous cycle structure in which domestic companies' R&D achievements generate hundreds of billions of won in health insurance financial savings is being established. According to IQVIA, a drug research agency on the 26th, sales of Lucentis in the first quarter were 5 billion won, down 34.2% from the same period last year. It decreased by 20.1% in one quarter from 6.2 billion won in the fourth quarter of last year. Lucentis, sold by Roche and Novartis, is a drug used to treat eye diseases such as macular degeneration and diabetic macular edema. This drug is used for ▲ the treatment of neovascular (wet) age-related macular degeneration, ▲ treatment of visual impairment due to diabetic macular edema, ▲ treatment of proliferative diabetic retinopathy, ▲ treatment of visual impairment due to retinal vein occlusive macular edema, ▲ It is used for treatment of visual impairment due to the formation of choroidal neovascularization. A direct factor behind the decline in Lucentis' sales was drug price cuts following the entry into biosimilars. Samsung Bioepis and Chong Kun Dang received permission for Lucentis' biosimilar products. Samsung Bioepis obtained approval for Lucentis biosimilar Ameliebou in May last year, and Chong Kun Dang got approval for Lusenbier in October last year. Ameliebou and Lusenbies have been listed on the health insurance benefit list since January. Lucentis has lowered its insurance cap by 30% since February. The insurance price of Lucentis 10mg (3mg/0.3mL) went down from 820,636 won to 574,445 won, and Lucentis 10mg (2.3mg/0.23mL) went down from 828,166 won to 579,716 won. The drug price of Lucentis PFS (826,231 won → 578,362 won) was also cut by 30%. In principle, when a biosimilar appears in the domestic drug price system, the upper price standard for original drugs is lowered by 30% compared to before the patent expiration. 'Items developed by a company that signed a joint contract with an innovative pharmaceutical company, a company equivalent to it, a domestic pharmaceutical company, or a foreign company, or items for which Korea was the first licensed country or items produced in Korea' Guaranteed up to 80% of the original product. With the advent of a biosimilar developed by a domestic company, Lucentis saw a 30 percent drop in drug prices, and a drop in sales equal to the rate of drug price cut became a reality at once. Recently, sales of global blockbuster products Humira and Avastin also plummeted due to drug price cuts following the entry of biosimilars. Autoimmune disease treatment Humira saw its sales drop 24.7% in the first quarter from 27.5 billion won in the first quarter of 2021 to 20.7 billion won in the second quarter. Humira is a TNF-alpha inhibitor that treats autoimmune diseases by suppressing the expression of tumor necrosis factor (TNF-α). As of June 7, 2021, Humira's insurance cap has been reduced by 30%. The price of Humira Pen 40mg/0.4mL, Humira PFS 40mg/0.4mL, and Humira 40mg vial fell 30% from 411,558 won to 288,091 won, and Humira PFS 20mg/0.2mL from 224,002 won to 156,801 won. When Samsung Bioepis registered Humira biosimilar Adalloce for reimbursement in May 2021, Humira's upper limit fell a month later. Humira posted sales of 104 billion won in 2020, but decreased by 12.3% to 91.2 billion won in 2021. Last year, it was 85.8 billion won, down 17.5% from two years ago. In just two years after the introduction of biosimilars, sales decreased by about 30 billion won. Roche’s anti-cancer drug Avastin recorded sales of 19.4 billion won in the first quarter, down 32.4 percent in two years from 28.7 billion won in the first quarter of 2021. Avastin is an anticancer drug used for metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer. Avastin showed a stable growth flow, such as 28.7 billion won, 30.2 billion won, and 30.8 billion won, from the first quarter of 2021 to the third quarter, but in the fourth quarter, it decreased by 28.6% from the previous quarter to 22 billion won. The drop in sales was inevitable due to drug price cuts following the introduction of biosimilars. Samsung Bioepis received permission for Avastin's first biosimilar, Onbevezy, in March 2021, and was listed on the health insurance list in September of the same year. With the listing of Onbevezy, the upper limit of Avastin 0.1g/4mL in October 2021 was reduced by 30% from 33,387 won to 231,271 won. Avastin 0.4g/16mL fell 30% from 1,077,531 won to 752,746 won.
- Company
- Shingles vaccine Shingrix occupies 29% of market in 3 months
- by Jung, Sae-Im May 26, 2023 06:47am
- GSK’s shingles vaccine ‘Shingrix’ occupied 29% of the market in Q1 this year. In only 3 months of its release, it beat MSD’s ‘Zostavax’ and ranked 2nd in the market. The company has made a smooth start by actively conducting marketing activities in partnership with a domestic pharmaceutical company. According to the market research institution IQVIA on the 25th, the shingles vaccine market in Korea in Q1 reached KRW 21.9 billion, a 147% increase from the KRW 8.9 billion in Q1 of the previous year. The shingles vaccine market, which had been on a downward curve due to COVID-19, has started rising again this year. In Korea, three shingles vaccines are currently available in the market - SKYZoster, Zostavax, and Shingrix. In particular, Shingrix made rapid advances after generating full-fledged sales for the first time this year. Shingrix's sales in Q1 were KRW 6.3 billion. Sales of Shingrix were recorded from Q4 last year, but considering that it started sales in mid-December, full-fledged sales occurred for the first time in Q1 this year. Data: IQVIA Shingrix recorded higher sales than MSD's Zostavax in Q1 and rose to 2nd place. Its share in the domestic shingles vaccine market also reached 29%. On the other hand, Zostavax’s only raised KRW 6 billion, similar to Q1 of the previous year. Although Zostavax sold more products, Shingrix quickly surpassed sales with its high-price strategy. SK Bioscience’s ‘SKYZoster’ also posted KRW 9.5 billion in sales in Q1 this year, which is a 152% increase from the same period in the previous year, contributing to the market expansion. Shingrix is a shingles vaccine that GSK ambitiously released in December last year. Last year, GSK selected GC Biopharma and Kwangdong Pharmaceutical as domestic marketing partners and set out to occupy the market. Expectations were high that Shingrix’s release will rebound the shingles vaccine market that had been on a downward trend due to COVID-19. In only six months of its launch, Shingrix has landed in more than 7,000 clinics and 200 general hospitals in Korea and greatly expanded its market. The company’s Q1 sales were KRW 6.3 billion, which exceeded the company’s initial target. The greatest benefit of Shignrix is its strong shingles prevention effect. In a Phase III clinical trial (ZOE-50) that was conducted on adults aged over 50 years of age, Shingrix showed a 97.2% efficacy compared to the non-vaccinated group at 3.2 years of follow-up. In another Phase III clinical trial (ZOE-70) conducted on adults aged 70 years and above, Shingrix showed an 89.8% efficacy at 3.7 years of follow-up. This is superior to the 5% protection in adults aged over 50 years of age and 41% in adults aged 70 years and above demonstrated with the use of Zostavax. The prevention rate of SKYZoster is also known to be similar to Zostavax. Also, Shingrix’s safety profile was confirmed through 5 clinical trials that were conducted on immunocompromised patients aged 18 years and older. Based on such evidence, patients who received autologous hematopoietic stem cell transplantation or those with solid cancer, blood cancer, or solid organ transplant patients who have an increased risk of shingles are also eligible to receive vaccination with Shingrix. Shingrix's rapid growth was analyzed to have been driven by its overwhelmingly high preventive effect and the distinction that it is the only inactivated vaccine that can be vaccinated to immunocompromised people. In the early days of Shingrix's release, there were concerns in the market due to its higher price than existing vaccines. The price of Shingrix, which is administered two times in total, is set at around KRW 500,000 to 600,000. This is more than twice as high as the existing vaccine, which costs KRW 150,000 to 200,000. For this reason, the vaccine is more used in general hospitals than in clinics. Vaccination with Shingrix is expected to become more active in front-line hospitals and clinics as the price burden felt by consumers gradually decreases. A GSK official said, "Shingrix showed superior results in clinical trials. Based on this, Shingrix is maintaining a high market share in the markets where live vaccines have already been released, such as the US, Canada, and Belgium. We will continue to make efforts to reduce the disease burden of shingles for healthcare professionals and those at risk by stably settling in the Korean market.”
- Company
- BMS’s oHCM drug Camzyos approved in Korea
- by Jung, Sae-Im May 25, 2023 05:46am
- BMS Korea (Country Manager: Hye Young Lee) announced on the 24th that the Ministry of Food and Drug Safety has approved the company’s obstructive hypertrophic cardiomyopathy (oHCM) treatment ‘Camzyos (mavacamten)’ to treat adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve exercise capacity and symptoms. Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets excess myosin actin cross-bridge formation, which is the main cause of oHCM. Camzyos can improve left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin and relaxing the over-contracted heart muscle. oHCM is a rare disease that occurs when the left ventricular muscle of the heart becomes abnormally thick, obstructing blood flow through the aorta to the rest of the body. Its main symptoms are shortness of breath, dizziness, chest pain, fainting, etc., which appear in various ways and can increase the risk of various cardiovascular complications such as heart failure and atrial fibrillation. It can cause sudden cardiac death during exercise, especially in young adults and children aged 10 to 35 years. There had remained a high unmet need for the treatment oHCM as its treatment focused more on symptom relief than fundamental cure. Treatment options such as beta-blockers and non-dihydropyridine calcium channel blockers can reduce the heart rate and myocardial contractility, but it is difficult to expect long-term improvement with these existing drug treatment options alone. In addition to this, other available options involve surgically removing the enlarged myocardium or injecting alcohol to cause necrosis of the muscle area, but such procedures are performed to a limited extent due to high risk. Sang-Chol Lee, Professor of Cardiology at Samsung Medical Center, said, “oHCM is a serious and rare condition that can even cause sudden cardiac death without warning. We had much difficulty with its treatment as no effective method of treatment had been available for the non-invasive treatment of the enlarged heart structure, which led to patients experiencing worsening symptoms. Camzyos is the first cardiac myosin inhibitor that specifically targets the source of oHCM. The drug, which only needs to be administered orally once a day, showed excellent symptom improvement effect from the beginning of treatment, and is expected to help restore the quality of life for our patients.” The Phase III EXPLORER-HCM trial, which served as the basis for approval, Camzyos demonstrated statistically significant improvements in heart function and exercise capacity compared to placebo. In the trial, the composite primary endpoint was set as the proportion of patients who achieved either an improvement of mixed venous oxygen tension (pVO2) plus maintenance or improvement in NYHA class. Trial results showed twice more patients receiving Camzyos achieved the primary endpoint compared to the placebo. In particular, 20% of the patients that received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement, and the heart function of half of those patients treated with Camzyos had improved to Class I, the mildest stage. The treatment effects of Camzyos remained consistent throughout the study for 30 weeks. Also, the left ventricular outflow tract (LVOT) gradient improved to the extent that 70% of the patients would not consider surgery. The proportion of patients who improved below the LVOT pressure difference of 50mmHg, which is the standard considered for surgery, showed a large difference of more than 50%, with 74% in the Camzyos arm and 21% in the placebo arm. The proportion of patients who improved to less than 30 mmHg, which is even lower, was also 57% in the Camzyos group, which was higher than the 7% in the placebo group. BMS Korea’s Country Manager Hye Young Lee, said “We are pleased to be able to provide a fundamental treatment benefit with Camzyos for Korean patients with oHCM who have been experiencing worsening symptoms, to the extent that patients had difficulty continuing on their daily life and were at risk of sudden death. We hope that the approval of Camzyos will be able to contribute not only to the treatment of domestic oHCM patients but also to restore their normal daily life," he said.
- Company
- Latecomer new CML drug Bosulif attempts reimb in Korea
- by Eo, Yun-Ho May 25, 2023 05:46am
- The latecomer leukemia treatment ‘Bosulif’ is attempting to receive reimbursement in Korea. According to industry sources, Pfizer Korea submitted an application for its Chronic Myelogenous Leukemia (CML) treatment Bosulif (bosutinib), and is receiving a review for its reimbursement. The drug, which was approved in January in Korea, was rather late in entering Korea after it was approved by the U.S. FDA in 2012. Bosulif is a 2nd generation targeted anticancer therapy like Novartis Kroea’s ’ ‘Tasigna (nilotinib),’ BMS Korea’s ‘Sprycel (dasatinib),’ Il-Yang Pharamceutical’s ‘Supect (radotinib)’. With so many drugs already on the market, no major difficulties are expected in Bosulif’s reimbursement process. Bosulif’s safety and efficacy were verified through a Phase III trial (NCT02130557) that was conducted on patients with newly-diagnosed Ph+ CML. The major efficacy outcome measure was the major molecular response (MMR) at 12 months. Results showed that MMR at 12 months was 47% in the Bosulif arm. The MMR in the comparator arm, which administered the 1st generation drug Glivec (imatinib), was 36%. MMR at 60 months was 74% in the Bosulif arm and 66% in the Glivec arm. The median time to MMR in respondents after 60 weeks of follow-up was 9.0 months in the Bosulif arm and 11.9 months in the Glivec arm In the market, next-generation CML-targeted anticancer drugs are already entering the market. Otsuka Pharmaceutical Korea’s Iclusig (ponatinib)’ is a 3rd generation treatment, and Novartis Korea’s Scemblix (asciminib) is available as a 4th generation treatment. Iclusig was listed for reimbursement in Korea in 2018, and Scemblix passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in April and the company is conducting drug pricing negotiations with the National Health Insurance Service.
- 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.
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- 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.”
