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- 2025-12-24 21:46:20
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- NSCLC drug Rybrevant can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 15, 2022 05:55am
- Janssen’s new lung cancer drug Rybrevant can now be prescribed at general hospitals in Korea. According to industry sources, the anticancer drug Rybrevant (amivantamab), which is used to treat EGFR exon 20 insertion non-small-cell lung cancer (NSCLC) that is insensitive to currently available EGFR tyrosine kinase inhibitors (TKIs), has passed the review of drug committees tertiary hospitals in Korea including the Seoul Asan Medical Center, and Sinchon Severance Hospital, as well as other institutions nationwide, such as Konyang University Hospital, Kyungpook National University Hospital, Seoul National University Bundang Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital. However, Rybrevant’s still non-reimbursed in Korea. Janssen Korea applied for reimbursement but was unable to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. The company is known to be preparing to reapply for reimbursement. EGFR exon 20 insertion mutation in NSCLC is so rare that it is found in only 2% of all NSCLC patients harboring EGFR mutations in Korea. With no suitable treatment available for the specific condition, even the NCCN guidelines have only been recommending platinum-based chemotherapy for the patients. And even this is subject to expenditure cuts. Although lung cancer in itself is not rare, NSCLC with EGFR exon 20 insertion mutation can be classified as a rare condition. Unlike other common EGFR mutations, NSCLC patients with EGFR exon 20 insertion mutations have a 75% higher risk of death, a 5-year survival rate of 8%, and a life expectancy of less than 2 years. Rybrevant, which is well known for its use in combination with ‘lasertinib (Leclaza),’ was the first targeted therapy approved in Korea for the treatment of NSCLC with EGFR exon 20 insertion mutations in February this year. The approval for the drug was based on the results from the CHRYSALIS study, where the drug demonstrated an overall response rate (ORR) of 40% and a 4% complete response (CR), 36% partial response (PR) rate in with Rybrevant use as monotherapy. The US Food and Drug Administration (FDA) granted accelerated approval based on Phase I trial results in recognition of its value as a treatment for a rare type of cancer. Following approval in the US, the drug also was designated for expedited review and approved in Korea as well. However, the issue lies in whether its value will be accepted during reimbursement review. As the drug was approved based on data from a single-arm clinical trial without a control group, Rybrevant needs to take the pharmacoeconomic evaluation exemption track for reimbursement. Therefore, the key is whether Rybrevant’s value as a treatment for rare cancer, not just lung cancer, will be acknowledged during the reimbursement review. Byoung-Chul Cho, Chief of the Lung Cancer Center at Yonsei Cancer Center, said “EGFR exon 20 insertion presents in various subtypes, and the sub-analysis of the CHRYSALIS study showed that Rybrevant showed an even response rate across rate in several subtypes. In addition to its target inhibition effect, Rybrevant shows more promise due to its immune cell-directing activity.”
- Company
- JW Pharm sells ₩10 bil with Actemra in 1H 2022
- by Chon, Seung-Hyun Sep 15, 2022 05:55am
- Actemra, JW Pharmaceutical’s rheumatoid arthritis treatment, rose and settled as the company’s flagship product, exceeding KRW 10 billion in sales in 1H this year. The product's increase in sales was fueled by the increase in its prescription as a rheumatoid arthritis treatment and its increased use as a COVID-19 treatment. According to the market research institution IQVIA on the 14th, Actemra recorded KRW 11.4 billion in sales 1H this year, a 39.7% YoY increase from the same period last year. The drug had raised KRW 6.2 billion in Q1 this year, which was a 59.9% YoY increase from the previous quarter, and then raised KRW 5.2 billion in Q2, marking a 21.2% increase. Although its growth slowed down in Q2 compared to Q1, the product still continued on its high growth. Quarterly sales of Actemra (Unit: KRW 1 million, Source: IQVIA) Actemra was approved in Korea in 2012 as a treatment for rheumatoid arthritis and other autoimmune diseases. The drug inhibits the binding of ‘Interleukin-6,’ the protein that causes inflammation in the body, and its receptor, in the body. JW Pharmaceutical introduced this new biologic drug after entering into a license agreement with Chugai Pharmaceutical, a subsidiary of Roche, for the co-development and exclusive marketing right of Actemra in Korea. The new drug candidate was developed by Chugai Pharmaceutical, based on which JW Pharmaceutical conducted clinical trials at major large hospitals in Korea including the Seoul National University Hospital, and received domestic approval. It is indicated for the treatment of adult patients with rheumatoid arthritis and children with juvenile idiopathic arthritis. Actemra did not exert much presence in the early stages of its release. The drug exceeded KRW 10 billion in annual sales for the first time in 2018. Actemra’s sales rose steeply since last year. After recording KRW 3.8 billion in sales in Q4 2020, it broke its own sales record for 5 consecutive quarters until Q1 this year. It is evaluated that the reliability of Actemra in the field has risen with its accumulated prescription experience in rheumatoid arthritis. Actemra has also attracted further attention as it had shown excellent therapeutic effects in patients who do not respond to TNF-alpha inhibitors like Humira, Seretide, and Enbrel. Recently, its sales growth has increased further with its rising demand for COVID-19 treatment purposes. Since last year, Actemra has been used off-label in more than 60 hospitals nationwide for the treatment of severely ill patients with COVID-19. Off-label use refers to the use of existing drugs on the market for purposes other than what it was approved to treat after receiving approval from each institution’s institutional review board (IRB). Demand for Actemra increased significantly in the domestic field after the U.S. Food and Drug Administration (FDA) and the European Commission (EC) authorized emergency use of Actemra as a treatment for severely ill patients in need of artificial respiration due to COVID-19 infection in June and December last year, respectively. The demand for Actemra, therefore, had surged last year to cause a shortage in its supply one time. Actemra’s scope of reimbursement was extended to COVID-19 treatment in March this year. The Ministry of Food and Drug Safety granted emergency approval for Actemra in March for use in severely ill COVID-19 patients over the age of 2. Actemra's high growth has led to improved company performance. JW Pharmaceutical’s operating profit rose 173.7% YoY to record KRW 10.3 billion in Q2, and sales rose 12.4% to record KRW 163 billion.
- Company
- The NHIS signed a MOU with Viatris to manage chronic dz
- by Eo, Yun-Ho Sep 15, 2022 05:55am
- Viatris is working with the NHIS to improve the chronic disease management environment. The NIHS and Viatris signed a MOU at the headquarters of the Wonju Industrial Complex in Gangwon-do on the 1st to utilize educational materials for patients with chronic medical care. Through this business agreement, the two institutions said they will contribute to efficient disease management by diversifying the contents to be used for patient education and counseling in the pilot project for chronic disease management in primary care. Viatris will establish mutual cooperation to improve the quality of patient education materials by providing chronic disease education contents for public interest purposes and proposing the use and improvement of educational contents provided by Viatris. The primary medical chronic disease management pilot project is a project to provide continuous health care services by conducting a comprehensive evaluation of hypertension and diabetes patients at local clinics and establishing individual management plans from January 2019. Viatris, which signed an agreement with the corporation, is a Korean subsidiary of Viatris, a global healthcare company launched in November 2020 by Upjohn, which was Pfizer's business division, combined with Mylan. Park Ji-young, head of NHIS' chronic disease management office, explained, "We expect that doctors and patients' educational satisfaction will increase by utilizing high-quality educational materials provided by Viatris in clinics participating in the project." Kwon Yong-cheol, executive director of the Viatris Department of Medicine, said, "We are happy to contribute to the primary medical chronic disease management project. Viatris will continue to strive to fulfill its social responsibilities as a global healthcare company to improve treatment access and provide information for patients and medical staff based on experience accumulated in chronic diseases such as high blood pressure, diabetes, and dyslipidemia, he said.
- Company
- Complicated patent extension period than foreign countries
- by Kim, Jin-Gu Sep 14, 2022 05:50am
- The current system is advantageous for multinational companies, and many domestic companies welcome reorganization. The system for extending the duration of drug patents is expected to be reorganized. The Korean Intellectual Property Office established a related TF and prepared an improvement plan, and recently inquired about opinions in the pharmaceutical bio industry. The direction of improvement of the system, which has sharp interests between the original and generic companies, is largely in international harmony with the United States and Europe. ◆Xeljanz patent period, 27 years in Korea, 25 years in the U.S. and Europe...From institutional differences The Korean Intellectual Property Office has come up with a total of four improvement plans, and as one of them, it is known that it is considering allowing it to extend only one of the several patents registered in one drug, such as the U.S. and Europe. According to the pharmaceutical bio industry on the 14th, Pfizer's rheumatoid arthritis treatment Xeljanz has a patent duration of 25 years in the United States. This is the result of an extension of five years, which was delayed by clinical trials or permission and examination by regulatory agencies, for 20 years of the typical patent period. In the case of Europe, a 25-year patent period is guaranteed. Xeljanz has a patent duration of 27 years in Korea. This is because the basic patent period is 20 years, but the extended patent duration is different. The reason why the extended patent duration of the U.S., Europe, and Korea is different despite the same drug and the same patent is due to differences in institutions between countries. The original company registers as many patents as possible when it develops a single drug. About 10 patents are also attached to one drug, including material patents, usage patents, usage and capacity patents, formulation patents, and crystalline patents. This is because the more patents there are, the more advantageous it is to defend the challenges of generic companies. In the United States and Europe, only one of the several patents registered in one drug item is selected and extended. In fact, Pfizer applied for an extension of the duration (up to five years) for two material patents and one legal patent in Korea, respectively. In the process of recognizing the extension of the duration of the three patents, overlapping occurred between each period. As a result, the patent period for Xeljanz in Korea was set to be about two years (732 days) longer than that of the United States and Europe. ◆Each of several patents can be extended…Original company patent period is 1~2 years longer Each company is very active in extending the duration of patent rights in Korea because the longer the patent period is, the more advantageous it is to the original company. A total of 24 new drugs were newly licensed in Korea last year. As in the case of Xeljanz, two to three patents were registered per item, and the entire patent period was extended by applying for an extension of the duration of each patent. The problem is that while registration is easy in the case of the duration of the drug patent, it is very difficult to overcome the generic. According to the Korean Intellectual Property Office, from 1999 to last year, when the patent extension system was implemented, the number of applications for the extension of the patent period by original companies totaled 750. Among them, a total of 612 cases were registered, 65 were rejected, and 22 were returned or withdrawn. The remaining 48 cases are under review as of the end of last year. It means that if the original company applies for the extension of the patent period, 9 out of 10 cases will succeed. The results of generic to the extended patent duration are pessimistic. There have been challenges over the duration of patents extended from 2015 to last year, but they have not been completely overcome once. ◆ Domestic pharmaceutical company 'yes' vs multinational pharmaceutical company 'no'…Delivering Opinions to the Korean Intellectual Property Office Multinational pharmaceutical companies are opposed to the reorganization plan, given that the current system is favorable to the original company. In fact, it is known that the KRPIA conveyed its opposition to the Korean Intellectual Property Office. A local pharmaceutical company official said, is "patent an extended duration that it is impossible to overcome the Patent and Trademark Office in the direction is welcome and reform the system." and "A release of significant impact on NHS finances in the process of the delay." Another pharmaceutical industry official said, "The current patent extension system is quite similar to Japan's system." "As the global pharmaceutical bio-industry environment has changed, it seems meaningful to reorganize Korea's system in the U.S. and European ways," he said.
- Company
- Novartis Korea to close down Respiratory BU next month
- by Sep 14, 2022 05:50am
- Novartis Korea is expected to close down its Respiratory Business Unit and dispose of related products from October this year. According to industry sources on the 14th, Novartis Korea’s Respiratory Business Unit will be officially closed down next month as part of the company’s large-scale reorganization in progress at the global level. Currently, Novartis Korea is operated in two business units - Pharmaceuticals BU and Oncology BU. The Pharmaceuticals BU consists of Cardiovascular & Metabolic Diseases; Autoimmunity, Transplantation & Inflammatory Diseases; Skin Diseases. The global reorganization is being made to first integrate the Pharmaceuticals and Oncology Business Units and then divide them into an Innovative Medicines (IM) Division and an off-patent drug division. Specifically, as of October this year, Novartis Korea will be reorganized into 5 Business Units, ▲Hematology, ▲Solid Tumor, ▲CV & GTX, ▲Immunology, and ▲ In-Market & Business Innovation. The unit that had been in charge of respiratory diseases has been removed in the process. Novartis’s respiratory pipeline consists of ‘Enerzair (indacaterol/glycopyrronium/mometasone),’ a three-drug combination drug for asthma, and ‘Atectura (indacaterol acetate/mometasone),’ a once-daily fixed-dose combination drug. Both drugs are fairly new in the market, being approved in December 2020 and granted reimbursement in September last year. However, sales of the two drugs have been low, making around KRW 800 million in 1H this year. The company is speculated to have made this decision after judging that the growth potential of its respiratory treatments is low. Xolair, Novartis Korea’s highest-grossing asthma treatment, was allocated to the Immunology BU due to its mechanism of action and excluded from the restructuring process. When a dedicated unit is shut down, products in its care may be transferred outside. However, due to the small sales volume of the relevant products, their effect on the company's aggregate sales is expected to be negligible even with such a transfer. Employees in the Respiratory BU will also be reassigned. According to a Novartis Korea employee, the Respiratory Unit has around 10 people, including those in charge of marketing and sales. With the shutdown of the Respiratory BU, about 30% of them are known to have applied for voluntary retirement (ERP) that is being offered by the company. Novartis Korea said, “We are in the process of reorganizing our business units to focus on our core therapeutic areas in line with the strategic direction taken by our headquarters. Employees in our Respiratory BU that apply for voluntary retirement will go through relevant procedures, and those who do not will be reassigned to other departments according to their wishes and business needs.”
- Company
- Tylenol-focused sales for COVID-19-related use dispersed
- by Kim, Jin-Gu Sep 14, 2022 05:50am
- The stock shortage of major over-the-counter drugs used to relieve symptoms of COVID-19, such as general cold medicines and antipyretic analgesics, has been prolonged due to the resurgence of COVID-19. In this prolonged shortage, the demand that had been concentrated on Tylenol is being dispersed to other drugs. Tylenol was the only major household medicine for COVID-19 to see reduced sales in 1H this year. The other major household medicines for COVID-19 have all enjoyed an increase in sales. In particular, sales of Panpyrin, Coldaewon, Brufen, Champ, etc. have shown marked growth. ◆1H sales of Tylenol series record KRW 38.5 billion…drop 15% in one year According to the market research institution IQVIA on the 9th, the combined sales of the Tylenol series in 1H this year were KRW 38.5 billion. This is a 15% drop from the KRW 45.1 billion it had made in 1H last year. In its product line, sales of Tylenol tab fell 16% from KRW 33.6 billion to KRW 28.1 billion, and Tylenol 8 Hour ER by 33% from KRW 10 billion to 6.7 billion. Sales of Women’s Tylenol had also fallen slightly from KRW 500 million to 400 million. However, sales of Tylenol Cold S had increased by over 3 times from KRW 1 billion to 3.3 billion. Sales of Tylenol had steadily increased since the outbreak of the COVID-19 crisis. Its sales, which had been in the KRW 15.5 billion range in 1H 2020, rose to KRW 20.3 billion in 2020, then to KRW 45.1 billion in 2021, a near threefold increase in two years. With the COVID-19 vaccinations that started in earnest in 1H last year, the number of people who wished to stock up on Tylenol to alleviate side effects of vaccinations such as fever and muscle pain had surged, resulting in an extreme shortage of the product. However, its growth seems to have slowed this year. This slower sales growth is attributed to the unstable supply of Tylenol and the consumers’ stronger tendency to purchase other medicines containing the same ingredient this year. ◆Sales of Coldaewon·Brufen rise threefold in one year …due to surge in demand and expanded production line Other major general cold medicine and antipyretic analgesic brands other than the Tylenol series enjoyed a rise in sales. In particular, Panpyrin, Coldaewon, Brufen, and Champ had shown marked growth. In the case of Dong-A Pharmaceutical’s general cold medicine Panpyrin series, its sales, which had been KRW 13.4 billion in 1H last year, had increased 62% to KRW 21.8 billion in one year. Sales of Dong-A’s antipyretic analgesic Champ had also increased 168% from KRW 1.5 billion to KRW 4.1 billion in the same period. Daewon Pharmaceutical’s general cold medicine Coldaewon series had made 3.3 times more sales from KRW 2.6 billion in 1H last year to KRW 8.6 billion this year. Sales of Samil Pharmaceutical’s Brufen rose nearly 3 times in a year from KRW 1.2 billion in 1H last year to KRW 3.7 billion this year. Such a rise in sales is interpreted to be the result of those pharmaceutical companies’ active engagement in expanding their production performance in preparation for the increase in demand. Dong-A Pharmaceutical, Daewon Pharmaceutical, and Samil Pharmaceutical, among other companies, had actively increased their production capacity by expanding production facilities and increasing factory production utilization rates in response to the surge in demand for cold medicines and antipyretic analgesics in the aftermath of the resurgence of COVID-19 in February this year. Samil Pharmaceutical greatly expanded its ibuprofen production line this year. The production capacity of its ibuprofen syrup increased 2.5 times from 50,000 liters in 1H last year to 170,000 liters in 1H this year, and the production capacity of Brufen tab increased around 1.5 times from 15.37 million to 22.5 million during the same period. Dong-A Pharmaceutical’s utilization rate of the Panpyrin production line had also increased from 78% to 126% in 1H this year, and Daewon Pharmaceutical had also focused on the manufacture of COVID-19-related medicines including Coldaewon. ◆Sales of Korean Drug’s 'Haben'·Chong Kun Dang 'Modcol' rise over fivefold In addition, sales of Korean Drug’s 'Haben' and Chong Kun Dang’s 'Modcol' had also risen over fivefold in one year, benefiting from the shortage of major household medicines for COVID-19. Celltrion Pharm’s general cold medicine Whituben, Sama Pharm’s antipyretic analgesics Cetophen, and Hanmi Pharmaceutical’s Maxibupen had also increased by over twofold in one year. Ahngook Pharm’s Anyfen, GSK Consumer Healthcare’s Theraflu, Kolon Pharma’s Tramol, KyungDong Pharm’s Gnal-N, Bukwang Pharm’s Tacenol, GC Cross’s Taxen, Daewoong Pharmaceutical’s eZn has also increased by over 50%. Samjin Pharmaceutical’s Geworin saw a relatively small increase in sales. Geworin’s sales, which stood at KRW 7.2 billion last year, increased only 5% to record KRW 7.6 billion in 1H this year.
- Company
- Novartis' application for voluntary retirement is closed
- by Sep 14, 2022 05:50am
- The application for ERP, which is underway by Novartis Korea, has ended. Attention is focusing on whether the relatively quiet voluntary retirement will be completed without any problems. According to the pharmaceutical industry on the 8th, the application for voluntary retirement, which was conducted by Novartis Korea for about two weeks, has recently been closed. The company announced the implementation of voluntary retirement on the 25th of last month. Novartis Korea is in the process of integrating and dividing its business units at the same time. The plan is to combine the Rx division and the anti-cancer drug division to unite innovative drugs into one and form a new division that collects patented drugs. New drugs such as Kymriah and Zolgensma are bound to be innovative drugs, and old drugs such as relatively low-cost chronic disease drugs are expected to be classified as patent expired drugs. ERP was also carried out in the process of integrating and dividing business units. The compensation condition is '2n+8' and additional compensation is given for each year. This means that an average salary of eight months is paid twice the number of years of service, and an additional six months' worth of employees for 10 to 15 years of service and 12 months' worth of employees for more than 15 years. It is reported that voluntary retirement is taking place in a relatively quiet atmosphere. It went through a meeting with the labor union before the announcement of his voluntary retirement, and it was found that it was not a coercive atmosphere because it did not specify the target. However, the key is how the company will respond if the applicant falls short of the desired retirement size the company thinks. The higher the number of years of service, the higher the desired retirement compensation. Last year, there was also a backlash against proceeding with voluntary retirement despite no management difficulties due to high profits. The NPU, which includes Novartis Korea, said at a meeting of National Assembly aides on the 7th, "Novartis is the world's most profitable pharmaceutical company last year, and this restructuring is also due to the unification of its business unit, not management reasons." The NPU said, "Novatis Korea also announced its voluntary retirement with a very passive attitude that it has no management difficulties, but has no choice but to follow global decisions." In the process, there is a concern about the risk of forced voluntary retirement, such as encouraging retirement, the NPU said. The union said, "There were some applicants for voluntary retirement, and the exact number of people is being determined. However, it remains to be seen how much the company thinks of voluntary retirement and whether it will make artificial adjustments beyond the legal part if they do not reach that level, he said. In response, the union said, "We have completed the application for voluntary retirement smoothly, and all procedures are conducted transparently and fairly in accordance with the law. The union said, "We will respect the will of our employees as much as possible and will not exercise compulsory pressure such as urging them to retire."
- Company
- Hanmi’s Rolontis receives US FDA marketing approval
- by Kim, Jin-Gu Sep 13, 2022 05:52am
- Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis (US product name: Rolvedon)' received approval from the US FDA. Hanmi Pharmaceutical and its partner Spectrum Pharmaceuticals announced on the 9th (local time) that it had received written notice of approval allowing for the marketing authorization of Rolontis from the FDA. This is the first new drug developed by Hanmi Pharmaceutical to be granted marketing authorization by the FDA. In terms of achievements made by the domestic biopharmaceutical industry, Hanmi Pharmaceutical’s approval this time marks the 6th new homegrown drug MA granted by the FDA and is the first among new anticancer drugs Hanmi Pharmaceutical and Spectrum Pharmaceuticals explained that they are ready to launch Rolontis in the US market. The companies expect to have the product available within the year based on the nationwide sales and marketing network they have established in the US. Se-Chang Kwon, President & CEO of Hanmi Pharmaceutical, said, “The approval holds significance as it is Hanmi’s first new drug to be granted approval and the first demonstration of the potential held by the company’s proprietary platform technology, LAPSCOVERY, The approval will be a decisive opportunity for the commercial success of Rolontis and the rise in the future value of new biologics based on LAPSCOVERY.
- Company
- Unilateral voluntary retirement
- by Sep 08, 2022 05:59am
- The GSK labor union of Korea has taken legal action, insisting on the management's unilateral voluntary retirement. The company is not taking any action, but the inside is "like the calm before the storm" as legal battles are predicted. Novartis Korea, where voluntary retirement is being carried out relatively quietly, is also nervous until the end. According to the pharmaceutical industry on the 8th, NPU's GSK branch recently filed an application with the Seoul Western Office of the Ministry of Employment and Labor and the Seoul Regional Labor Committee to file a petition for violation of the collective agreement and relieve unfair labor practices. It is claimed that the management violated the collective agreement and unilaterally proceeded with voluntary retirement. The union said, "According to Article 21 of the Korea Unification Association, in principle, it is necessary to agree with the union when the reduction is carried out due to unavoidable management circumstances. However, without any prior discussion, the management notified the union 30 minutes before the decision to reduce the number of employees and abruptly announced the voluntary retirement." Since then, they have pushed ahead with one-on-one meetings with employees, and they are putting psychological pressure on early applicants within a week by applying additional payment conditions. A union official added, "The decision is to make a legal judgment on HR's unfair labor practices and violations." It is reported that the management has not taken any action since the deadline for applications for voluntary retirement at the end of last month. Although the applicant did not meet the company's standards, there was no pressure or encouragement to meet the number of people. It is reported that there is no special response to the legal lawsuit filed by the union. Novartis Korea is better than this situation, a day before the deadline for voluntary retirement. Unlike GSK Korea, it has been consulted with the union and is found not to be coercive. Novartis Korea, the applicant union official said, " voluntary retirement and to understand the accurate number of people are. But the company's voluntary retirement is to think, how much remains to be part of what to do " said it would not.
- Company
- Sales of immuno-cancer drugs exceeded 200 billion won
- by Sep 08, 2022 05:58am
- In the first half of this year, the domestic immune anticancer drug market surpassed 200 billion won. In particular, Opdivo's performance, which showed his endurance, was remarkable. Opdivo sales increased 41% from the previous year, surpassing 50 billion won in half-year sales. According to IQVIA, a pharmaceutical market research firm, the size of the domestic immuno-cancer drug market in the first half of this year was 215.8 billion won, up 17.2% from 184.1 billion won a year earlier. The drug leading this market is MSD's Keytruda, which has the most indications. Keytruda posted 94.4 billion won in sales in the first half of this year, up 1.2% from the previous year. Sales seemed to be decreasing from the same period last year due to drug price cuts in the first quarter, but it turned upward again as benefits expanded in the second quarter, including primary treatment for non-small cell lung cancer. Currently, there are 15 cancers that can use Keytruda, including 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, ovarian cancer, pancreatic cancer, biliary cancer, colorectal cancer, and triple negative breast cancer. ◆Opdivo, which shows its endurance, surpasses 50 billion won in semi-annual prescriptions What stands out is Opdivo's rise. Opdivo sales in the first half of the year were 51.3 billion won, up 40.5% from 36.5 billion won a year earlier. The gap with Keytruda, which nearly tripled, has less than doubled. The market share of immuno-cancer drugs has also changed due to higher growth than Keytruda. Unlike last year, when Keytruda monopolized half of the total market, its share of Opdivo rose to 24% this year, reducing its share of Keytruda to 44%. Opdivo, developed by Ono and BMS, is an immuno-cancer drug licensed in Korea at the same time as Keytruda in 2015. It recorded sales similar to Keytruda until 2017, but the gap widened since 2018. This is because it has been relatively slow to expand indications and benefits compared to Keytruda, which aggressively increased indications. For this reason, Opdivo sales seemed to slow down between 2019 and 2020, but began to rise again from the end of last year. Opdivo, which stayed at 10 billion won for seven consecutive quarters from the fourth quarter of 2019, surpassed 20 billion won for the first time in the third quarter of last year. In the first and second quarters of this year, it settled in the mid-20 billion range with 25.1 billion won and 26.2 billion won, respectively. Opivo is expected to continue its upward trend as stomach cancer benefits are expected for the first time in an immuno-cancer drug. In June, the HIRA set Opdivo's standard for first-line gastric cancer treatment. Opdivo succeeded in re-challenging in about four months after suffering once in February. When the expansion process is completed, patients with HER2-negative stomach cancer will be able to use new drugs at low prices. HER2 negative gastric cancer patients account for nearly 90% of all patients, and there are no drugs other than Opdivo in the first treatment, so if it is expanded, it is expected to have a significant impact on sales. Yervoy, considered Opdivo's partner, also saw sales increase. Yervoy, which was only 1.3 billion won in the first half of last year, jumped to 6.1 billion won this year. Yervoy, the first immuno-cancer drug in Korea in the CTLA-4 family, is not well selected alone due to its limited effect and relatively high side effects. Instead, there is a combination therapy with Opdivo. Earlier this year, a combination therapy with Opdivo added a metastatic direct bowel cancer indication. ◆↑ 23% of Tecentriq & growth of Impinzi Roche Tecentriq and AstraZeneca Impinzi, generics of immuno-cancer drugs, are also steadily increasing their sales. It is Tecentriq which is showing greater performance. Tecentriq increased 22.6% year-on-year to 37.6 billion won in the first half of the year. During the same period, Impinzi increased 19.1% from 22.2 billion won to 26.4 billion won. Tecentriq succeeded in paying liver cancer for the first time among immuno-cancer drugs in April. The combination of Tecentriq and the targeted anticancer drug Avastin has become a standard treatment for liver cancer with excellent data beyond existing drugs. Analysts say that Tecentriq will gain momentum in expanding sales as it is prescribed for liver cancer in earnest. Impinzi is growing at a relatively slow pace this year with no special news. After surpassing 10 billion won for the first time in the first quarter of last year, quarterly sales remained in the early 10 billion range. Impinzi continues clinical trials in biliary tract cancer and liver cancer to expand further indications. Merck's Bavencio posted only 100 million won in sales in the first half of the year.
