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- 2026-03-18 15:06:10
- Company
- Menarini Korea presents Fulcare's digital campaign video
- by Feb 03, 2021 06:09am
- Fulcare’s new digital campaign capture Menarini Korea (CEO Hyeyoung Park) announced on the 2nd that it is releasing a new digital campaign video 'Re, Start Again' of Fulcare, a treatment for nail athlete's foot. The new campaign was planned as part of Fulcare's brand campaign 'Clear Again' from 2020. By emphasizing the keyword 'again' by focusing on 're' at the back of Fulcare's English spelling, it tried to deliver a message of support to consumers to overcome COVOID-19 and start again in the new year. The video for the new digital campaign was produced in two versions, 'Exercise Edition' and 'Hobby Edition'. In the daily life that had been withdrawn from COVID-19 for a while, it contained a message to regain healthy and clear nails with Fulcare's triple solution, along with narration and video to start over with small movements or hobbies. At the end of the video, a message was added to support the Korean pharmacists who are working in the field to take responsibility for the health of the local community despite the difficult situation of COVID-19. The new video was released on various online media including Fulcare's YouTube channel from the 1st. Menarini Korea marketing manager said, "Our daily life has changed over the past year due to the COVID-19 Incident. We will be conducting this campaign with the aim of re-starting the new year of 2021 with Fulcare hopefully. In 2021 we hope that Fulcare's triple solution, which has strengths 1, 2, and 3 for penetration, protection, and growth promotion, for patients in need of treatment for athlete's foot will be able to recover their daily life from athlete's foot and clear nails." Fulcare is OTC that can be purchased at pharmacies. Fulcare's own global patented technology, ONY-TEC technology, has the convenience of applying once a day without the need to grind or wipe the nails, making it easy to manage athlete's foot. It has been strengthening its position as a brand specializing in athlete's foot by launching 'Fulcare Plus Cream', a special treatment for athlete's foot.
- Company
- Profitable lazertinib makes 5-year income for Oscotec
- by An, Kyung-Jin Feb 02, 2021 06:25am
- Product image of Leclaza For last couple of years, Oscotec has generated 57 billion won from licensing out a new drug candidate. The South Korean company earned more than five years of income by selling a profitable new drug candidate to Yuhan Corporation. On Jan. 26, Oscotec announced Yuhan Corporation would pay out USD 22.1 million (approximately 24.8 billion won) out of the license-out milestone payment received from Janssen Biotec. The expected transaction would be processed within three months from the official announcement. The company explained, “The income is from the epidermal growth factor receptor (EGFR) targeted therapy candidate license-out deal signed with Yuhan Corporation in 2015. 40 percent out of the total milestone payment would be paid out to both Oscotec and a subsidiary company Genosco.” The payment Oscotec announced is for Janssen reaching the milestone of administering the combination of the company’s own dual anticancer treatment amivantamab and an EGFR targeted therapy lazertinib licensed in from Yuhan to initiate a Phase III trial. Lazertinib is the main substance of Yuhan’s non-small cell lung cancer (NSCLC) treatment Leclaza approved as the 31st new drug developed in South Korea. Oscotec and its subsidiary Genosco inked 1.5 billion won worth of a license-out deal with Yuhan in July 2015 for the EGFR targeted therapy candidate lazertinib. Within 30 days of the contract signing, the upfront payment of 1 billion won was received, and 500 million won is to be paid out after Yuhan’s Phase I clinical protocol is cleared. In the contract, Yuhan added a term to split the income 60 to 40 for the upfront payment and the clinical milestone payments from the global pharmaceutical company licensing out the candidate medicine. Yuhan took over the development rights on lazertinib in the preclinical trial phase, and licensed out the drug in November 2018, after optimizing the substance, designing the pipeline and undergoing the preclinical and clinical trials in South Korea. The deal is valued at maximum 1.26 billion dollars (approximately 1.5 trillion won) covering the initial contract payment of 50 million dollars and phase-by-phase milestone payments. Yuhan has earned total of 150 million dollars for last two years from licensing out lazertinib. Janssen provided 35 million dollars for achieving the milestone of initiating the global Phase I/II trial with a combination of amivantamab and lazertinib in last April. Also another 6.5 million won was given to Yuhan in last November for starting a global Phase III trial on the combination therapy. During the process, Oscotec also improved its income significantly. Oscotec received the upfront payment of 17 million dollars from Yuhan as the Janssen’s upfront contract payment went through in 2018. And as of the second milestone, additional 34 million dollars were paid out from splitting the income. The lazertinib license-out deal basically generated 51 million dollars (approximately 57 billion won) in last two years for the initial contract and further development. In five years from 2015 through 2019, Oscotec has made 48.9 billion won. The license-out deal signed six years ago generated more than the five-year income in just two years. The industry highly anticipates positive effect in Oscotec’s income structure based on lazertinib progressing smoothly. Janssen is also expediting the global Phase III clinical trial on amivantamab and lazertinib combination as the company confirmed a positive outcome during the initial clinical trial. In last December, the company applied for amivantamab Biologics License Application (BLA) to the U.S. Food and Drug Administration’s (FDA), and it also aims to complete the New Drug Application (NDA) for lazertinib by 2023. Besides Janssen’s progress, Yuhan is also independently conducting a global Phase III trial on lazertinib.
- Company
- COX-2 inhibitors recover and grow 56% in 5 years
- by Kim, Jin-Gu Feb 02, 2021 06:25am
- The prescription volume of cyclooxygenase-2 (COX-2) inhibiting nonsteroidal anti-inflammatory drugs (NSAIDs) seems to be increasing rapidly. A major product Celebrex (celecoxib) had its pricing cut by half after its patent was expired in 2015, but the prescription volume soared by 56 percent in five years until last year. The industry experts say the increased prescription frequency canceled out the decreased pricing. While the original Celebrex is still going dominating the market by annually making 40 billion won, 100 or so generics have doubled the prescription volume in five years and made a 65-billion-won market. However, other follow-on originals like Acelex (polmacoxib) and Arcoxia (etoricoxib) are making disappointing performance with narrow indication. ◆Half-priced COX-2 inhibitor prescription volume soars by 56% On Jan. 28, a pharmaceutical market research firm UBIST reported the COX-2 inhibitor NSAID market reached the volume of 112.9 billion won as of last year. Compared to 113.5 billion won recorded in 2019, the market shrunk by 1 percent, but considering the last six years, the market has been growing at a remarkable rate. The market size marked 72.3 billion won in 2015 grew by 11 percent, 7 percent, 19 percent and 11 percent in 2016 at 80.2 billion won, 2017 at 85.8 billion won, 2018 at 102.2 billion won and 2019 at 113.5 billion won, respectively. Except for 2017, the market has been making a two-digit growth annually until 2019. Considering the star product of the market Celebrex got its pricing halved to 53.55 percent since the patent expiration in June 2015 and a series of generic launched at similar pricing, the prescription volume itself has almost tripled. ◆20 years in South Korean market, Celebrex still generated 40 billion won The market is predominantly filled with celecoxibs. As of last year, the original Celebrex and celecoxib generics took up 36 percent and 57 percent of the market, respectively. In fact, Celebrex’ market presence is still substantial as it made 40.6 billion won last year, regardless of the patent expired five years ago. Although compared to the previous year (44.3 billion won), the prescription volume dropped 8 percent, but the market experts analyze it was due to the drug’s temporary shortage. Celebrex was out of stock for about two months last year due to delayed manufacturing schedule from February. Launched for the South Korean market in 2000, Celebrex prescription volume peaked in 2014 with 70 billion won. But the volume plummeted to 58.8 billion won the following year as the patent expired, and it continued to drop to 40.2 billion won and 36.5 billion won in 2016 and 2017, respectively. Mainly the generics entering the market and pricing cut caused the steep drop in the volume. Since 2018, however, the drug gained back the prescription volume up to 40 billion won. Releasing higher dose, expanding indication and healthcare providers’ high demand for the original seem to have affected the recovery. As the generic pricings were leveled with the off-patent original, the healthcare providers are firmly demanding for the original. ◆Over 100 generics released, the prescription volume doubles in five years Celebrex generic prescription volume was doubled in just five years. As soon as the patent expired in June 2015, 60 companies released their celecoxib generics. And as of late last year, over 100 companies are apparently supplying generics. The total prescription volume of the generics was at 64.9 billion won. Compared to 32.1 billion won in 2016, it is more than twice as much. While the COX-2 inhibitor market volume shrunk by 1 percent last year, the generic prescription was increased by 7 percent. The top selling generics were as follows; Samjin Pharm’s Klicox (4.2 billion won), Hanmi Pharmaceutical’s Coxib (4.2 billion won), Korea Arlico Pharm’s Celcobrex (3.5 billion won), Chong Kun Dang’s Coxbito (3.1 billion won), and Hutecs Korea Pharmaceutical’s Cybrex (2.5 billion won). ◆Original Acelex and Arcoxia generate below 5 billion won each Other original COX-2 inhibitors—Acelex and Arcoxia—are showing rather underwhelming performances. Acelex is a domestically developed new drug by Crystal Genomics. It emerged to the market in August 2015 and Dong-A ST handles the local sales. The two companies have signed a 8.5-billion-won exclusive local sales deal. But from 2018, Daewoong Pharmaceutical joined the force to accelerate the Acelex sales. The company was in charge of small and medium hospitals with 300 and less beds, whereas Dong-A ST marked general hospitals. Acelex’ prescription volume was at 4.2 billion won, 5.8 billion won, 4.9 billion won and 5.5 billion won in 2016 through 2019, respectively. The volume plummeted by 24 percent last year and made only 4.2 billion won. MSD’s Arcoxia is also underperforming. Ever since an older version of COX-2 inhibitor Vioxx was delisted from the market due to adverse reaction reports, MSD ambitiously launched Arcoxia as a follow-up. To avoid concerns on safety, the multinational company also conducted a clinical trial in South Korea as well. But its prescription generated 3.7 billion won, 5.7 billion won, 5.6 billion won, 3.4 billion won and 3.3 billion won in 2016 through 2020. The industry says the two originals’ limited indications are widening the prescription volume gap between Celebrex, and Acelex and Arcoxia. Currently, Acelex and Arcoxia are only indicated to treat osteoarthritis, when Celebrex is indicated to treat rheumatoid arthritis, ankylsoing spondylitis, primary dysmenorrheal and acute pain.
- Company
- MSD Korea reaches collective agreement with union
- by Feb 02, 2021 06:25am
- On Jan. 28, MSD Korea CEO Kevin Peter (right) and Labor Union Head Shim-sang Nam-won (left) sign the first collective agreement with negotiation representatives. MSD Korea (CEO Kevin Peters) announced the company reached a collective agreement with the labor union on Jan. 28 before fully splitting off Organon Korea. This marks the first collective agreement settled since the establishment of MSD Korea Labor Union. And the company noted that it was a mutual collaborative outcome of the management and the union before the split-off takes place. MSD Korea CEO, HR manager, MSD Korea Labor Union head and their negotiation council participated in the collective agreement signing ceremony held at MSD Korea headquarters and inked the final agreement. Under the agreement, both parties settled on 77 terms regarding the employee benefits and the working conditions. The agreed terms would be carried on to the new spin-off subsidiary Organon Korea. Moreover, the two parties confirmed for the last time that they would make mutual collaborative efforts to successfully launch the spin-off company. MSD Korea has decided to pay out incentive of 15 million won to each employees reassigned to Organon Korea to welcome them to the new environment. The labor union also promised to cooperate as much as possible during the corporate restructuring process. MSD Korea CEO Kevin Peters addressed, “I am exhilarated to see that the company and the labor union have come to an agreement after persistently engaging in conversation to make MSD Korea the best place to work and grow. Based on the outcome, MSD Korea would focus on our task at hand making the future changes for the Koreans’ healthy lives.” In last February, MSD announced its plan to spin off a subsidiary Organon. The spin-off company aims to seek global leadership and sustainable growth for the future of women’s health based on the diverse cardiovascular, urologic, respiratory, dermatology and women’s health portfolio. By concentrating on oncology, vaccine, hospital-acquired disease and diabetes, MSD plans to significantly enhance the market presence as the premier research-intensive biopharmaceutical company. Organon Korea is to kick off from this month in South Korea as a subsidiary of MSD until the global split off process is completed, which then the new company would be a full-fledged independent company from the latter half of the year.
- Company
- KRPIA appoints Oh Dong-wook Chairman & new BOD is launched
- by Eo, Yun-Ho Feb 01, 2021 06:16am
- Along with the appointment of a new chairman, there have been significant changes in the KRPIA’s BOD. On the 27th, the KRPIA announced that, after Avi BenShoshan, former CEO of MSD Korea, Oh Dong-wook, CEO of Pfizer Korea, was elected as the 14th chairman and will lead the association from February 2021. The KRPIA plans to newly launch a new board of directors (BOD), such as the Vice Chair and Director. Sang Pyo Kim, CEO of AstraZeneca Korea and Javed Alam, CEO of Merck Korea, were appointed for the Vice Chair, arising from the appointment of President Oh Dong-wook and the appointment of former GSK Korea CEO to the head office by Julien Samson. Kay Bae, CEO of Sanofi-aventis Korea maintains the Vice Chair. Status of the KRPIAFour new CEOs of multinational companies were newly appointed to the board. Alberto Riva, CEO of Lilly Korea, Kim Jinyoung, CEO of BMS Korea, Kevin Peters, CEO of MSD Korea, and Joshi Venugopal, CEO of Novartis Korea, were included in the new board of directors in 2021. The CEOs of Lundbeck Korea and Mundipharma Korea, former members of the BOD, were removed due to the change of CEOs. As a result, the KRPIA has been transformed into a Korean chairman system after 3 years since 2018. However, the number of Koreans decreased from 8 to 7 among a total of 14 directors. There has been a tendency for Koreans to assume the position of president of KRPIA. Former Chairman Avi BenShoshan was a foreign chairman who was elected after 7 years since 2011 after former Pfizer CEO Dong-Soo Lee, former GSK chairman Jin-ho Kim and former CEO Ok Yeon Kim.
- Company
- Daewoong & Roche were selected as Best Companies to Work for
- by Eo, Yun-Ho Feb 01, 2021 06:15am
- Employees of Daewoong, Roche, Baxter, and Medtronic are posing while communicating (clockwise from left)This year, many healthcare companies were listed as one of the top 100 companies to work for. According to related industries, companies such as Daewoong, Roche Diagnosis, Baxter, and Medtronic were selected as the 'Best Companies to Work for in Korea 2020' hosted by the global HR consulting firm GPTW Institute (Great Place to Work Institute). The awards ceremony for Best Companies to Work for in Korea 2020, which is celebrating its 19th anniversary this year, is a system that awards companies that build a good corporate culture for work by practicing trust management. An employee survey is conducted and reviewed on a scale of trust, pride, and fellowship, and then selection is made. The CEO's evaluation is also conducted based on the evaluation of actual employees. ◆Daewoong In the case of Daewoong, it has been highly praised for its excellent environment for employees to immerse themselves in work, high pride and pride, and fair treatment regardless of age or gender. In fact, Daewoong is constantly striving for employee growth with a management policy that employee growth takes precedence over the company's growth. The company is enabling employees to autonomously set their work environment and engage with smart work. By establishing a smart office for the first time in the domestic pharmaceutical industry, employees can freely choose where to work every day, and by introducing a flexible working system, they have used flexible work or partial work according to each individual's circumstances. By strictly following the principle of not asking why when using vacation, it created a work environment where people can take a break when they need to take a break. ◆Roche-diagnostics Roche-diagnostics received high marks for its high reliability management index and employee-centered organizational culture such as education support, career development, and work system. CEO Johnny Tse was selected as the most respected CEO in Korea, and Roche-diagnostics received a lot of great things. In addition, Lee Ji-sook, head of the P&C (People & Culture) department, was selected as the GWP Innovation Leader and won three medals in three categories. The company also won the 'Best Employer in Korea' award by Aon Hewitt three times in a row in 2015, 2016, and 2017. ◆Medtronic Medtronic was awarded the grand prize of 'Best Companies to Work for in Korea 2020' and received the award for the second consecutive year. The company's Asia-Pacific CEO Chris Lee was named “Korea's Most Admired CEO” for the second year in a row, and Medtronic Korea’s Managing Director Sunyoung Lee was named “Great Workplace Innovation Leader” and received a total of three awards. Medtronic Korea aims to provide welfare beyond the needs of its members. In the COVID-19 pandemic, it was focused on putting the safety and health of members first. It operates telecommuting and flexible work, and delivered quarantine packages including hand sanitizers and ultraviolet sterilizers to home to prevent COVID-19. In order to reduce the burden of continuing meal preparation as the work from home is prolonged, points to order food for delivery were provided, providing an environment in which people could concentrate on work comfortably. ◆Baxter Baxter Korea received a high score, especially in the category of pride for the company. The company also scored the highest point in the fairness category, ‘Employees of this company receive fairly regardless of gender.’ For the safety of employees, Baxter has been working from home from immediately after the outbreak of COVID-19 to now, and is implementing various virtual welfare programs to increase work immersion and encourage a happy working environment. It is showing a leading corporate culture by running a flexible work system, flex time (intensive work system), and Family Friday every afternoon on the third Friday of every month.
- Company
- Disappointing result of first 2021 Cancer Committee meeting
- by Eo, Yun-Ho Jan 29, 2021 06:14am
- The National Health Insurance (NHI) reimbursement expansion on the indication targeting ‘all-comer’ and a combined targeted therapy would have to wait for another time. The Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee convened a first meeting of the year yesterday, and they decided the coverage on Takeda Pharmaceuticals’ Zejula (niraparib) is only adequate as a first-line therapy treating BRCA mutation-positive ovarian cancer patients, and dismissed the Cyramza (ramucirumab) and Tarceva (erlotinib)-combined first-line therapy for lung cancer. Technically, the South Korean health authority took a conservative stance on all prescription, except for the marker for poly ADP-ribose polymerase (PPARP) inhibitor, and a combination of two different mechanisms of targeted therapies. Takeda’s Zejula failed to receive HIRA Cancer Deliberation Committee’s nod in last June, and immediately reapplied for the reimbursement expansion in August. The drug wanted to get the NHI benefit as a ‘first-line maintenance monotherapy for the patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first-line platinum-based chemotherapy, regardless of BRCA mutation. But the committee seems to have drawn the line on the indication due to the different level of efficacy depending on the marker and increased eligible patient size. Because Zejula is the first to demonstrate efficacy in ovarian cancer treatment, regardless of the biomarker status, the public had a heightened interest on the drug requesting for extended reimbursement on the first-line maintenance therapy indication. Meanwhile, the health authority appears to have felt the financial burden on the two-drug combination therapy Lilly applied to expand the reimbursement on vascular endothelial growth factor receptor-2 (VEGFR-2) antagonist Cyramza as a first-line therapy to treat patients with non-small lung cancer (NSCLC), in combination with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tarceva. Patients are showing great interest in the combination targeting both VEGFR-2 and EGFR as it showed efficacy in patients with EGFR exon 19 deletion or exon 21 mutation, although it used to demonstrate comparatively weak efficacy before. Originally, Zejula’s reimbursed price was set at 76,400 won per capsule. Compared to the alternative option, Lynparza (olaparib) by AstraZeneca, Takeda’s option was evaluated as more cost-effective. But because Lynparza was listed with a pharmacoeconomic analysis exemption via the risk sharing agreement (RSA), Zejula was also applied with the expenditure cap type RSA. Cyramza was listed for NHI reimbursement in May 2018 as a second-line therapy for stomach cancer with the refund type RSA.
- Company
- KRPIA appoints new Chair Oh Dongwook of Pfizer Korea
- by Eo, Yun-Ho Jan 29, 2021 06:14am
- On Jan. 27, Korean Research-based Pharmaceutical Industry Association (KRPIA) announced Country Manager Oh Dongwook of Pfizer Pharmaceutical Korea is appointed as he 14th Chair of KRPIA leading the organization from February 2021. The new chair was elected as a member of the board in January 2016, and has been contributing in pushing KRPIA forward, as a member of Vice Presidents from February 2018, with his comprehensive insight on healthcare policy and regulation and business environment home and abroad. Chair Oh Dongwook has been evaluated as an outstanding seasoned leader based on his 26 years of diverse and rich experience of being business lead and Asian regional manager in specialty care, vaccine and cardiovascular disease departments at South Korean and global pharmaceutical companies. Since January 2016, Chair Oh Dongwook has been the Pfizer Pharmaceutical Korea country manager. Also in 2014, Oh successfully led the vaccine business in 11 Asian countries including South Korea and Taiwan as a Vaccines Asia Country Cluster Lead. Before joining Pfizer Pharmaceutical Korea, Oh worked at Korean and Asia-Pacific offices at AstraZeneca, MSD and Hanil. Also his job vastly ranged from marketing to sales and R&D. Chair Oh Dongwook noted, “The global pharmaceutical industry is doing its best to overcome the COVID-19 crisis, and the companies would serve their responsibility to let the patients be healthy and happy with their lives by developing and delivering a wide variety of innovative new drugs.” “For the pharmaceutical and bio industry to drive the innovative economic growth in the post-COVID-19 era, the organization would closely engage in communication with the Korean government and companies to create a sustainable and innovative ecosystem,” he added.
- Company
- Going beyond antidiabetic, Forxiga to treat heart failure
- by Jan 28, 2021 05:59am
- AstraZeneca’s Forxiga has been approved in South Korea to treat diabetes and heart failure. The indication is obtained for the first time for a sodium-glucose co-transporter-2 (SGLT2) inhibitor. The industry experts noted, “Forxiga demonstrated reduction of cardiovascular death risk and hospitalization for heart failure in patients with or without diabetes.” In 2014, Forxiga was the first SGLT-2 inhibitor to be released in the South Korean market. Although initially developed as a type-2 diabetes treatment, a series of clinical studies showed a potential in reducing risk of cardiovascular and renal diseases. And in last December, the drug won the indication to lower the risk of heart failure based on additional study results. During a virtual online media conference convened on Jan. 25 by AstraZeneca Korea, experts projected the SGLT-2 inhibitor would bring a new change in the heart failure treatment scene. An online news media conference for Forxiga Mediating the conference, President Choi Dong-ju (Seoul National University Bundang Hospital Department of Internal Medicine) of the Korean Society of Heart Failure (KHFS) evaluated, “A SGLT-2 inhibitor acquiring an indication to treat heart failure holds a great significance. Along with the changes in drug use, the global cardiology association’s guidelines are changing accordingly as well.” In fact, the American College of Cardiology (ACC) has released the 2020 Expert Consensus Decision Pathway recommending cardiologists to choose SGLT-2 inhibitor of glucagon-like peptide 1 receptor agonists (GLP-1RA) over the previously recommended metformin, to treat patients who have been diagnosed with or have a high risk of cardiovascular disease. Also the practical guidance for cardiologist updated after four years recommends administering SGLT-2 inhibitor combination as a standard of care (SOC) for NYHA class II-IV patients who meet the estimated glomerular filtration rate (eGFR) standard and have heart failure with reduced ejection fraction. Professor Choi Seonghoon (Hallym University Medical Center Department of Cardiology) stated, “Particularly, the revised ACC guideline positioned SGLT-2 inhibitor as a second-line therapy for heart failure. Considering various efficacies Forxiga has confirmed, it would be helpful to use the drug as soon as possible for better treatment result.” The Phase III DECLARE-TIMI 58 study, evaluating Forxiga’s cardiovascular safety in type-2 diabetic patients, confirmed the drug reduced the risk of hospitalization for heart failure or cardiovascular death. And DAPA-HF study proved the drug’s effect to treat chronic heart failure patients regardless of type-2 diabetes. Professor Choi Seonghoon elaborated, “The DAPA-HF study presented highly significant data showing Forxiga lowering the risk of worsening heart failure by 30 percent, and the risk of cardiovascular death by 18 percent, especially because the clinical data proved the simple but integral benefit of combining Forxiga on the standard of care.” Another participant at the conference, Professor Kim Eung-ju (Korea University Guro Hospital Cardiovascular Center) positively highlighted Forxiga can provide double benefit as it was effective in renal disease, most frequently expressed in patients with heart failure. Professor Kim said, “In the DECLARE-TIMI 58 study, Forxiga lowered the eGFR by minimum 40 percent, compared to placebo, and the risk of renal disease death by 59 percent. Considering cardiovascular and renal diseases are closely related, SGLT-2 inhibitor could deliver a dual effect in heart and kidney.” Led by Forxiga, the SGLT-2 inhibitor prescription volume is expected to surge even higher as it expands indication. According to UBIST, the SGLT-2 inhibitor market generated 121.4 billion won last year. Compared to 12.2 billion won made in 2015, the prescription volume skyrocketed by 895 percent in just five years. Out of the total prescription volume, AstraZeneca’s Forxiga combination drug with metformin Xigduo takes up the biggest pie with 64.8 billion won.
- Company
- Leclaza’s lightning fast listing shocks global competitors
- by Eo, Yun-Ho Jan 27, 2021 06:15am
- As Yuhan Corporation dashes for the National Health Insurance (NHI) reimbursement talk on Leclaza (lazertinib), affected multinational pharmaceutical companies are tensing up. A Korean-made new drug Leclaza is to get reviewed by the Cancer Deliberation Committee in February, the related industry sees that the non-small cell lung cancer (NSCLC) treatment area would face a dynamic change sooner than expected. Especially, the targeted therapies waiting for reimbursement listing or expansion are closely following the progress of Yuhan’s third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Leclaza. ◆ Cyramza combined with a first-generation TKI: The industry projects two drugs would be impacted the most by the Korean-made drug. Lilly’s Cyramza (ramucirumab), one of the two drugs, is currently seeking for reimbursement expansion for a combination therapy with a first-generation EGFR TKI Tarceva (erlotinib). The Cancer Deliberation Committee is to be convened for the first time this year today Cyramza-Tarceva combination therapy Leclaza was first indicated as a second-line therapy for lung cancer treatment, which differs from the first-line therapy indication Cyramza combination therapy is targeting. However, Leclaza is also planning to acquire the first-line therapy indication, and its market influence would grow fast in Korea, considering the speed of approval and listing procedure it showed and its title of a Korean-made new drug. Meanwhile, patients are showing great interest in the combination of vascular endothelial growth factor receptor-2 (VEGFR-2) antagonist Cyramza, EGFR TKI Tarceva and two targeted therapies as it showed efficacy in patients with EGFR exon 19 deletion or exon 21 mutation, although it used to demonstrate comparatively weak efficacy before. ◆Same generation same class Tagrisso: Technically, AstraZeneca’s Tagrisso (osimertinib) would be the biggest competitor to Leclaza. Approved for the South Korean market in May 2016, Tagrisso is also categorized a third-generation EGFR TKI, same as Leclaza, and in December 2017 it received the NHI reimbursement for the second-line therapy indication Leclaza is applying for. Tagrisso, also adding a first-line therapy in December 2018, attempted to expand the reimbursement in 2019, but the Cancer Deliberation Committee in October that year deferred the decision until the Phase III FLAURA trial outcome is published to confirm the overall survival as a first-line therapy. However, the committee refused to approve the drug again noting the issue of the hazard ratio in the Asian subset analysis submitted along with the final findings of FLAURA. AstraZeneca is hoping to convince the committee with the FLAURA China study conducted with Chinese participants, but the review schedule has not been set. If Leclaza is to enter the market right now, Tagrisso would have to compete against it in the same class. With a record-breaking speed of NHI reimbursement progress, Leclaza may shake up the South Korean targeted therapy market for lung cancer. Currently, first-generation AstraZeneca’s Iressa (gefitinib) and Roche’s Tarceva, second-generation Giotrif (afatinib) and Vizimpro (dakomitinib), and a third-generation AstraZeneca’s Tagrisso are prescribed to patients as EGFR TKI.
