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- 2026-05-16 04:04:18
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- Tae-han Kim, CEO of BioLogics will be reappointed
- by Lee, Seok-Jun Jan 31, 2020 06:36am
- Samsungbioepis will operate the system of two vice presidents, and Tae-han Kim, CEO of SamsungbioLogics has confirmed that it is four consecutive years. The two companies made such key positions on January 30. The figures reflect results from last year's performance. Sang-Jin Park, Vice President of SamsungbioepisSeven people were promoted. Another vice president was appointed. Sang-jin Park, 50-year-old general manager, was promoted to vice president. Park is a physician and joined Samsungbioepis in July 2018 after serving as head of the German GSK and representative of AstraZeneca Korea. As a result, Samsungbioepis has two vice presidents. Until Sang-jin Park was appointed, Chang-hoon Choi(60) was Vice President . In addition to Sang-jin Park, Samsungbioepis has appointed Kyung-A Kim, QE (Quality Evaluation) Team Manager, and Young-Pil Lee. PD (Process Development) Team. Hyung-ki Park, CMC Group Head of RA (Regulatory Affairs), Won-young Yoo, Cell Line 1 Group Head of Development Division , Soyoung Lee, Head of SCM Team of Production Division, and Jinhan Jung ,Head of Production Management Group of were promoted. The promotions reflected achievements. Samsungbioepis expects its first profit in eight years. Samsungbioepis posted operating loss of ₩102.7 billion in 2017. The market revenue is expected to reach ₩1 trillion. Samsungbioepis entrusts global distribution to partner companies, and only a certain proportion of ₩ 1 trillion will be captured. Samsungbioepis had sales of ₩368.7 billion in 2018 and last year exceeded it in the third quarter. Tae-han Kim, CEO of Samsung BioLogics Kim Tae-han, CEO of Samsung Biologics, 63 years old, has virtually confirmed his term. If there is no change in the position of the representative on promotion on January 30, he will be reappointed on March 23. Samsung Biologics announced the promotion on the 30th, including promotion to the executive director of C & C Center, Ho-yeol Yoon. Four executives including Eun-young Yang, head of CDO project team, Se-kang Park, DS2 culture part process manager, Yong-hwan Jin, DS2 MSAT team leader, and Ki-jung Kim, executive director of global customer support team, were appointed as executive directors. There was no change in the position of representative in this performance assessment. Tae-han Kim , CEO of Samsung Biologics, is expected to be re-elected at the general shareholders' meeting on March 23. If he is re-elected, it is his fourth term. In general, Samsung affiliates' promotions are conducted after the presidents' appointments. Resignation of Kim's position as a CEO was a concern. Mr. Kim is the oldest and longest CEO of Samsung Group's listed subsidiaries, and he is at the center of controversy over the issue of fraudulent accounting. Samsung BioLogics posted ₩701.6 billion in sales last year. This is a 30.9% increase from the previous year (₩535.8 billion). Operating profit came in at ₩917.7 billion, up 64.8% from the previous year (₩55.7 billion).
- Company
- Resumed supply of Terramycin delayed from Feb to July
- by Jung, Hye-Jin Jan 31, 2020 06:35am
- The supply resumption date of Pfizer Korea’s Terramycin ophthalmic ointment has been pushed back. On Jan. 28, Pfizer Korea notified distributors, pharmacies and hospitals that Terramycin supply would resume around July. Apparently, the delayed production schedule is pushing down the resumption date. In last November, the company has notified the ointment is out of stock and informed the stock would be supplied around February 2020. Terramycin has struggled with a long-term shortage for 20 months previously, and is now considered as a frequently used drug with frequent shortage problem. Priced at 385 won with reimbursement, Terramycin ophthalmic ointment 3.5 g is commonly used to treat a vast variety of superficial ocular infections like corneal ulcer and conjectivitis. According to pharmaceutical market research firm UBIST, the ointment has generated 354.76 million won from over 920,000 outpatient prescriptions last year.
- Company
- Keytruda awaits Cancer Committee’s nod in February
- by Eo, Yun-Ho Jan 30, 2020 06:34am
- The pharmaceutical industry is keeping their eyes close to the Korean government and MSD’s tug-of-war over expanding reimbursement on immunotherapy Keytruda. The industry reported on Jan. 30, the Cancer Disease Deliberation Committee is scheduled to deliberate reimbursement on Keytruda’s five indications including first-line treatment for non-small cell lung cancer (NSCLC) in February. As recommended by the Cancer Committee, MSD Korea had two sessions of preliminary negotiation with Ministry of Health and Welfare (MOHW), each in May and September last year, but their talks fell through. Besides the indications of first-line treatment for NSCLC, bladder cancer, and Hodgkin’s disease, MSD is anticipating for the Cancer Committee to green light the reimbursement expansion in February on additional indications to treat metastatic non-squamous NSCLC as a first-line combination therapy with pemetrexed and platinum chemotherapy, and to treat metastatic squamous NSCLC as a first-line combination therapy with carboplatin and paclitaxel. So far, the key issues addressed at the attempted but failed negotiation were the conditions of granting reimbursement. The conditions are to limit to ‘patients showing response to the treatment,’ and the trade off card the government is pushing on to recognize the value of new drug while compensating the cost with reduced pricing of off-patent drugs. Considering the cards on the table, MSD has reportedly prepared somewhat of middle ground proposal to persuade the government at the next round of reimbursement deliberation. The global company official stated, “Over the span of two years, the company has been negotiating and narrowing the gap with the government over expanding Keytruda’s reimbursement, and we think the two parties have been engaged enough to have better understanding of each other. Based on the experience, the company is making sure to receive the expanded reimbursement this time.” Keytruda has been listed in August 2017 with a combination of risk sharing agreement (RSA) refund and expenditure cap types under the condition of PD-L1 expression rate. As immunotherapy alone, the drug is even trying to replace chemotherapy for first-line treatment. This holds a great meaning to the anticancer treatment scene. When the reimbursement expands on the drug’s indications, a patient diagnosed with stage IV lung cancer, but cannot be treated with targeted therapy due to EGFR mutation, could be instead prescribed with Keytruda.
- Company
- ‘No Japan’ no effect on drug trade with Japan last year
- by Kim, Jin-Gu Jan 30, 2020 06:33am
- Apparently, imported drug volume from Japan has gone up in last year by 8.3 percent. Experts analyze Koreans boycotting Japanese products took off from the latter half of last year had not affected the pharmaceutical industry. According to import and export statistics disclosed by Korea Customs Service on Jan. 28, Korean drug export volume to Japan last year has reached USD 250.6 million, making a significant increase of 48.9 percent from 168.35 million dollars in 2018. The import drug volume was increased by 8.3 percent in the same period from 364.27 million dollars to 394.36 million dollars. Overall, Korea’s pharmaceutical trade deficit with Japan improved from 195.93 million dollars to 143.76 million dollars in the same period. The massive increase in drug export volume has narrowed the gap with the import volume. Trade with Japan in last five years (Unit: USD 1 million) Source: Korea Customs Service ◆ Drug trade unaffected by ’Boycott Japan,’ but trade deficit improved The industry experts see that the so-called ‘No Japan,’ or the boycott on Japanese product, had unnoticeable effect on drug trade and resulted in increased Japanese drug import volume. In fact, the Japanese drug import volume last year hit the highest peak in the recent five years (from 2015 to 2019). However, the trend vastly contrasts with other industry of food and beverage, automobile, consumer goods and tourism. Last year, 39.76 million dollars of Japanese beer was imported to Korea, which halved from 78.30 million dollars made in 2018. The polarizing trend was even more prominent with statistic data from July last year when the boycott was encouraged seriously. In the second half of last year, 202.91 million dollars of drugs were imported from Japan, which leaped by 22.39 million dollars (12.4 percent) from latest three years (from 2016 to 2018) with 180.52 million dollars. Japanese drug volume Korea imported in 2019 (Unit: USD 1 million) Source: Korea Customs Service ◆ Drug export volume hits highest at USD 3.7 billion Last year’s drug export volume from Korea has reached a historic high at 3.7 billion dollars. Regardless, the import volume also hit the highest and the overall trade deficit worsened by a bit. Korea exported 3.7 billion dollars worth of drugs in 2019. It jumped by 13.0 percent from 3.3 billion dollars in 2018. The export volume in last decade surpassed the one-billion-dollar line for the first time in 2012, and broke the two-billion-dollar and three-billion-dollar lines in 2016 and 2018, respectively. Korean drug export volume in last decade (Unit: USD 1 million) Source: Korea Customs Service Despite breaking the highest record of export volume, last year’s trade deficit has gotten slightly bigger from 2.8 billion dollars in 2018 to 3.0 billion dollars in 2019. The deficit worsened because the import volume was broke the highest record. The drug import volume last year marked 6.7 billion dollars, a 9.20-percent increase from 6.1 billion dollars in 2018. As a result, the trade gap widened from 2.8 billion dollars to 3.0 billion dollars. ◆ Top importing country rank changes from the U.S. to Germany The top ranking of countries importing Korean drug the most has been shuffled. The U.S. has been on the top since 2017, but Germany took over last year. Germany and the U.S. have respectively imported 521.31 million won and 435.16 million won worth of Korean drugs last year, and Turkey (402.12 million dollars), Japan (250.64 million dollars) and China (248.05 million dollars) followed the top two countries. Top 10 Korean drug importing countries (Unit: USD 1,000) Source: Korea Customs Service
- Company
- A Employee, ahead of retirement at Merck, took his own life
- by Eo, Yun-Ho Jan 29, 2020 10:55am
- There was a pity that a salesperson at Merck Bio Pharma, who was about to leave, took his own life. According to the industry, Mr. A, a sales representative from Daejeon Branch of Merck, was found dead. Mr. A was included in the Early Retirement Program (ERP) during the sale of Merck's General Medicine primary care (GM) division, and retirement was confirmed in May. The exact cause of suicide is not known yet, and companies, unions, etc. are trying to figure out the truth. Meanwhile, Merck Korea has been experiencing considerable labor and management conflicts until recently after the sale of its GM division last year. The company decided to sell its business units to strengthen its capabilities in areas such as oncology, infertility, neurology and specialty care. Merck signed a sales contract for Glucophage, a diabetes drug, with GC Green Cross in last October, formulating a business division in November. In last November, the company signed a sales contract with Daewoong Pharmaceutical for its hypertension drug 'Concor'.
- Company
- Breakthrough anticancer Tagrisso makes KRW 29 billion
- by An, Kyung-Jin Jan 29, 2020 06:26am
- Tagrisso AstraZeneca’s new lung cancer treatment Tagrisso has continued to top the prescription drug market. After two years of reimbursement listing, the new drug has generated almost 30 billion won and expanded the overall epidermal growth factor (EGFR) targeted therapy prescription volume. According to pharmaceutical product research firm UBIST on Jan. 23, Tagrisso’s outpatient prescription volume reached 29 billion won last year. The treatment continued to lead the EGFR targeted therapy market as its outpatient prescription volume rose by 33.7 percent than the previous year at 21.7 billion won. Tagrisso (osimertinib) is a third generation tyrosine kinase inhibitor (TKI) developed to inhibit EGFR T790M resistance mutation. The treatment was approved by Korea’s Ministry of Food and Drug Safety (MFDS) in May 2016 as a once-daily treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), whose T790M has been mutated after being treated with other existing EGFR-TKI options like Iressa (gefitinib), Tarceva (erlotinib), and Giotrif (afatinib). In December 2018, the targeted therapy won an expanded indication as a first-line therapy on patients with locally advanced or metastatic NSCLC and an EGFR exon 19 deletion or exon 21 L858R mutation. Growth of Tragrisso outpatient prescription volume by month (Unit: KRW 1 million) Source: UBIST In December 2017, the first month of reimbursement listing, Tagrisso made 1.7 billion won and teased its future success from early on. From April 2018, its prescription volume soared as Hanmi Pharmaceutical’s Olita (olmutinib) that received reimbursement on the same day as Tagrisso was suspended from development and sales, and Tagrisso became the only third generation EGFR-TKI in the market. The prescription volume steeply peaked at 2.8 billion won in last July, and it has plateaued at around 2.7 billion won since then. But, the overall sales volume is estimated to be even higher as its inpatient prescription is significant. Due to Tagrisso’s exceptional performance, the overall EGFR targeted therapy’s outpatient prescription volume has increased up to 60.4 billion won. The figure has increased by 15.6 percent from the year before, and by 41.5 percent compared to figure prior to 2017 when Tagrisso was listed for reimbursement. Out of all four EGFR-TKIs, Tagrisso’s outpatient prescription takes 48.0 percent of the pie. During the same period, the prescription volume of first generation EGFR targeted therapies—AstraZeneca’s Iressa and Roche’s Tarceva—has been falling. Iressa’s outpatient prescription volume last year reached 17.5 billion won, or 18.3 percent less than the year before. Tarceva’s volume reached 3.6 billion won with 0.4 percent decrease. Boehringer Ingelheim’s second generation EGFR targeted therapy Giotrif’s outpatient prescription volume last year has doubled from the year before and made 10.3 billion won. Apparently, it was the highest figure the targeted therapy has reached since its release in Korea. Major EGFR targeted therapy’s outpatient prescription trend by month (Unit: KRW 1 million) Source: UBIST The pharmaceutical industry predicts the EGFR targeted therapy prescription landscape would take a sharp turn if Tagrisso successfully expands reimbursement on to the new indication as first-line treatment for lung cancer. The market experts expect that the prescription of first-line treatment for NSCLC would skyrocket, if AstraZeneca, which built a strong sales network in lung cancer for long period of time with Iressa, is to concentrate on marketing Tagrisso by differentiating it from other first and second generation drug. It also means Giotrif that just surpassed the ten-billion-won line last year for the first time could bounce back down. AstraZeneca is in the process of applying reimbursement on Tagrisso’s indication as first-line treatment for NSCLC patient. Recently, the company has reportedly applied for reimbursement expansion to Health Insurance Review and Assessment Service (HIRA) based on the findings of Phase 3 clinical study FLAURA that confirmed overall survival of patients with NSCLC, who were treated with Tagrisso as a fist-line treatment.
- Company
- Eylea biosimilar by SCD applies for Phase 3 global IND
- by Lee, Seok-Jun Jan 29, 2020 06:25am
- Samchundang Pharm (SCD) plans to have Phase 3 global clinical trial protocol approved for Eylea’s biosimilar ‘SCD411’ within the first quarter of the year. The protocol approval would be reviewed for 90 days at longest, and green light the company to start the Phase 3 trial by the coming second quarter. The multiregional study is planned to be conducted in the U.S., Europe and Japan with a set number of participants. When the trial in Japan starts, SCD would receive USD 3 million (about 3.4 billion won) as a milestone payment stated on the substance license-out deal. According to pharmaceutical industry on Jan. 23, SCD is submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the first quarter to obtain approval on a Phase 3 global clinical trial testing a biosimilar product of anti-vascular endothelial growth factor (VEGF) medication Eylea (aflibercept). When FDA clears the Phase 3 IND application, clinical trial in each region would be carried out with respective set number of participants. The approval would be reviewed within 90 days. SCD official stated, “Clinical trials in respective regions are ready to start immediately when the IND application is passed. The protocol review takes 90 days at most, but it could be a month at earliest. We are compiling a flawless application. The target schedule is to submit the IND application within the first quarter.” Initiating the study in Japan after the IND application approval would grant SCD three million dollars. In last March, SCD has signed a deal on SCD411 with Japan-based SENJU Pharmaceutical for 50 billion won. The deal gives exclusive sales rights of the drug in Japan. The Japanese company has paid upfront payment of 2.5 billion won, and agreed to pay out 47.5 billion won for achieving each clinical milestone. The Korean company has received total of 11.5 billion won from the upfront payment (2.5 billion won) and CRO deal related to global clinical trials (nine billion won). Preparation for IND approval has already been completed. In last August, SCD announced the company had a successful pre-IND meeting with the U.S. FDA as a preparation process prior to IND application submission. The company explained, at the meeting, the U.S. health authority generally reviewed the SCD 411’s quality equivalence test outcome and clinical protocol and confirmed the candidate medicine would not have an issue proceeding with IND application. Moreover, the company elaborated about the U.S. FDA recommending execution of Phase 3 trial straight without Phase 1, as recommended by European Medicine Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Basically, the company can simultaneously process the marketing approval in the U.S., Europe and Japan and other major global markets with the Phase 3 global clinical trial. The VEGF treatment has relatively high marketability due to rarity of the treatment option. At the moment, the only options available are Bayer’s Elyea (aflibercept) and Novartis’ Lucentis (ranibizumab). The market volume is expected to grow from seven trillion won in 2017 to 13 trillion won by 2026.
- Company
- General hospitals clear Norvasc for pediatric use
- by Eo, Yun-Ho Jan 28, 2020 11:18am
- More general hospitals are reportedly listing Norvasc on their drug codes for pediatric treatment. Pharmaceutical industry on Jan. 28 said respective Drug Committees in Seoul National University Hospital, Severance Hospital and Korea University Guro Hospital cleared Norvasc (Amlodipine) 2.5 mg for prescription from the release in last year to now. The 2.5 mg dose of high blood pressure medicine Norvasc is newly approved dose of the drug and the only calcium channel blocker (CCB) in Korea approved by Ministry of Food and Drug Safety (MFDS) for treating pediatric high blood pressure patients aged six to 17. The pediatric indication allows administrating minimum 2.5 mg or maximum 5 mg of the drug once daily. From 2013 to 2017, the number of child and adolescent patients treated in a hospital for high blood pressure has been increased from 4,500 to 6,497, respectively. A clinical study confirmed the drug’s effect in 268 high blood pressure patients ages six to 17, randomized to be administered 2.5 mg or 5 mg of the drug once daily for first four weeks of treatment. The study outcome found, the 2.5 mg and 5 mg arms demonstrated significantly lower systolic blood pressure than the placebo group. In particular, the study reported 5 mmHg systolic on the 5 mg dose and 3.3 mmHg systolic on the 2.5 mg dose. Pfizer Upjohn Korea has diversified the original amlodipine item’s dose and formulation into Norvasc, Norvasc T, and in lower doses to keep the high market share of the off-patent drug. According to UBIST, Norvasc in last year has generated 58.9 billion won from outpatient prescription and defended its title of top single antihypertensive drug. The drug is the first prescribed drug to have made 100 billion won in 2001. Other pharmaceutical companies in Korea have released products with the same active ingredient, and S-amlodipine drugs that maintain the equivalent effect with lowered dose are also available in the market.
- Company
- Repatha’s options for ultra high risk patients extended
- by Eo, Yun-Ho Jan 28, 2020 06:13am
- Professor Hyeon Cheol Gwon Since statins, the coverage of the PCK9 inhibitor Repatha, an option for managing dyslipidemia, is expected to increase utilization. Amgen Korea(the CEO Noh) held a press conference at the Westin Chosun Hotel in Seoul on the 22nd to commemorate the reinforcement of health insurance benefits for Repatha’s atherosclerotic cardiovascular disease (ASCVD). Repatha has been applied to the treatment of patients with atherosclerotic cardiovascular disease at very high risk and patients with heterozygous familial hypercholesterolemia with hypercholesterolemia and statin intolerance patients from January 1 this year. The press conference centered on atherosclerotic cardiovascular disease among them. Professor Hyeon Cheol Gwon, Director of circulatory internal medicine dept., Samsung Medical Center, who presented as the first speaker at the meeting, announced the theme of 'the latest knowledge on the treatment of atherosclerotic cardiovascular disease with ultra high risk group using PCSK9 inhibitor'. Atherosclerotic cardiovascular disease, known as myocardial infarction, stroke, or peripheral artery disease, is a type of atherosclerosis caused by the accumulation of cholesterol in the vascular lining. Patients who have experienced at least one atherosclerotic cardiovascular disease have a high risk of clinical recurrence and a poor prognosis, with a mortality rate of up to 85%. Professor Hyeon Cheol Gwon said, "A patient who has experienced atherosclerotic cardiovascular disease is a serious disease whose mortality rate increases rapidly with the second and third recurrences, and LDL-C, a major risk factor for the ultra high risk group, must be thoroughly managed". He said, “Statin and Ezetimibe are already standard treatment regimens, but some patients with ultra high risk group are still unable to reach their treatment goals because the LDL-C baseline is high and the target is low in the ultra high risk group. We look forward to lowering LDL-C to prevent recurrence of cardiovascular disease in more patients. And, the indication expansion is expected to lower the LDL-C in the high-risk group to prevent recurrence of cardiovascular disease in more patients”. Meanwhile, domestic treatment guidelines recommend that patients with atherosclerotic cardiovascular disease should be adjusted to less than 70 mg / dL of LDL-C to prevent recurrence of cardiovascular disease. However, in 2019, the European Heart Association lowered the target LDL-C level of the ultrahigh risk group to less than 55 mg/dL. Accordingly, there is increasing interest in the field of PCSK9 inhibitors that are useful for patients at very high risk who do not reach target levels with existing treatment regimens.
- Company
- Last year, Tamiflu sales fell by half
- by Jung, Hye-Jin Jan 28, 2020 06:13am
- Last year, the flu treatment Tamiflu market dropped sharply. The size of the market has shrunk as the number of flu patients has decreased significantly from 2018. The share of generics in the market has been expanding. Outpatient prescription performance of Oseltamivir were down ₩17.2 billion, down 50.4% from last year, according to UBIST, a drug research agency. This is the result of a survey of 37 products with recent prescriptions. Oseltamivir is a drug used to treat flu, and Roche's Tamiflu is the original medicine. Prescriptions for 37 items from 2017 to 2018 rose 103% from ₩17 billion to ₩34.6 billion, but fell back to ₩17.2 billion last year. In the winter of 2018, the flu was a very common epidemic. According to the KCDC(Korea Centers for Disease Control & Prevention), the number of influenza patients per 1,000 outpatients last year were 19.5 at 49 weeks, 28.5 at 50 weeks, 37.8 at 51 weeks, and decreased by more than 30% less than 49.8 at 52 weeks. 34.1, 48.7, 71.9, and 73.3 in the week 49-52 of 2018. In the prescriptions for Oseltamivir ingredients, Tamiflu, the original drug, was still ranked first last year. Tamiflu's prescription amount was ₩5.2 billion. Hanmiflu followed with ₩4.1 billion. After that, Comyflu came in third with ₩1.5 billion in earnings. Tamiflu and Hanmiflu, both of which ranked top in prescription performance, also saw a sharp decline. Both original and generic prescriptions declined, but Tamiflu was the largest among the top five. Tamiflu's prescriptions for 2019 decreased 58.4% year-on-year, while Hanmiflu also decreased 54.2%. Kolon's Comyflu decreased 31%, Yuhan's Yuhan N Flu decreased 50.6%, and Arlico's Tamipro decreased 20.8%. In particular, Tamiflu's share in the overall market of Oseltamivir is decreasing. Tamiflu's 2017 market share continued to decline from 51.3% to 36.2% in 2018 and 30.4% in 2019. The share of generics in the Oseltamivir market soared to around 70%. Generics such as Hanmiflu are interpreted as a competitive effect. However, as this winter is not over yet, it is necessary to observe the first quarter 2020 results. In 2018, the most common cases of influenza were in December, while in 2019, the number of patients has increased since the end of December, and the number of patients continues in January. The KCDC announced that the number of suspected influenza patients increased sharply in late December and January this year after the influenza watch warning was issued on last November 15. Last year, the number of suspected influenza patients per 1,000 outpatients fell 53.1 per week, down sharply from last December, but this week increased to 49.1 per week.
