- LOGIN
- MemberShip
- 2026-05-08 01:10:33
- Company
- Organizations and people change
- by Eo, Yun-Ho Mar 03, 2023 05:57am
- The Korean branch of Gilead is facing the most significant transformation since its inception in Korea. Various changes such as the establishment of a new business unit are expected along with changes in the composition of the workforce, such as the resignation of executive director Jeong Yeon-shin, a key member of Gilead Sciences Korea along with CEO Lee Seung-woo. First of all, CEO Lee Seung-woo will leave the company at the end of this month (March). Accordingly, Gilead is in the process of hiring a successor for CEO Lee. It is known that CEO Lee decided to retire with his resignation. CEO Lee is a symbol of a multinational company professional manager in the pharmaceutical industry. Having obtained MBA degrees from the University of Alberta in Canada and Columbia University in the U.S., he worked for Johnson & Johnson and the Korea Global Pharmaceutical Industry Association (KRPIA) before being appointed as the CEO of MSD Korea in 1996. He served as the CEO of a Korean subsidiary of a multinational company. In 2011, with the launch of Gilead's domestic corporation, he was appointed as the first head and has maintained his position. He has worked as a professional multinational company manager for over 25 years. Vice President Jeong Yeon-sim will also leave the company at the end of the first half of this year. Vice President Jeong joined Gilead Korea at the beginning of its establishment and was a key person who oversaw the company's external cooperation, such as drug pricing and public relations. His successor was recently confirmed. Director Kim Min-young, who was in charge of policy at the Korea Global Pharmaceutical Industry Association (KRPIA) until last month, will lead Gilead's drug pricing department. Significant changes are expected at the business level. Gilead, which has been a major player in antiviral drugs such as hepatitis B, hepatitis C, and HIV, is preparing to enter the anticancer drug market in earnest in Korea starting this year. He is concentrating on the composition of the anti-cancer drug division along with the introduction of drugs such as CAR-T treatment 'Yescata' and ADC drug 'Trodelby'. Actual recruitment is also actively underway, and there are observations that anticancer drug experience will play a major role in hiring a successor for CEO Lee Seung-woo.
- Company
- MFDS approves LG Chem’s P3T for new gout drug
- by Hwang, Jin-joon Mar 03, 2023 05:56am
- A reseracher from LG Chem is reviewing clinical trial data (Pic: LG Chem) On the 28th, LG Chem announced that its global Phase III clinical trial protocol (EURELIA 2 Study) for ‘tigulixostat’ was approved by the Ministry of Food and Drug Safety. Tigulixostat is a new gout drug candidate being developed by LG Chem. The Phase III trial will enroll 2,600 gout patients with hyperuricemia around the globe. LG Chem plans to evaluate the efficacy and safety of tigulixostat in comparison with the existing ‘allopurinol,’ which is commonly used in gout patients, by administering the two drugs for 12 months. LG Chem explained that it plans to conduct the global clinical trial by submitting the global Phase III protocol for approval in other countries as well. Tigulixostat is being developed as an oral treatment taken once daily. In the Phase II trial that had been previously conducted, the primary efficacy endpoint was the response rate achieving sUA < 5 mg/dL at month 3. In the trial, the proportion of gout patients reaching sUA < 5 mg/dL at month 3 by study arms was 62% with 200 mg Tigulixostat, 3% with placebo, and 23% with Febuxostat.
- Company
- Corona drug competition system is imminent
- by Jung, Sae-Im Mar 03, 2023 05:55am
- As the COVID-19 pandemic shows signs of ending this year, pharmaceutical companies supplying related medicines are in the midst of preparing marketing and sales personnel to prepare for the end of the pandemic. According to the pharmaceutical industry on the 24th, Pfizer Korea is currently hiring large-scale new sales staff. The number of recruits is in double digits. It is very unusual for a multinational pharmaceutical company to hire more than 10 new employees. Usually, when there is a vacancy in a specific position, multinational pharmaceutical companies tend to hire one or two experienced staff only for that position. It is known that the reason why Pfizer is rapidly increasing sales staff is because of sales of Corona 19 treatments and vaccines. According to Pfizer Korea Recruitment, new recruits will be in charge of sales activities in the Corona 19 treatment/vaccine division. The work area will be decided after joining the company in consideration of the business situation in Seoul, Gwangju, Daejeon, Daegu, and Busan. So far, vaccines and treatments for Corona 19 have been made in such a way that when the government signs a purchase contract, pharmaceutical companies supply the government with a number of medicines and distribute them to necessary front-line medical institutions through companies contracted with the government. But when the COVID-19 pandemic ends, government purchases are expected to drop significantly. Like flu vaccines or medicines, individuals have to pay for and receive vaccinations and prescriptions at medical institutions according to their needs. The supply and sale of COVID-19 medicines will be transferred to the private sector. Moving to the private market, marketing and sales strategies are seen as having a major impact on sales. In particular, unlike therapeutics, which are prescription areas, vaccines can vary in consumer choice depending on awareness and price. Modena Korean corporation (Moderna Korea) has also recruited vaccine marketing and partnership personnel early on. In November of last year, it signed a joint partnership agreement with Guangdong Pharmaceutical for a COVID-19 vaccine. Kwangdong Pharmaceutical is in charge of providing product information on Moderna's Corona 19 2-valent vaccine to medical staff. Moderna Korea, which has not yet had a large workforce due to the establishment of a Korean corporation during the COVID-19 pandemic, is promoting its vaccines through active partnerships with domestic companies. Symposiums have also been held recently in Seoul and Busan to expand skinship with private practice doctors. The dominant forecast is that the end of Corona 19 will be in the middle of this year. The World Health Organization (WHO) took the lead in maintaining the Corona-19 public health emergency in January, but it is expected that the recommendation will be lifted at the next quarterly (April) meeting. In line with this, the United States and Japan issued a policy to end the corona emergency in early May. Korea is expected to follow the same steps. Ji Young-mi, head of the Korea Centers for Disease Control and Prevention, said at a recent meeting, "This year will be the first year to end the emergency phase and transition to normal life." As planned, we will observe the overseas situation to determine the level of domestic quarantine."
- Company
- Sky Zoster ranked first in sales of shingles vaccine last yr
- by Kim, Jin-Gu Mar 02, 2023 05:53am
- SK Bioscience announced on the 28th, citing IMS data, a global market research institute, that its self-developed shingles vaccine Sky Zoster achieved the top share in sales in the domestic market last year. According to SK Bioscience, Sky Zoster's domestic market share last year reached 54% based on sales volume. Quarterly by quarter, 51% in the first quarter, 52% in the second quarter, 56% in the third quarter, and 57% in the fourth quarter. It is explained that it broke the record for the largest market share every quarter. Sky Zoster is the world's second and Korea's first shingles vaccine developed by SK Bioscience based on its own technology. SK Bioscience explained that Sky Zoster achieved 1 million doses in cumulative sales within two years after its launch in 2017 based on its excellent safety, immunogenicity, convenience, and reasonable price. As a result of phase 3 clinical trial conducted on 824 adults aged 50 years or older at 8 domestic institutions including Korea University Guro Hospital, it was found that the antibody titer against the varicella-zoster virus increased by 2.75 times after vaccination compared to before Skyzoster vaccination. Non-inferiority to the control vaccine was also demonstrated. As a result of examining the incidence of adverse reactions that occurred 6 weeks after vaccination with Skyzoster, it was similar to that of the control vaccine group, and no serious adverse reactions showing a causal relationship with Sky Zoster were reported even during 26 weeks after vaccination. According to the results of the post-marketing investigation of Sky Zoster announced by the Ministry of Food and Drug Safety in July of last year, as a result of analyzing 651 Sky Zoster inoculations for four years, no serious adverse drug reactions were reported after vaccination. Sky Zoster is released in the form of a 'pre-filled syringe' containing one inoculation per injection, so it has the advantage of low contamination risk and convenient vaccination. Unlike competitive products, the fact that the vaccine only needs to be vaccinated once is considered an advantage. An official from SK Bioscience said, "There was a prediction that there would be a change in market share as a global pharmaceutical company's shingles vaccine entered Korea at the end of last year, but Skyzoster maintained its No. 1 position with its safety and reasonable price competitiveness. Sky Zoster is also expanding its presence in overseas markets beyond Korea. In May 2020, the first global approval was obtained in Thailand, followed by item approval from the Malaysian National Drug Administration (NPRA) in January. In addition to these individual country permits, SK Bioscience plans to accelerate its efforts to target the global market by applying for WHO pre-qualification within this year. Ahn Jae-yong, CEO of SK Bioscience, said, “As the world is rapidly aging, the importance of vaccination against shingles, which is vulnerable to the elderly, is growing.” I hope to play a role," he said.
- Company
- Samsung Bioepis fiercely chases Celltrion in biosimilar mkt
- by Kim, Jin-Gu Mar 02, 2023 05:53am
- Samsung Bioepis has been rapidly chasing Celltrion in the domestic biosimilar business and expanding sales in the market. As of last year, domestic biosimilar sales of Samsung Bioepis and Celltrion were KRW 42.5 billion and KRW 69 billion, respectively. Samsung Bioepis’s sales more than tripled in one year, greatly narrowing the gap with Celltrion. Samsung Bioepis has been copromoting sales of its biosimilar products in the domestic market with Boryung, Yuhan Corp, Samil Pharm, and Daewoong Pharmaceutical. Samsung Bioepis’s new product releases and the sales power of domestic pharmaceutical companies are analyzed to have created synergy and driven an increase in sales last year. ◆Biosimilar sales in Korea KRW 69 billion for Celltrion vs Samsung Bioepis KRW 42.5 billion According to the market research institution IQVIA, Celltrion made total sales of KRW 69 billion with its biosimilars. In the same period, Samsung Bioepis made KRW 42.5 billion in total biosimilar sales. The sales gap between the two companies had been reduced greatly with Samsung Bioepis releasing a series of new products during the past 3 years. Celltrion’s domestic biosimilar sales by year increased from KRW 54.4 billion in 2019 to KRW 54.9 billion in 2020, KRW 60.7 billion in 2021, then to KRW 69 billion in 2022. In the same period, Samsung Bioepis’s biosimilar sales increased to a greater degree from KRW 8.5 billion to KRW 10.9 billion, KRW 13.2 billion, then to KRW 42.5 billion. Due to this rise in Samsung Bioepis’s sales, the gap between the two companies in biosimilar sales was reduced from KRW 45.9 billion in 2019 to KRW 44 billion in 2020, then to KRW 47.5 billion in 2021, and to KRW 26.5 billion last year. Samsung Bioepis’s biosimilar sales had been less than KRW 10 billion until 2019, but then succeeded in raising sales by releasing a series of new products. The industry's view is that Samsung Bioepis' domestic biosimilar business is now well on track. ◆ Onbevzi ‘s sales exceed KRW 20 billion in the second year of release... Adalloce’s sales reach KRW 7.6 billion last year In Samsung Bioepis’s case, the analysis is that the two biosimilars it had released in 2021 have been driving the rapid rise in sales. Samsung Bioepis has currently released 6 types of biosimilars in Korea - Avastin biosimilar ‘Onbevzi,’ Humira biosimilar ‘Adalloce,’ Herceptin biosimilar ‘Sampenet,’ Remicade biosimilar ‘Remaloce,’ and Enbrel biosimilar ‘Etoloce,’ and Lucentis biosimilar ‘Amelivu.’ Among the drugs, Adalloce was released in Q3 2021, and Onbevzi in Q4 2021. Onbevzi recorded sales of KRW 0.5 billion in 2021, in the first year of its release. Last year, its sales surged to KRW 20.5 billion. The analysis is that Boryung’s domestic sales activities contributed to the increase in sales. With the surge in sales, Onbevzi’s market share quickly expanded to occupy 21% of the market. In the case of Adalloce, its sales, which had only been KRW 1.2 billion in the first year of release, rose 6.5 times to KRW 7.6 billion last year. Samsung Bioepis had signed an agreement with Yuhan Corp to jointly promote sales of Adalloce in Korea. In the case of Sampenet, sales have risen 158% in 3 years, from KRW 2.2 billion in 2019 to KRW 5.6 billion last year. Remaloce’s sales rose 74% from KRW 2.8 billion to KRW 4.9 billion, and Etoloce's 15% from KRW 3.5 billion to KRW 4 billion. Samsung Bioepis is copromoting Sampenet with Daewoong Pharamceutical, and Remaloce and Etoloce with Yuhan Corp. Amelivu’s sales are also expected to be reflected in sales in earnest this year. Samsung Bioepis joined hands with Samil Pharmaceutical to sell Amelivu. Samil started domestic sales of Amelibu in January this year. Amelivu is currently the only Lucentis biosimilar available on market. ◆Remsima’s sales reach KRW 29.3 billion last year... Herzuma KRW 29.3 billion, Truxima KRW 10.2 billion In the case of Celltrion, its three major biosimilars are making smooth sales in the domestic market. In the case of Celltrion, it has been selling the Remicade biosimilar ‘Remsima,' Mabthera biosimilar ‘Truxima,’ Herceptin biosimilar ‘Herzuma,’ Humira biosimilar ‘Yuflyma,’ and Avastin biosimilar ‘Vegzelma’ in Korea. Among the drugs, Remsima accounts for the largest portion of Celltrion’s domestic biosimilar sales. Last year, Remsima’s sales had been KRW 29.3 billion, a 20% increase from the previous year. Herzuma and Truxima are also increasing their presence in the market. Herzuma recorded sales of KRW 29 billion last year, which was a 6% increase from the previous year. Truxima’s sales exceeded KRW 10 billion for the first time last year. Compared to the KRW 8.8 billion it had made the previous year, in 2021, Truxima’s sales rose 15% to reach KRW 10.2 billion last year. In addition, Yuflyma and Vegzelma, which were released in March and December of last year, are also expected to contribute to the company’s biosimilar sales this year. Last year, Yuflyma sold KRW 0.5 billion, and Vegzelma's sales were not aggregated. Celltrion Pharma is in charge of selling Celltrion's biosimilars in Korea.
- Company
- Verquvo takes one step toward insurance coverage listing
- by Eo, Yun-Ho Mar 02, 2023 05:53am
- According to related industries, Bayer Korea's soluble guanylate cyclase (sGC) promoter Verquvo, which promotes the synthesis of intracellular cyclic monophosphate (cGMP), recently passed the HIRA. As a result, attention is focused on the future schedule of the Pharmaceutical Reimbursement Evaluation Committee. In December 2021, death due to cardiovascular disease and hospitalization due to heart failure in patients with symptomatic chronic heart failure with a left ventricular ejection fraction lower than 45% who had recently been hospitalized for heart failure or received intravenous diuretics on an outpatient basis. It has been approved domestically as a combination therapy for risk reduction. After applying for benefits last year, it is not fast, but it is showing progress in the process little by little. Existing heart failure treatments were designed to block the harmful effects of the natural neurohormonal system activated by myocardial and vascular dysfunction. In contrast, Verquvo is a water-soluble sGC stimulant that has a new mechanism of improving myocardial and vascular functions by promoting the synthesis of intracellular cyclic guanosine monophosphate (cGMP), which regulates cardiac contraction, vascular tone, and cardiac remodeling. It was approved as the world's first (first-in-class) treatment for chronic heart failure as an sGC promoter. Verquvo has proven its effectiveness through phase 3 clinical trial VICTORIA. The VICTORIA study found a left ventricular ejection fraction of 45 patients with symptomatic chronic heart failure (NYHA Class (New York Heart Association) Grade 2-4, which is a criterion for moderate severity of heart failure) who were hospitalized for heart failure or who experienced intravenous diuretic administration on an outpatient basis. It was conducted on 5050 patients with high-risk heart failure that had decreased to less than 1%. 59.7% of the patients participating in the study were receiving triple therapy, and 41% of severely ill patients with NYHA grades 3 and 4 were included. Patients received a placebo or up to the target maintenance dose of Verquvo 10 mg in combination with other heart failure therapies. As a result, Verquvo met the primary endpoint with an absolute risk reduction of 4.2% and a 10% lower risk of cardiovascular death or first hospitalization due to heart failure during a follow-up of 10.8 months (median value) than the placebo group. The annual absolute risk reduction of hospitalization for heart failure was 3.2%, and the overall risk reduction of all-cause death or hospitalization for heart failure showed that the Verquvo group reduced the risk by 10% compared to the placebo group.
- Company
- Daewoong botulinum toxin Nuceiva launched in Germany and Aus
- by Hwang, Jin-joon Mar 02, 2023 05:52am
- Daewoong Pharmaceutical Botulinum Toxin Daewoong Pharmaceutical announced on the 28th that its botulinum toxin 'Nuceiva' was officially launched in Germany and Austria through Evolus, a cosmetic indication partner in developed countries. Evolus, a partner for cosmetic indications in North America and the European Union, will be in charge of the distribution and marketing of Nuciva in Germany and Austria. Evolus has been preparing for the local release by forming a strategic partnership with Novvia, a local distributor specializing in aesthetic medicine. From the middle of this month, we started product marketing activities targeting local medical personnel. According to a data report published by market research firm Decision Resource Group (DRG), the German botulinum toxin market is estimated at 100 billion won. It occupies the second largest share after the UK in the European Union, which has an annual market size of 690 billion won. As Germany is the most populous country in the European Union, this launch is expected to be a key point for Nuciva to expand its market share in the region. Daewoong Pharmaceutical and Evolus are planning to release Nuciva in other EU countries this year. It plans to launch it in Australia and Singapore, which have recently received product approval, within this year.
- Company
- Jardiance vs Forxiga, competition in chronic kidney dz
- by Eo, Yun-Ho Feb 28, 2023 05:53am
- Competition outside the diabetes area for SGLT-2 inhibitors will further expand this year Following heart failure, this time it is kidney disease. Following AstraZeneca's Forxiga, Lilly and Boehringer Ingelheim's Jardiance also secured indications for chronic kidney disease, and competition is intensifying. In terms of speed, Forxiga is ahead. Forxiga entered the approval process in major countries, including Korea, immediately after approval by the US FDA in April, and added indications for chronic kidney disease in Korea and Europe in August last year. However, insurance benefits have not yet been applied. Boehringer Ingelheim submitted an application for US FDA approval last month. If US approval is completed within this year, it is expected that major countries including Korea will immediately begin approval procedures. Chronic kidney disease (CKD) is a progressive disease that is estimated to affect 700 million patients worldwide. Currently, there are limited treatments available for this patient group, but new treatment options are needed in that chronic kidney disease increases the incidence of cardiovascular events such as heart failure and affects early death. The approval of Forxiga for chronic kidney disease was based on the phase 3 clinical DAPA-CKD study. Forxiga was designated for Priority Review by the FDA earlier this year. According to the DAPA-CKD study, Forxiga reduced the relative risk of decreased renal function, ESKD, and cardiovascular or renal death by 39% compared to placebo in chronic kidney disease stage 2-4 patients with increased UAE levels. The absolute risk reduction rate (ARR) was 5.3% over a median study period of 2.4 years. In the case of Jardiance, the validity was confirmed through the EMPA-KIDNEY study. EMPA-KIDNEY was a broad-spectrum, large-scale SGLT-2 inhibitor-only study involving 6609 patients with a variety of causes. Many of these patients had cardiovascular, renal, or metabolic comorbidities, and both renal and cardiovascular outcomes were evaluated at different CKD severity levels. As a result, Jardiance significantly reduced the risk of renal disease progression or cardiovascular death by 28% compared to placebo. It also significantly reduced all-cause hospitalizations, one of the predefined major composite secondary endpoints, by 14% compared to placebo.
- Company
- Last year’s sales of Yuhan Leclaza were 16.1 billion won
- by Chon, Seung-Hyun Feb 28, 2023 05:52am
- Cumulative sales of 20 billion won in 1 year and 6 months after release. High growth prospects when promoted to first-line treatment. Yuhan Corporation's anti-cancer drug Leclaza is successfully settling in the domestic market. In the second year of its release, it posted sales of 16.1 billion won, breaking the record for annual sales of a new anti-cancer drug developed in Korea. According to IQVIA, a drug research agency on the 24th, Leclaza recorded sales of 16.1 billion won last year. It increased by 4 times from 4.1 billion last year. Leclaza is a non-small cell lung cancer treatment approved as the 31st new drug developed in Korea in January 2021. Patients with locally advanced or metastatic non-small cell lung cancer who developed T790M resistance after administration of first- and second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are eligible for the treatment. It acts as a mechanism to inhibit the proliferation and growth of lung cancer cells by interfering with the signal transduction involved in the growth of lung cancer cells. Leclaza entered the prescription market in earnest in July 2021 with its listing on the health insurance benefit list. Sales of 1.5 billion won and KRW 2.6 billion occurred in the third and fourth quarters of 2021, respectively. In the past year, Leclaza's sales have grown even more. It sold 3.2 billion won and 3.7 billion won in the first and second quarters of last year, respectively, and expanded to 4.6 billion won and 4.5 billion won in the third and fourth quarters. Leclaza recorded cumulative sales of 20.2 billion won for a year and a half after its release. Leclaza has already broken the sales record for new anti-cancer drugs developed in Korea. Domestically developed anti-cancer drugs approved prior to Leclaza include Ilyang Pharm's Supect, Dongwha Pharm's Millican, Chong Kun Dang Camtobel, Samsung Pharm's Riavacs, and Hanmi Pharm's Olita. None of these products exceeded 10 billion won in annual sales. Supect recorded sales of 7.6 billion won last year. Supect, which was approved as the 18th domestically developed new drug in January 2012, is a drug used to treat chronic myelogenous leukemia. Supect drew attention as Asia's first treatment for chronic myeloid leukemia, but annual sales have never exceeded 10 billion won since its launch. Camtobel's sales last year were only 3.5 billion won. Camtobel is a drug approved as the 8th domestic new drug in 2003 and is used for ovarian cancer and small cell lung cancer. Leclaza's report card at the beginning of its release is evaluated as a good start. Since anticancer drugs, which are usually used in large medical institutions, can be prescribed after passing the drug committee, it takes a considerable amount of time for sales to occur at the initial stage of release. Due to the nature of direct competition with outstanding new drug products from multinational pharmaceutical companies, it is not easy for new anti-cancer drugs developed in Korea to achieve commercial results. Leclaza passed the Pharmaceutical Affairs Committee of major domestic medical institutions one after another. If Leclaza is approved as a first-line treatment, the pace of market expansion is expected to accelerate. Recently, clinical trials have confirmed the possibility of Leclaza as a first-line treatment. Leclaza demonstrated superior safety and efficacy compared to existing treatments in phase 3 clinical trial (LASER301) conducted on 393 patients with active EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer who had not previously received treatment. The clinical results were recently unveiled at the Asian Congress of the European Society for Oncology held in Singapore. Yuhan plans to apply for first-line treatment approval based on the LASER301 clinical trial results. Yuhan Corporation has secured $150 million in license fees for Leclaza. In November 2018, Leclaza was technology exported to Janssen Biotech, and at this time, it received a non-returnable down payment of $50 million. Yuhan received a milestone payment of $35 million from Janssen in April 2020. At the time, Janssen paid Yuhan Corporation an additional milestone when it started clinical trials for the combination therapy of Amivantamab and Leclaza. In November 2020, Janssen paid Yuhan an additional milestone of $65 million as it began recruiting subjects for this clinical trial.
- Company
- Recordati Korean subsidiary was launched
- by Eo, Yun-Ho Feb 28, 2023 05:52am
- Italian pharmaceutical company Recordati Korean corporation was launched. Recordati Korea (Representative Lee Yeon-jae in Asia) announced on the 27th that it will officially launch its Korean branch and Asia-Pacific regional headquarters. The company is an Italian pharmaceutical company with a history of more than 90 years. Accordingly, the corporate name of the existing EUSA Pharma Korea will be changed. Recordati will be in charge of marketing Sylvant, a treatment for multicentric Castleman's disease (MCD), and Carbaglu, a treatment for hyperammonemia, and is preparing a wide portfolio for rare diseases such as Neuroblastoma and Cushing's syndrome. Lee Yeon-jae, CEO of Asia, said, "Recordati has expanded its portfolio for rare pediatric cancers and blood diseases in addition to products for metabolic and endocrine rare diseases, which it originally specialized in through the acquisition of EUSA Pharma."
