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- 2026-05-09 09:56:05
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- Piqray can be prescribed in 18 hospitals
- by Eo, Yun-Ho Aug 30, 2022 05:54am
- Piqray, an anticancer drug targeting the PIK3CA gene, can be prescribed at a general hospital. According to related industries, Novartis' Piqray passed the Drug Committee of 18 medical institutions nationwide, including Samsung Medical Center, Seoul St. Mary's Hospital, and Seoul Asan Medical Center, as well as Bundang Medical Center and Korea University Anam Hospital. Piqray, approved in Korea in May last year, is a PIK3CAα inhibitor that blocks excessive activity of the PI3K pathway by inhibiting overactivation of PI3K-α due to PI3CA gene mutation, and is a target anticancer drug prescribed in combination with Faslodex in previously failed HR+/HER2-transitive and progressive breast cancer patients. However, Piqray is still a non-reimbursed drug. It submitted an application for benefits at the end of last year, but failed to pass at the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service in February. Novartis is currently working on a re-challenge to register insurance benefits. Piqray demonstrated efficacy through SOLAR-1 studies conducted on 572 menopause women and patients with advanced or metastatic breast cancer after receiving or receiving HR-positive, HER2 negative, and aromatase inhibitor (AI). Clinical results showed that when Faslodex and Piqray were used in tumor patients with PIK3CA mutations, the median value of PFS (Progress-Free Survival) in patients with PIK3 tumors improved by 5.7 months to 11 months. ORR, which represents the proportion of patients whose tumor size has decreased by at least 30%, also showed a combined therapy group of 35.7%, more than double the difference from the monotherapy group of 16.2%. The OS in PIK3CA mutant patients, a secondary evaluation variable, was 39.3 months in the combined therapy group, about 8 months longer than 31.4 months in the monotherapy group, but was not statistically significant. Sohn Joo-hyuk, a professor of oncology at Sinchon Severance Hospital, said, "we recommends a combination of Piqray and Fulvestrant therapy in category 1 for breast cancer patients with PIK3CA gene mutations in the NCCN guidelines. With the introduction in Korea, we can expect to overcome resistance to endocrine therapy."
- Company
- HIV tx Delstrigo is available in major national hospitals
- by Eo, Yun-Ho Aug 29, 2022 06:03am
- The HIV complex Delstrigo is available in general hospitals. According to related industries, Delstrigo, a fixed-dose HIV tx taken once a day by MSD Korea, has passed the D.C. of medical institutions such as Sinchon Severance Hospital, National Medical Center, Pusan National University, Kyungpook National University, Chonnam National University, and Seoul Medical Center. Due to the nature of HIV drugs, as prescriptions are mainly made at national hospitals, landing was conducted mainly at major national hospitals. The drug was approved in Korea in January 2020 and has been on the list since January last year. Delstrigo's indication is "treatment of human immunodeficiency virus (HIV-1) infection in adults who have no previous experience in antiretroviral treatment." As of November 22, 2019, 100 mg of Doravirine was approved by the Ministry of Food and Drug Safety under the product name Pifeltro, and is required to be administered in combination with other antiretroviral drugs. Both Pifeltro and Delstrigo received indications for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients with no previous antiretroviral treatment. Delstrigo confirmed its validity through DRIVE-AHEAD clinical trials. In the clinical trial, Delstrigo demonstrated non-inferiority compared to Efavirenz, Emtricitabine, and Tenofovir therapy. The proportion of patients who reached viral inhibition (less than HIV-1 RNA 40copies/mL) at 48 weeks was 84% in the Delstrigo treatment group and 80% in the EFV/FTC/TDF treatment group. The treatment discontinuation rates due to abnormal reactions were 3% and 6.6%, respectively, which were lower in the Delstrigo treatment group. Meanwhile, in the domestic market, Gilead, GSK, MSD, Janssen, Abbvie, and BMS are competing in the HIV field, of which Gilead and GSK account for about 90% of the market.
- Company
- Pfizer Korea receives tax audit...files tax appeal
- by Aug 29, 2022 06:03am
- On why Pfizer Korea filed a “tax appeal” against the National Tax Service, the company said it had “duly instituted administrative procedures, judging that some of the imposed taxation standards were unreasonable,” refuting the allegations that the company was fined due to ‘cost overstatements.’ According to the pharmaceutical industry on the 26th, the National Tax Service levied fines on some Korean subsidiaries of multinational pharmaceutical companies including Pfizer Korea after tax audits. Pfizer Korea did not disclose the specifics on its amount, but the amount is estimated to be in the tens of billion won range. Pfizer Korea filed a tax appeal regarding the additional fine levied by the NTS on the company, claiming that the tax levied by the NTS was excessive. Pfizer Korea said, “A tax appeal can be filed based on the reasonability of the taxation standards, regardless of the amount. Judging that there were some unreasonable parts in the taxation standards, the company has been taking due process for the tax appeal.” The company stressed, “We have no intention to avoid taxes or exaggerate costs.” Pfizer Korea also drew the line on the so-called ‘cost overstatement’ allegations that were made, on the claim that the company had been writing the product's price higher than the existing price when importing products to increase profits for its headquarters. The company stressed that the imposed fines were irrelevant to sales of the company’s COVID-19 vaccine or oral treatment. The company explained, “the import price is set in consideration of various factors including the product’s cost and terms of transactions, etc.” The fines were imposed not due to cost exaggerations but as part of regular tax audits. In particular, the company added that “the fine was imposed on taxes paid in 2015-2020, at a time unrelated to COVID-19. The fines were levied as a result of a regular tax audit made every 5 years, regarding the taxes paid in 2015-2020, and has no relation to the company’s sales made related to COVID-19.” Pfizer Korea made nearly ₩1.7 trillion last year, ₩1.3 trillion of which is estimated to be from COVID-19 vaccines. In 2020, before COVID-19 vaccines were imported, Pfizer Korea’s sales had been in the ₩300 billion range. When adding the sales of its spin-off company, Viatris, the combined sales had been in the ₩600 billion to ₩700 billion range. Pfizer Korea said, “The company has been faithfully filing its tax returns and payments so far, and will be judged through due process of the taxation standards that are deemed unreasonable on the company’s part."
- Company
- South Korea is looking forward to Xpovio's benefit
- by Aug 29, 2022 06:02am
- Xpovio, a treatment for multiple myeloma, succeeded in entering the benefit one after another overseas. Expectations are growing that the registration of overseas lists will have a positive effect on Korea, given that there has been no country to refer to drug prices. According to the pharmaceutical industry on the 25th, Canadian health authorities recently decided to reimburse for Antigen Pharmaceutical's new drug Xpovio, a multiple myeloma drug. Prior to this, it passed in Australia in March. Canada and Australia are not included in the A7 countries (US, UK, Germany, France, Italy, Switzerland, and Japan), which are drug reference countries. However, the domestic outlook is also bright as two countries with insurance registration systems similar to Korea have succeeded in registering insurance one after another. On top of that, last month, the European Commission (EC) approved Xpovio as a treatment for multiple myeloma. In the pharmaceutical industry, it is observed that benefits will be made in each country in Europe, starting with Germany and Switzerland. Xpovio received an item license from the Ministry of Food and Drug Safety in July last year. However, it has not passed the cancer disease review committee under the HIRA for a year. A review process, but was rejected. Because there is no suitable overseas country to refer to the drug price, Korea calculates the appropriate domestic drug price by referring to the drug price of seven overseas countries. Previously, xpovio was entered by permit only in the country, Medicaid and other benefits. But the drug price of the United States only appropriate that hard to calculate for the price of a position of the health authorities. That is currently released in January, the deliberative committee for the amjilhwan a xpovio, after failing to set wage did not meet the criteria number of benefits seven countries listed is sitting at a standstill, all the way. Multiple myeloma patients are asking for its speed in Australia and Canada for the price of a reference to benefits. Minhwan Back, the chairman of the KMPG said, "a third round of multiple myeloma after then developed an immunity to period is very quickly relapse. Xpovio is the only drug that can be used in the fifth round, but it is very economical because it can only be treated with non-reimbursement." He said, "Patients who failed the fourth treatment are waiting for the news of their benefits with the feeling of grasping at straws, Xpovio will be listed as soon as possible and give hope to patients who are in a difficult situation." The company position is to speed to the benefit is granted a measure of the station. The gimminyeong of Tianjin, the pharmaceutical representative said, "I am happy, and the results of a good rating agencies and other countries, waiting for a drug the molting season early to think I will try to local benefits can be made as soon as possible"
- Company
- NPU condemns the unilateral ERP of multinational companies
- by Aug 29, 2022 06:02am
- The NPU condemned global pharmaceutical companies' unilateral ERP moves. The NPU, which gathered 16 domestic and foreign pharmaceutical bio companies, issued a statement on the 24th, signaling a strong response, saying, "Some member companies have recently shown unilateral voluntary retirement, wage negotiations that do not fit common sense, and collective agreement negotiations." NPU claimed that even though global pharmaceutical company A made the largest sales ever with COVID-19 vaccines and treatments, it is trying to conduct forced restructuring under the guise of ERP for many sales department employees in the name of changing business models. Global B Pharmaceutical Company claims that it is conducting ERP without unilaterally breaking the agreement between labor and management on the logic that ERP is not a cut despite the agreement between labor and management regarding employee cuts. The NPU then noted, "Global Company C is shaking employees with rumors that they will inevitably take voluntary retirement as a global policy as if they were riding on this situation." Global companies D and E have a wage problem. Company D presented a very low wage increase rate of 1.5% in the unprecedented high price and high interest rate situation, and the NPU claims that Company E is changing employee performance pay disadvantageously and not providing fuel costs. Finally, Company F mentioned that it is attempting to neutralize the union so that the union cannot be involved in the collective agreement negotiations and that users can proceed unilaterally. The NPU said, "I'm sure that the reason why this happened is because there are forces that lead it, and I think that those forces are representatives of some HR's user interests." The NPU warned, "We will condemn the behavior of ignoring the union without recognizing it as a counterpart, and will carry out a campaign to step down so that the forces leading it will no longer be established in the industry." On the same day, the Korea GSK union also issued a statement condemning the management's unilateral voluntary retirement. GSK Korea announced on the 16th that it will conduct voluntary retirement for employees of the sales department. Applicants will be accepted by the end of this month. In response, the union said, "This voluntary retirement is due to outsourcing of certain departments, and according to Article 21 of the agreement, we agree with the union when the reduction is carried out due to unavoidable management," adding, "But the management notified the union 30 minutes ago." After the surprise announcement, they are pushing ahead with one-on-one interviews with the employees, and putting psychological pressure on early applicants within a week by applying additional payment conditions. The union said, "The union stopped the management's actions and demanded negotiations for discussions in accordance with the principle of good faith that has continued so far, but the ERP, which was able to proceed smoothly with avoidance, faced considerable conflict." The union urged "to immediately stop layoffs disguised as ERP."
- Company
- HK inno.N, Daewoong, & Jeil are competing to secure K-Cab
- by Kim, Jin-Gu Aug 29, 2022 06:02am
- HK Innoen K-Cab and Daewoong Pharmaceutical Fexclue Competition is expected to expand beyond P-CAB to PPI HK inno.N and Daewoong Pharmaceutical are competitively expanding the indication of P-CAB series gastroesophageal reflux disease treatment. On top of that, Jeil Pharmaceutical is planning to join the competition by operating two clinical trials at the same time to launch the third gastroesophageal reflux disease treatment. The pharmaceutical industry predicts that competition in the gastroesophageal reflux disease treatment market, including P-CAB-based drugs as well as PPI-based drugs, will intensify in the future. On the 22nd, Daewoong Pharmaceutical announced that the indication of Fexclue, a new drug for treating gastroesophageal reflux disease, has been added. Fexuclu, which previously received indication for treatment of erosive gastroesophageal reflux disease, added indication of "improvement of gastric mucosal lesions (10mg) of acute and chronic gastritis." In particular, acute and chronic gastritis is an indication that is not present in the competing drug HK Inno. N's K-Cab Daewoong Pharmaceutical plans to focus on highlighting such differences in competition with HK Inno.N. HK Inno. N is also focusing on expanding the indication of K-Cab. Currently, K-Cab has five indications, including erosive gastroesophageal reflux disease, non-irritating gastroesophageal reflux disease, gastric ulcer, combined antibiotic therapy for Helicobacter pylori eradication, and maintenance therapy (25 mg) after treatment of erosive gastroesophageal reflux disease. Phase 3 clinical trials are underway as a "preventive therapy for gastric and duodenal ulcers that induce nonsteroidal anti-inflammatory analgesics." The clinical trial began with the goal of recruiting 390 patients in October 2020. HK Innoen plans to complete clinical trials by the end of this year. Jeil, which aims to approve the third P-CAB-based gastroesophageal reflux disease treatment, also started two clinical phases at the same time. Jeil is developing a P-CAB-based gastroesophageal reflux disease treatment under the name JP-1366 through its subsidiary Oncherapeutics. In December last year, phase 3 clinical trials for patients with erosive esophagitis were launched, and in May this year, phase 3 clinical trials for patients with gastric ulcer were approved.
- Company
- Zerbaxa on the verge of entering insurance benefits in 5 yrs
- by Eo, Yun-Ho Aug 26, 2022 05:35am
- The next-generation antibiotic Zerbaxa is finally registered as insurance benefits. It is the first time in five years that a domestic permit has been granted. According to related industries, MSD recently concluded a drug price negotiation with the NHIS for the antibiotic Zerbaxa. Due to the improvement of the system, it is possible to step on the PE track. The drug was approved in Korea in April 2017, but the prevailing view was that it was difficult to register under the system at the time. This is because it is not easy to prove cost effectiveness compared to the existing Old Drug, and it is difficult to prove clinical superiority due to the nature of the drug. Zerbaxa submitted an application for registration in the second half of 2018 and went through the procedure, but failed to pass the HIRA's committee in 2019. Zerbaxa has seen hope as the government has implemented an improvement plan to include essential drugs such as antibiotics in PE targets as a way to expand coverage. Zerbaxa passed the Drug Evaluation Committee in June this year and concluded the drug price negotiations, leaving only the passage of the Health Insurance Policy Review Committee until its listing. New Cephalosporin antibiotics Ceftolozane and Zerbaxa, a beta-lactamase inhibitor Tazobactam complex, which have an antipseudomonas aeruginosa effect, can be used in adult patients with complexity urinary tract infections and Metronidazole combination therapy. It is meaningful that it is the first alternative option at a time when the three major super bacteria in urgent need of securing treatments are Cabapenem-resistant fungi, Cabapenem-resistant Acinetobacter baumannii bacteria, Cabapenem-resistant and third-generation Cephalosporin-resistant intestinal bacteria.
- Company
- First patient dosed with Yuhan’s degenerative disc drug
- by Aug 26, 2022 05:35am
- Yuhan Corp (President/CEO: Wook-Je Cho) announced on the 25th that the first patient was dosed with its new degenerative disc drug, “YH14618(SB-01, Remedisc).” The clinical trial was led by the US pharmaceutical company Spine BioPharma on 400 degenerative disc patients at 30 clinical sites in the US. The Phase III trial was conducted to evaluate the improvement in persistent pain and other related disorders and the safety of YH14618 for 6 months after initial intradiscal injection. With a 12-month follow-up period, the results of the Phase III trial are expected to be secured by 2024. Yuhan Corp received the license for YH14618 from Ensol Biosciences in 2009 for domestic development. The company had licensed out the development rights and global commercialization rights (in countries other than Korea) for YH14618 to Spine BioPharma in 2018. With the first dosing of a patient complete for the Phase III trial, Yuhan Corp will receive a $2 million milestone payment (₩2.7 billion) as royalty from Spine BioPharma. YH14618 is a peptide drug that is injected into the spine to induce disc regeneration that is receiving expectations to satisfy the unmet need in the degenerative disc market where no cause or cure is yet available. An official from Yuhan Corp said, “This smooth start in the Phase III trial had been made possible through several years of close cooperation between Yuhan and Spine BioPharma. Spine Biopharma was able to receive approval to bypass the Phase II trial and initiate a Phase III trial from the US FDA based on the results of the clinical trial conducted by Yuhan Corp in Korea. We expect the speed of development to commercialization to accelerate after entry of the Phase III trial.”
- Company
- LG Chem Life Science achieves new quarterly sales record
- by Kim, Jin-Gu Aug 25, 2022 05:52am
- LG Chem’s Life Science company, which is in charge of the company’s pharmaceutical business, has broken its quarterly sales record in the second quarter of this year. Its flagship products - the Zemiglo series and growth hormone - had shown strong sales performance in Korea and abroad, rising nearly 20% in one year. According to the Financial Supervisory Service on the 24th, LG Chem’s Life Science sector recorded ₩205.2 billion in sales in Q2 this year. This is a 17.8% increase from the ₩174.2 billion made in Q2 last year. The cumulative sales in 1H this year were ₩408 billion. If the company maintains the current growth rate, it may record sales of nearly ₩1 trillion by the end of the year. The company has continued stable growth despite the prolonged COVID-19 crisis. Compared to Q2 2019 (₩152.3 billion) before the COVID-19 crisis, this is a 34.8% increase made in three years. This strong growth is interpreted to be the result of the strong performance shown by the company’s flagship product, “Zemiglo” series, the growth hormone “Eutrophin,” and hyaluronic acid injection for arthritis, “Synovian inj.” According to LG Chem, combined sales of the DPP-4 inhibitor type diabetes treatment “Zemiglo (gemigliptin),” its metformin combo “Zemimet,” and rosuvastatin combo “Zemiro,” recorded ₩32.6 billion in Q2 this year. The series recorded a 3% external growth compared to the ₩31.5 billion in Q2 last year and maintained its lead among DPP-4 inhibitor class diabetes treatments in Korea. In the same period, its domestic market share increased from 21.1% to 22.5%. In the case of Eutropin, another flagship product, its market share increased by 1%p from 41.0% to 42.0% in the The flagship products performed well in both the domestic and overseas markets. LG Chem Life Science’s exports increased 17.3% from the same period last year from ₩65.3 billion to ₩76.5 billion in Q2 this year. Domestic market sales increased 18.1% from ₩109 billion to ₩128.7 billion during the same period. However, the operating profits of the Life Science company in Q2 decreased 16.6% from ₩29.1 billion to ₩24.2 billion. LG Chem explained that profitability had decreased somewhat due to the rise of R&D expenses in line with progress made in the company’s clinical trials. LG Chem is conducting various clinical trials in Korea and abroad. In Korea, the company received approval for the Phase III clinical trial protocol of its precocious puberty treatment candidate “GPP001” in June. When development is completed, it is expected to create further synergy with the company’s existing growth hormone Eutropin. The company had also completed a Phase 3 clinical trial of the Zemiglo+metformin+dapagliflozin combination. In June, the combination was approved under the name of Zemidapa. Dapagliflozin is an SGLT-2 inhibitor class diabetes treatment, and if development is completed, Zemidapa is expected to become the company’s fourth Zemiglo series drug. The company is also developing new drugs for hereditary obesity and gout abroad. Among them, the company applied for a Phase III clinical trial for its new gout drug candidate “tigulixostat” to the US Food and Drug Administration (FDA) on August 1st. Also, the company is participating in the development of the immuno-oncology drug ‘CUE-102’ with its partner, Cue Biopharma. LG Chem owns the exclusive right to develop and market CUE-102 in 11 Asian countries including Korea, China, and Japan. LG Chem explained, “We plan to further expand R&D investment to develop global new drugs. In particular, we will focus on oncology which has high growth potential, and diabetes and metabolic diseases where we own extensive R&D experience.”
- Company
- Celltrion Applies to Europe for IND to designate Yuflyma
- by Aug 24, 2022 05:55am
- Celltrion announced on the 23rd that it has applied to European regulators for IND to designate Humira biosimilar Yuflyma (CT-17) as an interchangeable similar. If it is designated as an interchangeable similar, it can be prescribed by replacing the original at a pharmacy without intervention by MD. Celltrion recently submitted IND to the U.S. Food and Drug Administration (FDA) to secure a mutual exchange between Yuflyma and Humira. European clinical trials are conducted on 366 Plaque psoriasis patients in many countries, including Estonia and Poland. It plans to compare and verify pharmacokinetics, efficacy, and safety between the multiple cross-medication group between Yuflyma and Humira and the Humira maintenance medication group. Celltrion previously confirmed the efficacy, pharmacokinetics, and safety results similar to Humira through Global Phase 3 clinical trials of Yuflyma in patients with rheumatoid arthritis. Based on the clinical results, Yuflyma obtained permission to sell all indications held by Humira, such as RA, IBD, and PS, from EMA in February 2021 and is in progress. In the U.S., it has completed a patent agreement in the U.S. with its developer AbbVie so that it can start selling on July 1st next year. Celltrion expects FDA approval to sell Yuflyma within this year. When sales of Yuflyma begin in the U.S., it is expected that the advantages of high-concentration formulation, whether to secure interchangeable similarity status, and clinical results on various indications will serve as important competitiveness. Yuflyma is the first high-concentration Humira biosimilar to obtain permission from EMA, characterized by halving drug administration compared to low concentrations and removing citrate that can cause pain. An official from Celltrion said, "We believe that if Yuflyma secures its interchangeable biosimilar status through interchangeable clinical trials, it will greatly help expand its market share by strengthening its competitiveness." "High-quality bio at reasonable prices for global markets, including in Korea, while making every effort to prepare for clinical and licensing, and we will do our best to proceed with the supply of medicines."
