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- 2026-03-18 22:46:44
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- Lurbinectedin by Boryung has been granted orphan drug
- by Lee, Seok-Jun Aug 05, 2020 06:24am
- #Boryung announced on the 3rd that the new small cell lung cancer (SCLC) drug Lurbinectedin has been granted orphan drug designation from the MFDS for the treatment of patients with small cell lung cancer (SCLC) Lurbinectedin is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. The disease is known to have an aggressive tendency among lung cancer and a high recurrence rate after treatment. Lurbinectedin obtained approval for phase III conditional accelerated approval and priority review from the United States Food and Drug Administration (FDA) in June. PharmaMar, the original developer in Spain, is conducting a global phase III for Lurbinectedin. Boryung holds exclusive rights to develop and sell domestic products through a technology introduction contract with Lurbinectedin signed by PharmaMar in 2017. Boryung plans to apply for domestic permit within the year and aims to release it in 2021.
- Company
- COVID-19 pandemic crushes Big Pharma sales in Q2
- by An, Kyung-Jin Aug 04, 2020 05:54am
- Top 13 global pharmaceutical companies and their second quarter sales growth (Unit: %) Source: respective companies Heavily impacted by COVID-19 pandemic, the Big Pharma’s second quarter performances have been underwhelming to say the least. As the World Health Organization (WHO) declared the COVID-19 pandemic on Mar. 11, the number of confirmed cases in the U.S. and Europe has exponentially surged and created a gap in pharmaceutical prescription. Based on the analysis of top 13 global pharmaceutical companies and their sales performances on Aug. 3, Daily Pharm found the gross sales of those companies in last two quarters have reached USD 130.06 billion (approximately 15.53 trillion won) which was 4.3 percent less 135.63 billion dollars made in last year same time. The cumulative sales in the first six months marked 266.26 billion dollars, increased by 1.1 percent from 263.3 billion dollars last year. EvaluatePharma reported this year’s performance so far of the top 13 global pharmaceutical companies of 2020 (Johnson & Johnson (J&J), Roche, Pfizer, Novartis, Merck, GlaxoSmithKline (GSK), Sanofi, Abbvie, AstraZeneca, Amgen, Eli Lilly and Gilead Sciences). Bristol Myers Squibb (BMS) and Bayer were excluded from the analysis as they have yet to publish their second quarter outcome. Top 13 global pharmaceutical companies and their first half of the year sales growth (Unit: %) Source: respective companies The pharmaceutical market research firm stated ten out of the top 13 companies had a fall in sales volume in the second quarter compared to last year second quarter. But only four companies had declined cumulative sales in the first half of the year. In early 2020, the positive COVID-19 cases in the U.S. and Europe were rare, but soon it skyrocketed after mid March and the critical impact in the second quarter sales was inevitable. The companies with massive sales volume had more noticeable slip in sales. The top three companies—J&J, Roche and Pfizer—had over 10-percent drop in the second quarter sales. The patent expiration on their leading products and the pandemic worsened the sales loss and the effect extended throughout the sales reported in the first half of the year. According to the sources, Pfizer took the steepest fall. The last second quarter’s sales at 11.81 billion dollars was pulled down by 11.0 percent from last year second quarter at 13.26 billion dollars. The company’s net profit in the same period plummeted by 32 percent and hit 3.43 billion dollars. Compared to 26.38 billion dollars generated last year, the cumulative sales in the first half of the year was brought down by 9.7 percent and reached 23.83 billion dollars. Pfizer’s stagnation in sales was caused not only by the pandemic, but also by the major products’ patent expiration and organization restructuring. The sales volume of Upjohn plummeted by 32 percent in the second quarter as an antiseizure drug Lyrica’s (pregabalin) patent expiration in the U.S. last year hugely affected the overall sales. Upjohn is an independent corporation of supplying off-patent drugs and generics. Also the company’s Consumer Healthcare sector’s sales were dropped from the calculation as it is in process of merge with GSK’s Consumer Healthcare sector. J&J, Roche and Pfizer’s sales in 2019 and 2020 H1 (Unit: USD 1 million) Source: respective companies Pfizer’s CEO Albert Bourla diagnosed, “Amid the global public health challenge posed by the COVID-19 pandemic, the company is actively responding with flexible management strategies and collaboration between the company and academia in the search of the vaccine.” He added “Although the sales were affected by Lyrica’s competition against generics, the sales loss was balanced out with Eliquis and Ibrance sales growing strong and the significantly improved sales in China in last second quarter.” J&J sales have also declined by 10.8 percent from 20.56 billion dollars made in second quarter last year as this year reached 18.34 billion dollars. The accumulated sales in the first six months of the year have marked 39.03 billion dollars with 3.8-percent dip compared to last year. Also the sharp drop in Remicade (infliximab) and Simponi (golimumab) sales have dragged the sales growth. Roche reported 4.3-percent drop in cumulative sales in the first half of the year as the last second quarter marked 10.0-percent drop in sales against last year. Meanwhile, AbbVie, AstraZeneca and Amgen have exceptionally shown positive growth amid COVID-19. AbbVie, AstraZeneca and Amgen’s sales in 2019 and 2020 H1 (Unit: USD 1 million) Source: respective companies For both the second quarter and the first half of the year, AbbVie demonstrated two-digit growth. In the second quarter, the company made 10.43 billion dollars and leapt by 26.3 percent from 8.26 billion dollars last year. The company also saw 18.4-percent growth as it accumulated 19.04 billion dollars in the first half of this year. Its star product Humira’s (adalimumab) patent is still valid in the U.S. and new line-ups like Skyrizi (risankizumab) and Rinvoq (upadacitinib) surged in growth, which led to a successful year so far for the company amid the pandemic. Making a growth of 8 percent from last year, AstraZeneca generated 6.28 billion dollars in the second quarter. The cumulative sales grew even further by 11.6 percent compared to last year. AstraZeneca’s recently launched novel anticancer line-ups like Tagrisso (osimertinib), Imfinzi (durvalumab) and Lynparza (olaparib) are continuing to grow rapidly. Amgen’s second quarter sales have grown 6 percent from last year with 6.21 billion dollars, and it accumulated 12.37 billion dollars in the first six months and showed off a steadfast 8.2-percent growth. Regardless of off-patent drugs like Enbrel (etanercept) and Neulasta (pegfilgrastim) performed sluggishly in sales, the company launched a Herceptin generic Kanjinti, Otezla (apremilast) and Evenity (romosozumab) and unfolded a successful defense strategy.
- Company
- Chong Kun Dang has maintained its highest performance
- by Lee, Seok-Jun Aug 04, 2020 05:54am
- Chong Kun Dang has maintained its highest performance in the past five years. During that period, the appearance was almost doubled as a large pharmaceutical company. The operating margin remained around 8% while increasing R&D. Meanwhile, R&D performance is also becoming visible. Chong Kun Dang's virtuous cycle is expected to continue as this year's top performance and investment momentum are maintained. On a separate basis, Chong Kun Dang announced that it recorded sales of ₩606 billion, operating profit of ₩62.4 billion, and net income of ₩43.2 billion. This is an increase of 21.13%, 74.79% and 85.41%, respectively, compared to the same period last year. Earnings surprise is expected this year. Chong Kun Dang's earnings have risen in the past four years (2015-2019) as well as this year. Sales increased 82.04% from ₩592.5 billion in 2015 to ₩1.08 trillion last year. In 2015, Chong Kun Dang's sales increased significantly with new drugs. Therefore, it is often used as a starting point for 2015 when discussing the performance of Chong Kun Dang. This year, even simple calculations, it seems possible to break through ₩1.2 trillion. The appearance doubles in 5 years. It is unusual for large pharmaceutical companies with large sales to double their sales in five years. This is because new drugs, etc., have been added to their own products. Looking at the second quarter of this year, JanuviaF (₩36 billion), Atozet (₩16.2 billion), Gliatilin (₩15.7 billion), Kcap (₩15.5 billion), Prevenar (₩13.7 billion), ProliaR (₩13.3 billion), Dilatrend (₩12.6 billion) and Lipilow (₩10.5 billion), exceeded ₩10 billion. It has 8 items of more than ₩40 billion per year. During this period, the operating margin remained around 8%. It was 7.21% in 2015, 7.37% in 2016, 8.83% in 2017, 8.16% in 2018, and 7.14% last year. This year's half was 10.3%. The industry highly appreciates the fact that Chong Kun Dang has made profits while increasing appearance and R&D costs. Chong Kun Dang spends more than 10% of sales as R&D expenses. It was 15.43% (₩91.4 billion) in 2015, 12.28% (₩102.2 billion) in 2016, 11.18% (₩98.9 billion) in 2017, and 12.01% (₩114.8 billion) in 2018. It spent ₩137.5 billion (12.75%) in last year and made the largest expenditure. An official said, "Usually, the higher the R&D cost, the more the profitability tends to deteriorate. It has both apperance-profitability-R&D as a strategy of introducing new drugs in the case of Chong Kun Dang." R&D performance is also becoming visible. In the case of EGFR/c-Met dual antibody (CKD-702), phase I/II clinical trials are currently underway for approximately 65 patients in 3 hospitals in Korea. The tumor suppression effect was confirmed in an animal model. There is a possibility of technology transfer, like 'Lazertinib', a tertiary non-small cell lung cancer treatment. Treatment for rheumatoid arthritis (CKD-506) will soon complete phase IIa clinical trials. The results will be announced at the American College of Rheumatology (ACR) in November. It can be expected to increase the value if the clinical effectiveness is confirmed.
- Company
- Sales of Duvie exceeded ₩10 billion in the first half
- by Chon, Seung-Hyun Aug 04, 2020 05:54am
- Chong Kun Dang's developed diabetes drug 'Duvie' exceeded the prescription record of ₩10 billion in the first half. It is strengthening its market competitiveness with the combination drug 'Duvimet'. Chong Kun DangAccording to UBIST on the 31st, the total amount of outpatient prescriptions for Duvie in June increased by 5.9% year-on-year to ₩10.4 billion. This is the first time that Duvie's prescription amount has exceeded ₩10 billion. Although the prescription drug market contracted somewhat in the aftermath of the COVID-19, Duvie’s sales continued to rise. Diabetic treatment drug 'Duvie', which was approved as a new domestic drug in 2013, is a Thiazolidinedione (TZD)-based diabetes treatment. It is a drug to treat type II diabetes called insulin-independent diabetes treatment. Duvie began to announce its presence by recording outpatient prescriptions of ₩6.6 billion in the first year of 2014. Chong Kun Dang surpassed ₩10 billion in sales for the first time, with a prescription of ₩12 billion in 2015. The prescription was recorded at ₩19.8 billion last year. If this trend continues, it seems likely that this year's prescription scale will exceed ₩20 billion. In fact, due to the risk of heart disease in 2010, Duvie was pointed out that the marketability is opaque because it is actually a drug like 'Avandia' that has been removed from the market. In November 2014, the US Food and Drug Administration (FDA) re-analyzed the clinical results of Avandia, and decided that Avandia's cardiovascular risk was not high, and released restrictions, so that Duvie came to be out of the risk of side effects. Since the experience of taking Duvie has accumulated, it is evaluated that the reliability has increased from medical staff and patients. In 2016, Chong Kun Dang released 'Duvimet', which added Metformin to Duvie. In the first half of this year, Duvimet increased by 29.1% from the previous year with a prescription of ₩900 million. Duvie and Duvimet jointly cooperated for ₩11.3 billion in the first half. Chong Kun Dang is also developing a new combination treatment using Duvie. Clinical trials are underway to explore the potential for combinations with the SGLT-2 inhibitor 'Empagliflozin' (Jardiance). A complex drug is being developed with the DPP-4 inhibitor 'Sitagliptin' (Januvia).
- Company
- Study of Statins vs Ezetimibe combination therapy is ongoing
- by Eo, Yun-Ho Aug 03, 2020 11:06am
- Studies are being conducted to directly compare Statin monotherapy and Ezetimibe combination therapy to Koreans. Yang-Soo Jang, professor at Yonsei University Severance Hospital, conducted a study comparing the efficacy of high-dose Statins and Ezetimibe combination therapy in primary therapy in patients with dyslipidemia with cardiovascular disease in more than 3,000 Korean patients. Major domestic medical institutions are participating. Statins showed excellent efficacy in the management of LDL-C and at the same time better efficacy in terms of cardiovascular mortality. There is no perfect medicine. However, there are concerns about musculoskeletal side effects and diabetes risk when using high-dose therapy. In this situation, the Statin + Ezetimibe combination has become a significant part of the prescription of dyslipidemia drugs with a great trend that the lower the LDL-C level, the lower is the better. But there is still a question of how good it is. In the 2015 IMPROVE-IT study, Ezetimibe was the only Non-Statin drug to prove its presence, but there was no study comparing Statin monotherapy with Ezetimibe combination therapy. Therefore, if the results of this study involving more than 3,000 Korean patients are drawn, the remaining questions will be resolved. The study will release its results in about three years. Heo Jung Ho, professor of cardiology at Kosin University Gospel Hospital, said, "Even if a high-dose Statin is prescribed, Ezetimibe combinations are currently selected when the 70mg/dL (Korean guidelines) or 55mg/dL (US guidelines), which can be called the LDL-C target values of various recommendations, is not reached. Personally, I expect the study to show clinically good results and efficacy in both groups."
- Company
- Next-gen Vemlidy prescription grows solely amid COVID-19
- by Kim, Jin-Gu Aug 03, 2020 11:06am
- Product image of Vemlidy The outpatient prescription sales of Gilead Science’s hepatitis B treatment Vemlidy (tenofovir) has gone up by 56 percent compared to the second quarter last year. Although the hepatitis B virus (HBV) infection treatment market size has shrunk amid COVID-19 pandemic, Vemlidy has performed at a satisfying level and salvaged the fall Viread took. ◆Vemlidy prescription volume leaps by 56 percent in a year According to pharmaceutical market research firm UBIST on Aug. 1, Vemlidy has made 6.6 billion won in the second quarter outpatient prescription. Compared to last year’s second quarter making 4.2 billion won, the figure grew by 56 percent. Vemlidy is a next generation HBV infection treatment Gilead Science has launched. It is an updated version of Viread, an existing blockbuster drug treating the infection. The two drugs share the same active pharmaceutical ingredient of tenofovir, but Vemlidy contains one-tenth of the substance. But its efficacy is on par with the existing drug and safety is improved. The novel drug was approved in May 2017. The prescription of the treatment took off from November of that year when it was listed. The prescription reached 7.4 billion won in 2018 and it grew up to 18.3 billion won last year, rightfully taking the title of blockbuster drug. In the first half of this year, the drug was already prescribed for over 10 billion won. Specifically, the prescription marked 12.5 billion won as of last June. Quarterly prescription volume of Viread, Baraclude and Vemlidy in last three years (Unit: KRW 100 million) Source: UBIST The prescription volume would rise even higher when the switch from Viread to Vemlidy, currently under discussion, is fully approved. Currently, the switch procedure is significantly complex according to the healthcare reimbursement standards. The coverage for the switched prescription is limited to patients developing tolerance, showing no reaction or demonstrating serious adverse reaction. The applicable adverse reaction is limited to patient showing estimated glomerular filtration rate (eGFR) less than 60ml/ min/ 1.73m2 and bone density T score lower than -2.5. Regardless, the medical professionals are arguing the standards are excessively tight. Basically, the switch is possible when a patient’s kidney fails completely. The issue was also addressed at last year’s National Assembly audit. The Ministry of Health and Welfare (MOHW) official said, “it would be reviewed when relevant guideline or literature are published overseas.” ◆Prescription dip in Baraclude by 13% and Viread by 28%, affected by COVID-19? Except for Vemlidy, most of the treatments experienced sharp fall in prescription volume. The top market leaders Viread and Baraclude (entecavir) have lost two-digit percent volume. From last year second quarter to this year second quarter, Gilead Science’s Viread prescription has plummeted by 28 percent from 30.6 billion won to 22 billion won. Bristol Myers Squibb’s (BMS) Baraclude prescription has also plunged by 13 percent from 20.2 billion won to 17.7 billion won. The research firm analyzes the COVID-19 pandemic has played a significant role in the rapid change. Due to the novel infectious disease, many patients avoided visiting the healthcare institute and naturally the prescription volume fell. Also the social distancing could have prevented the spreading of the HBV itself. Comparison of outpatient prescription volume of Baraclude generics (left) and Viread generics in second quarters of 2019 and 2020 (Unit: KRW 100 million) Source: UBIST The generics of Viread and Baraclude had mixed outcome. Baraclude generics took a fall in prescription volume, but Viread generics had a surge. The 20 Baraclude generics’ overall prescription volume fell by 10 percent from 8.2 billion won to 7.4 billion won. Dong-A ST’s Baracle was prescribed the most raising 2.2 billion won, followed by Bukwang Pharm’s Bukwang Entecavir (1.1 billion won), Samil Pharm’s Enped (1 billion won), Daewoong Pharmaceutical’s Baracross (500 million won) and Hanmi Pharmaceutical’s Cavir (500 million won). On the other hand, 18 Viread generics’ prescription volume has risen by 9 percent from 3.4 billion won to 3.7 billion won. Dong-A ST’s Virreal had a 45-percent surge from 600 million won to 900 million won. Following after Virreal, Chong Kun Dang’s Tenofobell (800 million won), Daewoong Pharmaceutical’s Virehepa (400 million won), Jeil Pharm’s Tecavir (300 million won) and Samjin Phrm’s Tenolid (300 million won) also had a positive growth in prescription over the year.
- Company
- Generics for NOAC will be released
- by Kim, Jin-Gu Aug 02, 2020 09:47pm
- In the oral anticoagulant (NOAC) market, which forms a market of ₩200 billion annually, the prescription performance of items other than Lixiana has decreased. Generics are gradually increasing sales. The competition in this market is expected to intensify if generics for Xarelto and Pradaxa are released next to generic for Eliquis next year. ◆Lyxiana's sales increased 6% over the same period last year According to UBIST, a pharmaceutical market research agency on the 28th, the total amount of NOAC outpatient prescriptions in the second quarter reached ₩46 billion. This is a 2% increase compared to ₩45.1 billion in the second quarter of 2019. Changes in NOAC The overall prescription size rose slightly, but the prescription amount of most of the original items decreased. Only Daiichi Sankyo's Lixiana increased 6% from ₩15 billion to ₩15.9 billion during the same period. Bayer's Xarelto decreased 4% from ₩13bn to ₩12.5bn, and BMS’ Eliquis fell 3% from ₩12.5bn to ₩11.2bn. Beringer Ingelheim's Pradaxa fell 21% from ₩4.6 billion to ₩3.6 billion. In the case of Eliquis, it was dropped due to the release of generics, but the BMS applied for suspension through administrative action and the court accepted it, and the disposition was postponed. In the future, The amount of prescriptions may decrease depending on the outcome of the lawsuit in the future. Outpatient ◆Generic sales are on the rise while original prescription performance is slow As the growth of original products in the NOAC market has stagnated since the second quarter of last year, generics are gradually increasing their influence. Generic for Eliquis 2nd Quarter of Rx Results (Unit: ₩1 million, Data:UBIST)Currently, only generics for Eliquis has been released on the market. Starting with Chong Kun Dang and Yuhan in the second quarter of last year, 12 pharmaceutical companies are currently selling generics. In the overall NOAC market, generics' prescription increased from 0.1% in the second quarter of 2019 to 0.8% in the third quarter, 1.7% in the fourth quarter, 3.0% in the first quarter of 2020, and 4.0% in the second quarter of 2020. Among the generic items in the second quarter of this year, Liquixia ranked first with ₩500 million of prescription results. It was followed by Samjin's Elxaban (₩400 million), Yuhan's Apixaban (₩300 million), and Aju's Eliban (₩200 million). ◆Generic for Xarelto and Pradaxa waiting to be released… Intensifying competition from next year Next year, generic for Xarelto and Pradaxa are on the way. Competition is expected to intensify from next year, when the trial period ends. The launch of generic for Pradaxa is the first. Huons, Aju, Introbiopharma, and Jinyang will take the right to generic exclusivity after July 2021, when the material patent expires. After April 2022, when the trial period ended, other pharmaceutical companies could also compete. Currently, the remaining items approved by the MFDS are 12 items from 6 companies. Xarelto’s patent expires in October 2021. SK Chemicals and Hanmi won the right. The remaining 28 pharmaceutical companies will be able to launch products after July 2022. In the case of Lixiana, which is currently the No. 1 item on the market, The patent expires in November 2026. Boryung, Samjin, HK inno.N, Chong Kun Dang, Kolmar, Hutex, Kolmar Korea, and Hanmi, which have succeeded in patent avoidance, are expected to compete for the launch of first generic.
- Company
- Choline alfoscerate companies anxious of returning claims
- by Chon, Seung-Hyun Jul 31, 2020 06:34am
- Companies with cognitive enhancer choline alfoscerate products are to face another hurdle. Specifically, the companies are concerned of the clause stipulating the return of the claimed reimbursement when failing the clinical reevaluation during the pricing renegotiation for a product surging in sales. As South Korea’s Ministry of Food and Drug Safety’s (MFDS) clinical reevaluation process has been set, some companies are faced with marketing approval revocation and prescription sales return in the worst case scenario. According to pharmaceutical industry sources on July 30, the price-volume agreement (PVA) negotiation that National Health Insurance Service (NHIS) and pharmaceutical companies are to engage has included a number of choline alfoscerate generics. PVA allows an adjustment of pricing of a drug with a significant surge in use volume through a negotiation between pharmaceutical company and NHIS. Regardless of original or generic, a drug falling under the category of ‘making over 60 percent increase in claim amount compared to the year before, or making over 10 percent increase but increased by over 5 billion won,’ would be designated as a subject for PVA negotiation. Apparently ten choline alfoscerate products have been included for the coming PVA negotiation. As the medication market tends to expand rapidly every year, many generics in the market saw a sharp increase in prescription volume. A pharmaceutical market research firm UBIST found the choline alfoscerate’s outpatient prescription volume in the first half of the year reached 224.1 billion won, growing 19.6 percent from last year. The market volume has tripled in five years from 70.5 billion won in the first half of 2015. Quarterly outpatient prescription volume made in choline alfoscerate (Unit: KRW 1 million) Source: UBIST Regardless, the choline alfoscerate companies notified to participate in the PVA negotiation seems to be pressured about the sales return regulation. In accordance to NHIS drug pricing agreement, a company conducting a clinical trial for item approval renewal and pharmaceutical reevaluation by MFDS is stipulated to notify the details to NHIS. In case the company fails the reevaluation and loses approval, the responsible company has to pay NHIS back all reimbursement claimed from the date the MFDS ordered clinical trial through the date the listing was removed. Ultimately, if a company decides to withdraw its product from the market due to reevaluation outcome after agreeing on the choline alfoscerate’s pricing cut according to PVA negotiation, the company has to return all sales generated in between to NHIS. Choline alfoscerate is actually subjected to undergo clinical reevaluation. MFDS has recently demanded companies with choline alfoscerate products to submit clinical trial data. The relevant protocol has to be submitted by Dec. 23. The companies unable to prove efficacy of their choline alfoscerate during the clinical trial, the products may lose the government approval. And those companies that settled on the PVA would have to refund all prescription sales made from negotiation through approval revocation. And the product partially changing the indication due to clinical reevaluation would also have to return the prescription sales generated from the removed indication. Choline alfoscerate has been indicated to treat patients showing secondary symptoms of cerebrovascular insufficiency and degenerative brain-organic psychiatric syndrome— impairment of sense of direction, motivation, judgment and concentration due to confusion and degenerated memory, judgment and motivation; changes in emotions and behaviors—emotionally insecure, hypersensitive to stimulation, and indifferent to surrounding; and senile pseudo-depression. If any one of the indication gets removed, the pharmaceutical companies would have to pay back a part of their sales to NHIS. And the pharmaceutical industry experts predict the clinical reevaluation would likely to remove at least one of the indications. In fact, another cognitive enhancer acetyl-L-carnitine has lost one of indications after undergoing the clinical reevaluation. The original acetyl-L-carnitine Nicetile by Dong-A ST was indicated to treat patients with primary degenerative disease and secondary degenerative disease induced by cerebrovascular disease. However, the medication failed to demonstrate the efficacy of treating primary degenerative disease in the clinical reevaluation ordered by MFDS in 2015, the indication was removed in July last year. Acetyl-L-carnitine product that had PVA negotiation has to pay back all prescription sales made from the point of negotiation through indication removal. While the health authority has decided to apply selective reimbursement on choline alfoscerate, the companies with the medication subjected to PVA negotiation are heavily burdened. On July 24, MOHW convened the Health Insurance Policy Deliberation Committee (HIPDC) meeting and deliberated reimbursement reevaluation result and applying selective reimbursement on choline alfoscerate. The patient copayment rate on choline alfoscerate would be raised from 30 percent to 80 percent. MOHW preannounced the amendment and plans to enforce it from August. A pharmaceutical company insider complained, “When the market is unstable due to coverage reduction and clinical reevaluation, the company feels even more strained about the risk of returning prescription sales only because of making a significant growth in recent sales and clinical reevaluation result.”
- Company
- LG Chem begins development of Zemiglo + SGLT-2 inhibitor
- by Kim, Jin-Gu Jul 31, 2020 06:33am
- LG Chem will develop a combination of DPP-4 inhibitor and SGLT-2 inhibitor. Currently, three items are permitted as a combination, but no drug has been developed by a domestic pharmaceutical company. According to the pharmaceutical industry on the 29th, the MFDS recently approved LG Chem's Phase I trial plan which comparing the pharmacokinetics, safety and tolerability when Gemigliptin 50mg and Dapagliflozin 10mg are administered respectively and together. ZemigloGemigliptin is a DPP-4 inhibitor developed by LG Chem itself. It is Zemiglo. Dapagliflozin is generic for AstraZeneca's SGLT-2 inhibitor Forxiga. Currently, there are three products approved in Korea for the combination of DPP-4 inhibitor and SGLT-2 inhibitor. No products have been developed by domestic companies yet. Beringer Ingelheim's Glyxambi (Empagliflozin-Linagliptin) and AstraZeneca's Qtern (Dapagliflozin-Saxagliptin) were each approved in March 2017. MSD's'Steagluzan (Citagliptin + Ertugliflozin)' was approved in September 2018. If LG Chem succeeds in developing complex drugs, it will be the fourth drug in the Zemiglo series. Currently, LG Chem possesses ▲DPP-4 inhibitor single ingredient Zemiglo ▲DM complex, Zemimet (Gemigliptin/Metformin) ▲DM and hyperlipidemia complex Zemiro (Gemigliptin/Rosuvastatin). The total prescription amount for the three products last year was ₩97.9 billion. This year, ₩56 billion worth was prescribed until the first half. The products are likely to exceed ₩100 billion annually. ◆The key is whether DPP-4·SGLT-2 combination therapy benefits are recognized. The Korean Diabetes Association submitted an opinion to the government in April that a combination of DPP-4 inhibitors and SGLT-2 inhibitors would require benefits. Prior to this, in 2018, the government tried to find a way to apply benefits. In February of this year, LG Chem and Dong-A ST launched in June, and in June, Handok launched clinical trials. In the case of LG Chem, it is to verify the combination therapy of Zemiglo and Dapagliflozin or Empagliflozin. Dong-A ST also entered a combination clinical trial of its DPP-4 inhibitor, Suganon (Evogliptin) and Dapagliflozin or Empagliflozin. Handok has also been approved for a clinical trial plan to verify the combination therapy of its DPP-4 inhibitor Tenelia (Teneligliptin) and SGLT-2 inhibitor. An official in the pharmaceutical industry said, "If the government recognizes the combination therapy of DPP-4 inhibitors and SGLT-2 inhibitors as reimbursed items, it will be possible to prescribe combination drugs as well as combination therapy."
- Company
- GC Pharma, applied for Phase II clinical trial of GC5131A
- by Kim, Jin-Gu Jul 31, 2020 06:31am
- GC Pharma announced on the 29th that it had applied to the MFDS for a clinical trial phase II plan for COVID-19 blood plasma tx, 'GC5131A'. Samsung Medical Center, Asan Medical Center, Chung-Ang University Hospital, Korea University Ansan Hospital, and Chungnam National University Hospital are targeting 60 people. 'GC5131A' is a Hyperimmune globulin made by extracting various effective immune antibodies from the plasma (liquid component of blood) of COVID-19 recovery patient. It has been reported that Hyperimmune globulin has been used in the human body for a long time, so it has been developed rapidly. If the MFDS approves the clinical trial plan, it will enter the Phase II clinical trial in Korea among the candidates for new drugs, excluding products that have initiated the clinical trial through drug re-creation. The GC Pharma explained that production of clinical trial preparations has been completed and that patients will be administered as approved by the MFDS. “We will do our best to put GC5131A into the medical field in a short period of time,” said Kim Jin, head of Medical division, GC PHarma. On the other hand, it is explained that the blood plasma treatment is different from convalescent plasma therapy, which is used to transfuse the plasma of patients in the recovery phase to severely ill patients. Blood plasma therapy is a kind of medical practice, and blood plasma treatment is a medicine made by fractionating only the immunoprotein containing antibodies from the plasma and concentrating it at a high concentration.
