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- 2026-04-16 11:26:58
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- Tecentriq can be prescribed at Big 5 hospitals
- by Eo, Yun-Ho Aug 05, 2020 06:25am
- The indication for triple negative breast cancer of the immuno-cancer drug'T-Sentric' is expanding. According to the related industry, Tecentriq 850mg used for triple-negative breast cancer (TNBC) passed the drug commitee (DC) at 20 major hospitals nationwide, including the Big 5 General Hospital, including Seoul National University Hospital, Severance Hospital, Asan Medical Center, and Seoul St. Mary's Hospital. Triple negative breast cancer among breast cancers, which has a negative response to all receptors (estrogen, progesterone, HER2), has been difficult to resolve for a long time. The anti-immune cancer drug 'Tecentriq (Atezolizumab)' with a mechanism of PD-L1 inhibition has been approved as TNBC therapeutic agent, and physicians are looking forward. Tecentriq is the only immune cancer drug that has secured TNBC indications. Tecentriq obtained approval from the MFDS on January 30 for combination therapy with Abraxane (albumin-bound Paclitaxel) in the treatment of patients with non-resectable, locally advanced or metastatic triple negative breast cancer, which is PD-L1 positive, who had not previously undergone chemotherapy at the metastatic stage. It is based on the results from the Phase III IMpassion130 study. Progression-free survival (PFS) results demonstrated a statistically significant benefit for Tecentriq in combination with nab-Paclitaxel (Abraxane) and showed that Tecentriq plus nab-Paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 38% compared with nab-paclitaxel alone (median PFS=7.5 vs 5 months; hazard ratio [HR]=0.62, 95% CI: 0.49-0.78, p
- Company
- Eisai’s lifestyle app HeLpy for living the healthier life
- by Eo, Yun-Ho Aug 05, 2020 06:25am
- Captured image of HeLpy app users logging and sharing the app use Eisai Korea reported their employees are enjoying the ‘Healthier HeLpy Life’ with the company’s personal lifestyle app ‘HeLpy’ launched in January. The employees health-conscious life started as the company decided to manage their health amid COVID-19, when the busy employees struggled to keep themselves healthy with restricted physical activity. The so-called ‘Healthier HeLpy Life’ project initiated from July 1 and had the employees to set their personal health goals on the HeLpy app and to constantly monitor their healthier lifestyle achieving the set goals. About 200 employees selected their concerning health issues, such as blood pressure, blood glucose level, drinking and smoking cessation and weight watch, and chose health goals personally recommended by the app by disease risk indicators. During the project, the employees kept a log of their changes and shared them on the community board to encourage each other. In just a month of using the HeLpy app, the employees reported their improved health indicators like blood pressure and blood sugar level through weight loss, and experiences of fixing body posture and losing pains in back and neck by regularly working out. The company anticipates the employees would continue to manage their health through the app for a while. Eisai Korea also plans to continue operating the employee health management program using the HeLpy app. Since its launch in January, HeLpy app has been downloaded for over 300,000 times and attracted 150,000 members. The app is scheduled to provide an extensive renewal update in September to enhance user experience and interface and introduce various points system to promote new membership and active use of the app.
- Company
- Indications for Keytruda·Tecentriq are actively expanding
- by Eo, Yun-Ho Aug 05, 2020 06:24am
- #Expansion of indications for immunocancer drugs continues. According to the related industry, MSD Korea recently obtained the approval for the expansion of indications of inhibitor 'Keytruda (Pembrolizumab)' in head and neck cancer, and Roche Korea's PD-L1 inhibitor 'Tecentriq (Atezolizumab)' in liver cancer. Keytruda can be prescribed for chemotherapy and combination therapy in primary treatment of metastatic or non-surgical recurrent head and neck squamous cell carcinoma and as monotherapy in primary treatment of metastatic or non-surgical recurrent head and neck squamous cell carcinoma with positive PD-L1 expression. The approval for this indication was based on KEYNOTE-048, a phase III clinical study in which Keytruda alone, anti-cancer chemotherapy and combination therapy were evaluated in comparison with a control group (Cetuximab and platinum-based chemotherapy). As a result of the study, the median overall survival (OS) of Keytruda alone and chemotherapy in patients with CPS 1 or higher was 12.3 months and 13.6 months, respectively, and significantly improved compared to 10.3 and 10.4 months in each control group. Median Progression Free Survival (PFS) values were 3.2 months and 5.0 months, respectively, in Keytruda alone and in combination therapy. The results of the study were published in Lancet. Tecentriq can be prescribed with a combination of the targeted anticancer drug 'Avastin (Bevacizumab)' as a primary therapy in patients with non-resectable hepatocellular carcinoma who have not previously received systemic treatment. The approval was based on the Phase III clinical trial of IMbrave150. The results of the IMbrave150 study were first unveiled at the European Society for Medical Oncology (ESMO) Asia Conference in November 2019, and in May of this year, the New England Journal of Medicine (NEJM). The IMbrave150 trial was conducted in patients with non-resectable hepatocellular carcinoma who had no previous systemic treatment experience. Patients who participated in the clinical trials were randomized to 2:1 in the treatment group of Tecentriq-Avastin and Sorafenib alone, and were treated until unacceptable toxicity or clinical efficacy was lost. The primary endpoints were overall survival (OS) and PFS. Studies have shown that the combination therapy of Tecentriq-Avastin reduced the risk of death by 42% compared to Sorafenib. The follow-up of 8.6 months (median value) in the group administered with Tecentriq-Avastin did not reach the median value until the data cut-off, whereas the control group was found to be 13.2 months (median value). In addition, the treatment with Tecentriq also improved the risk of disease progression and death by 41%. The PFS (median value) of the Tecentriq combination group was 6.8 months, which was 2.5 months longer than that of the control group.
- Company
- 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.
- Policy
- Zytiga, Mavyret and 161 items monitored for PVA negotiation
- by Lee, Hye-Kyung Aug 05, 2020 06:24am
- The South Korean health authority added Korea Otsuka Pharmaceutical’s Iclusig tablet (ponatinib hydrochloride hydrate), Jassen Korea’s Imbruvica capsule (ibrutinib), Zytiga tablet (abiraterone acetate) and Darzalex (daratumumab) as subject for the third quarter price-volume agreement (PVA) negotiation and monitoring. Merck’s Erbitux injection (cetuximab), MSD Korea’s Zepatier tablet and AbbVie Korea’s Mavyret tablet are other addition to the list. On its website, National Health Insurance Service (NHIS) recently posted the list of drugs to be monitored for the PVA negotiation (Type Ga and Na) during the third quarter. The PVA system stipulates NHIS and pharmaceutical companies to share the NHI finance risk, and lowers pricing of a drug with surged use volume after negotiating with NHIS. In the third quarter, 163 items in 89 classes would be monitored. The PVA monitoring list included Sam-oh Pharm’s Vimizim injection (elosulfase alfa), Sanofi-Aventis Korea’s Mozobil injection (plerixafor), SK Plasma’s SK Albumin, and Roche Korea’s Mircera prefilled injection (methoxypolyethyleneglycol-epoetin beta). Korea Otsuka Pharmaceutical’s Samsca tablet (tolvaptan spray dry powder) and Yuhan’s Prakanon tablet (pranlukast hydrate) have also been added to the list. The Type Ga (가) PVA negotiation is applicable on a drug that exceeded the benefit claim amount by 30 percent over the projected claim amount set according to pricing negotiation with NHIS, projected claim negotiation, pricing increase adjustment negotiation and indication expansion negotiation. The Type Na (나) PVA negotiation is applicable on a drug either completed the Type Ga negotiation or reaches annual claim amount after a year since the day the Type Ga monitoring period ended without a negotiation in four years that exceeds previous year’s claim by 60 percent or 10 percent but surpassing 5 billion won. However, drugs claiming less than 1.5 billion won annually or having upper limit pricing lower than average pricing among same class drugs, low-priced drug and shortage prevention drug are exempted from the PVA negotiation.
- 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.
- Policy
- COVID-19 vaccine release time can be judged in phase III
- by Lee, Hye-Kyung Aug 04, 2020 05:54am
- Mook Hyun-sang, Head of the KDDF With the time to release the COVID-19 vaccine, a domestic expert said that it is not yet in the stage of discussion. Mook Hyun-sang, the head of Korea Drug Development Fund (KDDF) announced the results at the future open discussion with the theme of 'COVID-19 vaccine, global development trend and securing strategy' co-sponsored by the MOHW and the KHIDI. He said, "In the WHO announcement as of July 28, there are five COVID-19 vaccines in progress in phase III, and there are opinions among foreign experts that if the phase I/II drugs are confirmed, the vaccine can be released within this year, and safety must be carefully considered." In relation to the release of the vaccine, the director of the NIAID, Fauci, said, "If only phase I and II drugs are confirmed, a licensed vaccine can be released within this year." Ken Frazier, the president and CEO of MSD, who developed the Gardasil said, "we have developed most of the new vaccines in the last 25 years, but it's not a simple thing to prove safety." He said that Dr. Fauci is hopeful, and President Frazier is in a position to go safely. No one can say that the vaccine will be released within six months, a year or two. The conclusion emphasized that it is possible to discuss the timing of vaccine release only after confirming the data of the inoculated patients after 3 and 6 months in phase III. In addition, regarding the price of vaccines, AstraZeneca predicts that supply contracts will be made at around $8 per person and Moderna at around $50 per person. He was concerned that vaccine prices range from $8 to $50 depending on how they are negotiated, If the Korean population is 1 billion, it will receive a good price, but negotiations are ambiguous in the situation of 50 million. He judged that it is reasonable for the government's strategy to make efforts to develop and secure the COVID-19 vaccine through a two-track strategy, such as the introduction of the vaccine itself and the introduction of overseas vaccines. He said, "Since we haven't made efforts on the vaccine source technology, it is not easy to enter into global joint research and development. Therefore, the government is pursuing a strategy to introduce the vaccine itself and introduce it into overseas development. Japan has also signed a CMO contract with AstraZeneca and Daichi Sankyo, and the MOHW is also making efforts to sign a CMO contract with SK Biosciences."
- 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."
