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- 2026-03-19 04:06:25
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- 902 trials around the world seeking for COVID-19 treatment
- by Kim, Jin-Gu May 06, 2020 06:32am
- 100 days have passed since the first confirmed case of COVID-19 was reported in Korea. While Korea seems to have flattened the curve, other countries like the U.S. and European countries are still enforcing strict emergency orders. Meanwhile, the global community is unprecedentedly speeding up the treatment and vaccine development. As of Apr. 27, total 902 cases of COVID-19 related clinical trials are reportedly in process. Compared to 66 cases reported in early March, the number has multiplied by 13.6 times. The world’s largest clinical trial registry by the U.S. National Institutes of Health (NIH), ClinicalTrials.gov has been keeping up with the number. Among those trials, 404 cases are testing pharmaceuticals. 190 drugs or candidate medicine are undergoing clinical trial to be labeled as a COVID-19 treatment. Most of the ongoing studies around the world are for drug repurposing. Instead of testing new candidate medicine, the studies aim to reevaluate existing drugs as a COVID-19 treatment. COVID-19 related clinical trials conducted around the world as of Apr. 27 (Source: ClinicalTrials.gov) Currently, hydroxychloroquine has been the most popular medicine to be tested. Total 114 cases are confirming hydroxychloroquine’s efficacy and safety profile (including redundant cases). And axithromycin is the second most popular medicine with 28 cases. Industry sources see that the U.S. President Donald Trump’s comments have heavily affected the number of studies in hydroxychloroquine and axithromycin. At the White House press conference, President Trump has expressed his optimism for those two drugs to be the game changer amid pandemic. Unlike his words, however, the outcome seems to have been rather disappointing. An interim report of a U.S. study found the treatment did not demonstrate significant effect, but almost doubled the mortality rate. Following those two drugs, AbbVie’s HIV treatment Kaletra (lopinavir plus ritonavir) is running 21 clinical trials. But Kaletra also had a number of studies reporting no significant effect on COVID-19 treatment. The sources say the drug would unlikely to be labeled as a COVID-19 treatment, unless it reports otherwise in other studies. Tocilizumab (Brand name: Actemra) used for treating multiple myeloma has ranked itself on the fourth spot with 20 ongoing trials. The interleukin-6 inhibitor is expected to prevent the cytokine storm. As a majority of the COVID-19 patients experience cytokine storm, a form of systemic inflammatory response syndrome, pharmaceutical experts have high hopes for the treatment. Interestingly, a number of hypertension treatments were included in the COVID-19 treatment related studies. 12 studies are testing losartan and other angiotensin II receptor blockers (ARBs), eight studies are testing angiotensin-converting enzyme (ACE) inhibitors, and calcium-channel blockers (CCB) and diuretic each have one study in progress. In total, there are 22 antihypertensives in testing. Among ARBs, losartan (6), telmisartan (2), candesartan (1) and valsartan (1) have the most number of ongoing tests, in the order. Two other studies have undisclosed substances in trial. Other drugs like myelofibrosis treatment ruxolitinib (Brand name: Kakavi) and a corticosteroid methylprednisolone have 11 and 10 clinical trials in progress, respectively. Remdesivir, a highly anticipated potential COVID-19 treatment, has total of nine trials in progress at the moment, which the three of them are conducted in Korea. The results of remdesivir clinical trials would be unveiled next month at earliest. Also, Japanese-made favipiravir (Brand name: Avigan), a rheumatoid arthritis treatment sarilumab co-developed by Sanofi and Regeneron, and an antiprotozoal medicine nitaxosanide respectively have eight trials in process. While a gout treatment colchicine and a rheumatoid arthritis treatment anakinra have seven and six ongoing trials, a Soviet-developed flu drug Arbidol and a corticosteroid medication dexamethasone each have five ongoing clinical trials.
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- General hospitals ready to prescribe Verzenio
- by Eo, Yun-Ho Apr 28, 2020 06:24am
- The general hospitals in Korea have started entering the anticancer treatment Verzenio’s prescription code. According to pharmaceutical industry sources, drug committees at major general hospitals like Seoul National University Hospital, National Cancer Center, Ajou University Hospital and Chonnam National University Hwasun Hospital have recently cleared Lilly’s Verzenio (abemaciclib). When the company successfully completes the pricing negotiation with National Health Insurance Service (NHIS), Verzenio would be prescribed more consistently with the insurance reimbursement. The medication is in process of settling a risk sharing agreement (RSA) to receive reimbursement to treat patients with HER2- advanced breast cancer in combination with AstraZeneca’s Faslodex (fulvestrant). Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor Verzenio can be prescribed to perimenopausal women with HR+/HER2- advanced or metastatic breast cancer either for first-line endocrine therapy combined with an aromatase inhibitor, or for combination therapy with Faslodex after receiving endocrine therapy. The first-in-class CDK4/6 inhibitor Ibrance by Pfizer requires seven days of off treatment after 21 consecutive days of once-daily 125 mg administration, whereas Verzenio can be administered every day. Ibrance is also negating with the government over the pricing, at the moment. Ibrance’ efficacy of significantly improving progression-free survival (PFS) as a second-line therapy has been confirmed during PALOMA-3 study. Besides patients with early stage breast cancer, the CDK4/6 inhibitor showed consistent effect on patients with stage 4 metastatic breast cancer that affected their lungs and bones. Verzenio has recently attracted the industry’s interest, when it completed MONARCH2 study as it not only improved PFS, but also improved overall survival (OS). The achievement was unprecedented for a CDK4/6 inhibitor. As a part of secondary endpoints, the OS of both pre and postmenopausal women was observed.
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- Boryung records new quarterly operating profit
- by Chon, Seung-Hyun Apr 28, 2020 06:23am
- Boryung showed good results in the first quarter. Despite COVID-19, operating profit was the largest ever. Sales also rose from last year. The self-developed drug 'Kanarb Family' led the improvement. Boryung announced on the 24th that its operating profit in the first quarter increased by 42.1% year-on-year to ₩13.4 billion. During the same period, sales increased by 13.0% year-on-year to ₩134.2 billion, and net profit decreased 6.1% to ₩8.3 billion. 1Q operating profit is the largest ever. It surpassed ₩11.9 billion recorded in the third quarter of last year. After the spread of COVID-19, patients' concerns about sluggish sales due to a decrease in visits to medical institutions were dispelled. Kanarb Family led the rise in earnings. According to pharmaceutical research firm UBIST, Kanarb recorded an outpatient prescription amount of ₩12.3 billion in the first quarter. It increased 5.8% from the same period last year. Kanarb (Fimasartan), is an ARB (Angiotensin II receptor blocker) type hypertension treatment developed by Boryung. The growth trend of combination drugs using Kanarb was remarkable. 'Dukarb', a combination of Kanarb and calcium channel blocker (CCB) drug 'Amlodipine', was prescribed in the first quarter of ₩8.4 billion, an increase of 26.2% from the same period last year. 'Tuvero', which combines Kanarb with 'Rosuvastatin', an ingredient for hyperlipidemia treatment, was prescribed amount of ₩1 billion. The four combination drugs including Kanarb, such as Dukaro (₩200 million) combination of “Fimasartan, Amlodipine, and Rosuvastatin” released in February, jointly totaled ₩21.9 billion in the first quarter alone. The anti-ulcer drug “Stogar” also contributed to the increase in earnings. Stogar's prescription performance in the first quarter was ₩5.1 billion, up 64.5% from the previous year. Stogar is the same H2 receptor antagonist that was discontinued last year due to excessive detection of impurities, and prescriptions surged due to reflex benefits from Ranitidine withdrawal. The growth trend of new drug products, which have been licensed by multinational pharmaceutical companies, also contributed to the expansion. 'Trulicity', a diabetes treatment drug introduced and sold by Boryung from Lily, recorded an outpatient prescription amount of ₩8.3 billion, up 19.4% YoY in 1Q. The company explained that the spread of COVID-19 contributed to improved profitability. The decrease in sales management expenses due to the contraction of operating activities contributed to the increase in operating profit.
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- Flu drug prescription plummets by 21% due to COVID-19
- by Kim, Jin-Gu Apr 28, 2020 06:23am
- The general prescription volume of influenza medications treatment has gone down drastically. Compared to the previous season, this season’s volume has plummeted by 21.0 percent. The flu treatment prescription seems to have been affected by the COVID-19 outbreak. The threat of the virus has particularly raised the awareness of personal hygiene nationwide, which ironically ended the flu season earlier than expected. ◆Lowest prescription volume in last six seasons, generics got impacted worse than the original According to the data released by pharmaceutical market research firm UBIST on Apr. 23, total 15.3 billion won was generated from prescribed flu medications in Korea from November 2019 to March 2020. Compared to 19.4 billion won made in the previous flu season (November 2018 to March 2019), the volume fell significantly by 21.0 percent. Since the 2014-2015 season six years ago, the prescription volume has hit the lowest point. (Left) Prescription volume of Tamiflu and generic in last six influenza season (Unit: KRW 100 million) Source: UBIST. (Right) Number of influenza patients in last six seasons* (Unit: 10,000 people) Source: Health Insurance Review and Assessment Service. *Accurate number of patients has not been reported, yet, for the 2019-2000 season. Most of the 38 medications in Korea took the steep fall. Even the prescription volume of Roche’s Tamiflu, the original oseltamivir, was decreased by 18.3 percent from 6.2 billion won to 5.0 billion won. The 37 oseltamivir generics had even steeper fall of 22.5 percent and the volume plunged from 13.2 billion won in the previous season to 10.3 billion won this season. Major generic products like Hanmi Pharmaceutical’s Hanmi Flu prescription volume had a 31.0 percent dip from 4.7 billion won to 3.2 billion won, while the volumes of Kolon Pharmaceutical’s Comyflu, Yuhan’s Yuhan N Flu and Jeil Pharm’s Flu-one were loweredl by 8.4 percent (from 1.3 billion won to 1.2 billion won), 25.7 percent (from 1.1 billion won to 800 million won) and 16.8 percent (from 600 million won to 500 million won), respectively. In this season, on the contrary, the prescription volumes of Arlico Pharm’s Tamipro (30.8 percent), CTC Bio’s Easy Flu (16.9 percent) and Boryung Biopharma’s Boryung Flu (1.8 percent) have surged, regardless of the decrease in general patient size. Comparing prescription volume of major flu treatment in 2018-2019 season and 2019-2020 season (Unit: KRW 1 million) Source: UBIST ◆Flu season ends 84 days shorter, “Infection was well-controlled due to COVID-19”” The flu medication prescription volume is heavily affected by the severity and patient size of the respective flu season. In the 2017-2018 flu season that reach the highest flu treatment prescription volume at 30.7 billion won, the flu patient size also reached the highest at 2.24 million. And this season has ended earlier than usual with far less patient size. The Korea Centers for Disease Control and Prevention (KCDC) has lifted the influenza alert on Mar. 27, after 134 days. Considering the 2018-2019 flu season lasted for 218 days, the last season lasted 84 days shorter. Apparently, the severity of the influenza was not so potent. Only average of 5.9 out of 1,000 people was infected by the flu, which is the lowest figure in the latest six seasons. In the previous season, the average rate was at 6.3 out of 1,000 people. Duration of flu seasons and average patient number in 1,000 people. Source: KCDC The pharmaceutical industry experts claim the COVID-19 outbreak has ironically help the flu season to end faster. As the novel coronavirus spread through the country, majority of the people in Korea stayed at home and paid an extreme attention to their own personal hygiene, which prevented severe spread of the influenza. A pharmacist with a pharmacy in the metropolitan area commented, “Even in last January, three or five Tamiflus were sold a day, but since the COVID-19 outbreak the number dropped to zero. As so many people are avoiding outdoor activity and paying a close attention to personal hygiene, the number of patients with influenza and common colds has gone down significantly.”
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- Rx amount for Ezetimibe·Statin increased 5 times in 4 years
- by Chon, Seung-Hyun Apr 28, 2020 06:23am
- The combination of Statin and Ezetimibe in the hyperlipidemic drug market is rapidly increasing. Over the past four years, outpatient prescription amount has increased five times. It was prescribed more than ₩100 billion in the first quarter. The prescription scale of the combination of 'Rosuvastatin·Ezetimibe' such as Hanmi's 'Rosuzet', MSD's 'Atozet', and Yuhan's 'Rosuvamibe' has expanded rapidly. According to UBIST, a pharmaceutical research institute on the 23rd, the outpatient prescription scale of the combination of Ezetimibe and Statin in the first quarter was ₩109.1 billion, an increase of 23.3% from the previous year's ₩885 billion. The combinations of Statin·Ezetimibe have become increasingly popular in recent years. In the first quarter of 2016, the prescription amount of Statin·Ezetimibe was only ₩23.8 billion, but it expanded 4.6 times in four years. Quarterly Statin·Ezetimibe outpatient Rx amount (Unit: ₩100 million, Source: UBIST) The combinations of Statin·Ezetimibe have an excellent effect on lowering low-density low-protein cholesterol (LDL-C), and it is not expensive, so it seems to have a high preference. In recent years, it is analyzed that the market size has expanded as domestic pharmaceutical companies have competitively released combination drugs combining Rosuvastatin and Ezetimibe. In Korea, a combination of Ezetimibe and Statins such as Simvastatin, Rosuvastatin or Atorvastatin is on the market. The growth of 'Rosuvastatin and Ezetimibe' combinations has been outstanding. In the first quarter, the prescription size of 'Rosuvastatin and Ezetimibe' combinations amounted to ₩80.9 billion, accounting for 74.1% of the prescription amount of 'Statin and Ezetimibe' combinations. At the end of 2015, Hanmi’s Rosuzet, the combination of 'Rosuvastatin and Ezetimibe' first released on the market. The combination of 'Rosuvastatin and Ezetimibe' continued to rise sharply after exceeding ₩10 billion in prescriptions in the second quarter of 2016. In the first quarter of 2017, it soared from ₩27.4 billion to three times in three years. Currently, the competition is fierce, with 29 pharmaceutical companies offering 'Rosuvastatin·Ezetimibe' combinations. Rosuzet's 1Q prescription amount was ₩22.8 billion, up 27.4% from the previous year. After recording the prescription amount of ₩80 billion last year, this year is expected to exceed ₩100 billion. Outpatient Rx amount of Statin·Ezetimibe by month (Unit: ₩1 million, Source: UBIST) Hanmi secured the right to use Ezetimibe from patent holder MSD, and the strategy that entered the market before competitors was effective. Since October last year, Rosuzet has continued its monthly prescription amount of ₩7 billion and recorded ₩8 billion last month. Among the combinations of 'Rosuvastatin·Ezetimibe', Yuhan's Rosuvamibie recorded a prescription amount of ₩13.3 billion in the first quarter. It has risen 27.9% YoY and has established itself as the company's flagship product. HK inno.N's 'Robazet' was prescribed by ₩5.3 billion in the first quarter, up 21.5% from the same period of the previous year, leading the rise in the combination of 'Rosuvastatin·Ezetimibe'. The rise in the combination of Atorvastatin·Ezetimibe is also noteworthy. The MSD's Atozet, combination of Atorvastatin·Ezetimibe, which was ₩10.8 billion in the first quarter, up 20.8% from the previous year. Atozet is being sold jointly by MSD and Chong Kun Dang. On the other hand, the prescription amount of Simvastatin·Ezetimibe was somewhat low. In the first quarter, the prescription amount of Simvastatin·Ezetimibe was ₩10.3 billion, a 3.9% decrease from the same period last year. The combination of Simvastatin·Ezetimibe released first among the combination of statin·ezetimibe, but its share was the lowest. The original product MSD's 'Vytorin' prescription amount in the first quarter was ₩5.3 billion, down 19.8% from the previous year. Vytorin is analyzed to have significantly lowered its market share due to advances such as Rosuvastatin· Ezetimibe combinations.
- Company
- Xarelto-Eliquis follow Lixiana dominating NOAC market
- by Kim, Jin-Gu Apr 27, 2020 06:11am
- Lixiana has reaffirmed its dominance in the non-vitamin K antagonist oral anticoagulant (NOAC) market. Eliquis has gotten close to taking over the second place from Xarelto with ever more intense competition in the market,. First released in last June, generic products of Eliquis are expanding their pies. Currently, 12 products are released and their total prescription volume takes about 11.1 percent of Eliquis’. ◆Lixiana tops again, Xarelto and Eliquis head-to-head over the second place According to pharmaceutical market research firm UBIST on Apr. 22, Lixiana has generated 15.8 billion won from prescription in the first quarter. The figure was up by 15.1 percent than last year’s first quarter at 13.7 billion won. After taking over the top place in January last year, the drug has been leading the market for last 15 months straight. Although it followed into the market after the first-in-class, Lixiana’s prescription volume skyrocketed with a boost from a co-marketing deal with Daewoong Pharmaceutical. And the long-term stock-out period of Xarelto, caused by the maintenance work at Bayer’s German manufacturing facility, has probably affected Lixiana’s successful run. Quarterly prescription volume trend in major NOAC products (Unit: KRW 100 million) Source: UBIST On the other hand, Xarelto and Eliquis were battling over the second place. Both drugs actually made 12.3 billion won from prescription in the first quarter. But at the end, Xarelto made 12,283,260,000 won and Eliquis made 12,280,810,000 won, ranking them on the second and the third, respectively, with the difference of 2.45 million won. Their prescription volumes compared to last year’s first quarter were increased by 2.3 percent and 6.8 percent, respectively. Xarelto had to give up its top spot to Lixiana in January 2019, and now its second place is threatened by Eliquis. From last November to past February, Eliquis topped over Xarelto in prescription volume. ◆Apixaban generic’s prescription volume grows over 2.7 times in six months The apixaban generics would eventually affect the fierce competition between Eliquis and Xarelto. Since June last year, generic version of Eliquis like Chong Kun Dang’s Liquisia, Yuhan’s Yuhan Apixaban, Samjin Pharm’s Elxaban, Hanmi Pharamceutical’s Apixban, Aju Pharm’s Eliban and YooYoung Pharmaceutical’s Yupix have entered the NOAC market. In the first quarter, Liquisia has generated the most at 394.56 million won and Yuhan Apixaban, Elxaban, Apixban, Eliban and Yupix followed with 226.64 million won, 222.0 million won, 145.14 million won, 131.06 million won and 114.67 million won, respectively. The generic prescription volume has not been so overpowering to threat the originals, yet. The total volume took up 11.1 percent of the original’s, generating approximately 1.4 billion won. But the volume has increased steeply by 2.7 times since the last third quarter making 400 million won, while the original Eliquis’ volume growth has been sluggish. Considering other generics jumping into the NOAC market, the apixaban generic pie would grow even further. So far, the Ministry of Food and Drug Safety (MFDS) has approved of 42 apixaban generics. Quarterly Apixaban generic prescription volume in last one year (Unit: KRW 1 million) Source: UBIST ◆Eliquis pricing reduction postponed yet again Another variable in the market is pricing reduction in Eliquis. According to the court’s decision, the government-authorized Eliquis pricing reduction has been suspended temporarily. In January, the Seoul High Court has ordered the Ministry of Health and Welfare (MOHW) to temporarily halt the pricing reduction execution on Eliquis. The court ruled the pricing reduction should be postponed until the current proceeding of litigation is concluded. Initially, Eliquis’ pricing was supposed to be reduced by 30 percent from July last year after the generics’ launch in June. But the enforcement of the new pricing was halted as Bristol-Myers Squibb (BMS) has filed for an administrative litigation. Although the first trial was rejected as the court ruled in favor of the ministry and the pricing reduction, the ministry’s action was halted again as BMS filed for an appeal. The appeal is expected to be concluded in the latter half of the year. If the court rules favorable for MOHW again, Eliquis’ pricing would be reduced by 30 percent and its prescription sales would drop, accordingly.
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- “Considering treatment options for ankylosing spondylitis”
- by Eo, Yun-Ho Apr 27, 2020 06:10am
- Professor Nam Seoung Wan In the autoimmune disease area, where tumor necrosis factor alpha (TNF alpha) inhibitor is leading the prescription market, various options of oral Janus kinase (JAK) inhibitors have been released so far. Guidelines on treating ankylosing spondylitis and spondylarthritis in Korea and other countries have a tendency to emphasize starting the first-line treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients showing symptoms. And for patients not sufficiently benefiting from NSAIDs, the treatment guidelines recommend using biologics like TNF alpha inhibitor, considering the patient’s disease activity. And in 2016, a guideline by Assessment of Spondyloarthritis International Society/ European League Against Rheumatism (ASAS-EULAR) recommended using TFN alpha inhibitor for first-line biologics with the most amount of clinical data accumulated, but also recommended switching to other TNF alpha inhibitor or interleukin (IL)-17 inhibitor options when showing no response to the initial option. Moreover, American College of Rheumatology (ACR) and Spondyloarthritis Research and Treatment Network (SPARTAN) updated their guidelines last year and made a notable recommendation of using oral JAK inhibitor Xeljanz (tofacitinib) with an ongoing Phase III clinical study, besides using biologics like TNF alpha inhibitor (injection) and IL-17 inhibitor. Also, instead of using Cosentyx (secukinumab) that received approval first, the updated recommendations mentioned of using Taltz (ixekixumab) and TNF alpha’s biosimilars approved for use in Korea recently. Professor Nam Seoung Wan of Rheumatology Department at Wonju Severance Christian Hospital explained “Other than tofacitinib, various JAK inhibitors like upadacitinib have been tried on treating patients with ankylosing spondylitis. Compared to other biologics, JAK inhibitors have a great advantage in medication convenience with oral administration.” However, the professor stated the treatment’s limitation is its underperforming response rate at week 12 compared to existing TNF alpha inhibitor and IL-17 inhibitor options, regardless of its better effect confirmed in head-to-head Phase II study. Professor Nam stressed, “Continuous search for more treatment options in diverse biologics are encouraging for patient treatment, because each biologics have different effects on various symptoms apparent in many organs including ankylosing spondylitis, and also they bring out respective adverse reaction like risk in tuberculosis relapse.” However, the professor claimed the prescribers should be well aware of issues regarding tolerance development when using biologics for a long term. Professor Nam said, “Repetitive use of biologics could possibly diminish the effect of the drug gradually due to patient’s immune response on the drugs like developing an antibody on specific medicine. As for rheumatoid arthritis, there was a report claiming such tolerance is less likely to be developed when combining TNF alpha inhibitor and methotrexate (MTX). But there has not been any clinical evidence reported on the benefit of using MTX combination therapy on ankylosing spondylitis.” The professor added, “However, a number of treatment strategy could be considered depending on the patient’s clinical state, as various biologic treatment options have been recently introduced to treat patients with ankylosing spondylitis. And each biologics show different rate of antibody development and reaction depending on the patients.”
- Company
- Keytruda to finally get Cancer Committee nod after 2years?
- by Eo, Yun-Ho Apr 24, 2020 06:27am
- After waiting for two long years, MSD is committed to receive the Korean health authority’s approval on Keytruda’s coverage expansion this time. According to pharmaceutical industry sources, the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee’s deliberation on Keytruda (pembrolizumab) has been scheduled on Apr. 29 after it has been delayed twice due to the COVID-19 outbreak. Although the deliberation would review Keytruda’s reimbursement expansion on the added indication as a first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), MSD has reportedly submitted related economic evaluation data. For a reimbursement expansion case, the committee assesses financial impact but it does not ask for a submission of economic evaluation data. In March 2017, Keytruda monotherapy has been approved as a first-line treatment in patients with NSCLC. And the MSD Korea has submitted an application for reimbursement approval on the monotherapy indication in September 2017 and continued to talk with the government for over two years. Regardless of the effort, the talks fell through in September last year. And in October last year, MSD Korea has reapplied for reimbursement expansion on Keytruda’s five indications including pembrolizumab monotherapy and combination therapy as first-line treatment in NSCLC, monotherapy as second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. So far at the broken off talks with the government, key issues like conditionally limiting the reimbursement to ‘patients showing response to the treatment,’ and ‘the trade-off (a government initiative to recognize the value of new drug while compensating the cost with reduced pricing of off-patent drugs)’ were addressed. MSD’s desperation is also apparent on the negotiating table due to the long wait. Prior to the coming deliberation, MSD has reportedly expressed its intention to accept the government’s proposal on sharing financial burden of expanded reimbursement by lowering drug pricing. The global company official stated, “Over the span of two years, the company has been negotiating and narrowing the gap with the government over expanding Keytruda’s reimbursement, and we think the two parties have been engaged enough to have better understanding of each other. Based on the experience, the company is making sure to receive the expanded reimbursement this time.” The National Comprehensive Cancer Network (NCCN) guideline has added pembrolizumab plus chemotherapy combination therapy as a Category 1 first-line treatment in all patients with metastatic NSCLC, which is also listed as preferred. The pembrolizumab monotherapy is also listed as preferred for first-line therapy in patients with positive PD-L1 expression over 50 percent.
- Company
- The KPBMA promotes of co-development of COVID-19 treatments
- by Lee, Seok-Jun Apr 24, 2020 06:26am
- The KPBMA promotes joint development of COVID-19 treatment. This is the first 'co-investment and joint development' method among member companies. The KPBMA held a board of directors meeting on the 21st to discuss this. Participants decided to aggregate their competencies at the industrial level, not individual companies, based on the prospects of domestic and foreign experts that another COVID-19 outbreak would occur frequently. In addition, they considered ways to establish joint ventures with co-investments by companies and to establish private and public joint funds such as the European IMI (Innovative Medicines Organization). In the future, if the KPBMA materializes joint investment and joint development plans through consultation with related experts, the industry will actively participate. An association official said that the joint R&D situation among member companies for developing new drugs is more mature than ever before, and they agreed that it is necessary to change the concept of sharing profits if profits arise and sharing risks if they fail for new drugs. Chairman Hee-mok Won emphasized, "In order to overcome a crisis that can be repeated in the future, such as COVID-19, a revolutionary idea change is needed. The cross-border energy with joint research and development efforts of the industry and full support from the government must be brought together."
- Company
- Amid COVID-19, March drug export hits record high
- by Kim, Jin-Gu Apr 24, 2020 06:26am
- A monthly export volume of Korean pharmaceuticals has reached a record high in last March. Sources view the COVID-19 outbreak has not affected the pharmaceutical production and export significantly. According to the import and export statistics data published by Korea Customs Service (KCS), Korea has exported USD 538.09 million (approximately 660.2 billion won) worth of pharmaceuticals in March. The Korean-made pharmaceutical export volume has gone up by 51.3 percent, compared to March 2019 at 356.52 million dollars (approximately 437.1 billion won). Also, the volume increased by 51.3 percent as well only in a month from February (355.57 million dollars) to March 2020. Korean pharmaceutical volume in March 2020 has marked the record high (Unit: USD 1,000) Source: KSS In the same period, the import volume has also reached the highest in the history at 688.78 million dollars (approximately 845.1 billion won). Compared to the year before, the volume was increased by 27.5 percent from 540.36 million dollars (approximately 663.0 billion won). The huge surge in export volume has noticeably improved the pharmaceutical trade balance. In March, Korea has made trade deficit of 120.69 million dollars. Compared to the two months last year, the deficit figure was reduced by 18.0 percent. However, the overall export volume in Korea has gone down by 0.7 percent from 47.03 billion dollars to 46.69 billion dollars in the same period. This is why the pharmaceutical export volume has emerged as the highlight of the month. The COVID-19 outbreak does not seem to have directly affected production or export of pharmaceuticals in Korea. ◆Export to Germany and Japan soars, when export to the U.S. and China drops Sorting by country, the export to Germany and Japan has significantly increased. On the other hand, the export to the U.S. and China has diminished. In March alone, the exports to Germany have generated 164.42 million dollars. The figure has tripled from 48.19 million dollars in the year before. More specifically, the exports to Germany exceeded last December’s record high volume at 112 million dollars. The exports to Japan soared by 53.5 percent in March at 28.33 million dollars, compared to 18.45 million dollars last year. Meanwhile, the volume exported to the U.S. has been decreased by 16.3 percent than the previous year at 64.11 million dollars. And the export volume to China in the same month has plunged by 26.0 percent from 24.44 million dollars last year to 18.58 million dollars this year. Trend in export volume with major pharmaceutical trading countries (Unit: USD 1,000) Source: KSS) The pharmaceutical ingredient distribution issues in China and India that the industry insiders were concerned about does not seem to have surfaced in the export statistics. On the contrary, the Chinese and Indian-made pharmaceutical import volumes have rather increased than the year before. 90 percent of pharmaceutical active ingredients are currently imported from China and India. Korea has been importing pharmaceuticals from China, which the volume has grown by 33.8 percent from 7.52 million dollars in March last year to 10.06 million dollars in March this year. Comparing the figure in March to February at 7.53 million dollars, the volume has gone up by 33.5 percent. The pharmaceutical import from India has reached 5.64 million dollars in March. Compared to the year before at 4.91 million dollars, the volume was increased by 14.9 percent, but compared to Febraury at 1.95 million dollars, the March figure has skyrocketed by 189.5 percent.
