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- 2026-03-18 17:36:35
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- Boryung's FAH is expected to be released soon
- by Kim, Jin-Gu Dec 22, 2020 06:10am
- (From left) Dukarb, Tuvero, and Kanarb Boryung's hypertension combination drug is expected to be released in the second half of next year. If FAH is released next year as planned by Boryung, it will be the 7th 'Kanarb Family'. Interest is focused on whether to continue the Ducaro and Archave successes as the 5th and 6th Kanarb family this year. According to the pharmaceutical industry on the 21st, phase III clinical trial of Boryeong's three-drug hypertension drug based on Kanarb is in the final stage. Product release is possible as early as the second half of next year. Boryung is developing under the name 'FAH', a combination of Fimasartan, Amlodipine, and a diuretic (HCTZ) for high blood pressure. Boryung has conducted Phase III clinical trial on 250 hypertensive patients at 32 domestic hospitals since May 2019. Boryung released its own Fimasartan-based hypertension drug Kanarb in 2010, and has added five combinations so far. Boryung It started with Lacor (Fimasartan potassium/HCTZ) in 2013, Dukarb (Fimasartan potassium/Amlodipine) and Tuvero (Fimasartan + Rosuvastatin) in 2016. In February of this year, Dukaro (Amlodipine Besylate/ Fimasartan Potassium Trihydrate Granule/ Rosuvastatin Calcium (Micronized)) was released, and in September, Akarb (Atorvastatin Calcium Trihydrate/ Fimasartan Potassium Trihydrate Granule) was released, expanding the Kanarb family lineup. The Kanarb family is promising to exceed ₩100 billion in outpatient prescriptions this year. According to the drug market research institute UBIST, the Kanarb family recorded a prescription record of ₩94.3 billion until November. This is because, while the prescription amount of the single drug Kanarb has slowed, the prescription amount of the combination drugs, led by Dukarb, has increased significantly. Dukaro and Akarb, launched this year, are considered successful. Dukaro produced ₩5.4 billion by November, and Akarb produced ₩700 million in two months of launch. If the 7th Kanarb family is released next year, attention is focused on whether it will continue to succeed. The key is the competition drugs. The market for a combination drug for hypertension with ARB + CCB + diuretics is already dominating the market. Daiichisankyo's Sevikar HCT (Amlodipine/Olmesartan medoxomil/HCTZ), Hanmi's Amosartan plus (Amlodipine/Losartan potassium/Chlorthalidone), Ildong's Twotops Plus (Telmisartan/Amlodipine/HCTZ), Yuhan's True Set (Amlodilate/Chlorthalidone) /Telmisartan) is in competition. Until the third quarter of this year, Sevikar HCT had sales of ₩24.6 billion, Amosartan plus ₩17.4 billion, True Set ₩7.4 billion, and Twotops Plus ₩4.7 billion 20 items have been released as generics for Sevikar HCT due to the expiration of the patent. An official from the pharmaceutical industry said, "Kanarb's material patent will expire in February 2023. Boryung will try to launch as much variety of Kanarb-based combination drugs as possible before the patent expires." He said, "How much synergy between Boryung and its existing products in the competitive high blood pressure triple-drug market will determine the performance of the 7th Kanarb family."
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- First line therapy for NSNLC, starts of combination therapy
- by Eo, Yun-Ho Dec 22, 2020 06:09am
- Various combinations have been approved for NSNLC (non-small cell lung cancer), the most competitive field for new anticancer drugs. Competition is expected to intensify in the future as numerous studies are underway based on immuno-cancer drugs and targeted anti-cancer drugs. Lilly threw the hat into the ring in Korea. The company is in the process of expanding insurance benefits for primary prescriptions of NSCLC of VEGF receptor 2 antagonist Cyramza (Ramucirumab) and epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tarceva (Erlotinib). Cyramza's combination therapy was approved in Korea in July. The new combination targeting VEGF and EGFR is attracting attention because it has shown efficacy in mutant patients such as EGFR exon 19 deletion and exon 21 (L858R), which have been relatively weak so far. The possibility of Cyramza+Tarceva combination therapy was confirmed through a phase III RELAY. The Cyramza+Tarceva combined group reduced the risk of death by 40% compared to the Tarceva alone group, and the combined group showed a difference of more than 7 months from the control group at 19.4 months. Overall survival (OS) has not yet been derived. The median follow-up was 20.7 months, and the objective response rate was 76.3% in the Cyramza combination group and 74.7% in the Erlotinib alone group, but the median response duration was 18.0 months and 11.1 months. It is also encouraging that about 70% of the patients who participated in the RELAY study included East Asians. The immune anticancer drug Opdivo((Nivolumab), which has suffered from wage issues in Korea, is also starting a new challenge. Ono and BMS added a first-line indication for non-small cell lung cancer in combination with PD-1 inhibitor Opdivo and CTLA4 inhibitor Yervoy (Ipilimumab) on the 16th. The effectiveness of Opdivo-Yervoy combination therapy in the first line of NSNLC was confirmed through a Phase 3 CheckMate-9LA study. CheckMate 9LA (NCT03215706) is a phase III randomized study evaluating NIVO + IPI + 2 cycles chemo vs chemo in 1L stage IV/recurrent NSCLC A statistically significant improvement in OS was observed with NIVO + NSCLC-optimized IPI + a limited course of chemo vs chemo (4 cycles) in 1L advanced NSCLC. No new safety signals were reported. In addition, the results of extended follow-up for 12.7 months showed that the median OS of the two cycles of Opdivo+Yervoy chemotherapy was 15.6 months, which was consistently improved compared to 10.9 months of chemotherapy. Meanwhile, Opdivo+Yervoy combination therapy was approved as an indication for renal cell carcinoma in Korea, and it is in the process of registration after passing the Cancer Disease Review Committee in June. Cyramza was listed as a refund-type risk sharing agreement (RSA) in second-line gastric cancer therapy in May 2018.
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- CKD to outrun SK and Hanmi with Xarelto patent challenge
- by Kim, Jin-Gu Dec 22, 2020 06:09am
- 자렐토 제품사진 Chong Kun Dang is now the sole contender to challenge Bayer’s non-Vitamin K antagonist oral anticoagulants (NOAC) Xarelto (rivaroxaban) substance patent. As it overcame Xarelto’s formulation patent, Chong Kun Dang plans to enter the follow-on drug market faster than SK Chemicals and Hanmi Pharmaceutical, who won the preferential sales rights. According to a pharmaceutical industry source on Dec. 18, the South Korean company has requested the Patent Court to provide a negative scope confirmation on Xarelto’s substance patent. So far, Chong Kun Dang is the only one filed the suit. Xarelto own three patents; a formulation patent expiring in 2024, an indication patent expiring I 2022, and a substance patent expiring in 2021. A number of Korean companies have successfully evaded the formulation patent. Bayer registered the indication patent, after the court ruled favorable for the Korean companies on evading the formulation patent. In 2015, SK Chemicals and Hanmi Pharmaceutical jointly filed for the negative scope confirmation on Xarelto’s formulation patent and won the first and second cases. Since then, Hanlim Pharm, GC Pharma, Samjin Pharm and Yungjin Pharm were also able to evade the patent. Currently, Bayer’s appeal case is pending in the Supreme Court. SK Chemicals and Hanmi Pharmaceutical that evaded the formulation patent, were the first ones to receive the preferential sales rights. The two companies can sell the generic drugs exclusively for nine months from Oct. 3 next year, when the substance patent is expired. And now, Chong Kun Dang is intercepting by challenging the substance patent. If the company succeeds and overcomes the substance patent, Chong Kun Dang would be able to launch its product faster than SK Chemicals and Hanmi Pharmaceutical with the preferential sales rights. However, the feasibility of the substance patent would be the deciding factor. Unlike the formulation and indication patents, the substance patent challenge tends to be even more difficult. In 2015, Daewoong Pharmaceutical filed a substance patent challenge on Xarelto to nullify the patent, the court has dismissed the case and there has never been another substance patent challenge. At the moment, Chong Kun Dang has a generic named ‘Riroxia’ approved to market. Both the tablet and capsule forms have been approved. Capsule form option is only offered by Chong Kun Dang. Even if Chong Kun Dang fails to challenge the substance patent but succeeds in evading formulation and indication patents, Riroxia in a capsule form can be sold regardless of the preferential sales right. However, the company has not tapped on either formulation or indication patents, yet. A pharmaceutical market research firm UBIST found Xarelto has raised 50.8 billion won last year for outpatient prescription. Up until the last third quarter, the prescription volume of the drug reached 37.6 billion won.
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- Another effect of Botox, possible to treat hair loss
- by Dec 21, 2020 06:19am
- Following cosmetic surgery, botulinum toxin formulations are expanding their scope to treat hair loss. It is noteworthy as researches confirming the potential as a treatment for hair loss in Korea are ongoing. Byeong-cheol Park, Professor of Dermatology, Dankook UniversityDankook University dermatology professor Park Byeong-cheol confirmed the effect of botulinum toxin on hair loss improvement in the Sponsor- Investigator Trials conducted by Daewoong Pharmaceutical's Nabota. In 22 subjects, Nabota was treated for 6 months and the reaction was confirmed. As a result, the number of hairs increased statistically significantly at week 24. The study results were published in the December issue of the SCI-level journal Journal of the American Academy of Dermatology (JAAD). This study is a kind of exploratory study, and there is a limitation that there is no control group and the number of subjects is small. However, Professor Park Byung-cheol said, "It is meaningful that we have confirmed the mechanism of hair loss treatment of botulinum toxin through a cell experiment, and that the researcher's clinical trial has confirmed its potential. We can proceed to the later phase II clinical trial and the phase III study according to the results. It was an opportunity to lay the groundwork for that,” he revealed the significance of the study. Dailypharm conducted an interview with Professor Park to find out the potential of botulinum toxin preparations to treat hair loss. ▶What are the limits in the treatment of androgenetic hair loss? -The oral drugs Finasteride (Propecia), Dutasteride (Avodart) and minoxidil are the treatments for androgenic hair loss that have been approved by the US Food and Drug Administration (FDA) so far. These are the most important treatments and the basis of hair loss treatment. However, in some patients, the effectiveness of these treatments may be insufficient, and it is true that each drug has side effects. In addition, Finasteride and Dutasteride have limitations that women of childbearing potential cannot take. ▶A study on hair loss treatment was conducted with botulinum toxin. Please explain the research background, design, and results. -Botulinum toxin is used not only to improve wrinkles but also to prevent and treat scars, and one of the main mechanisms at this time is to inhibit TGF-β. TGF-β is also known to inhibit hair growth and progression from hair to telogen hair. I thought there would be something in common, so I started my research. This study was a pilot study, comparing before and after treatment in 22 subjects without a control group. Except that there was no control group, the reaction was confirmed after treatment for at least 6 months following the general guidelines for confirming the improvement in the efficacy of hair loss suggested by the Ministry of Food and Drug Safety. Effectiveness evaluation statistically verified the change in the number of hairs per unit area at 12 and 24 weeks compared to the baseline at week 0 and the degree of improvement by clinical pictures. Side effects were confirmed through vital signs at each visit, medical examination, and blood tests at weeks 0 and 24. The treatment method was to inject botulinum toxin (Nabota) into the hair follicle of the subject every 4 weeks with 30 units of botulinum toxin (Nabota) for a total of 24 weeks for a total of 24 weeks. At week 24 of treatment, the number of hairs increased significantly (p=0.012). No serious drug-related adverse events were reported. Daewoong ▶How was the satisfaction the patient felt after treatment? -In addition to the researcher's objective evaluation, the subject's subjective satisfaction was evaluated through a questionnaire. △ Overall scalp shape improvement, △ improvement of hair density in the area of hair loss, △ improvement of the degree of hair loss, △ improvement of hair growth rate, △ improvement of hair thickness. ▶What mechanism of botulinum toxin preparations has the effect of treating hair loss? -It is assumed that botulinum toxin inhibits the secretion of TGF-β1 from hair follicle cells, which inhibits the progression and growth of hair at rest. The increase in TGF-β1 secretion by'dihydrotestosterone (DHT)' is known to be one of the major causes of androgenic hair loss. In this study, an increase in TGF-β1 was also observed by DHT, and it was confirmed by cell experiments that the expression was decreased when treated with botulinum toxin. ▶Looking at the results of this study, there was a significant improvement at week 24, but not at week 12 (p=0.803). In other words, it means that the change was insignificant until 3 months of the procedure. What do you think is the reason? -I think the cycle of hair or the cumulative concentration of the drug may have had an effect. Normally, the hair growth period is 4-6 years, and the period of regression is 3 weeks, and the period of rest is about 3 months. Considering this, it can be interpreted that it may not be effective at the third month. Or it is thought that a period of cumulative concentration may have been necessary for the drug to exert its effect. Accordingly, a follow-up study currently underway is confirming the treatment response by increasing the concentration slightly. ▶This study was only for men. Could female hair loss patients benefit from hair loss treatment with botulinum toxin? -In fact, there are few treatments for female type hair loss, so many people are also interested in this. Although clinical studies have not been conducted yet, the results cannot be predicted, but since TGF-β1 inhibits general hair growth, it is expected that botulinum toxin that blocks this will be effective in female-type hair loss. Currently, botulinum toxin is also injected into female hair loss patients with consent at the clinic site for therapeutic purposes. ▶Isn't there a tolerance problem even in hair loss treatment of botulinum toxin? -Botulinum toxin has been used for a long time as a treatment for wrinkle improvement, and since it is a topical injection treatment, it has been used without significant side effects. Since hair loss treatment is also a local treatment, it has the advantage that it can be treated while minimizing systemic side effects. In particular, in existing wrinkles, injections are made into muscles with abundant blood supply, but in hair loss, because dermal hair follicle injections are performed, systemic absorption through blood vessels is expected to be less, so there is a high possibility that no noticeable systemic side effects were observed. Since this study was only conducted for 6 months, long-term observation is necessary. Problems have also been raised about the formation of neutralizing antibodies and resistance to botulinum toxin injections, but this is known to occur mainly in patients who frequently receive high-dose intramuscular injections. Hair loss treatment is expected to have less resistance, but this part will be confirmed through follow-up studies. ▶Aren't patients reluctant to get an injection into the scalp? -Because getting an injection into the scalp itself causes pain, there is a factor to be reluctant. However, since there is a motive for the treatment of hair loss, they are injected once a month, and various tips are used to minimize pain during injection, so most patients at the actual clinic say that they have pain, but it is acceptable. ▶Wouldn't the temporary effect of botulinum toxin formulations be a disadvantage? What new treatment benefits do you think can offer more than existing hair loss treatments? -Androgenic hair loss is basically a progressive disease caused by genetic factors, so if you stop taking any medication, hair loss may progress again, and this is the same with botulinum toxin treatment. However, in this study, there are cases in which it was unofficially confirmed that hair loss does not progress for about 3 months after the last treatment. Factors that cause hair loss can vary, and the effects on hair loss treatment are also diverse. Accordingly, botulinum toxin can be used in a variety of ways, including the purpose of increasing the effect in patients with insignificant effect on the existing treatment, the purpose of maximizing the effect in patients with good effect in the past, and alternative purposes in patients with no effect on treatment. .In particular, it is expected that it can be used in patients who are unable to take existing drugs .▶Please tell us about the significance and limitations of this study and the follow-up studies This study is meaningful in that it has confirmed its possibility as an exploratory study as the first step to find out whether botulinum toxin can be used as a hair loss treatment .In particular, the mechanism was also confirmed through cell experiments .Since it is a small-scale study without a control group, it can be recognized as a universal treatment only when the later phase 2 and final phase 3 clinical trials are completed, but it is meaningful in that the basis for these studies has been prepared .As a follow-up study, a study is underway to find the optimal concentration and usage to maximize the therapeutic effect .In the future, we plan to study the therapeutic effect in gynecomastia, the presence or absence of neutralizing antibodies that may occur during treatment, and further analysis of the therapeutic mechanism at the cellular and hair follicle organ levels.
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- US ITC bans Nabota from importing for 21 months
- by An, Kyung-Jin Dec 21, 2020 06:19am
- The US International Trade Commission (ITC) issued an order to ban imports from the US for 21 months on Jubo (Nabota), a botulinum toxin product developed by Daewoong. According to industry sources on the 17th, the US ITC issued a final ruling on the 16th (local time) in a lawsuit between Medy Tox and Daewoong infringement of trade secrets of botulinum strains. However, the period for the US import ban was drastically reduced from 10 years to 21 months. As a result of the preliminary judgment, they accepted the allegations of stealing Medy Tox strain and manufacturing technology, but decided that the strain was not a trade secret and therefore did not fall under the ITC's regulatory matters. Medy Tox and Daewoong have been struggling for a long time over the source of the botulinum strain. In 2019, Medy Tox and Allergan filed a lawsuit against Daewoong and Evolus to the US ITC, and in July this year, the ITC administrative judge ruled that Daewoong's Nabota was banned from US imports for 10 years. Since then, Daewoong has filed for an objection, and ITC accepted it and proceeded with a re-examination. The final judgment was also postponed three times from November 6 to November 19 and again to December 17. The ITC is a federally independent, quasi-judicial body directly under the President of the United States with extensive investigative power on trade issues. After the ITC makes a final decision that a violation of Article 337 exists, it will be passed on to the President and approved by the President. The President of the United States has the right to veto a decision within 60 days of the date of delivery by the ITC. If the President exercises his veto power, the ITC's final decision and action shall take effect on the date the President's veto is notified. In the US, it is believed that Allergan won the ruling. Bloomberg reported on the ITC ruling, "AbbVie has blocked Botox rivals from importing to the United States. As the ITC decided to ban US imports for 21 months on Jubo, which Evolus sells, it will be able to maintain a monopoly." AbbVie owns the license and sales rights of Botox through the acquisition of Allergan. Immediately after the final ITC decision was delivered, Evolus shares, which are listed on the NASDAQ, fell 3.9% from the previous trading day. Evolus, as a partner of Daewoong, is in charge of selling Jubo in the US. However, with this ruling, the dispute between the two companies over the source of the botulinum strain is not expected to end immediately. Daewoong said that the decision made by the ITC Committee regarding the final decision of the ITC was based on Allergan's domestic industrial protectionism to protect the monopoly market, and therefore Daewoong will appeal. An official of Daewoong said, "It is clear that Daewoong developed Nabota without infringement of trade secrets. We will fight to the end by mobilizing all legal procedures in the ongoing dispute to uncover the truth." Nabota's US sales portion of annual sales is currently less than 2%, so the impact on corporate management is expected to be insignificant.”
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- Orally taken Rinvoq to be prescribed in general hospitals
- by Eo, Yun-Ho Dec 18, 2020 06:07am
- A third Janus kinase (JAK) inhibitor in South Korea, Rinvoq is swiftly seeking for prescription authorization in general hospitals nationwide immediately after it was listed for the healthcare reimbursement. An industry source reported AbbVie’s Rinvoq (upadacitinib) has been recently passed by the drug committees (DCs) at Seoul Asan Medical Center, Chungnam National University Hospital, Inje University Haeundae Hospital, Hanyang University Hospital, Seoul Medical Center, Kangbuk Samsung Hospital, Wonkwang University Hospital and Sahmyook Medical Center. Listed by the South Korean health authority for reimbursement since Nov. 1, Rinvoq is indicated to treat adult rheumatoid arthritis patients, who qualify the diagnostic criteria set by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR); patients whose Disease Activity Score (DAS) 28 exceeds 5.1, or over 3.2 and under 5.1 but has developed joint damage confirmed by image exams; patients who did not respond sufficiently to two or more types of anti-rheumatic drugs including methotrexate (MTX) for three months each and six months total, or who halted the treatment due to adverse reaction. Rinvoq was able to earn the reimbursement approval by using the approval-reimbursement linkage system and accepting the weighted average pricing of an alternative drug. Only five months after the official marketing approval was granted in last June, the drug received the healthcare coverage. The industry predicts the general hospitals clearing the prescription code would fully open up the market for the drug. Regarding the treatment for an autoimmune disease, the interest on a JAK inhibitor, such as Xeljaz (tofacitinib), Olumiant (baricitinib) and Rinvoq, has been growing as it is the first to offer an oral option with confirmed effect equal to anti-tumor necrosis factor (anti-TNF) drugs to the patients. .However, the JAK inhibitors’ impact in the market has not been too prominent as other biologics .Compared to the market leader anti-TNF drug and popular anti-interleukin drugs, JAK inhibitors’ indications are limited to rheumatoid arthritis and few other diseases .The first-in-class Xeljanz has expanded its indication to treat ulcerative colitis and psoriatic arthritis, and other follow-on drugs have ongoing studies to expand indication in autoimmune diseases like atopic dermatitis, Crohn’s disease and ankylosing spondylitis .Rinvoq has demonstrated its treatment effect in 4,443 patients with severe level of active rheumatoid arthritis through five Phase III SELECT trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY) .The result found using Rinvoq alone or with conventional synthetic DMARD (csCMARD) showed lower disease activity and improved remission rate, compared to using a placebo, methotrexate or Humira (adalimumab) .An internal medicine professor at Hanyang University Rheumatoid Hospital, Dr .Kim Tae-hwan commented, “Rinvoq was able to reach a level of clinical remission improved than the existing standard of care during a clinical trial conducted on various groups of patients .As it also demonstrated an improved effect of reducing pain, patients may anticipate daily life free from pain, joint damage and faltering cognitive function with the help of the reimbursed option of Rinvoq.”
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- When will K-COVID-19 vaccine be released?
- by Kim, Jin-Gu Dec 18, 2020 06:06am
- As Pfizer's COVID-19 vaccination has begun one after another in the UK and the US, interest in domestic companies that have jumped into COVID-19 vaccine development is also increasing. Currently, it is predicted that the commercialization of vaccines developed by domestic companies will be possible only in 2023 even if the commercialization is early. ◆Four domestic companies were clinically approved, results announced in 2023 According to the MFDS on the 15th, five companies and institutions in Korea have been approved for clinical trials for vaccine development. International Vaccine Research Institute (IVI), Genexine, SK Bioscience, Geneone Life Science, Cellid, etc. IVI is conducting global clinical trials of INO-4800 being developed by the US pharmaceutical company Inovio in Korea. However, in the case of IVI, additional information on phase II/III of clinical trials was requested from the US Food and Drug Administration (FDA). There are four domestic companies including Genexine, SK Bioscience, Geneone Life Science, and Cellid. All four companies are in the early stages of development. Genexine, Geneone Life Science, and Cellid are in Phase I/IIa, and SK Bioscience is in Phase 1. According to the MFDS, their target clinical completion is in 2022. ◆Genexine changes candidate substances and starts again from Phase I Genexine was approved by the MFDS on June 11, as a substance called GX-19. On September 4th, it is confirmed that the patient recruitment was successful. However, it is estimated that the clinical results were not satisfactory. Genexine recently announced that it will restart clinical trials by changing the candidate substance to a substance called GX-19N. According to the revised clinical plan, Genexine will re-challenge in Phase I/IIa, targeting 170 people at 8 locations including Severance Hospital and Gangnam Severance Hospital. As Genexine starts again from Phase I, the results are expected to be delayed by 2-3 months. The target date for completion of the clinical trial that Genexine originally submitted to the MFDS as GX-19 was June 2022. According to Genexine's description, the results of Phase I/IIa will be released only in August 2022. However, there is a possibility that the vaccine will be commercialized earlier if the results of phase I/IIa are obtained earlier. The target date for completion of the first results of clinical I/IIa announced by Genexine is March 17, 2021, and the initial clinical results will come out from May to June next year, considering the delay of 2-3 months due to the change of candidate substances. Based on this, it is explained that if phase III clinical trials are initiated promptly, there is a possibility of completing phase III within next year as planned by Genexin and the government. Jun-wook Kwon, head of the 2nd vice president of Central Disease Control Headquarters, explained at a regular briefing on the 15th, "We will discuss with the pharmaceutical company managers at the Therapeutic Vaccine Specialized Committee on the 16th. We will proceed with the goal of completing phase III clinical trials of domestic vaccines by the second half of next year." . ◆SK·Geneone Life Science· Cellid, commercialized after 2023 The development status of domestic companies is in contrast to the fact that 57 global pharmaceutical companies are in the final stage of vaccine development. According to The Korea National Enterprise for Clinical Trials, there are a total of 127 COVID-19 vaccine clinical trials in progress worldwide on the 15th. Of these, 57 cases (45%) entered Phase III. It has entered the final stage of clinical trials less than a year since development began. For example, in the case of Pfizer, vaccination has already begun in the United States and the United Kingdom after receiving urgent approval from the FDA. For Modena, FDA approval is expected as early as this week. AstraZeneca and Johnson & Johnson are looking for approval early next year. Of course, it is not worthless that the timing of vaccine commercialization is delayed compared to global pharmaceutical companies. An official in the pharmaceutical industry said, "We do not know how many years the immune effect of vaccines developed by Pfizer and others will last. If we succeed in developing products with improved effectiveness, safety, and convenience, it will be sufficiently competitive."
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- Drug export breaks record making near KRW 7 trillion
- by Kim, Jin-Gu Dec 18, 2020 06:05am
- The South Korean-made pharmaceutical export broke the record this year. The accumulated export volume up to November has already exceeded the total export volume in last year. Due to a steep surge in pharmaceutical export, the industry trade performance is expected to hit the highest point in the history. According to the Korea Customs Service on Dec. 15, the cumulative pharmaceutical export in November reached USD 5.89 billion (approximately 6.44 trillion won). Keeping up the inclining trend, the figure could even hit 6.4 billion dollars (7 trillion won) by the end of the year. This year has already recorded the highest pharmaceutical export volume. Even since August, the accumulated export volume has passed the last year’s total export volume 3.70 billion dollars (approximately 4.4 trillion won). Yearly volume of pharmaceutical export reported by the Korea Customs Service (Unit: USD 1 million) As of November this year, the pharmaceutical import volume marked 6.82 billion dollars (approximately 7.42 trillion won). Compared to the same 11 months last year generating 6.01 billion dollars (approximately 6.55 trillion won), this year’s figure was increased by 13 percent. The import volume is expected to increase up to 7 billion dollars by the year end. But as the export volume skyrocketed compared to the import volume, the gap between the pharmaceutical import and export is also expected to narrow down the most in the history. The last year’s import and export had deficit of 2.98 billion dollars, which was lowest since 3.21 billion dollars in 2014. The deficit in this year as of November was 911 million dollars. Since 2010, the pharmaceutical trade deficit was constantly above the 2.5 billion dollar-line. Yearly trade balance in pharmaceutical products reported by the Korea Customs Service (Unit: USD 1 million) By month, the trade balance made surplus four times this year. The trade surplus of 40.38 million dollars, 6.28 million dollars, 82.90 million dollars ad 65.25 million dollars were reported in May, August, September and November, respectively. Ever since the industry statistics were collected, the monthly trade balance has never made surplus. Monthly trade balance in last two years (Unit: USD 1 million) Source: Korea Customs Service The pharmaceutical industry analyzes the big leap in biosimilar export has played a significant role in breaking the record of pharmaceutical export and trade balance performance. In fact, the half-year report each submitted to the Financial Supervisory Service by Celltrion Healthcare ad Samsung Biologics found the two companies have generated export volume of 777.2 billion won and 380.5 billion won, respectively. Compared to last year same time, both companies have made historic records. Celltrion’s exports in Europe and the U.S. have been impressive. From early this year, the company started marketing Remsima SC in Europe, and their Truxima and Herzuma have started making revenue in the U.S. Remsima SC is the world’s first subcutaneous injection with infliximab substance. Samsung Biologics’ performance started to take off from the second half of last year, and its business entered a stable state. The comprehensive performance was boosted by the overall production capacity increased with the third manufacturing plant in full motion, and CMO sales leaned heavy on more highly priced products.
- Company
- Who distributes Pfizer-Moderna vaccine in South Korea?
- by Kim, Jin-Gu Dec 17, 2020 06:12am
- Just as Pfizer has, Moderna is getting close to receive the U.S. Food and Drug Administration’s (FDA) emergency use authorization for its COVID-19 vaccine. Currently, the South Korean government is in negotiation with two companies to supply their vaccines in the country. The attention is focused on how the vaccines would be manufactured and distributed as the government promised to ink the vaccine supply contract for 10 million people from each company. Ultimately, Pfizer’s vaccine would likely to be manufactured in the vaccine manufacturing facility in Belgium and exported to South Korea via Pfizer Pharmaceutical Korea. The vaccine purchasing cost would be covered by the Korean government, but the import and distribution would be handled by Pfizer Pharmaceutical Korea. Moderna, on the other hand, does not own its manufacturing facility or a South Korean branch. The rumor has it that a Korean company could sign a deal with the company to distribute the vaccine. ◆SK Bioscience to manufacture and distribute AstraZeneca vaccine The government has decided to import COVID-19 vaccine doses for total 44 million people. Out of the total, the finalized contract secured doses for 10 million people each via COVAX Facility and AstraZeneca. The government is in negotiation for the rest of the doses for 24 million people with Pfizer (10 million), Moderna (10 million) and Janssen (4 million). SK Bioscience is to manufacture and distribute AstraZeneca With the finalized contract, AstraZeneca’s vaccine would be manufactured and distributed by SK Bioscience. Previously, the Korean government, AstraZeneca and SK Bioscience have signed a three-way contract for the COVID-19 vaccine. The contract states SK Bioscience would manufacture the vaccine when AstraZeneca succeeds in developing one. AstraZeneca has no other vaccine line up other than the COVID-19 vaccine. The company has to seek after manufacturing facility around the world to manufacture the product, and SK Bioscience was selected in the end for the Asian region. The vaccines manufactured by the Korean-based company would be supplied to other countries in Asian region that also made deals with AstraZeneca. However, the biggest issue is that the multinational company’s vaccine has not completed the Phase III trial. The supply can initiate only when the vaccine finishes its Phase III trial. And after it confirms the efficacy and safety, the company needs to undergo a procedure starting from approval application to the Ministry of Food and Drug Safety (MFDS) approval and the state authorization for shipping. AstraZeneca expects the vaccine would conclude the Phase III trial in early next year. The government’s announcement on the plan to begin the vaccination from March next year seems to have been influenced by the company’s news. ◆Inked a contract with CEPI, GC Pharma to supply through the Facility The vaccine doses for 10 million people contracted through COVAX Facility have not decided which product vaccine would be manufactured and supplied for how many doses. The COVAX Facility is an international cooperation project, created by the World Health Organization (WHO), Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi the Vaccine Alliance, to ensure fair distriution of COVID-19. So far, 180 countries have joined the effort. With the fund raised by the participating countries, COVAX Facility is currently funding nine vaccine developments, including the ones by Moderna, AstraZeneca, Novavax, Inovio, CureVac and GSK. From the list of the companies, Moderna has the vaccine within arm’s reach to commercialization. The U.S. FDA Advisory Committee is scheduled to convene a meeting on Dec. 17, and the emergency use authorization could be granted on Dec. 18 at earliest. The pharmaceutical companies that received the funding from COVAX Facility are responsible to supply vaccines to 180 member countries. When Moderna earns the FDA approval for the vaccine use, other COVAX member countries would also get access the vaccine. During the process, GC Pharma is getting the spotlight. GC Pharma has signed a contract with CEPI for the use of manufacturing facility in last October. When a company supported by CEPI successfully develops a COVID-19 vaccine, the Korean company can manufacture 500 million doses from its vaccine factory. The company already plans to manufacture CEPI-designated COVID-19 vaccines from March 2021 through May 2022. The company would use brings vaccine components to the factory to fill and finish the complete product. Some of these manufactured doses may be distributed throughout South Korea, but the government has not signed the contract completely, yet. If Moderna or other candidate company shakes hands with CEPI on manufacturing facility, GC Pharma would then sign an official contract with the companies. But as Moderna has not received the official green light, the detailed manufacturing volume has not even been set. ◆Pfizer vaccine for 10 million to be imported via Pfizer Pharmaceutical Korea Pfizer Pharmaceutical Korea is most likely to supply Pfizer’s vaccine for 10 million people. Pfizer owns vaccine manufacturing plants in Michigan and Belgium. The plants in Michigan are to supply vaccines in the U.S., and the supplies for other countries including Europe would be manufactured in Belgium. Similar to the novel influenza breakout in 2009, Pfizer Pharmaceutical Korea would import the supply manufactured in Belgium. Back then, the government signed a deal with Roche for the sales handling storage to distribution. As Pfizer is not funded by either COVAX Facility or CEPI, the company holds no responsibility to supply to any country without a contract. Currently, the Korean government is working on the settling the contract.
- Company
- Keytruda can be prescribed for TNBC patients in Korea
- by Eo, Yun-Ho Dec 17, 2020 06:11am
- It is expected to be able to prescribe Keytruda, an immune anticancer drug, to patients with triple-negative breast cancer (TNBC) in Korea. According to related industries, MSD Korea recently submitted an application for additional indications for the combination of chemotherapy in the first line therapy of metastatic TNBC of PD-1 inhibitor Keytruda (Pembrolizumab) to the MFDS. After approval by the US FDA, the approval process is rapidly progressing in Korea. Keytruda's effectiveness in TNBC patients was demonstrated in the KEYNOTE-355 study. In this study, Keytruda showed improvement in Progression Free Survival (PFS) and an objective response rate of 53% (17% for complete, 36% for partial) in the entire patient group including patients with poor prognosis who recurred rapidly for more than 6 months, suggesting the possibility of cure in metastatic TNBC with a high rate of complete remission. Through a sub-analysis that confirmed the therapeutic effects of TNBC's combination of various chemotherapy and Keytruda at the San Antonio Breast Cancer Symposium, SABCS 2020 recently, the PFS improvement effect was shown regardless of the type of chemotherapy. It means that various combinations of chemotherapy such as Paclitaxel, Albumin-binding Paclitaxel, Gemcitabine·Carboplatin can be used in combination therapy with immuno-cancer drugs. TNBC, which responds negatively to all receptors (Estrogen, Progesterone, HER2) among breast cancer, has been an unsolved challenge for a long time. Chemotherapy was the only treatment option for TNBC, and Roche's target anticancer drug Avastin (Bevacizumab) was the first in Korea to obtain indications, but it has remained as non reimbursed drug. However, PARP (poly ADP ribose polymerase) inhibitor Lynparza (Olaparib) was added as a target anticancer option, and Roche's PD-L1 inhibitor Tecentriq (Atezolizumab) was the first to be introduced as an immune anticancer agent. Roche submitted an application for benefits in Korea in October and is waiting for the HIRA's Cancer Disease Review Committee's appointment.
