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- 2026-03-17 19:30:53
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- Reimbursement for Olumiant in AD is being discussed
- by Eo, Yun-Ho Nov 05, 2021 05:24am
- Discussions on increasing coverage for atopic dermatitis treatments continue. According to industry sources, the authorities have completed collecting expert opinions on Lilly’s JAK inhibitor ‘Olumiant (baricitinib)’ Sanofi’s ‘Dupixent (dupilumab)’ and is awaiting deliberation by the Health Insurance Review and Assessment Service’s Insurance Benefit Standard Subcommittee. The progress comes 5 months after the company submitted its application in May. Discussions for another JAK inhibitor, Dupixent, had also started in earnest 7 months after its application. In this context, whether the addition of Olumiant will spur discussions on expanding coverage in atopic dermatitis remains to be seen. Olumiant is a new drug for moderate-to-severe atopic dermatitis that applied for reimbursement at a more economical price than the recently-listed new atopic dermatitis treatment, ‘Dupixent (dupilumab).’ The drug t selectively and reversibly inhibits JAK1 and JAK2 to reduce the expression of inflammatory cytokines and shows an overall anti-inflammatory effect. The efficacy and safety of Olumiant was identified in the three clinical trials - BREEZE-AD1, BREEZE-AD2, BREEZE-AD7 – as a monotherapy and combination therapy with a topical corticosteroid (TCS) in adult patients with moderate to severe AD. In particular, Olumiant rapidly improved itching that severely deteriorates the quality of life from Day 2 in the three clinical trials. Chang-Wook Park, Professor of Dermatology at Severance Hospital said, “Olumiant can bring hope to AD patients in Korea who have had limited treatment options, as the drug showed rapid symptom improvement in patient-reported outcomes from Day 2 of treatment.” Also, one other JAK inhibitor is attempting to expand its reimbursement to atopic dermatitis. Last month, Abbvie applied to expand reimbursement of its ‘Rinvoq (upadacitinib)’ to atopic dermatitis. Discussion for Rinvoq has not started yet, but its efficacy was verified through the Phase IIIb Heads Up study, a head-to-head trial between Rinvoq and Dupixent.
- Company
- LG Chem, developing a new drug that has never existed before
- by Lee, Seok-Jun Nov 05, 2021 05:24am
- LG Chem has started clinical development to develop next-generation osteoarthritis treatments that have not existed before. Osteoarthritis is a degenerative disease that causes pain and gait disorders due to inflammation in the joints and cartilage wear. LG Chem announced on the 4th that it has been approved for phase 1b/2 clinical trials of LG34053, a new drug candidate for osteoarthritis treatment. The company will conduct a study at SMC to evaluate indicators such as safety and drug resistance, pharmacokinetics (drug absorption, distribution, metabolism, and elimination) and select optimal doses for patients with mild and moderate knee osteoarthritis (K&L 2-3). LG34053 is an injection-type new drug that blocks inflammatory pathways of new mechanisms and inhibits cartilage cell death. Preclinical results have improved pain relief effects, as well as cartilage damage, the root cause of arthritis. LG Chem is planning to expand its region to Australia and conduct phase 1b/2 clinical trials to secure global clinical data. Since then, it plans to carry out Phase III global commercialization in the U.S. and other regions and start global commercialization from 2028. According to global market research data, the osteoarthritis market in seven major countries with large medical markets, including the United States, Japan, Germany, France, the United Kingdom, Italy and Spain, is expected to form KRW 2 trillion by 2028.
- Company
- The Galvus patent dispute continues
- by Kim, Jin-Gu Nov 03, 2021 05:47am
- Although the Supreme Court had made its ruling on the ‘Galvus (vildagliptin)’ patent dispute, it seems that the fierce battle is yet far from being over. The case will now again be dealt by Intellectual Property Trial and Appeal Board, and depending on its result, there remains the possibility that the original developer may abuse irrelevant follow-up clinical trials that were conducted abroad to extend its drug’s patent duration. ◆The battle continues… will be again dealt at IPTAB On October 28th, the Supreme Court dismissed Novartis’ appeal against Hanmi Pharmaceutical and Ahngook Pharmaceutical over the Galvus patent dispute. The written judgment showed that the court ‘found no profit in appeal for Novartis.’ As Novartis had already won the second trial and achieved its purpose, the court decided that there was no need to file an appeal in the first place. Even if Novartis was dissatisfied with the judgment from the 2nd trial, the court decided that appealing this to the Supreme Court was procedurally right. As a result, the case will again be dealt by IPTAB. The industry expects a decision will be made early next year, which will finally conclude the 4-year patent dispute over Galvus’s patent term. ◆Novartis extends substance patent duration by 2 years, of which Ahngook claims187 days invalid On the surface, the Supreme Court’s ruling is in favor of the generic companies, as the court dismissed Novartis’ appeal against the 2nd trial ruling. However, the key point of the case lies elsewhere. Domestic pharmaceutical companies are raising the concern that the original developer may abuse irrelevant follow-up clinical trials that were conducted abroad to extend its drug’s substant patent duration, depending on the ruling that will be made by IPTAB. The key issue in the 4-year long dispute was how much of the ‘extended patent duration’ of a drug’s substance patent should be considered invalid. Patent rights are usually protected for 20 years from the filing date. For pharmaceutical products, the time taken for clinical trials and for regulatory approval is added onto the term as companies cannot release their product immediately after applying for a patent. Depending on how much of this period is recognized, patent protection for a drug can be extended to last 21 years or even 22 years. Novartis had succeeded in extending Galvus’ substance patent for 2 years, 2months, and 23 days (813 days). With the extension, the patent, which was to originally expire on December 9, 2019, was extended to expire on March 4, 2022. ◆Mixed rulings at the 1st and 2nd trial regarding the ‘132 days’ extended for overseas clinical trials of Galvus Ahn-Gook Pharmaceutical claimed that ‘187 days’ of the extended term for Galvus’s substance patent was invalid. Ahn-Gook claimed that Novartis did not do its due care during the ‘132 days,’ from the completion of the bridging trial on Koreans to the submission of API report, and the ’55 days’ from receiving the MFDS’ notice to supplement its data to the data submission, rendering the 187 days invalid. The court ruled in favor of Ahn-Gook Pharmaceutical in the first trial. The Patent Court of Korea accepted Ahn-Gook’s claim and ruled all of the 187 days invalid. With the ruling, the substance patent expiry date of Galvus was shortened to August 30th, 2021. In the second trial, the IPTAB partially accepted Novartis’ claim and ruled only 55 days of the 187 days invalid, making the substance patent expiry date of Galvus January 9th, 2022. Acceptance of Novartis’ claims on the 132 days that the company conducted clinical trials overseas was what made the difference between the rulings The claim, which was not accepted at the 1st trial, was then accepted at the 2nd. In other words, the overseas trial that was deemed irrelevant to the drug’s domestic approval in the 1st trial was deemed necessary in the 2nd trial. ◆Dispute continues for no real benefit on either side Novartis, discontent with the 132-day extension recognized at the 2nd trial, appealed to the Supreme Court to receive acceptance for the remaining 55 days. However, the Supreme Court returned the case to IPTAB. Right now, how hard the two parties will continue to fight this battle remains unclear as both parties - the original developer and generic companies – have little to earn from the continued battle. On Novartis’ part, it is now difficult to implement a strategy to delay the entry of latecomer drugs through litigations, as its substance patent is likely to expire while the case is reassigned to IPTAB and again reviewed. Novartis can always file a claim for damages after winning the dispute and being recognized for patent infringement. However, even so, the period of infringement will only be around 2 months, and not be very profitable. The cost of litigation may be greater than the profit earned from the suit for damages. Also, on the generic companies’ part, the companies have already succeeded in moving up the release of their latecomer drugs by 2 months and have no need to actively continue the dispute. ◆Original developers may ‘abuse’ the system to extend the duration of their substance patent The issue arises when the IPTAB follows the existing ruling of its higher court, the Patent Court of Korea. If the companies do not actively engage in the legal dispute, the IPTAB will highly likely follow the existing ruling made by the Patent Court. If the dispute ends this way, Novartis’ claim of ‘132 days of follow-up trial overseas’ will also be recognized for the extension. This has been raising concern among domestic pharmaceutical companies that it may be abused as a basis for original developers in extending their substance patents in the future. Until now, no period for overseas follow-up trials was accepted for extension of substance patents. Until now, the Korean Intellectual Property Office and the Ministry of Food and Drug Safety both had deemed follow-up trials that were only conducted overseas irrelevant, unlike global trials that include Koreans or bridging studies on Koreans. The Patent Act stipulates that the patent duration may be extended to 5 years at most. If overseas follow-up trials are included in the term of patent duration, original developers may abuse the system to extend their patent’s duration to the maximum 5 years. In other words, the concern is that the existing substance patent duration of ‘20+2 years’ may be prolonged to ‘20+5 years.’
- Company
- New ATTR-CM drug Vyndamax to be prescribed at GHs
- by Eo, Yun-Ho Nov 02, 2021 05:54am
- Vyndamax, a new drug for transthyretin amyloid cardiomyopathy (ATTR-CM), is now available for prescription at general hospitals. According to industry sources, Pfizer Korea’s ATTR-CM drug, 'Vyndamax (tafamidis 61mg),' passed the review of drug committees (DCs) at various medical institutions including Samsung Medical Center, Seoul Asan Medical Center, Hanyang University Medical Center, etc. However still, the landing may not directly translate to active prescriptions, as Vyndamax is being prescribed to certain patients without reimbursement. After the company failed to receive designation as an essential drug earlier this year, the company had applied for reimbursement once again after conducting the PE assessment for the Risk Sharing Agreement (RSA) scheme. Being deemed inappropriate even after submitting data for PE evaluation, reimbursement of Vyndamax is at a standstill. ATTR-CM is a fatal condition with a poor treatment outcome due to a lack of specific treatment and is often mistaken for simple heart failure If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. Vyndamax is the only drug that demonstrated its survival benefit in patients with ATTR-CM (ATTR amyloidosis with cardiomyopathy) and is virtually the only drug available, as there are no alternatives. Vyndamax's efficacy was demonstrated through the Phase III ATTR-ACT and a long-term extension study. Analysis of the results of the Phase III ATTR-ACT study and its long-term extension study that was presented recently demonstrated a 30% relative reduction in the risk of death among patients with ATTR-CM who transitioned to Vyndamax 61mg after being initially treated with Vyndaqel 80 mg versus patients who transitioned to Vyndamax 61 mg after being initially treated with Vyndaqel 20 mg. When adjusting for covariates, including age, biomarkers, and functional capacity, the risk reduction was increased to 43% for Vyndaqel 80 mg/Vyndamax 61 mg versus Vyndaqel 20 mg. Both Vyndaqel 80 mg/Vyndamax 61 mg and Vyndaqel 20 mg were associated with safety profiles similar to placebo.
- Company
- AstraZeneca co-sells Qtern with Ildong Pharmaceutical
- by Eo, Yun-Ho Nov 01, 2021 05:56am
- According to related industries, AstraZeneca Korea and Ildong Pharmaceutical have decided to jointly promote Qtern, which combines DPP-4 inhibitor Onglyza (Saxagliptin) and SGLT-2 inhibitor Forxiga(Dapagliflozin), which will be released today (1st). Since March 2014, the two companies have already been conducting co-marketing on diabetes treatments such as Onglyza and Kombiglyze XR(Metformin·Saxagliptin). Qtern jointly conducts sales and marketing of the product at general hospitals and Ildong Pharmaceutical alone at clinics. With the official launch of Qtern, the market for diabetes combination drugs is expected to change. Currently, in addition to Qtern, combinations of DPP-4 inhibitors and SGLT-2 inhibitors are licensed in Korea, Beringer Ingelheim's Esglito(Linagliptin+Empagliflozin) and MSD's Stegluzan(Ertugliflozin+Sitagliptin). It has been confirmed that they are also preparing to launch along with resolving benefit issues. GC Pharma received approval from the MFDS on the 25th for the biological equivalence test plan of GC2123A. The active ingredient of this product candidate is known as Empaglipozin+Linaglipin. Meanwhile, Qtern was approved in Korea in March 2017, but its launch in Korea was delayed as the problem of combined diabetes insurance benefits was not resolved. However, a change in the market is expected as insurance authorities have recently discussed recognizing the combined benefits of SGLT-2 inhibitors. Not long ago, a meeting of diabetes experts convened by the HIRA is trying to integrate and recognize the combined use and three-drug benefits between DPP-4 inhibitors and SGLT-inhibitors.
- Company
- Hanmi & Ahn-Gook finally won the Galvus patent dispute
- by Kim, Jin-Gu Nov 01, 2021 05:55am
- The Supreme Court sided with Generic companies in a patent dispute over Galvus (Vildagliptin), a DPP-4 inhibitor-based diabetes treatment. On the morning of the 28th, the Supreme Court dismissed Novartis' appeal against Ahn-Gook Pharmaceutical and Hanmi Pharmaceutical to invalidate the extension of the patent duration. There is a problem with the reason for the appeal claimed by Novartis. Generics succeeded in invalidating 55 days of the material patent duration. Ahn-Gook and Hanmi Pharmaceutical began early launch of generics for Galvus in accordance with the ruling. Generic is likely to be released early next year. The issue of this case is which period of the "extended duration" of the drug substance patent will be considered invalid. So far, there has never been a case in which generic has overcome the extended duration of drug substance patents against the original company. Ahn-Gook claimed that "187 days" out of the 1,068 days of Galvus' extended material patent duration was invalid. On top of that, Hanmi also requested an extension invalidation trial. Ahn-Gook won the first trial. Intellectual Property Trial and Appeal Board sided with Ahn-Gook and said 187 days were invalid. Ahn-Gook was qualified to release the generic 187 days earlier. Novartis won some of the second trials. The patent court ruled that only 55 days out of 187 days were invalid. Novartis once again objected and filed an appeal to the Supreme Court. Novartis argued that it could not be considered invalid.
- Company
- Qtern will be released in Korea after 4 years of approval
- by Eo, Yun-Ho Oct 29, 2021 05:53am
- The DPP-4 inhibitor and SGLT-2 inhibitor diabetes complex Qtern will be released four years after approval in Korea. According to related industries, AstraZeneca Korea will start promotional activities for Qtern, a product that combines Onglyza and Forxiga, on the 1st of next month (November). Qtern was approved in Korea in March 2017, but its launch in Korea was delayed as the problem of insurance benefits for diabetes combined therapy was not resolved. However, a change in the market is expected as insurance authorities have recently discussed recognizing the combined benefits of SGLT-2 inhibitors. A meeting of diabetes experts convened by the HIRA integrated the benefits of a combination of DPP-4 inhibitors and SGLT-inhibitors. The reason for the decision to release Qtern is also believed to have reflected this. Currently, in addition to Qtern, combinations of DPP-4 inhibitors and SGLT-2 inhibitors are licensed in Korea, Beringer Ingelheim's Esglito and MSD's Sitagliptin+Ertugliflozin. It has been confirmed that they are also preparing to launch as the benefit issue has been resolved. On the 25th, GC Pharma's GC2123A received approval from the MFDS for a biological equivalence test plan. The active ingredient of this product candidate is known as the same ingredient drug Empagliflozin+Linagliptin. In addition, Dongkoo Bio applied for permission for a combination drug of Januvia (Sitagliptin) and Forxiga in March. LG Chem is conducting commercialization clinical trials for Zemiglo and SGLT-2 inhibitors, while Aju is conducting commercialization clinical trials for a combination drug of Jardiance and Forxiga. Meanwhile, the PMS period of the DPP-4 inhibitor and SGLT-2 inhibitor combination is now less than two years away. The PMS period ends in March 2023. Since March 2023, news of generic development has continued as it is possible to apply for a generic license.
- Company
- Bayer’s ‘Nubeqa’ can be prescribed at general hospitals
- by Eo, Yun-Ho Oct 28, 2021 05:59am
- The new prostate cancer drug ‘Nubeqa’’ can now be prescribed at general hospitals in Korea. According to industry sources, Bayer’s oral androgen receptor inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), ‘Nubeqa (larotrectinib)’ has recently passed the review of drug committees (DC) in three major hospitals - the Samsung Medical Center, Asan Medical Center, and Gangnam Severance Hospital. Nubeqa is an androgen receptor inhibitor with a distinct chemical structure that binds to the receptor and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The drug was approved based on the Phase III ARAMIS study that assessed the safety and efficacy of Nubeqa in combination with androgen deprivation therapy (ADT) compared to ADT alone. Study results demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) in Nubeqa +ADT, with a median of 40.4 months, compared to the 18.4 months for placebo+ADT. Also, Nubeqa+ADT reduced the risk of death by 31%. Also, the full overall survival (OS) results from the pre-specified final OS analysis of the Phase III ARAMIS trial were published in the New England Journal of Medicine (NEJM) on the 9th. Results showed that Nubeqa+ADT showed a statistically significant improvement in OS compared to placebo plus ADT, with a 31% reduction in risk of death. The results hold significance as the OS improvement was achieved despite 55% of patients that taking placebo received subsequent Nubeqa or other life-prolonging therapy after the trial was unblinded at data cut-off for final analysis (November 15, 2019). Meanwhile, Nubeqa has not been added to the insurance benefit list yet. The drug has been determined inappropriate for reimbursement by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in February, and the company has supplemented the data and is again undergoing the listing process.
- Company
- “Prolia·Evenity drives the osteoporosis treatment market”
- by Oct 28, 2021 05:59am
- Amgen has long been considered the company that has changed the osteoporosis treatment paradigm with potent new drugs. After sweeping over the osteoporosis treatment market with ‘Prolia (denosumab),’ a bone resorption inhibitor, the company then presented a new treatment strategy with ‘Evenity (romosozumab),’ a bone builder with a dual mechanism of action that increases bone formation and inhibits bone resorption. The sequential therapy strategy of using Evenity then Prolia is regarded as the top-priority treatment option in patients at very high risk of fractures. Prolia recorded 75 billion won (based on IQVIA) in domestic sales in just 4 years after its release, and Evenity, which has been rapidly approved for reimbursement, is also settling well in the market. Behind such great success are the hidden efforts of three Amgen Korea’s three PMs in charge of marketing Amgen’s osteoporosis treatments. The PMs Yoochae Park, Ga-eul Lee, and Saim Shin, who have an average of 10 years of experience in the industry, work to make known the importance of treatment to those at high risk of osteoporosis that were left unattended while introducing the effect and treatment strategy of Prolia and Evenity to HCPs. Dailypharm met with the three Amgen Korea PMs that have been driving the growth of Prolia and Evenity to hear about the marketing strategies of the two products and the changing paradigm in osteoporosis treatment. (From the left) PMs Yoochae Park, Ga-eul Lee, Saim Shin in charge of Amgen’s osteoporosis treatments -Could you tell us about your roles in marketing Amgen’s osteoporosis treatments? PM Yoochae Park (hereinafter “Park”)= I joined the marketing team as a PM for Prolia in Januarya last year. My main tasks include strategy establishment, planning, and material production to strengthen Prolia's position as a market leader in osteoporosis treatment. PM Saim Shin (hereinafter “Shin”)= I joined Amgen ahead of Prolia’s launch in 2016 and worked at its sales team until 2019 when I started to work as a PM for Prolia. I am mainly responsible for overall branding activities such as the development of Prolia messages as well as HCP support activities such as symposiums and webinars. PM Ga-eul Lee (Hereinafter “Lee”)=I am a PM for Evenity. I joined Amgen in March last year and prepared for and executed the non-reimbursed launch of Evenity. My marketing activities are similar to those done by the Prolia team, but more focused on branding activities such as message development and market positioning to promote Evenity, as Evenity is still in the early stages of its launch. -Prolia holds a solid position in the osteoporosis treatment market, recording an annual sales of 75 billion won in Korea. What factors do you believe contributed to Prolia's rapid growth? Shin=In the past, an unmet need among HCPs had existed as there had been insufficient clinical grounds to support the need for long-term treatment in osteoporosis. In other words, treatment efficacy, such as the continued reduction in risk of fractures and continuous increase in bone density from long-term treatment, were not established for the long-term treatment. The long-term data of Prolia in the 10-year FREEDOM clinical study demonstrated the drug’s effect in improving bone density and reducing the risk of fractures. The longer-term between treatments, with a single shot every 6 months, had also improved convenience in administration in patients, allowing them to more realistically receive long-term treatments. Such characteristics that differentiated Prolia from other existing treatments for HCPs and patients were the biggest factor that pushed the growth of Prolia. Park=We were able to directly see the patients’ bone health and density improve after being prescribed Prolia. The HCPs prescription experience and trust in our product has allowed for the continuous growth of Prolia. -With Evenity recently approved for reimbursement, there must be a lot on your plate. What are you most focused on for Evenity? There must be some regrets due to the somewhat limited conditions for Evenity’s reimbursement. Lee=The most important activity for us now is to position Evenity to be used as a first-line treatment after fractures. In this regard, we are focusing more on expanding the market for anabolic agents so that patients who have already experienced fractures can prevent additional fractures. Our focus is on delivering the personalized treatment message to more very-high-risk patients so that they can receive the appropriate treatment to prevent osteoporosis fractures, rather than is limited reimbursement -How have HCPs in the field responded to Prolia-Evenity? Shin=The most difficult issue that the HCPs had faced was that patients were unable to receive continuous treatment despite the HCP’s strong will for their treatment. However, the doctors have acknowledged that continued osteoporosis treatment became a lot easier with the introduction of the once-every-6-months injection, Prolia. According to research, the reduction in fracture risk is lessened if the patients miss 1 of the 2 osteoporosis treatments. In this sense, the high medication adherence in Prolia is a great advantage Lee=With expectations also high for Evenity overseas, HCPs in Korea have shown much interest in the therapeutic benefits of Evenity. In this sense, the most feedback I receive is about how much the HCPs expect a good effect. In addition, the continuous treatment rate of Evenity in HCPs who have previous prescription experience has been maintained high. Also, we were able to confirm successful treatment cases where patients were able to act and return to daily life without protective gear only 3-4 months after receiving surgery for their fractures. -Were there any difficulties in switching the previous face-to-face marketing methods to online due to COVId-19? Shin=At first, digitalizing all marketing directions came as a great burden. All the pharmaceutical companies had launched similar online marketing activities in the same period, and we paid special attention to the online materials that we prepare to increase the mail check rate and the number of webinar viewers. As a result, we have hosted the 24th webcast symposium for osteoporosis experts this year, which has been running for 4 years now. An average of 500 HCPs accessed the symposium live in real-time. It was a difficult but rewarding year in which our symposium was recognized for its quality lectures that address the questions made by HCPs on Prolia and Evenity. Park=Switching all our work to online had increased our load, and also brought concern whether the messages that need to be effectively delivered to the HCPs are being sent one-way. In the field, many HCPs seem to have a positive view of online marketing activities. The HCPs immediately check the material online and request additional material, if necessary. We have been better utilizing the advantages of online communication than our initial concerns, and our message and the advantages of our product are being well delivered online. Lee=Evenity was approved for reimbursement after the COVID-19 pandemic, and the launch symposium for the drug was held as a hybrid event, increasing the need for marketing activities in the online environment. Therefore we considered various measures to organically utilize the brochures, emails, and iPad contents on and offline. Due to our continued efforts, we saw high viewer numbers and e-mail checks from HCPs from the start of the launch.
- Company
- Samsung BioLogics' sales surpassed ₩1 trillion
- by Chon, Seung-Hyun Oct 28, 2021 05:58am
- View of Samsung BioLogics Plant 3Samsung BioLogics surpassed 1 trillion won in sales in three quarters. Sales exceeded 1 trillion won in nine years after its establishment last year, and it showed a steeper rise this year. Samsung Biologics announced on the 26th that its operating profit as of the third quarter was 167.4 billion won, up 196.12% from a year earlier. Sales amounted to 408.5 billion won, up 104.02% from the previous year. Both sales and operating profit are the largest ever. It broke new records of sales (412.2 billion won) and operating profit (166.8 billion won) set in the second quarter again in one quarter. Samsung Biologics' cumulative sales in the third quarter amounted to 1.1237 trillion won, up 42.34% from the previous year. Founded in 2010, Samsung Biologics recorded sales of 1.1648 trillion won last year, exceeding 1 trillion won for the first time in nine years. This year, it surpassed 1 trillion won for the second consecutive year in three quarters. The company's cumulative operating profit in the third quarter was 408.5 billion won, up 104.02% from a year earlier. The operating profit ratio to sales reached 36.4%. The company explained, "In the third quarter, sales increased 64% year-on-year due to the rise in the utilization rate of the third plant due to the performance of new product orders, and operating profit increased significantly due to the operating leverage effect of the third plant operation rate." Samsung Biologics is currently operating three biopharmaceutical plants. As the world's largest (180,000 liters) three plants as a single factory were in full operation in October 2018, the volume of consignment contracts is also soaring. Samsung Biologics signed consignment production contracts with global pharmaceutical companies such as Roche and MSD in the third quarter of this year alone, surpassing $7.1 billion in cumulative orders. Samsung Biologics is building its fourth plant with the aim of operating it in 2023. The fourth plant is the largest ever with 256,000 liters of production. When the fourth plant is in operation, Samsung Biologics will secure a total of 618,000 liters of production facilities along with its third plant (3,000 liters of first plant, 152,000 liters of second plant, and 180,000 liters of third plant).
