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- 2025-12-23 04:23:08
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- SK Chemical ‘will continue pharma business without selling'
- by Kim, Jin-Gu Feb 15, 2024 05:58am
- SK Chemicals made an official announcement on the 14th that it has decided not to pursue the sale of its pharmaceutical business. The company said, "Amid the various internal and external variables and a rapidly changing business environment, SK Chemicals has decided to maintain its current business portfolio and pursue stable operation of its business." Last September, SK Chemicals began negotiations with Glenwood Private Equity, a South Korean private equity firm. At the time, the company formalized the sale, saying, "We are revisiting the sale of the pharmaceutical business unit and have signed a memorandum of understanding to set out the basic details prior to the signing of this agreement." The selling price was reportedly around KRW 600 billion. In October of last year and January of this year, the company made two clarifying disclosures, stating that "the parties are in talks on the specific terms and conditions." However, just over a month after the last announcement, the company made a final decision to continue the business. Going forward, SK Chemicals plans to focus on growing its pharmaceutical business and creating a new vision under the existing business portfolio structure. SK Chemicals will continue to expand its global CDMO business as it did last year, while also pursuing strategic tasks such as further growth of existing flagship products and joint marketing with domestic and foreign partners. In the mid-to-long term, SK Chemicals plans to secure tangible results from its recent open innovation program and build a new R&D infrastructure. SK Chemicals made record high sales with its pharmaceutical business last year. Last year, sales in SK Chemicals' pharmaceuticals business increased 19.9% YoY to record KRW 376.1 billion, driven by the sales of its flagship products. Operating profit was KRW 31.5 billion, down 6.3% from the previous year. SK Chemicals launched SK Plasma in May 2015 to focus on its blood products business. SK Plasma was established as a wholly owned subsidiary of SK Chemicals through a spin-off. At the end of 2017, SK Plasma became a subsidiary of SK Discovery as part of SK Chemical's reorganization into a holding company. In July 2018, its vaccine business was spun off to form SK Bioscience. SK Bioscience was initially launched as a 100% subsidiary of SK Chemicals, but its shareholding was diluted to 68.4% when SK Chemicals sold 7.65 million shares in a public offering in March 2021.
- Company
- Statin+ezetimibe combo mkt size nears ₩1 tril in KOR
- by Chon, Seung-Hyun Feb 15, 2024 05:58am
- The statin and ezetimibe combination continues to dominate the dyslipidemia treatment market. Prescriptions have more than tripled over the past 5 years, with the market size approaching nearly KRW 1 trillion. The rosuvastatin-ezetimibe combination drove market growth, posting more than KRW 600 billion in sales, while the atorvastatin-ezetimibe combination expanded more than threefold after the arrival of its generics. Prescriptions for pitavastatin-ezetimibe combinations also surged. According to the market research institution UBIST, the outpatient prescription market for the statin-ezetimibe combinations totaled at KRW 990 billion ($90.9 million) last year. This is up 24.1% from the KRW 797.6 billion in 2022. The statin-ezetimibe combination market has more than tripled in 5 years from KRW 282.3 billion in 2018. The growth has accelerated recently, more than doubling in the last 3 years from KRW 474.6 billion in 2020. This is because statin-ezetimibe combinations are more effective in lowering low-density lipoprotein cholesterol (LDL-C) and are less expensive than taking two separate drugs. Currently, 4 statin-ezetimibe combinations are available: simvastatin, rosuvastatin, atorvastatin, and pitavastatin. The rosuvastatin-ezetimibe combination owns the largest share of the statin-ezetimibe combination market. Last year, outpatient prescriptions for rosuvastatin-ezetimibe combinations totaled at KRW 616.4 billion, up 18.7% year-on-year. This is a 33.1% rise in 2 years from the KRW 450.6 billion in 2021. Compared to the KRW 197.1 billion it had made in 2018, the market has more than tripled in size in just 5 years. The rosuvastatin-ezetimibe combination accounted for 62.3% of the statin-ezetimibe combination market last year. Hanmi Pharmaceutical was the first to enter the market with the rosuvastatin-ezetimibe combination Rosuzet in 2015. Hanmi entered the market before its competitors by securing the rights to use ezetimibe from the patent holder MSD. Currently, 50 domestic pharmaceutical companies have entered the rosuvastatin-ezetimibe combination market. Prescription sales of Rosuzet amounted to KRW 178.8 billion last year, up 19.3% from the previous year, ranking second among all drugs. This is the third consecutive year it has ranked second since 2021. Rosuzet has boasted its flagship statin-ezetimibe combination drug status, posting outpatient prescription sales in the KRW 100 billion range for 4 consecutive years, after surpassing the KRW 100 billion mark for the first time in 2020. Last year, Rosuzet accounted for 29.0% of the rosuvastatin-ezetimibe combination market. Atorvastatin-ezetimibe combinations have also seen steep growth in recent years. Last year, prescriptions for atorvastatin-ezetimibe combinations totaled at KRW 267.3 billion, up 27.7% year-on-year. Their sales soared 103.4% in 2 years, from KRW 44.2 billion in 2021 to KRW 131.4 billion. The market size has expanded rapidly in a short period of time with the introduction of Atozet generics into the market in bulk. Until 2020, only 1 atorvastatin-ezetimibe combination product – Organon Korea’s Atozet, was available in Korea. However, Since 2021, more than 100 domestic companies have entered the atorvastatin-ezetimibe market simultaneously, expanding the market size. In October 2020, Chong Kun Dang received approval for Lipilouzet, a combination drug that contains the same ingredients as Atozet, after clinical trials. By this time, 22 companies had been approved to produce Lipilouzet-authorized generics and were listed for reimbursement from April 2021. Beginning in February 2021, 88 pharmaceutical companies additionally received authorizations for Atozet generics and were listed for reimbursement in May, one month later than Lipilouzet-authorized generics. In June 2021, two more companies received approval for Atozet generics, bringing the total number of domestic companies entering the Atozet market to 113. The atorvastatin-ezetimibe combination market has expanded by 240.5% in 3 years since the introduction of the generics, up from KRW 82.8 billion in 2020 when only Atozet was available. The atorvastatin-ezetimibe combination's share of the statin-ezetimibe market rose to 43.3% last year from just 22.0% in 2018. Livalozet, the first pitavastatin-ezetimibe combination that was launched by JW Pharmaceuticals in 2021, has recently gained prominence in the statin-ezetimibe combination market. Pitavastatin is the active ingredient in JW Pharmaceutical's flagship hyperlipidemia drug Livalo. After launched in October 2021, Livalozet posted prescription sales of KRW 31.8 billion in 2022, which more than doubled to KRW 72 billion last year. Simvastatin-ezetimibe combinations have been less successful. Last year, prescription of the simvastatin-ezetimibe combinations amounted to KRW 34.3 billion, down 8.0% YoY. It was the third consecutive year of decline after reaching KRW 42.9 billion in 2020. Prescriptions for the simvastatin-ezetimibe combinations were down 20.1% last year compared to 3 years ago. The original simvastatin-ezetimibe combination product, Vytorin from Organon Korea, was the first to enter the statin-ezetimibe combination market. However, its prescription market has gradually shrunk compared to other combinations. The simvastatin-ezetimibe combination accounted for 21.4% of the statin-ezetimibe market in 2017, but its share shrank to 5.6% last year.
- Company
- SK Chemical’s pharma biz recorded sales of 376.1 bil. won
- by Chon, Seung-Hyun Feb 14, 2024 05:40am
- SK Chemical's pharmaceutical business, which is to be sold, has reached its sales peak. The company's pharmaceuticals and new drugs under contract have demonstrated stable growth in the prescription market. On the 8th, SK Chemical reported that its pharmaceutical business generated sales of 376.1 won last year, representing an increase of 19.9% YoY. The operating profit for the same period was 31.5 billion won, showing a slight decrease of 6.3% YoY. Last year, the sales of SK Chemical’s pharmaceutical business recorded the highest amount in its history. In Q4 of last year, SK Chemical’s pharmaceutical business generated sales of 105.8 billion won, marking an increase of 32.4% YoY. As a result, the quarterly sales exceeded 100 billion won for the first time. The Quarterly sales of SK Chemical Pharmaceutical business (Left) Operating Profit (Right) trend (Unit: 100 million won, Source: SK Chemical). In the prescription market, SK Chemical’s primary products performed well. According to UBIST, a pharmaceutical market research company, the total prescription sales of ‘Joins,’ an osteoarthritis treatment, was 48.3 billion won last year, reflecting a 2.3% YoY increase. Despite being launched in 2002, Joins, a natural medicine developed by SK Chemical, continues to perform well in the market even after 20 years. The blood circulation improvement drug ‘Ginexin-F’ has generated prescription sales of 26 billion won, marking a 12.3% YoY compared to the prescription volume of the previous year. The prescription sales of Arthritis treatment Feburic in Q2 of last year amounted to 18.7 billion won, an increase by 20.2% YoY. Ultracet, a new drug introduced by SK Chemical, is showing significant growth. In February 2021, SK Chemical signed a domestic sales contract with Janssen to distribute painkiller Ultracet in Korea. The agreement included four products of Ultracet Tab, Ultracet Semi Tab, Ultracet ER Tab, and Ultracet ER Semi Tab. In the last year, Ultracet ER Tab generated outpatient prescription sales of 22.7 billion won, a 13.8% YoY increase. The analysis suggests that the surge in patients with influenza and common cold following Covid-19 endemic increased demand for painkillers, thereby resulting in the rise in prescriptions of Ultracet. SK Chemical is in talks with Korean private equity fund (PEF) Glenwood Private Equity Co (Glenwood PE) to sell its pharmaceutical business. SK Chemical is in the process of selling its pharmaceutical business. In September of last year, the company announced that “We are reviewing terms for selling the pharmaceutical division and we have signed a memorandum of understanding (MoU) before the contract.” The selling price is expected to be around 600 billion won. “We are discussing specific terms,” SK Chemical provided further explanation last month in an official announcement. If SK Chemical divests its pharmaceutical business, it will focus solely on its green chemical business, including copolyesters and functional materials. SK Chemical sold its bioenergy business in 2020. SK Chemical spun off its blood and vaccine businesses into separate entities. In May 2015, the company established SK Plasma to specialize in blood products, followed by SK Bioscience, which focuses on vaccines, in July 2018.
- Company
- Market for Pulmicort and Pulmican soars 2.6 times in 2 years
- by Chon, Seung-Hyun Feb 14, 2024 05:40am
- Last year, the prescription market for asthma medications containing the ‘budesonide’ ingredient expanded to its largest size ever. There have been significant demands for the treatment due to the circumstances surrounding the pandemic and endemic. At the end of last year, the drug pricing increase led to manufacturing and the prescription market expansion. Raising drug prices during shortages yielded a virtuous cycle of resolving the imbalance between supply and demand. According to UBIST, a pharmaceutical market research agency, on the 14th, outpatient prescription sales of asthma medications with a single component of budesonide totaled 9.9 billion won last year, representing an increase of 39.1% compared to the previous year. Budesonide is a medication used to treat asthmatic bronchitis and acute bronchitis in the larynx of infants and young children. There are two available budesonide products in Korea, including AstraZeneca’s Pulmicort and Kuhnil’s Pulmican. The yearly sales of Pulmicort and Pulmican in outpatient prescriptions (Unit: 1 million won, Source: UBIST). Pulmicort and Pulmican prescription sales last year rose 163.1% in two years compared to the 3.8 billion won generated in 2021. In the same period, Pulmicort rose 155.6%, from 2 billion won to 5 billion won, and Pulmican rose 171.3%, from 1.8 billion won to 4.9 billion won. Since the end of 2021, the treatment market for budesonide has expanded significantly due to the rapid increase in the number of COVID-19 patients. There was a higher demand for Asthma medications last year due to an increased number of patients with the common cold or influenza in addition to COVID-19 patients. The surge in demand resulted in an inadequate supply of drugs due to an imbalance between supply and demand. The increase in drug pricing of Pulmicort and Pulmican in the end of last year may have contributed to market expansion. The Ministry of Health and Welfare (MOHW) raised the insurance upper price limit of Pulmican by 18.5% from 946 won to 1,121 won. Pulmicort price rose 12.5% from 1,000 won to 1,125 won. The ministry reached an agreement with pharmaceutical companies to increase drug prices to encourage production expansion. This was to address the issue of drug shortages resulting from rising demand. Pulmicort and Pulmican coproduced prescription sales of 1 billion won in November of last year. After the increase in drug pricing, prescription sales in December rose by 39.4% to 1.4 billion won compared to the previous month. Compared to the 1 billion won in December 2022, the sales rose 36.1% YoY. Pulmicort generated prescription sales of 700 million won in December last year, a 43.3% expansion compared to the previous month and an increase by 76.8% YoY. Pulmican generated prescription sales of 500 million won in November and 700 million won in December, an increase by 35.5%. The monthly sales of Pulmicort and Pulmican in outpatient prescriptions (Unit: 1 million won, Source: UBIST). Prescription volumes for both Pulmicort and Pulmican increased more than the rate of drug price increases. Pharmaceutical companies expanded supply following insurance price raises, and with supply imbalances resolved, the prescription market showed growth rates higher than those of drug price increases. The increase in drug pricing for Pulmican and Pulmicort is the fourth instance of drug pricing adjustments for drugs in short supply. The MOHW raised the insurance upper price limit of 18 items containing acetaminophen 650 mg by up to 76.5% beginning in December 2022. The insurance upper price limit of acetaminophen 650 mg used to be between 43 to 51 won, but it has now increased to 90 won. Since pharmaceutical companies were reluctant to expand production due to the low-profit cost structure, the MOHW decided to raise the prices collectively. The MOHW initially agreed to collectively adjust the prices to 70 won last December and maintain the raised price until March. The MOHW increased the drug pricing of laxatives with magnesium hydroxide as an ingredient. Magmil’s price grew by 27.8%, from 18 won to 23 won. Cho-A’s Marogel price increased from 15 won to 22 won. Sinil Pharm’s M Tab. Sinil saw an increase in price from 16 won to 22 won. In October of last year, the prices of four pseudoephedrine drugs with a single-component were raised by up to 45%. Insurance upper price limit of Shinil Pharmaceutical's Sinil Pseudoephedrine increased from 20 won to 29 won, up by 45%. Samil Pharmaceutical's Sudafed increased from 23 won to 32 won, up by 39%. Sama Pharm's Schdafen and Kolon Pharma's Cosue also saw their insurance drug prices adjusted upwards by more than 30%, from 23 won to 30 won and 31 won, respectively.
- Company
- Unstoppable sales growth of Entresto
- by Kim, Jin-Gu Feb 13, 2024 06:18am
- Entresto. Novartis Korea’s Entresto, a heart failure treatment, repeatedly shows significant growth. Entresto has consistently achieved over 30% growth in sales each year since its release in October 2017, having passed six years. Since its release, Entresto has undergone five price reductions to suppress the steep increase in prescription sales. However, as Entresto’s simultaneous reimbursement range expanded, efforts to suppress sales were ineffective. Prescription sales of Entresto exceeds 50 billion won. The drug has shown a steep growth of more than 30% annually IQVIA, a drug market research agency, reported on the 8th that Entresto’s outpatient prescription sales reached 57.5 billion won last year, showing a 35% year-over-year (YoY) increase from 42.5 billion won in 2022. Entresto is a new class of drugs called angiotensin receptor neprilysin inhibitor (ARNI), a combination of Valsartan, an angiotensin II receptor blocker (ARB) inhibitor, and Sacubitril, a neprilysin inhibitor. After receiving reimbursement approval, Entresto was released in October 2017. The annual prescription performance of Entresto (Unit 100 million won, Source: UBIST). After its release, Entresto continued to experience rapid growth. Entresto’s prescription sales grew from 5.5 billion won in 2018 to 14.3 billion won the following year, a 2.6-fold increase. Despite the exacerbation of Covid-19 in 2020, Entresto continue to experience an upward trend in sales. Annual prescription sales increased by more than 30%, from 20 billion won in 2020 to 30 billion won in 2021 and further to 40 billion won in 2022. Last year, its sales exceeded 50 billion won and are now approaching 60 billion won. Entresto underwent pricing reductions five times until last year, a 21% ↓ from 2243 won to 1774 won Entresto has undergone five price reductions, including adjustments made through the price-volume agreement and voluntary price reduction. The price of Entresto was initially listed at 2243 won for 500 mg, 1,000 mg, and 2,000 mg in October 2017. It was subsequently reduced by 1.9% reduction to 2,200 won in September 2019, by 7.0% reduction to 2,046 won in June the following year, and by an additional 6.6% reduction to 1,910 won in February 2022. In January 2023, the price was reduced by 6.2% to 1,792 won due to the price-volume agreement. In July of the same year, it was further reduced by 1.0% to 1,774 won due to price adjustments related to expansion of reimbursement. During this period, the total reduction in drug pricing was 20.9%. The trend of Entresto's drug pricing reductions (Source: HIRA). Although it hasn’t been updated to last year’s prescription, Entresto saw two additional price reductions this year. In January last year, it saw a 5% reduction from 1,774 won to 1,690 won due to the volume-price agreement. In January, Novartis voluntarily reduced the price of Entresto by 0.4% to 1,683 won as Luxturna was reimbursement listed. The reduction in drug pricing was nullified by additional expansion applications The analysis suggests that despite consistent decreases in drug prices, there has been a significant increase in prescription volume due to expansions in reimbursements. In 2017, Entresto got reimbursed as a ‘treatment for patients with heart failure with reduced ejection fraction (HFrEF) and decreased heart rate.’ The reimbursement was limited to patients who underwent a combination therapy of standard treatment and stable doses of ACE inhibitor or ARB inhibitor for over four weeks. In March 2022, Entresto was approved as a first-line treatment, making it available for patients who had not previously been treated with ACE inhibitor or ARB inhibitor. In July of the following year, Entresto was approved for prescription to both hospitalized patients and outpatients. There have also been suggestions for the possibility of additional expansion. In 2021, the United States Food and Drug Administration (FDA) approved Entresto for the indication of treating patients with heart failure with preserved ejection fraction (HFpEF). Analysis suggests Korea can expect Entresto’s reimbursement to be expanded to include HFpEF, a condition affecting half of the heart failure patients. Will the upward growth in sales continue? Factors such as generic companies challenging patents and competing drugs affect this trend The pharmaceutical industry anticipates that Entresto will likely continue its upward trend in sales, especially given the possibility of additional expansion. There could be two factors affecting this trend. The first is the outcome of patent challenges by Korean pharmaceutical companies. A patent dispute related to Entresto is awaiting the Supreme Court’s ruling. If the Supreme Court rules in favor of the patent-challenging companies, it could lead to the early release of generic versions. In this case, Entresto’s drug pricing could potentially see a 30% reduction in the first year. Since 2021, companies like Elyson Pharm have filed successive challenges to Entresto patents, with generic companies winning in all first-instance rulings. Novartis has appealed three of these cases. The verdict for one of the appeals was reached in the second instance, ruled in favor of generics as in the first-instance. Subsequently, Novartis has submitted an appeal to the Supreme Court. Entresto's potential competing drugs: Verquvo, Forxiga, and Jardiance. As for Forxiga, AstraZeneca Korea has decided to withdraw Forxiga from the Korean market. Another factor is the emergence of competing drugs. Last September, Bayer released Verquvo as a reimbursed treatment for chronic heart failure. This therapy, containing the active ingredient vericiguat, promotes the synthesis of cyclic guanosine monophosphate within cells, regulating heart contraction, vascular tension, and cardiac remodeling. It represents a novel mechanism for improving myocardial and vascular function. By the end of last year, prescription sales were approximately 20 million won. With approval from major hospital pharmacy committees last year, Bayer expects significant prescriptions starting this year. Additionally, SGLT-2 inhibitor drugs are considered potential competing products for Entresto. Last year, Forxiga (dapagliflozin) and Jardiance (empagliflozin) received approval for the indication of chronic heart failure. However, their reimbursements are currently limited to patients with heart failure accompanied by diabetes. Industry experts anticipate that these two drugs will receive expanded reimbursement for treating patients with chronic heart failure and reduced ejection fraction regardless of having diabetes. The government is analyzing the financial effects related to expanding reimbursement for SGLT-inhibitor drugs.
- Company
- ‘Biobetter Nexviazyme is a better treatment option'
- by Eo, Yun-Ho Feb 13, 2024 05:51am
- Professor Hyunjoo Lee There are times when a single treatment has a significant impact on the overall management of the disease. This is especially true for rare and incurable diseases. In the field of metabolic diseases, a paradigm shift occurred when researchers found that certain rare patients lacked a single enzyme, which led to the development of therapies to introduce a substitute into the body to fulfill the enzyme’s role. As a result, patients suffering from these conditions, which are referred to as ‘LSDs (Lysosomal Storage Diseases),’ include Hunter syndrome, Gaucher disease, Fabry disease, and Pompe disease, are currently being treated with enzyme replacement therapy (ERT). Among these diseases, recent advances have been made in the treatment landscape of Pompe disease. About a decade after the ERT drug Myozyme (alglucosidase alfa) was introduced, the biobetter Nexviazyme (avalglucosidase alfa-ngpt) has been granted reimbursement coverage in Korea. Nexviazyme, which was added to the reimbursement list in September last year, became the first drug to receive pricing benefits as a biobetter in Korea. Dailypharm met with Hyunjoo Lee, Professor of Pediatrics at Gangnam Severance Hospital, to learn more about the significance of Nexviazyme’s arrival in Korea. -Nexviazyme can now be prescribed with reimbursement in Korea. What is the benefit of this new treatment option? Pompe disease is a progressive, genetic neuromuscular disease. Despite the many advances in the treatment landscape, there still remained an unmet need as patients were unable to achieve 100% improvement with existing treatments. Nexviazyme was developed to address this unmet need. Nexviazyme is a biobetter drug that was approved for its improved formulation and advancements over the existing Myozyme. It increases intracellular drug uptake by expressing approximately 15 times more mannose 6-phosphate (M6P) on the surface of the therapeutic enzyme than existing therapies. As a result, it can reduce muscle cell damage through effective glycogenolysis by improving glucosidase activity, and it is also beneficial in terms of safety due to improved immunogenicity. -Could you elaborate on the unmet needs that had existed in Korea? Pompe disease is divided into 2 types: infantile-onset Pompe Disease (IOPD), and late-onset Pompe Disease (LOPD), which is characterized by irreversible muscle damage. Myozyme use in patients with infantile-onset Pompe disease has been associated with rapid improvement in heart-related symptoms, such as enlargement of the heart, but there remained room for improvement in muscle-related symptoms, which did not improve 100% and progressed over time. Patients with Pompe disease experience ongoing issues, such as difficulty walking due to arm and leg muscle damage and breathing difficulties due to respiratory muscle damage, but they had limited options as there was only one treatment available for their use. - I understand that forced vital capacity (FVC) and the ability to walk were key endpoints in the Nexviazyme trial. That is correct. In addition to cardiac symptoms, improvements in respiratory and skeletal muscles are important in Pompe disease, to the extent that researchers seek to understand which muscles are most affected. This is most often determined by a six-minute walk test or a forced vital capacity test, but since the walk test cannot be conducted on pediatric patients, symptom improvement in these patients is determined by respiratory and infectious disease susceptibility, and muscle strength for daily activities. The FDA approval in late-onset Pompe disease was granted first for Nexviazyme because of the drug’s effect in improving skeletal muscle, respiratory failure, and muscle-related symptoms. - Are there any risks associated with long-term treatment with Nexviazyme? Because it is an injectable, an infusion-related reaction may occur. Also, regular hospital visits are needed for the injections, which can be challenging. Younger children may have difficulty with vascularization, but there are no other risks. - I remember a few years ago, there was a lot of talk on the need to improve the diagnostic system for genetic diseases such as Pompe disease. What is the current diagnostic landscape like for Pompe disease in Korea? Early diagnosis is important in infantile-onset Pompe disease because of its rapid symptom progression, which can to severe cardiorespiratory disorders and death within a year if the patient does not start treatment immediately. In Korea, diagnostic testing itself is not difficult due to good medical access, and since January this year, lysosomal storage diseases have been included in the neonatal screening test, which means that many patients will be diagnosed more quickly. This is expected to increase the diagnosis rate of lysosomal storage diseases and enable better collection of accurate data about the disease, including the prevalence of Pompe disease patients in Korea. - Lastly, what area do you think needs improvement in the Pompe disease treatment environment? Despite much support from the government, relevant organizations, and pharmaceutical companies, there still are some neglected areas that require attention. For example, in adults, we can evaluate the patient's improvement through FVC and 6-minute walk tests, etc. but it is difficult to do these tests on children. Urine tests are a good option, but these tests are often performed overseas, making it difficult to find out the results immediately. I hope that national or rare disease organizations will recognize this need and create a system to enable efficient testing in Korea. False positives can occur in newborn babies that are born too small or prematurely, depending on their condition. In such cases, I believe the additional tests that are performed at the discretion of the doctor on these patients should also be covered. Also, screening newborns after 28 days of age or those with late-onset Pompe disease is not reimbursed in Korea, and I would like the initial screening process for these patients to be covered so that those with late-onset Pompe disease can be more proactively diagnosed.
- Company
- Yuhan Chemical completes FDA and ANVISA inspections
- by Nho, Byung Chul Feb 07, 2024 05:59am
- Yuhan Chemical’s manufacturing plant in Hwaseong. Yuhan Chemical (CEO & President: Sang-Hun Seo) has confirmed its global-scale capacity for manufacturing and quality management systems. Yuhan Chemical announced on the 5th that the company has successfully completed the inspections of the United States Food and Drug Associations (FDA) and the Brazilian Health Surveillance Agency (ANVISA). As a result, the current inspection likely verified that Yuhan Chemical has the global-scale capacity for manufacturing and quality management systems, firmly establishing its position as Korea’s top active pharmaceutical ingredient (API) manufacturing company. The current FDA inspection lasted five days, serving as a Pre-Approval Inspection and a routine inspection for APIs intended for U.S. exports. The FDA assessed the company’s compliance with stringent good manufacturing practice (cGMP) standards, and the inspection successfully concluded with only minor notifications issued. Yuhan Chemical also cleared Pre-Approval Inspection of Brazil’s ANVISA, known to be as stringent as the FDA approval, with no observations. Regarding the current inspections, Yuhan Chemical stated, “This round of inspections reaffirmed that Yuhan Chemical holds a strong position as an API company. We have demonstrated our superior manufacturing facility, quality system, and commitment to Data Integrity, utilizing an IT-based quality system while upholding the company’s values of honesty and integrity.” Yuhan Chemical, a subsidiary of Yuhan Corporation, is an API development and manufacturing company. Founded in July 1980, the company has been pursuing global quality standards. Yuhan Chemical received FDA approval for its Ansan manufacturing plant in 2002 and is certified to comply with the advanced GMP quality standards of regulatory agencies in various countries, including European EDQM, Japanese PMDA, Brazil ANVISA, and Australia TGA. In January 2016, the company established its second plant in Hwaseong, Gyeonggi Province. To expand its manufacturing capacity to achieve further growth, Yuhan Chemical completed the construction of a new facility, HB Dong, in November 2023. The facility has the capacity to produce 144,000 liters annually. With these developments, Yuhan Chemical has a total production capacity of 843,000 liters annually. The company expects to secure new contracts with potential clients with its expanded manufacturing capacity. With scheduled inspections by regulatory agencies and client companies, Yuhan Chemical aims to achieve high-quality growth and further development. “Yuhan Chemical is strengthening its competitive position in producing top-quality APIs. Our company is actively working to implement a Continuous Manufacturing system, which will become a new industry standard worldwide,” Yuhan Chemical stated. “Yuhan Chemical aims to overcome the difficulties posed by the diminishing domestic API manufacturing landscape due to low price competitiveness. The company will strive to become a global API CDMO leader.”
- Company
- Bayer partners with Chong Kun Dang to sell Kerendia
- by Nho, Byung Chul Feb 07, 2024 05:59am
- An upturn is expected in the KRW 20 billion markets for chronic kidney disease treatments, with Bayer and Chong Kun Dang joining forces to establish a joint sales front for its chronic kidney disease treatment, Kerendia Tab, According to industry sources, Bayer and Chong Kun Dang signed a joint sales agreement for Kerendia Tab today (February 6) and will challenge the market as a ‘first-line treatment’ for chronic kidney disease. Bayer's innovative new drug Kerendia Tab. 10-20mg (finerenone) was approved by the Ministry of Food and Drug Safety in April 2022 for indications including as chronic kidney disease and was listed for reimbursement on the 1st of this month. The drug price is KRW 1,670 for both the 10m and 20 mg doses. Although there had been some hypertension drugs, the CKD treatment market had been virtually dominated by HK Inno.N’s Kremezin and Daewon’s Renamezin. Although Kerendia (finerenone) and Kremezin (spherical sorbent) or Renamezin (spherical sorbent) do not contain the same active ingredient, in terms of their 'broad indications,’ Kerendia is likely to pull the brakes on the growth of existing products. Although the field of kidney disease treatment is not divided into first-line and second-line like diabetes or hypertension drugs, it is likely that Kerendia will be prescribed first due to its initial treatment efficacy. Kerendia is a treatment for adult patients with chronic kidney disease (CKD) and type 2 diabetes (T2D)that reduces the risk of end-stage kidney disease (ESKD) and a sustained decrease in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure. Kremezin and Renamezin, on the other hand, has indications for improving uremia and delaying dialysis, which occurs in in later stage chronic kidney disease. However, the launch of Bayer's new treatment option Kerendia, which adds on to the previous options of Kremezin and Renamezin, is welcome news for the patients, given that the drug is intended to prevent hemodialysis, a major costly treatment that can cost up to KRW 30 million per year. In addition, the introduction of Daewon Pharmaceutical's new formulation, Renamezin Cap., is expected to quickly penetrate the existing market that consists of fine-grained and fast-acting tablets, building on its strength of improved dosing convenience. This, coupled with Chong Kun Dang’s strong sales and marketing capabilities, is expected to raise Kerendia into a dark horse in the market.
- Company
- KRW 40 bil JAKi market is in a fierce three-way race
- by Kim, Jin-Gu Feb 07, 2024 05:59am
- (Clockwise) Jyseleca, Civinqo, Rinvoq, Olumiant, Xeljanz 제품사진. The competition is intensifying leadership in the Janus kinase (JAK) inhibitor market, an oral autoimmune disease treatment, in Korea. Lilly's Olumiant (baricitinib) became the market leader in Q2 last year, as sales of the longtime leader Pfizer's Xeljanz (tofacitinib) faltered. Then, in just 2 quarters, AbbVie's Rinvoq (upadacitinib) took over the lead. In addition, new drugs such as Pfizer's Civinqo (abrocitinib) and Eisai’s Jyseleca (filgotinib) have also been introduced to the market. This is why the pharmaceutical industry is competing to further intensify in the JAK inhibitor market. JAK inhibitor market amounts to KRW 40 bil last year…Rinvoq’s sales soar 61% YoY According to the market research institution UBIST on the 6th, the outpatient JAK inhibitor prescription market sold KRw 40 billion last year. This is a 19% increase from KRW 33.5 billion in 2022. JAK inhibitors are used for autoimmune diseases such as rheumatoid arthritis and atopic dermatitis. They block inflammation, pain, and cell activation by inhibiting inflammatory cytokines. Since the launch of Xeljanz in 2015, Olumiant and Rinvoq joined in the race in 2019 and 2021, respectively. Yearly prescriptions of major JAK inhibitors (Unit: KRW 100 million, Data: UBIST). By product, Olumiant, Xeljanz, and Rinvoq are in a three-way race. Last year, Olumiant’s prescriptions reached KRW 13.7 billion, Xeljanz KRW 13.3 billion, and Rinvoq KRW 12.4 billion. In particular, Rinvoq's rise in prescription sales stands out. Its sales rose 61% in 1 year, compared with the KW 7.7 billion it had posted in 2022. In the same period, Olumiant’s sales increased by 19% from KRW 11.5 billion and Xeljanz’s sales decreased by 8% from KRW 14.4 billion. Back and forth battle for the lead...Rinvoq tops the market in Q4 last year The quarterly battle for leadership in this market had been even more intense. Olumiant surpassed Xeljanz’s sales and rose to lead the market in Q2 this year with KRW 3.3 billion in prescription sales. It maintained its lead in Q3 with KRW 3.7 billion. However, in Q4, the lead changed hands. While Olumiant fared well in Q4 as well, posting prescription sales of KRW 3.7 billion, Rinvoq took the lead with KRW 4.1 billion. Rinvoq, which was released later than its competitors, Xeljanz and Olumiant, has been the most aggressive in expanding its indications and has grown rapidly. Changes in quarterly prescriptions of major JAK inhibitors (Unit: KRW 100 million, Data: UBIST). Rinvoq is indicated for the treatment of ▲rheumatoid arthritis, ▲psoriatic arthritis, ▲ankylosing spondylitis, ▲atopic dermatitis, ▲ulcerative colitis, and ▲Crohn's disease. Olumiant is indicated for ▲rheumatoid arthritis, ▲atopic dermatitis, and ▲alopecia areata, and Xeljanz is indicated for ▲rheumatoid arthritis, ▲psoriatic arthritis, and ▲ankylosing spondylitis. Among these, the atopic dermatitis indication is known to have led to the rise in the prescription performance of Rinvoq and Olumiant. However, the two products have different indications. Rinvoq is indicated for moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older, while Olumiant is indicated for moderate-to-severe atopic dermatitis in adult patients. 4th and 5th JAKis – ‘Civinqo’ and ‘Jyseleca’ released to market…further heating competition in the market The pharmaceutical industry is expected to see fiercer competition in the market this year with the entry of 2 new drugs that joined the market last year. Last year, Pfizer launched Civinqo as a follow-up to its Xeljanz. Its prescriptions for the 6 months from July through the end of the year totaled at. KRW 700 million. Civinqo is approved for atopic dermatitis, an indication that has been driving prescription growth for Rinvoq and Olumiant. Civinqo’s sales are expected to grow rapidly as it is approved for moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older, like Rinvoq. Last November, the 5th JAK inhibitor, Jyseleca, was released in Korea. Jyseleca is indicated for rheumatoid arthritis and ulcerative colitis. Prescription sales of the drug the 2 two months after its release amounted to KRW 20 million.
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- Colorectal cancer drug Fruzaqla gets Orphan Drug Designation
- by Eo, Yun-Ho Feb 07, 2024 05:59am
- Fruzaqla (fruquintinib). The new colorectal drug ‘Fruzaqla’ received the Orphan Drug Designation in Korea. On the 1st, the Ministry of Food and Drug Safety (MFDS) announced this decision through the Orphan Drug Designation posting. Fruzaqla is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with flouropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF treatment, and if RAS wild-type, an anti-EFGR treatment (RAS); and at least one of trifluridine plus tipiracil or regorafenib treatment. Fruzaqla (fruquintinib) is a VEGFR-1, -2, -3 receptors inhibitor that Takeda Pharmaceutical acquired the rights to the drug from Hong Kong Hutchmed. The FDA designated Fruzaqla for priority review in May last year and approved the drug in November of the same year. The efficacy of Fruzaqla was evaluated based on the FRESCO clinical trial conducted in China and published in JAMA and the global FRESCO-2 clinical trial published in LANSET. These clinical trialss compared the combination therapy of Fruzaqla plus best supportive care (BSC) with placebo combination therapy in patients with previously treated metastatic CRC (mCRC). The FRESCO and FRESCO-2 clinical trials acheived primary endpoints and crucial secondary endpoints, demonstrating consistent effectiveness in 734 patients who received Fruzaqla treatment. In FRESCRO-2 clinical trial, the fruquintinib-treatment group yielded a median overall survival (OS) of 7.4 months, versus 4.8 months for the placebo group. In FRESCO clinical trial, the fruquintinib-treatment group yielded a median OS of 9.3 months, versus 6.6 months in the placebo group. In January last year, Takeda entered into an exclusive licensing agreement with Hutchmed, obtaining the rights for the further development and commercialization of Fruzaqla in territories outside of China. At that time, Takeda agreed to an upfront payment of $400 million (526.9 billion won) and $730 million (961.6 billion won) in additional payments related to milestones.
