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- 2026-03-16 22:36:06
- Company
- Gov improvement plan may reduce patient drug access
- by Eo, Yun-Ho Aug 10, 2022 05:53am
- The focus is on lowering the price of the drug rather than improving the registration, shortening the time and effectiveness are insignificant." "There was no discussion with the consultative body. It's hard to gather opinions from the industry." The KRPIA expressed strong opposition to the government's plan to strengthen access to new drugs. Rather, it is pointed out that it will reduce patient accessibility. According to KPRIA on the 9th, the "plan to enhance patient access to high-priced severe disease treatments and strengthen salary management" reviewed by the Health Insurance Policy Review Committee of the MOHW on the 20th of last month focuses only on strengthening follow-up management of insurance drugs such as "PVA reduction rate revision" and "foreign drug price adjustment". Among the contents of "Quick registration through benefit evaluation and negotiation" included in the management plan, the part that shortens 60 days during the 210-day deliberation period of the current regulation does not have a practical shortening the period. It is argued that this not only hinders the motivation for innovative growth of the domestic pharmaceutical bio industry, which is currently developing new drugs, but also goes against the new government's stance to become a bio powerhouse as it can shrink the entire industry. According to a 2022 study, the average period for new drugs registered over the past 10 years was more than 690 days for rare drugs and 930 days for anticancer drugs. Through this, the association has already suggested that the effect of improving accessibility felt by patients will be very insignificant by shortening some periods (60 days) in the current salary evaluation system, which requires more than three to four times the actual legal period. The KRPIA said, "It is necessary to review and introduce a more proactive rapid registration system." It evaluated that "expansion of the PVA rate" and "additional restriction of the PE system to minority patients" included in the announcement of the management plan overlooked the fact that it could reduce the motivation to develop innovative new drugs and hinder access to treatments for severe rare diseases. The current system is already listed as the lowest in the world through comparison of foreign drug prices and has a longer evaluation period, making it difficult for domestic pharmaceutical companies as well as global pharmaceutical companies to release new drugs. The KRPIA also expressed concern about the fact that it did not collect opinions with related industries in the process of reviewing management plans. He added, "The MOHW's public-private consultative body for improving the drug price system, which has been operated by the HIRA, the NHIS and pharmaceutical organizations since early last year, also had a chance to review and discuss it in advance with the industry."
- Company
- Baxter International’s GM Dong-Wook Hyun suddenly resigns
- by Eo, Yun-Ho Aug 09, 2022 05:56am
- Former General Manager Dong-Wook Hyun Dong-Wook Hyun, General Manager of Baxter International Korea, resigned. According to industry sources, Hyun submitted his letter of resignation last month and left the company. The exact reason for his resignation remains unknown. With Hyun’s resignation, Baxter is now seeking a new head, during which Kwang-hyuk Im, Vice President of Renal Care at Baxter Korea, will be acting as interim CEO. The former GM Dong-Wook Hyun graduated from the University of California in the U.S. with a degree in Biology and Bioscience. Hyun accumulated extensive experience in the industry, beginning at the medical device company Medtronic from 1999 to 2004. After serving various posts in sales and marketing in the Asia-Pacific region, Hyun was appointed the Country Manager of Medtronic. Since then, Hyun served as the General Manager of Baxter from 2004 to 2008, and then as the Managing Director of MSD Korea for 8 years, after which he was again appointed as the General Manager of Baxter Korea in 2018. Meanwhile, Baxter is a global healthcare company based in the U.S. that entered the Korean market with its hemodialysis business in 1972. The company established its Korean subsidiary in 1991 and has been supplying pharmaceuticals such as anesthetics, intravenous nutrition, etc. as well as medical devices including peritoneal dialysis solutions and automated peritoneal dialysis systems to Korea.
- Company
- Korean companies win first round of Entresto patent suit
- by Kim, Jin-Gu Aug 08, 2022 06:09am
- Pic of Entresto. The first patent dispute over Novartis’s heart failure treatment ‘Entresto (valsartan+ sacubitril) ended with the victory of the Korean generic companies. The exclusive market approval (first generic exclusivity) that received attention is expected to be granted to 10 companies including Hanmi Pharmaceuticals, with the possibility of Daewoong Pharmaceuticals additionally receiving generic exclusivity. However, the industry analysis is that there remain risks for the generic companies' early release of Entresto latecomers as the original company Novartis has announced its plan to appeal, and separate legal disputes such as patent infringement suits and injunction applications are still ongoing. ◆10 companies overcome the fourfold patent hurdle…meets first generic exclusivity requirements According to industry sources on the 28th, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies in the 2 trials to confirm the passive scope of rights of Entresto’s composition patent that was filed by 9 companies including Chong Kun Dang against Novartis. Nine generic companies including Chong Kun Dang, YooYoung Pharmaceutical, Hanlim Pharm, Hana Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Elyson Pharm received the favorable ruling. With the ruling, on which companies will be receiving generic exclusivity has been somewhat revealed. Hanmi Pharmaceuticals was the first company to overcome all 4 of Entresto’s patents, and with the addition of the 9 companies that received the recent ruling, a total of 10 companies have now paved the way for the early release of their generics. The companies have obtained the ‘first to request for trial’ requirement by filing claims from January 2021. In April, the companies also applied for generic marketing authorization together and fulfilled the ‘application for first latecomer drug approval’ requirement as well. By ‘winning the patent suit,’ the companies met the last requirement to receive first generic exclusivity. The companies would now only need to receive official approval from the Ministry of Food and Drug Safety. Also, Daewoong Pharmaceuticals may also additionally secure first generic exclusivity. Daewoong Pharmaceuticals succeeded in invalidating or avoiding 3 of 4 Entresto’s patents. The company is currently challenging Novartis to invalidate the last remaining patent, and if Daewoong wins the last suit, the company will also be able to satisfy all of the first generic exclusivity requirements like the other 10 companies. The ruling on the trial is expected to be made within this month. ◆"Non-listed and newly-listed patents remain risk factors on the safe release of generics" The industry evaluates that Entresto’s patent dispute has virtually been settled with the generic companies’ win in the first trial. However, there is also an analysis that risks remain for the early release of the generic companies’ generics despite the complete victory they had made in the first round. The biggest risk factor is Novartis’s appeal. Novartis appealed against the first trial ruling and filed a suit for the annulment of the first trial decision, taking the case to the second trial. The company may likely file appeals for the other cases that it had not yet appealed to as well. If the first trial decision is reversed in the second trial, the early release of generics by generic companies will be reinterpreted as patent infringement. In this case, Novartis will file claims for damages on the patent infringement to the companies. In line with this, the generic companies need to overcome the patent infringement suit and the injunction application filed by Novartis to the Seoul Central District Court and others. Novartis filed a suit against the generic companies for infringing Entresto’s patent, and also filed an injunction requesting that the release of generics be banned until the results are made. The results of the injunction application are yet to be released. On the generic companies’ part, Novartis’s remaining non-listed and newly listed patents remain a burden. In the case of Entresto, 2 other patents remain in addition to the 4 patents that generic companies have now overcome. One of the 2 remaining patents is a salt·hydrate patent that was not listed in the patent register. This patent is set to expire in November 2026. Daewoong Pharmaceuticals, Hanmi Pharmaceuticals, and Elyson Pharm have challenged the patent, and a ruling has not been made yet. The other patent is a newly listed use patent that was registered after the generic companies applied for marketing authorization. The new patent will expire in August 2033, and no company has yet challenged the patent. The generic companies can release their generics without avoiding or invalidating the two patents. The two remaining patents will not affect the companies’ acquisition of first generic exclusivity. However, there is the possibility that the court may make a patent infringement judgment apart from the Intellectual Property Trial and Appeal Board’s ruling based on those two patents. From the generic companies’ point of view, the companies cannot rule out the concern over compensation for damages that may arise from this patent infringement. An industry official said, “Entresto is protected with several layers of patents, and generic companies have to bear the burden of overcoming all the patents; On the other hand, Novartis can prevent the early release of its generics even if it wins only one of all of its disputes.” Entresto’s ongoing patent dispute is the largest single product lawsuit in progress in the Korean pharmaceutical industry. 20 Korean companies have filed trials to confirm the passive scope of rights and patent invalidation trials on 4 patents. Novartis countered the suits by filing patent infringement and injunction applications to the Seoul Central District Court. The number of trials and litigations related to Entresto patents that have been filed with the Intellectual Property Trial and Appeal Board, the Patent Court of Korea, and the Seoul Central District Court has reached 130.
- Company
- Revised guidelines for dyslipidemia in Korea
- by Eo, Yun-Ho Aug 08, 2022 06:09am
- In the management of dyslipidemia, it is believed that drug prescriptions will be more aggressive in Korea. In April, The Korean Society of Lipid and Atherosclerosis unveiled some of the contents of the fifth edition of the 2022 dyslipidemia treatment guidelines at the Spring Conference, and will officially announce it in September. What is noteworthy in the new guidelines is that patients with Chronic kidney disease stage 1-3 are considered to be at high risk, and a reduction in low-density lipoprotein cholesterol (LDL-C) is recommended as a basic treatment goal. In 2017, the American Association of Clinical Endocrinologists (AACE) established an extreme risk for cardiovascular disease and recommended that LDL cholesterol be adjusted to less than 55 mg/dL (future unit omitted). The 2019 European Society of Cardiology (ESC) has emerged as an important issue, with LDL-C levels in extreme risk groups considering up to less than 40. On the other hand, in 2018, Korea stuck to the LDL-C treatment target of the ultra-high-risk group at 70. The guideline recognized the need to actively reduce LDL-C for high-risk patients in the trend that "The lower is the better," and the lower the LDL-C level, the higher the cardiovascular disease-related benefits. Drugs that are expected to increase their utilization are Ezetimibe and Atorvastatin. If 70 is viewed as an ideal number, it is correct that Ezetimibe has less needs in primary treatment. However, if LDL-C reduction is targeted in CKD patients, Ezetimibe combination therapy is more likely to be supported as statin alone therapy may not be achieved. The fact that Atorvastatin's mechanism of action is excreted as a liver rather than a kidney is also likely to act as an advantage. Atorvastatin, including Lipitor, is not affected by the plasma concentration or LDL-C reduction effect depending on whether it is a kidney disease, so you can freely select it without having to adjust the dose when administered to the patients.
- Company
- Nabota's sales in US in 1Q of the year were 92 billion won
- by Aug 08, 2022 06:09am
- Daewoong Pharmaceutical's botulinum toxin drug Nabota broke a new quarterly sales record in North America. Sales also improved in the second quarter following the first quarter, surpassing 90 billion won in sales in the first half. Daewoong Pharmaceutical's partner Evolus announced on the 3rd (local time) that its sales of Jubo (Nabota) reached $37.16 million in the second quarter. This is an increase of 46.3% compared to the same period last year. This quarter's sales are the highest since Navota's launch in North America in the second quarter of 2019. It surpassed 34.66 million dollars in the fourth quarter of last year, breaking a new quarterly sales record. Nabota's sales in North America in the first half of the year increased 87% year-on-year to $70.39 million. Since its launch, its cumulative sales have reached $260.2 million. Evolus is a global copyrighted partner of botulinum toxin Nabota developed by Daewoong Pharmaceutical. Since approval by the U.S. Food and Drug Administration (FDA) in February 2019, Nabota has been actively sold in North America. In particular, it resolved the negative factors by ending the International Trade Commission (ITC) dispute with Allergan and Medy Tox early last year. It has become possible to actively market Jubo without legal concerns. Navota's quarterly sales, which stood at $20 million last year, exceeded $30 million for the first time in the fourth quarter of last year. Nabota added 590 new accounts in the second quarter, securing more than 8,100 customers so far. The percentage of re-orders remains above 70%. In the first half of this year, about 180,000 Evolus Reward loyalty programs were used. Evolus is conducting more aggressive marketing. Following the creation of more than 250 million media exposures in the second quarter, it also launched the largest promotional campaign under the name of "Switch Your Tox and Love Evolus Forever" last month.
- Company
- 3rd PD-1i Jemperli to soon receive approval in Korea
- by Eo, Yun-Ho Aug 05, 2022 06:06am
- A third PD-1 inhibitor is knocking to enter the Korean market. According to industry sources, GSK Korea’s PD-1 inhibitor cancer immunotherapy ‘Jemperli (dostarlimab),’ which the company applied for approval earlier this year, may be approved within the year. If approved, Jemperli will become the third PD-1 inhibitor introduced to the Korean market following Ono·BMS’s ‘Opdivo (nivolumab),’ and MSD’s ‘Keytruda (pembrolizumab).’ Unlike the other two drugs that were first indicated as melanoma treatments, Jemperli was first approved in the US in April last year as a treatment for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.’ In August of the same year, Jemperli was additionally approved for the treatment of adults with dMMR recurrent or advanced solid tumors who have progressed on or following previous treatment and have no satisfactory therapeutic options. GSK plans to add other indications to endometrial cancer in Korea as well. The efficacy of Jemperli was confirmed through the multicohort GARNET trial that included a cohort of patients with dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen. Trial results showed an objective response rate (ORR) of 43.5% and the disease control rate of 55.6% in the Jemperli-treated group. The median duration of response was not reached yet, and the rate of patients whose duration lasted 6 months and 12 months were 97.9% and 90.9%, respectively. Meanwhile, the other companies are also actively working to expand their indication and reimbursement for Keytruda and Opdivo in Korea as well. MSD succeeded in expanding the reimbursement standards for Keytruda to first-line NSCLC in 1H this year, and Opdivo's indication as a first-line treatment in gastric cancer has passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee.
- Company
- Celltrion, applies for Phase III U.S. Targeting
- by Lee, Seok-Jun Aug 05, 2022 03:32am
- A clinical trial will be conducted so that Celltrion can alternatively prescribe CT-P17 (Yuflyma), an autoimmune disease treatment developed by itself, with the original Humira. Celltrion announced on the 1st that it recently submitted a global phase 3 to the FDA to secure interchangeability between CT-P17 and Humira. If it is designated as an interchangeable biosimilar, it can be prescribed by replacing the original at a pharmacy without intervention by a doctor. Phase 3 is conducted in 366 patients with plaque psoriasis. Pharmacokinetics, efficacy, and safety will be compared and verified between the group that took multiple intersections between Yuflyma and Humira and the group that administered Humira. Yuflyma is the world's first high-concentration Humira biosimilar that obtained permission from the European Medicines Agency (EMA). It was developed as a formulation that halves drug administration compared to low concentrations and removes citrate, which can cause pain. It started selling in major European countries, and the U.S. has completed a patent agreement with U.S. developer Abbvie so that it can start selling on July 1st next year, and expects FDA approval by the end of this year. Celltrion plans to secure Humira's interchangeable biosimilar status in the U.S. through interchangeable clinical trials with the advantages of Yuflyma's high-concentration formulation. Humira's global sales last year were about $20.69 billion and $17.33 billion in the United States.
- Company
- Oncaspar changed supplier
- by Eo, Yun-Ho Aug 05, 2022 03:28am
- Oncaspar, a combination treatment for acute lymphocytic leukemia (ALL), which has been supplied by developer Servier, is forming a stable prescription maintenance environment. According to related industries, it passed the Drug Committee (DC) of the Big 5 general hospitals, including Samsung Medical Center, Seoul National University Hospital, and Sinchon Severance Hospital. Since May, the supplier has been changed at the rare drug center, but the prescription code has been quickly secured. Oncaspar obtained permission for import items from the MFDS in February last year as a combination therapy with other anti-tumor drugs when treating Acute Lymphoblastic Leukemia (ALL). This drug maximizes the drug circulation half-life through pegylation, dramatically reducing the frequency of administration to be administered once every 14 days compared to L-asparaginase, which was previously administered once every other day. Considering the high incidence of Acute Lymphoblastic Leukemia, in particular in pediatric patients, improved use to allow administration every 14 days is expected to reduce injection burden, physical pain, and hypersensitivity to injection treatments in pediatric patients and patient caregivers suffering from frequent anti-cancer injections. In addition, it is expected to have a positive effect on medical costs such as hospital visits or hospitalization for injection treatment. First approved in 1994 as a secondary treatment for Acute Lymphoblastic Leukemia in the United States and Germany, Oncaspar was recognized as a primary treatment for all Acute Lymphoblastic Leukemia in the United States in 2006. Since birth in Europe in 2016, it has been approved as a combination therapy with other anticancer drugs in children and adults with acute lymphocytic leukemia aged 18. Oncaspar is currently a treatment for Acute Lymphoblastic Leukemia, which is primarily recommended in major international guidelines and treatment protocols such as NCCN, ESMO, and Children's Oncology Group (COG), and is used in 62 countries.
- Company
- Samjin, will develop new drugs with AI company in Canada
- by Lee, Seok-Jun Aug 05, 2022 03:28am
- Samjin Pharmaceutical announced on the 2nd that it has signed a joint research contract for AI new drug development with Cyclica, a Canadian artificial intelligence new drug development platform company. Through the agreement, Samjin Pharmaceutical will propose to Cyclica multiple drug targets currently under review. Cyclica is going to secure candidate materials that are highly likely to be developed by applying AI-based new drug candidate material discovery platform (Ligand DesignTM) technology. Lee Soo-min, head of the Samjin Pharmaceutical Research Center, said, "Joint research using AI technology with Cyclica will significantly reduce the time and cost required to develop new drugs. We will cooperate with leading domestic and foreign research institutes and companies to efficiently discover and develop innovative new drugs through open innovation strategies." Cyclica was selected as one of the world's 13 healthcare AI startups by CB Insights, a technology market research institute in 2020. It is conducting joint research with many domestic and foreign companies including global Big Pharma such as Merck KGaA and AstraZeneca.
- Company
- Chinese partner terminates agreement with Medytox
- by Nho, Byung Chul Aug 04, 2022 06:04am
- Medytox is having difficulty making entry into the Chinese market. At a presentation on ‘Follow-up regarding Bloomage·Medytox joint venture Medybloom's progress' that was held on the 1st, Bloomage Biotechnology announced that “the company will discontinue the partnership with Medytox and seek opportunities with other botulinum toxin companies." As one of the largest hyaluronic acid production and marketing enterprises in the world, Bloomage Biotechnology is known for its professional sales power in China's cosmetic surgery market. With the termination of the partnership, Medytox will now have to seek new venues for entry into the Chinese market without achieving much during the 5 years after establishing the joint venture, MedyBloom China, with Bloomage Biotechnology in 2017. Medytox applied for the approval for its botox product Meditoxin (Neuronox) to the National Medical Products Administration in China in February 2018, but the agenda is pending for over 4 years. Moreover, the global pharmaceutical company Allergan (currently Abbvie) returned the rights of Medytox’s liquid botulinum toxin candidate (MT-10109L) to Medytox in September last year. This return of rights, which occurred 8 years after the company licensed out the development and global sales rights of its liquid botulinum toxin candidate to Allergan in September 2013, was expected to have caused considerable aftermaths for the company. With the termination of the agreement, Medytox will not be able to receive the remaining milestone payments ($262 million/ ₩342.5 billion) from Allergan. Allergan had planned to sell the liquid botulinum toxin in the global market excluding Korea and Japan after undergoing clinical trials and approval processes, but this is also now unclear. With Medytox facing difficulties in 2 of the 3 largest global botulinum toxin markets - the US and China - other competitors are accelerating their market defense and penetration strategies for their botox products. Hugel’s Letybo continues to rank first in the Korean market and is solidifying its position as the market leader with the recent marketing authorization and launch of its botulinum toxin in China. Daewoong’s Nabota has also been increasing its global market sales and shares upon receiving marketing authorization and release in the US. Also, Nabota is coordinating the timing for its entry into the European market, and is on the verge of achieving a grand slam of being approved in all three global major markets as it has completed Phase III clinical trials and is about to receive marketing authorization in China. Meanwhile, Medytox had relayed to the press that “We received a letter from Bloomage regarding the contract termination, but nothing has been finalized. We will be reviewing measures from various angles to come up with the optimal plan for entering the Chinese botulinum toxin market.”
