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- 2026-05-08 19:39:35
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- The popular Daewoong's Nabota
- by Nov 14, 2022 06:06am
- EvolusDaewoong Pharmaceutical's botulinum toxin drug Nabota exceeded $100 million in cumulative sales in North America this year. This is an increase of 61% compared to the previous year. According to the earnings report of Daewoong Pharmaceutical partner Evolus on the 9th (local time), Jeuveau, which is sold by the company, recorded cumulative sales of $13.6 million (14.3 billion won) in the third quarter of this year, up 61.1% from a year earlier. Jeuveau is the North American product name of Nabota, a botulinum toxin formulation exported by Daewoong Pharmaceutical. Sales in the third quarter were $33.21 million (45.6 billion won), the lowest this year, but increased by 24.5% compared to the same period last year. Evolus is a global copyright partner of Nabota developed by Daewoong Pharmaceutical. Since the approval of the U.S. Food and Drug Administration (FDA) in February 2019, Nabota has been actively sold in North America. Early last year, the ITC dispute with Allergan and Medytox was terminated to resolve the negative factors. Nabota has recorded more than $30 million in sales for the fourth consecutive quarter as active marketing for Nabota and demand that had slowed down due to COVID-19 have increased. In the second quarter of last year, it broke its biggest quarterly sales of $37.16 million (51 billion won). Evolus predicted that growth momentum will continue in the fourth quarter with the recently launched large-scale campaign "Switch Your Tox." The campaign added 650 new customer accounts in the third quarter, securing more than 8,800 customers so far. The rate of reordering remains above 70%. The number of consumers who wrote the Evolus Reward loyalty program reached nearly 450,000. "The large-scale campaign has kept demand for Nabota strong," said David Moatazedi, CEO of Evolus. "Evolus will be able to reach the top of this year's revenue guidance range of 143 million to 150 million dollars, which is about 50% annual growth." This is about three times the expected growth rate of the toxin market, he said. Evolus also started selling Nabota in the UK in October. Nabota, which was officially released under the name Nuceiva, delivered its first order last month. Evolus will also launch Nabota in other countries in Europe next year.
- Company
- Daewoong obtained an item license for Fexuclu
- by Nov 11, 2022 05:52am
- FexuclueDaewoong Pharmaceutical announced on the 10th that Fexuclu, a new drug for gastroesophageal reflux disease, obtained an item license from the Philippines FDA on the 3rd. The approval was made about eight months after submitting an application for item permission (NDA) at the end of February. It takes about three years to obtain an item license in the Philippines, and Daewoong Pharmaceutical explained that it has greatly shortened the period based on its know-how. Daewoong Pharmaceutical will invite KOLs, including the chairman of the Philippine Gastroenterological Society, to hold a Fexuclu symposium on the 24th and share directions and opinions on entering the Philippine market. Starting from the Philippines, the company will accelerate its overseas expansion of Fexuclu. It plans to submit NDA to 10 countries around the world by the end of this year. So far, a total of eight countries have applied for item permits, including the Philippines, Brazil, Indonesia, Thailand, Mexico, Chile, Ecuador, and Peru. Fexuclu is a new drug for gastroesophageal reflux disease in the P-CAB series officially launched in Korea by Daewoong in July. By improving the shortcomings of existing PPI preparations, it is characterized by fast and stable suppression of gastric acid secretion by combining with a proton pump without the need for activation by gastric acid. There are a total of two indications of Fexuclu: ▲ treatment of erosive gastroesophageal reflux disease (40 mg) ▲ improvement of gastric mucosal lesions of acute gastritis, and chronic gastritis (10 mg). In particular, Fexuclu is the only P-CAB drug in Korea for gastritis indication, and the 2022 European Gastroenterology Association recently published the results of Fexuclu's gastritis adaptation study. Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "It is very encouraging that Fexuclu received approval for the first time overseas by drastically shortening the license period in the Philippines, one of Daewoong Pharmaceutical's branch offices, and this is a proven case of Daewoong Pharmaceutical's global business capabilities."
- Company
- SK Biopharm’s Q3 sales rise 270% with rise in Xcopri sales
- by Nov 11, 2022 05:51am
- SK Biopharmaceutical’s sales rose greatly in Q3 with the rising sales of its new anti-epileptic drug ‘Xcopri (cenobamate)’ in the US. On the 10th, SK Biopharmaceutical announced sales of KRW 88.8 billion in Q3 this year, a 270.9% on-year increase. The company also reported an operating loss of KRW 9.2 billion in the same period. Almost half of its sales were driven by Xcopri. Xcopri generated sales of KRW 47.4 billion in the US in Q3 this year. This is over a twofold increase on-year from the KRW 19.9 billion it had generated in Q3 last year. Xcopri’s sales have been driving the performance of the company after getting on track this year. After recording KRW 10 billion in sales in Q1 2021, Xcopri’s sales exceeded KRW 20 billion by Q4 last year. Only a half year later, its sales exceeded KRW 40 billion. Xcopri’s cumulative sales this year reached KRW 119.4 billion. Xcopri’s amount of prescriptions in the US has also been rising continuously. Its prescriptions in Q3 this year rose 12% compared to those in Q2. Xcopri’s monthly prescriptions exceeded 15,000 in August. The company explained that this is a 1.8-time increase compared to the average prescription amount of its competitors at 29 months. SK Biopharmaceutical attributed the rise in US sales to the active online and digital marketing it had relayed in the US. To strengthen its sales capabilities for Xcopri in the US, the company carried out active marketing activities to HCPs and patients. Also, in line with the improvement seen in the face-to-face sales environment, the company reorganized its US local sales and marketing organization and maximized sales efficiency. The company’s analysis is that the activities led to the improvement of relevant indicators, including the total number of calls, rate of face-to-face sales activities, new prescription amount, etc. The company also actively embraced the use of social media and delivered various experiences of patients using Xcopri on the company’s official YouTube channel and sent Direct Messages to patients and their caregivers. Also, the company reserved a large booth at the American Epilepsy Society Annual Meeting that will be held in Q4 to further raise Xcopri’s brand awareness. The company plans to attend various academic conferences and focus on promoting and marketing its drug to epilepsy specialists. Also, a TV commercial for epilepsy patients is planned for the next year. SK Biopharmaceuticals predicted that this year's global sales of Xcopri will exceed its target of KRW 185 billion, with the product’s accelerated entry into new markets in Europe and Latin America. Xcopriis scheduled to be released in Finland, Switzerland, Spain, and France through its European partner Angelini Pharma within the year. The company’s operating loss was reduced by KRW 40.7 billion on-year to record KRW 9.2 billion. However, the cumulative operating loss amounted to KRW 86.5 billion due to its investments in clinical trials for follow-up drugs and promotional activity in the US in the first half of the year.
- Company
- Impinzi's indication is expected to be approved in Korea
- by Eo, Yun-Ho Nov 10, 2022 05:46am
- Impinzi is also expected to have options for treating immuno-cancer drugs in the area of biliary tract cancer. According to related industries, the Ministry of Food and Drug Safety is reviewing the expansion of biliary tract cancer indications of Imfinzi, an immuno-cancer drug before PD-L1 inhibition mechanism. Permission is possible as early as this year. Impinzi is drawing more attention in Korea as researcher-led clinical trials conducted by Oh Do-yeon, a professor of oncology at Seoul National University Hospital, played a leading role in adding indications. Impinzi's specific biliary tract cancer indication was validated through a TOPAZ-1 study with "conventional chemotherapy (Gemcitabine·Cisplatin, GemCis) in the primary treatment of local progressive or metastatic biliary tract cancer" and obtained approval from the U.S. FDA in September. The TOPAZ-1 study is a multinational, randomized, double-blind, and placebo-controlled phase 3 clinical trial in 685 patients with progressive biliary tract cancer that compared and evaluated the combination of Impinzi, which is added to the existing standard treatment "GemCis." It is also worth noting that in the TOPAZ-1 study, patient recruitment was conducted in 17 countries, including the United States, Europe, and South America, and about 55% of the total was registered in Asian countries including Korea, Thailand, Japan, and China. As a result of the study, the Impinzi combined group had a 20% lower risk of death than the placebo combined group. However, the extension of the median value of the total survival period was only 1.3 months compared to the control group. The most commonly reported side effects were anemia (48.2%), neutropenia (31.7%), and zones (40.2%). Potentially serious side effects were 62.7% in the Impinge combined group and 64.9% in the placebo combined group, suggesting that most side effects were due to chemotherapy in both groups. Impinzi's expansion of biliary tract cancer indication was made under Project Orbis, priority screening, and designation of rare drugs. AstraZeneca, a developer, is currently in the process of expanding its indication in many countries, including Korea, Europe, and Japan.
- Company
- Samjin-Pin to co-develop new targeted protein degrader
- by Lee, Seok-Jun Nov 10, 2022 05:46am
- Samjin Pharm announced on the 9th that it had signed a strategic Memorandum of Understanding (MOU) with the new drug developer Pin Therapeutics to develop a radical and improved treatment for cancer and fibrosis. Under the MOU, Samjin Pharm will conduct a comprehensive study on the targeted protein degrader (TPD) candidate to assess its efficacy, toxicity, formulation, and CMC. Pin Therapeutics will study its structural design and conduct screening on the drug. Pin Therapeutics is a new TPD drug developer that was established in 2017. Through collaboration with ‘PinUS,’ its 100% US subsidiary, the company has been conducting research and development at a global level. In addition to individual pipelines that degrade specific proteins, the company is also securing platform technology to overcome technical limitations in the field of TPD. New TPD therapies are a next-generation new drug development platform that can specifically degrade target proteins using the Ubiquitin-Proteasome system (UPS), which is one of the natural protein degradation systems in cells. TPD drugs fundamentally degrade and remove the pathogenic proteins whose function had been only inhibited with conventional small molecule inhibitors. It is a superior therapeutic modality compared to existing small molecule inhibitors in terms of efficacy and target selectivity. Sumin Lee, head of Samjin Pharmaceutical’s research center, said, “The TPD technology is expected to become a game changer in the field of new drug development as it can target more than 80% of the pathogenic proteins that could not be controlled by existing small molecule compounds.”
- Company
- The number of reimbursed drugs is the lowest in 33 months
- by Chon, Seung-Hyun Nov 09, 2022 05:47am
- The number of medicines listed on the health insurance benefit list is the smallest in about three years. New-entry drugs have decreased significantly due to the price reorganization of generic drugs and joint development regulations. The size of the reimbursed drug has been greatly reduced due to the reorganization of items such as microbial or unclaimed deletion of drug benefits. Prior to the reorganization of the drug price system, reimbursed drugs exploded, but they are rapidly recovering to the previous level. According to the HIRA on the 8th, a total of 23,604 drugs were registered as of the 1st of this month. It decreased by 1,057 in a month from 24,661 in the previous month. The health authorities delete drugs that have not claimed insurance benefits in the past two years or have not reported production or import performance for three years from the payroll list. The number of medicines has been on a steady decline since it hit 26,527 in October 2020. It has decreased by 2,923 in the past two years and one month. This means that there have been 2,923 more withdrawals or exits from the market than new entries into health insurance benefits over the past two years. In November 2018, the number of reimbursed drugs was recorded at 26,689, but in October 2020, the number increased by 5,838 in a year and 11 months to 26,527. During this period, new entries overwhelmed the number of withdrawals from the market, with the size of salary-listed drugs expanding by 28.2%. In the 22 months from November 2018 to October 2020, the number of salary-listed drugs decreased compared to the previous month only once on November 8 and December 2019. In other words, the remaining 21 months have all increased the size of salary-listed drugs compared to the previous month. During this period, the average number of unproduced and unclaimed drug benefits was deleted twice a year, but the number of new entries was higher. The number of times listed drugs has decreased from the previous month 16 times in 25 months from October 2020 to this month. Since August last year, the number of drugs listed has decreased for six consecutive months. Currently, the number of drugs listed has fallen to 25,694 in February 2020, the lowest in 33 months. It is analyzed that the overall number of listed drugs has continued to decline as the speed of the health authorities' continuous arrangement of reimbursed drug items has advanced to the new entry. Recently, the number of new generics has decreased significantly. According to the Ministry of Food and Drug Safety, the number of Rx drugs licensed from January to October this year was 942, an average of 94 per month. Last year, 1,603 Rx drugs were licensed, recording an average of 134 per month, down 41.2% in a year. Compared to the 2,616 Rx drug licenses (218 per month on average) in 2020, it has fallen to less than half in two years. The number of Rx drug permits was 1,562 in 2018, recording an average of 130 per month, but in 2019, it soared to an average of 350 per month. Since then, it has been gradually decreasing. It is analyzed that the number of permits for generic drugs, which account for the largest proportion of Rx drugs, has decreased. The reorganization drug price system, which took effect in July 2020, focuses on maintaining the 53.55% upper limit of the current original drug before the expiration of the patent only when generic products meet both the direct performance of BA Test and the use of registered raw materials. The reorganized drug price system includes a stepped drug price system in which the upper limit decreases as the registration period is delayed. If more than 20 generics are listed in the specific ingredient market, the upper limit of newly listed items will be up to 85% of the existing lowest price. It is analyzed that the approval of the manufacturing consignment generic for the entire process has decreased significantly due to the structure in which the drug price drops significantly if pharmaceutical companies do not develop the generic themselves and perform BA tests. Some say that the regulation on joint drug development, which took effect in July last year, has promoted the decline in generic permits. The revised Pharmaceutical Act, which was passed at the plenary session of the National Assembly in May last year, limits the number of IMDs and generics that can be approved as a single clinical trial. If all manufacturing processes are manufactured the same with the same prescription and manufacturing method at the same manufacturer as the pharmaceutical company that directly conducted the BA test, the use of BA data will be limited to three times. This means that only four generics can be licensed with one BA test. Clinical trial data can also be agreed on up to three items other than medicines by direct pharmaceutical companies. In the past, when certain pharmaceutical companies received generic permits through BA test, dozens of pharmaceutical companies often received consignment generic permits with the same data, but joint development regulations made it impossible to "unlimited generic replication." It is analyzed that pharmaceutical companies received generic permits indiscriminately regardless of marketability before tightening regulations, and there are many cases that lead to market withdrawal without sales performance.
- Company
- Atozet market ↑40% in 1 year...Lipitor Plus leads generics
- by Kim, Jin-Gu Nov 09, 2022 05:47am
- The atorvastatin and ezetimibe combination market has grown 40% in a single year. The cumulative prescription amount of related generics increased over twofold and drove the market growth. In particular, Jeil Pharmaceutical and Viatris Korea’s Lipitor Plus is rapidly increasing its influence in the market. Prescription sales of Lipitor Plus rose 4.6 times in one year and became the highest-performing product among all generics. ◆Prescipriton of Atozet generics rise 96% in a year…market share increases to 56% According to the market research institution UBIST on the 7th, the outpatient prescription sales of the atorvastatin and ezetimibe combination had reached KRW 51.1 billion in Q3 this year. This is a 39.8% increase from the KRW 36.6 billion made in Q3 last year. The original product in the market is MSD’s Atozet. Atozet’s prescriptions in Q3 this year were KRW 22.5 billion, rising 2.3% in one year. With sales of the original drug slowing down, the market growth is being evaluated to have been driven by the generics. Prescription of Atozet generics rose around twofold (96%) in one year, from KRW 14.6 billion in Q3 last year to KRW 28.6 billion in Q3 this year. The market share of atorvastatin and ezetimibe combination generics has been growing rapidly since their release in Q2 last year. Their prescriptions, which had amounted to KRW 6.9 billion in Q2, had risen to KRW 14.6 billion in Q3, and KRW 19.3 billion in Q4. In Q1 this year, the generics made KRW 22.1 billion, exceeding sales of the original version (KRW 21.4 billion). Its growth continued on since then to occupy 56.0% of the market in Q3. In Korea, 112 companies were approved to manufacture atorvastatin and ezetimibe combination generics. Chong Kun Dang first received approval for ‘Lipilouzet’, a combination drug that contains the same ingredients as Atozet in October 2020. In January of the following year, 21 companies received approval for their authorized generics of Lipilouzet. Authorized generics refer to already approved generic products with different packaging. The drugs were listed for reimbursement in April last year. Latecomer generics joined the competition in February. 88 companies received approval for Atozet generics then, which were listed for reimbursement in May last year, one year later than the authorized generics of Lipilouzet. Among the companies, 83 are currently selling atorvastatin and ezetimibe combination drugs. ◆Lipitor Plus rises as the leading generic in the market despite low price Among the selling atorvastatin and ezetimibe combination generics, Lipitor Plus’s rapid growth is gathering attention. Pic of Lipitor PlusLipitor Plus’s Q3 prescription amount was KRW 3.7 billion, a 4.6 times rise from the KRW 0.8 billion it had made in Q3 last year. At the same time, the drug recorded the highest prescription performance among all atorvastatin and ezetimibe combination generics. Its cumulative prescription amount by Q3 this year is KRW 8.6 billion, and the analysis is that its annual prescription is highly likely to exceed KRW 10 billion this year. Lipitor Plus was released as an Atozet generic, not an authorized generic of Lipilouzet. Being listed a month later than the authorized generics of Lipilouzet, its price was set at a lower price than other generics. Based on the 10/10mg dose, the insured ceiling price of Lipilouzet is KRW 1,037, whereas the price of authorized generics of Lipilouzet is 85% of that at KRW 881, and Atozet generics 30% of that at KRW 637. In accordance with the reform of the drug pricing system in July 2020, the price ceiling of 20 of the 21 authorized generics that were listed at the same time as Lipilouzet was set at 85% of the highest price. This is because the drugs did not meet the requirement of “directly conducting a bioequivalence test”, one of the two requirements that need to be met to receive the highest ceiling price among generics. As the number listed identical products exceeded 20 by the time the Atozet generics were listed a month later, their price was set as the lower of the two - '85% of the price of the drug that did not meet the two requirements' or '85% of the previous lowest price’ - regardless of whether or not the two requirements were met. As a result, the price ceiling of Atozet generics was set around 30% lower than the authorized generics of Lipilouzet. Due to its low price, the sales performance of Lipitor Plus had not been good earlier in its release. In Q3 last year, its prescriptions had been lower than that of its competitors, such as Daewoong Pharmaceutical’s Litorvazet (KRW 1.7 billion), Boryung Pharmaceutical’s L50 (KRW 1.6 billion), Yuhan Corp’s Atovamibe (KRW 1.4 billion), HK Inno.N’s Zepitor (KRW 1 billion). Q3 prescription sales of major atorvastatin+ezetimibe generics However, Viatris and Jeil Pharmaceutical made a joint promotion agreement and rapidly increased prescriptions of Lipitor Plus. For Lipitor Plus, Viatris will be supplying the API of Lipitor, atorvastatin to Jeil Pharmaceutical, and the final product will be manufactured and produced by Jeil Pharmaceutical. The two companies will manage and jointly promote sales of the drug. The fact that Lipitor (atorvastatin), one of the main ingredients in Lipitor Plus, is still exerting much influence in the prescription field, positively influencing the sales performance of its follow-on, Lipitor Plus. Following Lipitor Plus, Daewoong’s Litorvazet sold KRW 3.6 billion, Boryung’s L50 sold KRW 2.4 billion, Yuhan Corp’s Atovamibe KRW 2.2 billion, HK.Inno.N’s Zepitor KRW 2 billion, and Ahngook’s Lipozet KRW 1.5 billion in Q3 this year. Quarterly sales of other products in the market were less than KRW 1 billion.
- Company
- SGLT-2 diabetes medication is on the rise
- by Kim, Jin-Gu Nov 08, 2022 05:43am
- By product, AstraZeneca Forxiga and Xigduo are chased by Beringer Ingelheim Jardiance and Jardiance DuoThe market for diabetes treatments related to SGLT-2 inhibitors has grown by 16% in a year. Analysts say that the use of this drug in the diabetes treatment market is steadily expanding and that major drugs have recently added indications for heart failure treatment, leading to the expansion of appearance. In the first half of next year, Daewoong Pharmaceutical's new SGLT-2 inhibitor-based diabetes drug is expected to launch, which is expected to intensify competition in the market in the future. ◆SGLT-2 Diabetes Treatment Market Expanded by 15% According to UBIST, a pharmaceutical market research firm, the domestic SGLT-2 inhibitor market in the third quarter of this year was 44.6 billion won. It increased by 15% compared to 38.7 billion won in the third quarter of last year. The cumulative prescription amount increased by 16% from 109.6 billion won in the third quarter of last year to 126.6 billion won in the third quarter of this year. The SGLT-2 inhibitor market was formed in 2014 when AstraZeneca released Forxiga. Astellas Suglat was added in 2015, and Beringer Ingelheim Jardiance and MSD Steglatro were added in 2016 and 2018. With the addition of new drugs, the market has grown rapidly. In the first quarter of 2017, the quarterly prescription exceeded 10 billion won for the first time. It then surpassed 20 billion won in the fourth quarter of 2018, 30 billion won in the second quarter of 2020, and 40 billion won in the fourth quarter of last year. Analysts say that the use of complex drugs at the prescription site is expanding, driving the growth of the overall market. These combinations include AstraZeneca Xigduo and Beringer Ingelheim Jardiance Duo. It is a drug that combines Metformin with SGLT-2 inhibitors. Sugar and Steglatro have no combination. In the third quarter, the number of outpatient prescriptions for the single SGLT-2 inhibitor was 25.3 billion won in total for four products. It increased by 11% compared to 22.8 billion won in the third quarter of last year. During the same period, the total amount of prescriptions for the two combination products increased by 21% from 15.9 billion won to 19.3 billion won. Although the single market is still larger, the gap is expected to gradually decrease in that the complex is rapidly increasing its influence. The expansion of the prescription area to heart failure also positively affected the market growth. In July, the Korean Society of Cardiology issued a "complete revision of the 2022 Heart Failure Treatment Guidelines" and recommended SGLT-2 inhibitors as a major drug for the treatment of chronic heart failure regardless of the presence or absence of diabetes. The SGLT-2 inhibitors specified in the guidelines are limited to Jardiance and Forxiga, which have been based on clinical research. Following the revision of the guidelines, if health insurance benefits expand to heart failure, the market is expected to grow even more. Forxiga and Xigduo's total prescription amount in the third quarter of this year was 23.7 billion won. It increased by 14% compared to 20.8 billion won in the third quarter of last year. Jardiance and Jardiance Duo increased by 19% from 16.7 billion won to 19.8 billion won during the same period. Suglat and Steglatro recorded prescription performances of 800 million won and 400 million won, respectively, in the third quarter of this year. In terms of market share, Forxiga and Xigduo decreased by 1%p from 54% in the third quarter of last year to 53% in the third quarter of this year, and Jadiang and Jadiang Duo increased by 1%p from 43% to 44%. Suglat and Steglatro are insignificant at 2% and 1% respectively. Daewoong Pharmaceutical plans to release a new self-developed SGLT-2 inhibitor in the first half of next year. I applied for an item permit in April. Daewoong Pharmaceutical is expected to receive an item license this year. As Daewoong Pharmaceutical is building strong sales power in the diabetes treatment market, competition in the SGLT-2 inhibitor market is expected to intensify with the addition of DWP16001. Daewoong Pharmaceutical is jointly selling Forxiga and Xigduo, the No. 1 product in the SGLT-2 inhibitor market. In the DPP-4 inhibitor treatment market, another diabetes drug, Daewoong Pharmaceutical is also jointly selling LG Chem's "Zemiglo Series," the No. 1 product in the market.
- Company
- 2 new myelofibrosis drugs fail to extend coverage
- by Eo, Yun-Ho Nov 07, 2022 06:06am
- New drugs for the rare disease myelofibrosis are having difficulty expanding coverage in Korea. According to industry sources, after ‘Jakabi (ruxolitinib)’ failed to expand reimbursement in Korea in May, ‘Inrebic (pedratinib),’ the first new drug to be introduced to the field in one decade, also failed to pass the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review in June this year. At the meeting, expanding reimbursement for Jakabi as a treatment for intermediate- or high-risk patients with myelofibrosis had been discussed. However, the applicant that applied for the reimbursement extension was the Korean Society of Hematology, not its supplier Novartis. Therefore, resuming or advancing discussions on its reimbursement may be unlikely. The case was more disappointing for Inrebic as it was the first new drug to be introduced to the field since Jakabi. Discussions had been made to extend the drug’s reimbursement as a treatment for patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis, but the reimbursement standards had not been set. In the U.K., Inrebic is covered by the Cancer Drugs Fund (CDF). Although the drug’s reimbursement was rejected by the National Institute for Health and Care Excellence last year, this alternative has been prepared due to a consensus made on its need. Therefore, both the pharmaceutical company and the government needs to be willing to receive and grant reimbursement for Inrebic in Korea. Meanwhile, the once-daily oral treatment Inrebic has been for a broader indication that includes patients who have no treatment experience with Jakabi, but BMS had proposed a more limited patient population during the NICE evaluation process. As a JAK-2 inhibitor, Inrebic is receiving another level of expectations from the JAK1/2 inhibitor Jakabi. Inrebic was the first drug to obtain approval in Korea as a once-a-day oral medication that greatly reduces the burden from spleen volume and symptoms in treatment-naive patients with myelofibrosis.
- Company
- Recobell can be prescribed at infertility centers
- by Eo, Yun-Ho Nov 03, 2022 05:54am
- The infertility treatment Recobell is available in general hospitals. According to related industries, Ferring Pharmaceutical's Recobell passed the Drug Committee of medical institutions with infertility centers such as Sinchon Severance Hospital, Bundang Seoul National University Hospital, and Bundang Cha Hospital. Along with the expansion of insurance benefit standards in May, the benefit is also expanding. Originally, the drug, which was only administered alone, is covered by Controlled Ovarian Stimulation to mature a number of oocytes in women undergoing auxiliary reproduction such as IVF or ICSI with hMG combination therapy. The expansion of Recobell's benefit criteria was based on the MARCS study, a multi-agency, open-label, and single-cohort clinical trial, which evaluated the efficacy and safety profile of Recobell's hMG combination therapy in 110 infertile patients with IVF/ICSI. According to the Gardner classification system, 3BB or higher is defined as a qualitative good-quality blastocyst. As a result of the MARCS study, it was confirmed that Recobell increased the possibility of collecting qualitatively good vesicles in combination therapy with hMG. The average number of qualitatively good distributions available on Day 5 or Day 6 of treatment, which is the primary evaluation variable, was 4.9, and the results were significantly higher than 2.0 in the ESTHER-1 study conducted with Recobell alone therapy. The number of mature oocyte collections, a major secondary evaluation variable, was also reported to be 11.3 on average, significantly higher than the ESTHER-1 study, which showed 7.4. In particular, it was confirmed that the proportion of appropriate oocyte (8-14 oocyte) collection was higher in patients aged 35 or older than those under 35, proving that combination therapy is more effective than single administration in elderly patients with relatively low pregnancy rates. Lee Won-don, director of Maria Hospital, said, "We expect that the use of Recobell and hMG combination therapy will be possible, greatly reducing the economic burden of patients who needed more effective treatment, and leading to a more improved pregnancy success rate."
