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- 2026-03-16 18:59:05
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- 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.”
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- 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.
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- 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.
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- 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.
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- 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.
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- 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."
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- Immuno-oncology drugs set out to conquer early stage cancer
- by Nov 03, 2022 05:54am
- Pic of Opdivo, Keytruda, Tecentriq, Imfinzi The use of immuno-oncology drugs has advanced to the frontline of early-stage cancers. This is because data has demonstrated that the use of immuno-oncology drugs in the early stages increases the possibility of surgery and reduces the possibility of metastasis and recurrence. Following their use in the field of non-small cell lung cancer (NSCLC), immuno-oncology drugs are evaluated to be paving the way for early treatment in difficult-to-treat cancer types such as melanoma, bladder cancer, esophageal cancer, and breast cancer. BMS and Ono Pharmaceutical’s anti-PD-1 immunotherapy Opdivo (nivolumab) has recently received approval for use in early-stage NSCLC. The Ministry of Food and Drug Safety approved the drug in combination with platinum-based chemotherapy for ‘resectable (tumor size larger than 4cm or benign lymph node) on the 26th of last month. With the approval, Opdivo became the first immuno-oncology drug allowed for use as adjuvant therapy in early-stage, resectable lung cancer patients. Even with the addition of targeted anticancer drugs, Opdivo is the only drug that can be used as neoadjuvant therapy. Previously, Tagrisso, an EGFR-targeted treatment, was approved as an adjuvant treatment in NSCLC. The Phase III CheckMate-816 trial(ONO-4538-55), which became the basis for the approval, enrolled patients with stage IB-IIIA NSCLC to compare Opdivo+chemotherapy with chemotherapy monotherapy. Its primary efficacy endpoint was event-free survival (EFS) and pathologic complete response (pCR) rate as assessed by the blinded independent central review (BICR). The secondary efficacy endpoint was overall survival (OS) and major pathologic response (MPR), and time to death or distant metastases. Results showed that in patients receiving Opdivo+chemotherapy, the median EFS was 31.6 months, decreasing the risk of relapse or death by 37% compared to 20.8 months of patients treated with chemotherapy alone. The pCR was 24% in the Opdivo group, and 2.2% in the control group. While the data are still immature, favorable early overall survival (OS) results were observed with Opdivo in combination with chemotherapy. In the interim analysis, Opdivo+chemotherapy reduced the risk of death by 43%. Further analysis will be conducted in the future as the data is yet to reach statistical significance. Compared to how 83% of the patients that received treatment with Opdivo+chemotherapy survived after 2 years, the survival rate of those that only received chemotherapy was 71%. Also, 83% of the patients who received Opdivo+chemotherapy received operations, compared with the 75% in chemotherapy-treated patients. Rates of Grade 3-4 treatment-related adverse events were similar even with the addition of Opdivo to chemotherapy versus chemotherapy alone (34% vs. 37%). Immuno-oncology competition extends to early-stage lung cancer In addition to Opdivo, other immuno-oncology drugs are also challenging the market. Companies are conducting trials on Keytruda, Imfinzi, and Tecentriq to verify their efficacy as adjuvant or neoadjuvant therapy. In October last year, the FDA approved Roche’s Tecentriq (atezolizumab) as adjuvant treatment in patients with stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells. In Europe, the indication was expanded for patients whose tumors have a PD-L1 expression ≥ 50% based on the interim analysis that showed a high effect in that patient group. Interim analysis results showed that adjuvant Tecentriq resulted in a 57% reduction in the risk of disease recurrence or death compared with best supportive care (BSC) in patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher. Based on such findings, Roche is also planning to expand Tecentriq’s indication in Korea within the year. MSD’s Keytruda (pembrolizumab) is aiming to expand its indication as adjuvant therapy in patients with early-stage NSCLC (Stage IB-IIIA) regardless of PD-L1 expression. Interim analysis results of the Phase III KEYNOTE-091 study that was presented earlier this year showed that Keytruda significantly improved disease-free survival (DFS), which was one of the primary efficacy endpoints, and reduced risk of recurrence or death by 24% compared with placebo. The median progression-free survival [PFS] of the Keytruda-treated group was 53.6 months and 42.0 months for the placebo group. AstraZeneca’s Imfinzi (durvalumab) also presented positive results as a neoadjuvant therapy before surgery based on the interim results from the Phase III AEGEAN trial that was presented in July. The trial evaluated Imfinzi in combination with neoadjuvant chemotherapy as perioperative treatment for patients with resectable Stage IIA-IIIB NSCLC, and results showed that the combination therapy significantly improved pathologic complete response (pCR) compared to neoadjuvant chemotherapy alone. However, other primary and secondary efficacy endpoints of the trial, including event-free survival (EFS), disease-free survival, overall survival, etc. To esophageal cancer, bladder cancer, and melanoma... use as early treatment expanded to various cancer types The entry of immuno-oncology drugs to early-stage cancer is not limited to NSCLC. Opdivo demonstrated its efficacy as adjuvant therapy in melanoma, bladder cancer, and esophageal cancer as well. Its indications are: ▲as adjuvant therapy in patients with lymph node involvement or metastatic Stage IIIB/C or IIII melanoma who have undergone complete resection; ▲as adjuvant therapy in patients with non-muscle-invasive bladder cancer (NMIBC) at high risk of recurrence after radical surgical resection ▲as neoadjuvant therapy for completely resected esophageal or gastroesophageal junction cancer in patients with residual pathologic disease who have received neoadjuvant chemoradiotherapy. Moreover, study results that demonstrate Opdivo’s effect as adjuvant therapy in patients with Stage IIB-IIC melanoma, an earlier stage than the existing indications, were also presented recently. Interim analysis results of CheckMate-76K that was presented last month showed that Opdivo as adjuvant therapy reduced the risk of recurrence or death by 58% versus placebo in patients with completely resected Stage IIB or IIC melanoma. Opdivo’s 12-month recurrence-free survival (RFS) was 89% versus 79% for the placebo group. Keytruda also obtained an indication as adjuvant therapy in patients with Stage IIB or IIC melanoma who have undergone complete resection and renal cell carcinoma (RCC) with a high risk of recurrence following nephrectomy. In triple-negative breast cancer (TNBC), Keytruda was approved as both adjuvant and neoadjuvant therapy. In other words, in TNBC, Keytruda can be used in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
- Company
- Hanmi achieves record quarterly performance in 7 years
- by Chon, Seung-Hyun Nov 02, 2022 05:36am
- Hanmi Pharmaceutical recorded the highest performance in 7 years since 2015. Its sales and operating profit were the largest since Q4 2015 when it signed a series of mega technology export deals, thanks to the success of its new combination drug and Beijing Hanmi. On the 1st, Hanmi Pharmaceutical officially announced that its operating profit had increased 26.9% compared to the same period of the previous year to reach KRW 46.8 billion in Q3. Its sales revenue had also increased 12.9% to reach KRW 342.1 billion, and net profit by 11.5% to reach KRW 31.3 billion. The company’s cumulative operating profit had risen 44.2% compared to the same period of the previous year to reach KRW 119.2 billion, and its sales rose 15.0% in the same period to reach KRW 980.4 billion. The sales and operating profit made by Hanmi Pharmaceuticals in Q3 this year are the largest made since Q4 2015. In Q4 2015, Hanmi Pharmaceuticals signed a series of mega licensing-out deals and recorded sales of KRW 589.9 billion and an operating profit of KRW 171.5 billion. Quarterly Sales of Hanmi (left) operating profit (right) (Unit: KRW 1 million, data: FSS) Hanmi Pharmaceuticals said, “This is the first time since our establishment that our quarterly sales exceed KRW340 billion excluding technology fees from overseas.” The new combination drug developed by Hanmi Pharmaceuticals outperformed itself in the domestic market. According to the market research institution UBIST, outpatient prescription sales of its hyperlipidemia combination drug Rosuzet reached KRW 36.4 billion in Q3, which is a 13.5% increase from Q3 of the previous year. Its cumulative sales reached KRW 103 billion in Q3 this year. Launched at the end of 2015, Rosuzet is a combination drug that consists of two ingredients - rosuvastatin and ezetimibe – and is used to treat hyperlipidemia. Rosuzet is the first homegrown new drug to exceed outpatient prescription sales of KRW 100 billion in only 3 quarters. As Rosuzet’s sales exceeded KRW 100 billion in 2020 and the previous year, with the record, Rosuzet’s sales are set to exceed KRW 100 billion for three consecutive years. The company’s new fixed-dose drug combination, the Amosartan family, is also showing steady growth. Hanmi Pharmaceuticals has been selling the amlodipine and losartan combination Amosartan as well as Amosartan Plus, Amosartan Q, and Amosartan XQ. Amosartan Plus is a combination of three drugs, amlodipine, losartan, and chlorthalidone. Amosartan Q is a combination of Amosartan and the hyperlipidemia treatment rosuvastatin. Amosartan XQ is a combination of Amosartan, rosuvastatin, and ezetimibe that was released last year. Prescriptions of Amosartan in Q3 increased 1.1% from the same period of the previous year to record KRW 21.1 billion. Prescription of Amosartan Plus decreased 1.1% YoY to record KRW 7.1 billion, and Amosartan Q, Amosartan made KRW 2.9 billion and KRW 1.8 billion, respectively. Also, Hanmi Pharmaceutical’s Chinese subsidiary, Beijing Hanmi, showed improved performance. Beijing Hanmi recorded sales of KRW 93 billion in Q3 this year, making a 23.4% YoY increase. Its operating profit has also grown 25.5% to reach KRW 24.2 billion. Beijing Hanmi has been growing with the annual rise in demand for its key products including Mamiai (pediatric digestive supplement with lactic acid bacteria), Etanjing (cough medicine), and Leeddong (laxative), etc. An official from Hanmi Pharmaceutical said, “We have living up to our management slogan of ‘sustainable innovative management,' which was demonstrated through our excellent performance this year. We will do our best to present a management model for the Korean pharma-bio industry while endeavoring to support Korea's growth into a pharmaceutical powerhouse as a native Korean pharmaceutical company.”
- Company
- JW signs new anti-cancer drug R&D contract with KURE AI
- by Nho, Byung Chul Nov 02, 2022 05:35am
- Park Chan-hee, chief technology officer of JW Group (left) and David Ward, CEO of KURE AI Theraputics, are taking photosJW Group announced on the 1st that it has signed a joint research contract with U.S. bio venture company KURE AI Therapeutics to develop innovative anti-cancer drugs based on artificial intelligence (AI). Under this contract, JW Pharma and JW CreaGene will launch research and development of three new anticancer drugs using KURE AI's artificial intelligence and machine learning-based genetic analysis and biomarker search platform. JW Pharmaceutical will discover a new low-molecular anticancer drug task with KURE AI targeting patients with immune anticancer drug-resistant solid cancer. It will also establish a strategy to increase the clinical success rate of candidates for new anticancer drugs developed by JW Pharmaceutical. JW CreaGene, a research firm of JW, works with KURE AI to derive candidates for new CAR-NK cell therapy for solid cancer treatment. It plans to expand the pipeline of new immune cell treatments along with dendritic cell treatments and CAR-macrophage treatments that are currently being researched and developed. "We are very excited to promote an innovative joint research project with JW Group, which has competitiveness in developing new drugs tailored to patients," said David Wald, CEO of KURE AI. "We will strengthen cooperation to achieve the result of developing next-generation new drugs for precise cancer treatment." Park Chan-hee, CTO of JW Group, said, "We will expand the new drug pipeline through joint research with KURE AI, which has a global-level anti-cancer drug brokerage clinical research platform." CTO Park Chan-hee said, "We plan to further expand joint research with overseas companies that have specialized innovation R&D platforms." JW Pharma and JW CreaGene are actively promoting open innovation) to expand the new drug pipeline by combining their own R&D platform to discover new drug candidate materials and platforms of promising bio companies at home and abroad. Currently, in addition to KURE AI in the U.S., it is collaborating with seven domestic biotech companies, including Voronoi, Deargen, Iliasbio, Organoidsciences, Oncocross, SyntekaBio, Oncoinsight Since July, it has been looking for joint research partners with ARCH Venture Partners, the largest bio and healthcare venture capital in the United States, to expand its open innovation target overseas.
- Company
- RET-targeted Retevmo reattempts reimb listing in Korea
- by Eo, Yun-Ho Nov 01, 2022 06:02am
- The RET-targeted anticancer therapy ‘Retevmo’ will reattempt reimbursement listing in Korea. According to industry sources, Lilly Korea’s Retevmo (selpercatinib) will be deliberated by the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) tomorrow on November 2nd. Retevmo received marketing authorization in March this year and was deliberated by CDDC for reimbursement in May. After deliberation, the CDDC decided not to set reimbursement standards for the drug. Whether a different conclusion will be made this time remains to be seen. The CDDC’s review process was raised as an issue at the recent NA Audit. Rep. Gi-Yoon Kang of the People Power Party pointed out the lack of rationale for the CDDC’s not setting reimbursement standards within HIRA’s reimbursement process. According to Rep. Kang, the CDDC made the decision not to set reimbursement standards for anticancer drugs that had applied for reimbursement with Phase II clinical trials due to their absence of Phase III trial data, but this undermines the purpose of drugs that received approval under the condition of conducting Phase III trials in the future. However, HIRA said what it requested was additional data, not Phase III trial data, that could explain the clinical efficacy of the drugs, as it lacks data comparing its efficacy with existing treatments (indirect comparative data with existing treatments, real-world data, reimbursement evaluation results abroad, etc.) In 2020, Retevmo was approved as the first treatment option for cancer patients with RET gene alternations in the US after the FDA reviewed the drug through the Accelerated Approval and Priority Review pathway and granted the Breakthrough Therapy & Orphan Drug Designation. The drug demonstrated its efficacy through the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations. In the trial, the overall response rate (ORR) of patients with RET fusion-positive NSCLC without prior platinum-based treatment experience that was treated with Retevmo was 85%. Although the median duration of response (DoR) was not yet reached, 79% of the patients showed continued response during the follow-up period (median 7.4 months). In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months.
