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- 2026-03-14 11:09:48
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- Ibrance emerges as a new drug partner for metastatic breast
- by Jung, Sae-Im May 19, 2023 05:46am
- Professor Joo-Hyeok Son, Department of Oncology, Yonsei Cancer Hospital CDK4/6 inhibitor Ibrance is emerging as a combination partner for metastatic breast cancer drug developers based on its long-accumulated treatment experience. Even if the dose is increased, there is little concern about side effects, so it is expected that it will be used as a variety of combination drugs. Ibrance is the first CDK4/6 inhibitor developed by Pfizer and was launched in Korea in the fourth quarter of 2016. It provided a new treatment option for patients with HR+/HER2- metastatic breast cancer who had to use anti-hormonal drugs such as aromatase inhibitors or chemotherapy if not managed with these drugs. Ibrance, which held the top spot in the CDK4/6 market for five years, faced a decline for the first time last year. According to IQVIA, a pharmaceutical market research institute, Ibrance sales decreased 14% from 65.6 billion won in 2021 to 56.2 billion won last year. The rapid growth of generics has affected Ibrance's sales. Generics such as Verzenio and Kisqali are breaking down Ibrance's dominance through more sophisticated clinical trials and new field development. In particular, with generic drugs expanding their scope to early breast cancer, prospects are raised that Ibrance's position, which is limited to metastatic breast cancer, will narrow. In this situation, Iran is trying to turn around by emerging as a new drug combination partner for metastatic breast cancer. In an interview with Daily Pharm, Professor Sohn Joo-hyeok of the Department of Oncology at Yonsei Cancer Hospital said, "To use an oral SERD instead of an aromatase inhibitor, it must be used in combination with CDK4/6, but Irance is widely adopted as a combination drug." It means being recognized." Recently, oral SERD development is in full swing as a CDK4/6 inhibitor combination therapy for breast cancer. Many global pharmaceutical companies such as Pfizer, AstraZeneca, and Menarini jumped into the market. Big pharma is in the midst of studying combination therapy with CDK4/6 inhibitors as well as oral SERD monotherapy, and most of them chose Ibrance as the combination drug. Professor Sohn cited safety as the reason why Ibrance received much love calls as a combination drug. Professor Sohn said, "Ibrance's strength is that it is stable as it has accumulated the longest treatment experience among CDK4/6 inhibitors." It's less, so I'll consider it first," he explained. This evaluation was proven with real-world data. The Ibrance P-REALITY X study conducted by Pfizer is a large-scale real-world study that retrospectively analyzed the data of 2888 patients with HR+/HER2- metastatic breast cancer enrolled from February 2015 to March 2020. Patients receiving Ibrance plus Letrozole combination therapy as a first-line treatment option were compared with patients on Letrozole monotherapy. As a result of matching the baseline characteristics of the two groups similarly, the median overall survival (mOS) of the Ibrance group was 49.1 months, which was significantly prolonged compared to 43.2 months of the Letrozole single group, reducing the risk of death by 24%. It is less toxic, so even elderly patients can use it without burden. As a result of a sub-analysis examining Ibrance and Letrozole combination therapy in elderly patients aged 65 years or older, the median progression-free survival (mPFS) was 30.6 months, compared to 19.1 months in the control group. Professor Sohn said, "Recently, I prescribed Ibrance to an 80-year-old elderly patient with an anti-hormone drug. The treatment went well, and people around me said, 'How can you correct this when you are receiving chemotherapy at an advanced age?' I always worry about prescribing medications for cancer, but Ibrance greatly eases that burden."
- Company
- Chong Kun Dang has the domestic license for the 110 billion
- by Chon, Seung-Hyun May 18, 2023 05:44am
- Chong Kun Dang bought the domestic license for MSD’s blockbuster diabetes treatment ‘Januvia series’. It is equipped with a stable cash cow that raises more than 100 billion won a year. Chong Kun Dang signed a license agreement with MSD headquarters in Switzerland to introduce all domestic rights for three diabetes treatments, Januvia, Janumet, and Janumet XR. Chong Kun Dang acquires not only domestic sales and distribution rights for the three Januvia series, but also all rights such as licenses, trademarks, and manufacturing. The contract period is from July 15th to August 31st, 2038. The total contract amount is 45.5 billion won. Chong Kun Dang paid MSD headquarters a down payment of 23 billion won, and the milestone scale according to sales is 17 million dollars (approximately 22.5 billion won). But Since 2016, Chong Kun Dang has jointly sold the Januvia series with MSD Korea. Through this contract, it exclusively secured domestic rights for the Januvia series for the next 15 years. Chong Kun Dang receives the Januvia series from MSD headquarters and sells them exclusively in Korea. Januvia is a DPP-4 inhibitory antidiabetic drug containing Sitagliptin. Janumet is a combination drug combining Januvia and metformin. According to UBIST, a pharmaceutical research institute, the Januvia series jointly invested a total of 109.4 billion won in outpatient prescriptions last year. Januvia and Janumet raised 40.5 billion won and 68.9 billion won, respectively. Outpatient prescription amount of Januvia series by year (unit: KRW 100 million, source: UBIST) The amount of prescriptions for the Januvia series last year decreased from 130.7 billion won in 2020 and 124.6 billion won in 2021, which is the aftermath of drug price cuts. In March of last year, through a 'trade-off' agreement with the government, MSD lowered the insurance cap for the Januvia series by an average of 6.0%. The drug price of the Januvia series was voluntarily lowered as a condition of expanding reimbursement for Keytruda, an immuno-oncology drug. Considering the drug price reduction rate of the Januvia series, it means that it still has a great influence in the market. As Chong Kun Dang has secured all licenses for the Januvia series, profitability from future sales is expected to increase. An official from Chong Kun Dang said, “We were leading the market with a diverse portfolio of diabetes treatments, including Duvie,” and “We stably expanded the treatment options for patients by securing the Januvia series.”
- Company
- Benefit extended DM Drug
- by Moon, sung-ho May 17, 2023 05:38am
- Clinical sites are busy finding the optimal prescription combination while the expansion of diabetes treatment reimbursement standards for each class and the release of generics following the patent expiration of original items coincided. It is an effort to find the optimal combination for each treatment category that can be covered by health insurance to minimize patient burden. According to the pharmaceutical industry on the 26th, the Ministry of Health and Welfare significantly eased the criteria for the accreditation of diabetes medications this month. The key is that various drug combinations are possible without specifying the SGLT-2 inhibitor component. With this revision, SGLT-2 inhibitors such as Ipragliflozin, Empagliflozin, and Ertugliflozin can be reimbursed when used together. Combinations of Metformin + SGLT-2 inhibitor + DPP-4 inhibitor and Metformin + SGLT-2 inhibitor + TDZ combination are also acceptable if the HbA1C is 7% or higher even if the two-drug regimen is administered for more than 2 to 4 months. Insurance cannot be provided if only SGLT-2 inhibitor + DPP-4 inhibitor or TZD is used without Metformin. In the clinical field, following the release of Forxiga's generic products in April, guidance is being given to prescribing DPP-4 inhibitors or TZD with reimbursement instead of prescribing inexpensive SGLT-2 inhibitors through the full cost of the patient's expenses. This is because the 2nd union is excluded from the benefit target. A professor of endocrinology at A University Hospital, an executive officer of the Korean Diabetes Association, said, "Three-drug therapy was applied as reimbursement, but SGLT-2 inhibitor + DPP-4 inhibitor or TZD two-drug therapy is not reimbursed, so it can be a prescription form." It is still in the early stages of expanding the salary standard, so there are various opinions coming and going.” In addition, there is an opinion that there may be a situation where there is no choice but to recommend the patient to take without 'metformin' instead of prescribing the three-drug therapy as the two-drug regimen is not covered. In the case of patients who cannot take metformin due to side effects, SGLT-2 inhibitor + DPP-4 inhibitor or TZD two-drug therapy is a prescription pattern that can occur in clinical settings because reimbursement is not possible. As the two-drug regimen is not possible, instead of prescribing SGLT-2 inhibitors as non-covered drugs, it is possible to recommend taking metformin out of the three-drug regimen that can be covered. In the pharmaceutical industry, it is a phenomenon that can occur in clinical settings, but it is evaluated that it will be only a small part. An executive of a domestic company A, who used to be a doctor, said, “It is a prescription pattern that can happen at the moment, but it is a concern raised because of changes in the clinical field due to the expansion of the reimbursement standard have not yet taken place.” The Ministry of Health and Welfare plans to list SGLT-2 inhibitors and DPP-4 inhibitor complexes of major pharmaceutical companies in May, following the expansion of the reimbursement standard and the Forshiga generic this month. Specifically, ▲AstraZeneca Qtern, ▲Boehringer Ingelheim's Esgliteo, ▲MSD Stegluzan, and ▲LG Chem's Zemidapa are included. In addition, Daewoong Pharmaceutical's Envlo, a new diabetes drug in the domestic SGLT-2 inhibitor class, will enter the prescription market in earnest with reimbursement.
- Company
- SK Bioscience & MSD signed a consignment production contract
- by Jung, Sae-Im May 17, 2023 05:38am
- At the contract signing ceremony held in Jongno-gu, Seoul, government officials such as Second Vice Minister of Health and Welfare Park Min-soo, MSD Vice President Sanat Chattopadhyay, Hilleman Research Center CEO Raman Rao, SK Discovery Vice Chairman Choi Chang-won, SK Bioscience President Ahn Jae-yong, Hoon Kim, CEO of Global R&BD, etc. attended. MSD is developing a next-generation Zaire Ebola vaccine candidate with improved process efficiency and stability of the currently approved and used Zaire Ebola vaccine Ervebo with the Hillemann Institute, an international non-profit research institute. In the future, if the candidate substance is successfully developed and approved by regulatory authorities, it is expected to contribute to increasing the global supply and improving accessibility of the Zaire Ebola virus vaccine. The candidate material will be produced at Andong L House after SK Bioscience has transferred related development and technology, and will be supplied to international organizations after obtaining approval from relevant health authorities to be used in the management of Ebola virus disease. Ebola virus disease is a serious hemorrhagic fever disease caused by infection with the Ebola virus. The main cause of outbreaks in the past 20 years has been the Zaire Ebola virus. Since the Ebola virus was first discovered in 1976, several outbreaks have caused serious human and economic damage. Starting with this contract, SK Bioscience plans to expand its CMO and CDMO business in earnest. Based on R&D technology proven with various self-developed vaccines and state-of-the-art vaccine production facilities, it is a strategy to expand the C(D)MO business for various infectious diseases to respond quickly to new pandemics and take the lead in promoting public health. In addition to the existing vaccine platform, C(D)MO business for new platforms such as mRNA and CGT will also be promoted. A pilot plant that will enhance competitiveness in the C(D)MO market will be built in the ‘Global R&PD Center’ established in Songdo, Incheon through the largest facility investment by SK Bioscience after its launch. The pilot plant, which is a small-scale test facility built before introducing new methods or products, will be equipped with facilities that can carry out research tasks such as CGT, mRNA, and viral vectors. Vice Chairman Choi Chang-won of SK Discovery said, "This collaboration is the result of SK bioscience's production capacity and global network recognized through COVID-19, and it will be an important milestone in our efforts to contribute to the promotion of human health." We hope that the cooperation between SK, MSD, and Hilleman Laboratories will be further expanded with the government, such as the Ministry of Health and Welfare and the Korea Centers for Disease Control and Prevention, based on the common belief that it will solve the problem of imbalance in the country's vaccine supply and expand access to vaccines."
- Company
- Duloxetine shows strength in ₩30B antidepressant mkt
- by Nho, Byung Chul May 17, 2023 05:38am
- Last year, top-line sales of the antidepressant duloxetine recorded KRW 17.7 billion, taking a big lead ahead of venlafaxine, which achieved KRW 12.7 billion in sales, and is solidifying its position in the relevant prescription market. According to drug distribution data, sales of duloxetine drugs grew from KRW 15.5 billion to KRW 17.7 billion from 2019 to 2022, whereas sales of venlafaxine drugs showed a declining trend from KRW 13.1 billion to KRW 12.7 billion. The contrasting performance of the top two major antidepressant substances in the market is interpreted to be attributed to the difference in their indications. The duloxetine original, Lilly’s Korea’s Cymbalta Cap can be prescribed in a broader scope as its indications include the treatment of generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and musculoskeletal pain that does not respond appropriately to non-steroidal anti-inflammatory drugs (NSAIDs). On the other hand, the venlafaxine leader, the indication of Viatris Korea’s Efexor Xr Cap. Is limited to depression, such as social phobia and panic disorder, which fall under the category of generalized anxiety disorder. The unwavering lead in the duloxetine antidepressant market is Cymbalta, which has raised sales of KRW 8.6 billion in 2018, KRW 9.1 billion in 2019, KRW 9.3 billion in 2020, KRW 9.7 billion in 2021, then KRW 9.7 billion in 2022. The second duloxetine in line is Hanlim Pharm’s Duxela Cap., which raised sales of KRW 1.7 billion last year. Myung-In Pharm’s Droctin Cap ranked third has shown aa over twofold growth from KRW 0.74 billion in 2018 to KRW 1.35 billion last year. Top-line sales of the duloxetine drugs that followed are HR Inno. N’s Culocta, ‘Hwan-In Pharm’s Duloxeptol, Korea Celltrion Pharm’s Julotine, then Korea Pharm’s Duroprex. The respective drugs raised sales of KRW 0.85 billion, 0.77 billion, 0.53 billion, and 0.38 billion, respectively. The combined sales of the 18 other minor products in 2022 were in the KRW 1.4 billion range. The lead product among venlafaxine drugs is Efexor XR, which recorded KRW 4.4 billion last year. The rapid growth of generic versions of venlafaxine is noteworthy in the market. Korea Pharma’s Pharma Venlafaxine arose to become the second-most sold the drug in the venlafaxine market, making a 1800% growth from KRW 0.15 billion in 2018 to KRW 2.89 billion in 2022. The third was Hanlim Pharm’s Venexor XR, which recorded sales of KRW 2.1 billion last year. Sales of Myung-In Pharm’s Cofexor, which had been in the KRW 3 billion range until 2019, were reduced to sales of KRW 1.7 billion last year. Daewoong Bio’s Verakan and Sam Chung Dang Pharm’s Venlafect, Youngjin Pharm’s Venfaxine raised sales of KRW 0.26 billion, 0.53 billion, and KRW 6.8 billion last year. Meanwhile, observations show that Alvogen Korea’s Ivenxine withdrew from the prescription market after raising KRW 12 million in sales in 2019.
- Company
- Hemophilia drug Hemlibra coverage expansion
- by Chon, Seung-Hyun May 17, 2023 05:37am
- Hemlibra JW Pharmaceutical has laid the foundation for developing Hemlibra, a treatment for hemophilia, into a large-scale product. With the expansion of benefits, treatment benefits are provided to more patients, and expectations for sales growth are rising due to increased prescriptions. According to the Ministry of Health and Welfare on the 16th, Hemlibra will be covered for hemophilia A patients over the age of 1 who do not possess factor VIII antibodies from this month. Hemlibra is a routine prophylaxis for hemophilia A, which is caused by a deficiency of coagulation factor VIII. It is a product that applies bispecific antibody technology that simultaneously binds to blood coagulation factor 9 and factor 10. Unlike existing coagulation factor 8 preparations, it is the first non-coagulation factor preparation and can be administered subcutaneously once every 4 weeks at most. Hemlibra was developed by Chugai Pharmaceutical, a subsidiary of the global pharmaceutical company Roche. JW Pharmaceutical secured domestic development and sales rights for Hemlibra in 2017 and received permission from the Ministry of Food and Drug Safety in 2019. Chugai Pharmaceutical applied health insurance benefits to severe hemophilia A antibody patients in May 2020, and from this month, benefits were extended to non-antibody patients. According to JW Pharmaceutical, there are 1,746 patients with hemophilia A in Korea. Among them, severe hemophilia A patients were 1259, or 72%. Among patients with severe hemophilia A, 27 patients had antibodies and 1171 patients had non-antibodies. JW Pharmaceutical explained, “More than 60% of hemophilia A patients in Korea are covered by Chugai Pharmaceutical’s benefits.” JW Pharmaceutical expects that Hemlibra will provide great treatment benefits to patients based on the efficacy and safety proven by large-scale clinical trials. In the HAVEN1 clinical trial for antibody patients, it was confirmed that Hemlibra prophylaxis compared to the existing bypass therapy prophylaxis therapy reduced the annual bleeding rate (ABR) by 3.3 times by about 79%. In the HAVEN3 clinical trial for non-antibody patients, it proved an effect of reducing approximately 68% of the ABR (Annual Bleeding Rate) 1.5 times compared to prophylactic factor 8 therapy. The company explains that Hemlibra has also proven safety through clinical results. HAVEN 1~4 Clinical Results Among patients who received Hemlibra, most side effects were mild injection site manifestations. Quarterly Hemlibra sales (unit: million won, source: IQVIA) The company said, "Hemlibra has a long half-life of 28 days, so it increases patient convenience by reducing the number of administrations once every 4 weeks, compared to 2-3 times a week for conventional prophylaxis." In contrast to having to do intravenous injection, subcutaneous injection is possible, so it can help patients who have difficulty in intravenous injection or pediatric patients.” According to IQVIA, a pharmaceutical research institute, Hemlibra recorded sales of 7.6 billion won last year. In the first year of application in 2020, it raised 2.1 billion won, followed by 7.2 billion won in 2021, and showed an upward trend last year. Looking at quarterly sales, it recorded 2.2 billion won in the fourth quarter of last year, surpassing 2 billion won in sales for the first time. The cumulative sales of Hemlibra over the past three years were 17 billion won. The company expects that the amount of use will increase sharply as the target of benefit coverage expands significantly in the future. Last year, Hemlibra's global sales increased by 27% to CHF 3.823 billion. Currently, more than 20,000 patients in 144 countries around the world are using Hemlibra. “Hemlibra is an innovative new drug that can dramatically improve the quality of life of hemophilia patients with ease of administration and excellent efficacy,” said an official from JW Pharmaceutical. He said, "We expect that this new standard will expand the treatment accessibility of patients suffering from hemophilia and the choice of medicines for medical staff."
- Company
- Crysvita, the first fast-track drug by Yoon gov, is expected
- by Eo, Yun-Ho May 16, 2023 09:06pm
- It is now possible to prescribe 'Crysvita', the No. 1 rapidly registered drug of the Yoon government. This drug recently passed the Drug Committee (DC) of medical institutions such as SNUH. Kyowa Kirin Korea's (XLH rickets treatment Crysvita is a pediatric treatment that has been clinically proven effective in the field of diseases for which there is no equivalent drug or treatment. ) was listed on the list of insurance benefits. Since it is a drug that requires prior approval for reimbursement, it will take more time until the first prescription comes out. Crysvita's reimbursement criteria are for patients with X chromosome-linked hypophosphatemic (XLH) rickets aged 1 to 12 years who have not been controlled despite continuous administration of existing treatments (active vitamin D preparations, etc.) for more than 6 months. Symptoms such as growth retardation, dental abnormalities, lower extremity bone deformity, premature cranial fusion, and increased intracranial pressure are confirmed, and 'RSS level is 2 points or more, hypophosphatemia (less than 3.0 mg/dL) and loss of renal phosphorus (TmP/GFR reference value) less) must be proven. Until the registration of Crysvita, pediatric XLH rickets was treated with large doses of phosphate and vitamin D, but it was administered 4 to 6 times a day, and about 30% required surgery. Kang Hee-kyung, a professor of pediatrics at Seoul National University Hospital, said, "The existing treatment method of directly administering insufficient phosphate has a limit in that a vicious cycle occurs in which 'FGG23' is further activated and the degree of phosphate reabsorption further decreases. Crysvita is not a method of adding phosphate, It is a fundamental treatment that inhibits FGG23.”
- Company
- JAKi Cibinqo owns strengths in dosage adjustments
- by Jung, Sae-Im May 16, 2023 05:40am
- Pfizer's JAK inhibitor ‘Cibinqo (abrocitinib)' has embarked on a full-fledged journey to expand its prescriptions. After landing in major general hospitals at the end of last year, the drug is likely to be registered for reimbursement within the first half of this year. Cibinqo is a Janus kinase 1 (JAK1) inhibitor approved by the Ministry of Food and Drug Safety in November 2021. It is the 4th JAK inhibitor introduced to Korea and the second JAK inhibitor drug introduced by Pfizer after Xeljanz. Unlike Xeljanz, which is only used for ulcerative colitis, Cibinqo is used to treat severe atopic dermatitis. Treatment options have increased significantly for severe atopic dermatitis starting with the introduction of the injection-type biologic medication and oral JAI inhibitors. In particular, a total of 3 oral JAK inhibitors are available for patient use in Korea. Olumiant (baricitinib) and Rinvoq (upadacitinib) have first entered the market and are being used with reimbursement, followed by Cibinqo. Although Cibinqo is a latecomer, it owns a differentia table property from existing drugs. Dailypharm met with Jung-Im Na, Professor of Dermatology at Seoul National University Bundang Hospital to hear about its differentiable properties in the field. Jung-Im Na, Professor of Dermatology at Seoul National University Bundang Hospital Its first advantage is in its free dose control. Cibinqo comes in three doses: 50, 100, and 200mg. Although the recommended starting dose is 200mg, the dosage can be adjusted to 100 mg or 50 mg depending on the progress of treatment. If symptoms worsen with dose reduction, the doctor can increase treatment response again by increasing the dose and using local treatment together (JADE REGIMEN study). Professor Na said, “JAK inhibitors are fast and effective, but its exit strategy is considered a problem after the patient’s condition improves. In other words, ending treatment after seeing an effect is difficult with the use of JAK inhibitors. However still, due to its free dosage adjustments, it is attractive that the dosage can be reduced step by step from 200mg to 50mg.” He added, “No drug can be used for the rest of one’s life. Therefore, how to complete the treatment well is an important factor, and dose plays an important role. In particular, JAK inhibitors generally have a short half-life, and therefore disappear quickly from the body, leading to recurrence. Therefore, you cannot terminate treatment at once,” emphasizing the importance of dosage control. Major efficacy endpoint results in the JADE DARE trial Another advantage is in how it holds grounds based on a head-to-head trial for switching to the biological drug Dupixent. Among Cibinqo’s 7 Phase III clinical trials, the JADE DARE study is a head-to-head clinical trial comparing Cibinqo with Dupixent. As a result of separately administering Cibinqo 200mg and dupilumab 300mg in combination with a topical treatment for 26 weeks, the proportion of patients who achieved an improvement of 4 points or larger in the Peak Pruritus Numerical Rating Scale (PP-NRS4) at 2 weeks was 48.2% in the Cibinqo group, higher than the 25.5% of the Dupixent group. The proportion of patients who achieved a 90% improvement in the Eczema Area and Severity Index (EASI-90) at Week 4 was also significantly higher in the Cibinqo group (28.5%) than in the Dupixent group (14.6%). Moreover, the company also conducted the JADE EXTEND study, which studied the effect of switching patients who used Dupixent to Cibinqo. Patients were divided into those who were responsive to Dupixent and those that were non-responsive to Dupixent. 93.5% and 90.2% of patients who showed a response to Dupixent achieved EASI-75 after switching to Cibinqo 200mg and 100mg, respectively. PP-NRS4 was 89.7% and 81.6%, respectively. Among patients who did not respond to Dupxient, the proportion of those that reached EASI-75 was 80% and 67.7%, respectively, and PP-NRS4 was 77.3% and 37.8%, respectively. Efficacy of switchin gto Cibinqo(Abrocitinib) among patients thatresponsive to Dupxient(left) and those that were unresponsive (Data: Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab). The study provided evidence that patients who did not see an effect with Dupixent can expect an effect when they switch to Cibinqo. Previously, a clinical trial was also conducted with the JAK inhibitor Rinvoq on switching therapy from Dupixent. However, Cibinqo is the only drug that analyzed the effect of switching administration according to the patient’s presence or absence of an effect with Dupixent. This is why the trials have raised expectations of JAK inhibitors receiving expanded reimbursement as a replacement therapy when switching from Dupixent. Professor Na said, “The reason why the JADE EXTEND clinical trial is significant is that there are many patients who do not see an effect while using Dupixent, even though it is a good drug. However, these patients have to discontinue treatment and use immunotherapies for 3 months and see a deterioration in their condition before switching to a different treatment to receive reimbursement due to limited reimbursement standards. As Cibinqo has evidence prepared with clinical trials, the trials may be grounds to extend the drug’s reimbursement to switching medications. Also, For those who have not seen any effect after using Dupixent, the evidence is there to switch to Civinco.”
- Company
- Samil, a series of love calls from multinational companies
- by Lee, Seok-Jun May 16, 2023 12:16am
- Samil Pharmaceutical is receiving a series of love calls from multinational companies. This time, it has decided to exclusively distribute and sell all Sandoz products, including the central nervous system (CNS). The CNS division, which was newly established in 2021, will gain momentum for business expansion. It is evaluated that Samil Pharmaceutical's expansion of partners is because it has met global standards in sales and marketing. Even before Sandoz, the company has partnered with global pharmaceutical companies such as GSK, Abbott, AbbVie, Mundipharma, and Beatrice. It is also affiliated with domestic companies such as Samsung Bioepis. Samil Pharmaceutical exclusively distributes and sells all products, including Sandoz CNS (Central Nervous System). The two companies recently signed such an agreement. Sandoz changed its Korean business to a 100% third-party distribution model. Sandoz is a subsidiary of Novartis in the generic and biosimilar business. Samil Pharmaceutical plans to strengthen the recently expanding CNS field while holding Sandoz products. In order to broaden the CNS lineup in 2021, the company established a new CNS division for sales of the existing neurology team and psychiatric products. In the same year, it signed an exclusive distribution and sales contract for Beatrice's Xanax, Zeldox, and Zoloft in the Korean market. A company official said confidently, "Samil Pharmaceutical will provide the best treatment options for domestic patients by further strengthening its powerful central nervous system disease lineup through the distribution and sales of Sandoz medicines." Sandoz currently has about 40 items in stock. In addition to CNS, it deals with chronic disease products such as Sandoz Amlodipine and Sandos Atorvastatin. This is also exclusively distributed and sold by Samil Pharmaceutical. This is where Samil Pharm's external expansion is expected. The company's sales last year were 179.7 billion won. It is expected to break through 200 billion won this year. Samil Pharmaceutical’s factory in Vietnam Samil Pharmaceutical is receiving a series of love calls from multinational companies in addition to Sandoz. Prior to Sandoz, it partnered with global pharmaceutical companies such as GSK, Abbott, AbbVie, Mundipharma, and Beatrice. There are also domestic companies such as Samsung Bioepis. It is evaluated that it is because it has met global standards in sales, marketing, and distribution. Sandoz Korea also explained that the decision to partner with Samil Pharmaceutical was made considering △company size, △professionalism in supplying medicines in ophthalmology, liver and stomach, musculoskeletal system, and CNS areas, and long-term collaboration experience and capabilities with many global companies. Samil Pharmaceutical has been making efforts to grow into a global company for several years. △ Established a subsidiary in Vietnam in 2018, △completed the construction of a CDMO plant for eye drops in Vietnam in 2022, △Established a North American subsidiary in Canada in 2022, and △Secured future growth engines by signing contracts for new drug candidates in the global phase 3 clinical trials such as Aramchol and Lorecivivint △ Domestic introduction of excellent foreign medicines, etc. In particular, the Vietnam global eye drop CDMO plant, which had a completion ceremony in November last year, is expected to serve as a stepping stone for global expansion. The factory can produce about 330 million eyedrops per year. It is aiming to obtain GMP approval for DAV in Vietnam and MFDS in Korea by the end of the year at the earliest. Within the next two to three years, the company plans to supply high-quality medicines to the global market through US FDA cGMP, European EMA EU GMP, and Health Canada GMP approvals.
- Company
- New diabetes treatment guidelines released
- by Kim, Jin-Gu May 15, 2023 05:41am
- The status of GLP-1 analogues and SGLT-2 inhibitors has risen further in Korea’s new diabetes treatment guidelines. In the revised guidelines, when considering options to use in combination with injection therapy, GLP-1 analogues were recommended over basal insulin, and SGLT-2 inhibitors were recommended first for diabetic patients with heart failure, kidney disease, or cardiovascular disease. Kyu-Chang Won, Chairman of KDA (Endoctriology, Yeungnam University Hospital) is introducing KDA On the 12th, Korean Diabetes Association introduced the key contents of its ‘KDA clinical practice guidelines for diabetes: 8th edition’ at the 2023 Spring Conference of the Korean Diabetes Association that was held at the Kimdaejung Convention Center in Gwangju. The KDA publishes treatment guidelines for diabetes every 2 years. The association organized a clinical practice guideline committee around Director Min Kyong Moon (Internal Medicine, Seoul National University Medical School) and developed the new practice guidelines from January last year to April this year. The most notable change observed in the new guideline is the use of GLP-1 analogues and SGLT-2 inhibitors. In general, the two classes of drugs were more strongly recommended. GLP-1 analogues currently available in Korea include Trulicity (dulaglutide) and Ozempic (semaglutide), and SGLT-2 inhibitors include Forxiga (dapagliflozin) and Jardiance (dapagliflozin). ◆GLP-1 analogues = The new clinical practice guidelines ‘recommend GLP-1 analogues over basal insulin when considering injection-based combination therapy.’ Previously, treatments in combination with injection therapy were recommended as priority for potent blood sugar-lowering effect. In addition, GLP-1 analogues in combination with basal insulin were recommended to enhance blood sugar control. The newly revised guidelines went a step further from the previous guidelines to recommend GLP-1 analogues first. Jung-Hyun Noh, professor of internal medicine at Inje University, said, “In a study that directly compared the results of using GLP-1 analogues+oral medications to separate use of GLP-1 analogues or insulin, there was no significant difference in their HbA1c level reduction effect. However, the use of GLP-1 analogues was found to maintain the lowering effect longer.” In addition, the content that if the target blood sugar level cannot be achieved with either the GLP-1 analogue or basal insulin alone, the two drugs shall be used together, was newly added to the guideline. It was also added that if the target blood sugar level is not reached even with GLP-1 analogue or basal insulin treatment, insulin potentiation therapy should be attempted. ◆SGLT-2 inhibitors = SGLT-2 inhibitors were also more strongly recommended. The revised guideline recommends, "'in case of accompanying heart failure, the use of SGLT-2 inhibitors with proven heart failure benefits is recommended in priority regardless of HbA1c level, and the treatment should be continued unless contraindications or side effects arise.' In the case of renal disease as well, the revised guideline recommend 'in case of albuminuria or decreased estimated glomerular filtration rate, SGLT-2 inhibitors with proven renal benefits should be used first regardless of HbA1c level, and be maintained unless contraindications or side effects arise." Previous guidelines have recommended ‘treatment including SGLT-2 inhibitors to be considered first in patients with heart failure.’ Here, the phrase 'regardless of the HbA1c level’ was newly added with the revision. Professor Noh said, “New studies have demonstrated the benefit of SGLT-2 inhibitors in heart failure and renal disease. The effect was consistent in patients without diabetes. This is why we recommended the use of SGLT-2 inhibitors if there is a risk of disease, regardless of HbA1c level." In addition, it was recommended that "treatment including GLP-1 analogues or SGLT-2 inhibitors with proven cardiovascular benefits should be prioritized in patients with atherosclerosis cardiovascular disease. Previously, SGLT-2 inhibitors were recommended as monotherapy for such patients, but this time, GLP-1 analogues were added to the recommendations."
