- LOGIN
- MemberShip
- 2026-05-07 06:48:03
- Policy
- Drugs with 'amlodipine' formulation get pediatric indication
- by Lee, Hye-Kyung Apr 15, 2024 06:06am
- Now, the 109 items of 'amlodipine besylate' monotherapy, which is used for the treatment of hypertension and angina, can be used for treating pediatric patients with hypertension. The Ministry of Food and Drug Safety (MFDS) ordered the change of approval conditions for 'amlodipine besylate monotherapy (doses 5mg, 10mg, tab)'. The change of approval conditions will be in effect starting May 2nd. According to the details of the change of approval conditions, the previous precaution, 'Safety and efficacy have not been established in pediatric patients,' has been revised to 'This medication (2.5 mg-5 mg per day) has a blood pressure-lowering effect in patients aged 6-17 years.' However, the precaution will note that the drug’s effectiveness for hypertension in patients under the age of six has not been established. The Ministry of Food and Drug Safety (MFDS) ordered the change of approval conditions for According to the pediatric clinical trial data, 62 pediatric patients aged 6-17 years with hypertension received doses ranging from 1.25 mg to 20 mg daily. Pharmacokinetic parameters such as clearance and volume of distribution, when adjusted for body weight, were similar to those in adults. The clinical trial involved 268 pediatric patients aged 6-17 years with hypertension who were randomly assigned to receive either 2.5 mg or 5 mg of amlodipine once daily for the first four weeks. Then, the patients were randomly assigned to groups of the same amlodipine doses or the placebo group for the following four weeks. All patients who received amlodipine 2.5 mg or 5 mg showed a significant reduction in systolic blood pressure compared to placebo after eight weeks. Safety and efficacy studies in pediatric patients beyond eight weeks have not been conducted, and the long-term effects of amlodipine on growth and development, myocardial growth, and vascular smooth muscle in pediatric patients have not been studied. Furthermore, the drug was previously limited to 'pregnant women or women who may be pregnant' but now includes 'lactating women.' In the meantime, Ahngook Pharm is the first company in South Korea to receive approval for a formulation containing amlodipine for the treatment of pediatric hypertension. Last June, Ahngook Pharm received the MFDS approval for 'Levotension Tab' for the treatment of pediatric patients with hypertension between the ages of six and seventeen.
- Company
- Pharma, Biotech had outstanding export performance last year
- by Kim, Jin-Gu Apr 15, 2024 06:06am
- It is reported that 30 of the listed pharmaceutical and biotechnology companies achieved a year-over-year (YoY) growth of 18% in export performance. Samsung Biologics’ exports significantly increased from KRW 2.85 trillion in 2022 to KRW 3.58 trillion last year. SK Biopharmaceuticals, ST Pharm, and Hanmi Pharmaceutical also experienced notable rises in export performance. Chon Kun Dang Pharmaceutical’s large-scale technology export last year impacted its export figures, which represented an increase of 2.6-fold over a year. 30 major pharmaceutical companies have experienced an 18% increase in export performance…Samsung Biologics has exceeded KRW 3.5 trillion in export figures According to the Financial Supervisory Service on April 11, thirty major pharmaceutical and biotechnology companies generated the total export figure of KRW 6.52 trillion last year. It was an 18% increase compared to KRW 5.52 in 2022. The data was collected from 30 pharmaceutical and biotechnology companies primarily focused on pharmaceutical businesses listed on the South Korean stock market (KOSPI) and the KOSDAQ stock market. Celltrion and its subsidiaries, which had not publicly disclosed their export performance in business reports, were excluded from the counting. The export performances of 30 major pharmaceutical and biotechnology companies have seen a notable increase recently. The total export figures were KRW 2.65 trillion in 2020, KRW 3.65 trillion in 2021, and KRW 5.52 trillion in 2022. Last year, they exceeded KRW 6.5 trillion, a 2.5-fold increase within the past three years. Samsung Biologics has exceeded KRW 3.5 trillion in export figures. Samsung Biologics is driving this upward trend. Its export figure surged from KRW 868.2 billion in 2020 to KRW 1.22 trillion in 2021, KRW 2.85 trillion in 2022, and KRW 3.58 trillion last year. Notably, exports to Europe have been surged. Last year, exports to Europe amounted to KRW 2.35 trillion, representing an increase of 32% compared to KRW 1.86 trillion in 2022. Samsung Biologics' exports to Europe exceeded KRW 500 billion in 2020 and soared to KRW 1.8 trillion in just two years. Furthermore, it recorded over KRW 2.3 trillion last year, a 4.5-fold increase over the past three years. Exports to North America expanded from KRW 289.5 billion in 2020 to KRW 448.6 in 2021 and then to KRW 854 in 2022. Last year, the export figure was KRW 971.1 billion, nearing KRW 1 trillion. Exports to countries other than Europe and North America amounted to KRW 19.3 billion in 2021, but it surged to KRW 255.1 billion last year. The upward trend in Samsung Biologics' export performance is expected to continue. At the end of last year, Samsung Biologics' cumulative order amount was US$12.03 billion (approximately KRW 16.3 trillion). Among them, Samsung Biologics delivered US$6.1 billion (approximately KRW 8.3 trillion), with the remaining orders totaling US$5.93 billion (approximately KRW 8.4 trillion). If the client succeeds in product development, the backlog of orders will increase to US$12.36 billion (approximately KRW 16.75 trillion). With the addition of new contracts this year, Samsung Biologics' backlog of orders is expected to further increase. SK Biopharmaceuticals·Hanmi achieved over 30% increase in export figures…With ’large-scale technology exports,’ CKD had a 2.6-fold increase in performance The export performance of 29 companies, excluding Samsung Biologics, amounted to KRW 2.68 trillion in 2022 and then increased over 10% to KRW 2.94 trillion last year. Compared to their KRW 1.78 in 2020, they saw a 1.7-fold increase over the past three years. In particular, SK Biopharmaceuticals, Hanmi Pharmaceutical, and Chong Kun Dang Pharm have shown notable growth in export performance. SK Biopharmaceuticals' export figure increased by 44% from KRW 246.2 billion in 2022 to KRW 354.9 billion last year, driven by expanded prescription of the anti-seizure medication 'Cenobamate' in the North American market. Revenue from Cenobamate and sleep disorders medication 'Solriamfetol' increased by 46%, from KRW 192.9 billion to KRW 282.3 billion. Additionally, export performance from contract manufacturing for global partners increased by 36%, from KRW 53.2 billion to KRW 72.6 billion. Hanmi Pharmaceutical's export figure increased by 37% from KRW 147.7 billion in 2022 to KRW 202.6 billion last year. Exports increased by 70%, from KRW 25.5 billion to KRW 43.3 billion, while exports of raw materials and pharmaceutical ingredients increased by 13%, from KRW 118.6 billion to KRW 133.8 billion. Technology exports, which stood at KRW 3.6 billion in 2022, increased significantly to KRW 25.5 billion last year. Chong Kun Dang Pharm's export figure increased 2.6-fold, from KRW 65.1 billion to KRW 169.4 billion over the past year, due to a large-scale technology export contract signed at the end of last year. In November last year, Chong Kun Dang Pharm signed a technology export contract with Novartis for the histone deacetylase 6 (HDAC6) inhibitor 'CKD-510'. Under this contract, Chong Kun Dang Pharm received an upfront payment of US$80 million (approximately KRW 106.1 billion), and it agreed to receive milestone payments totaling US$1.23 billion (approximately KRW 1.6 trillion) and sales royalties based on future development and approval stages. Trends in the export performance of 30 listed pharmaceutical and biotechnology companies. Samsung Biologics, SK Biopharm, GC Labs, ST Pharm, Yuhan, SK Biosciences, Hanmi Pharmaceutical, Hugel, Chong Kun Dang Pharm, Daewoong Pharmaceutical, Dong-A ST, Medytox, Kolon Life Science, PharmaResearch, DongKook Pharmaceutical, Huons, Kyongbo Pharmaceutical, Il-Yang Pharmaceutical, HK inno.N, JW Pharmaceutical, and others (from the top). In addition, PharmaResearch and Huons saw an increase in export performance by over 60%. PharmaResearch's export figure increased by 65% from KRW 56.1 billion to KRW 92.8 billion, generated from medical devices such as Rejuran and Conjuran. Huons' export performance increased by 62% from KRW 34.2 billion to KRW 55.5 billion, driven by exports of local anesthetics to the North American market. The export figures of Yuhan, ST Pharm, Huons, Daewoong Pharmaceutical, Medytox, Dongkook Pharmaceutical, Kwangdong Pharmaceutical, and Daehan New Pharm increased by more than 10%. Il-Yang Pharmaceutical and JW Pharmaceutical also saw an increase in export performance compared to the previous year. Among 30 companies, 13 companies, including Samsung Biologics, SK Biopharm, GC Labs, ST Pharm, Yuhan, SK Biosciences, Hanmi Pharmaceutical, Hugel, Chong Kun Dang Pharm, Daewoong Pharmaceutical, Dong-A ST, Medytox, and Kolon Life Science, achieved export figures amounted to KRW 100 billion last year.
- Company
- Samsung Bioepis’s Stelara biosimilar Epyztek is approved
- by Son, Hyung-Min Apr 15, 2024 06:06am
- Samsung Bioepis announced on the 11th that it has obtained the first biosimilar approval in Korea for its autoimmune disease treatment Stelara biosimilar, Epyztek (project name SB17), from the Ministry of Food and Drug Safety. Stelara, which was developed by global pharmaceutical giant Janssen, is used to treat plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Epyztek is the fourth autoimmune disease treatment developed by Samsung Bioepis, following Etoloce (Enbrel biosimilar), Remaloce (Remicade biosimilar), and Adaloche (Humira biosimilar). With the approval of Epyztek, Samsung Bioepis will now have three tumor necrosis factor-alpha (TNF-α) inhibitors (Etoloce, Remaloce, and Adaloche) and an interleukin inhibitor (Epiztek), further expanding its product portfolio for the treatment of patients with autoimmune diseases. "We are pleased to be able to offer more treatment options to patients by receiving the first approval for a Stelara biosimilar in Korea.” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. From July 2021 to November 2022, Samsung Bioepis conducted a Phase III clinical trial on Epyztek (SB17) in 503 patients with plaque psoriasis in 8 countries including Korea, and the results of the study confirmed the clinical equivalence in efficacy and safety of Epyztek with the original drug.
- Company
- Interleukin inhibitors approved for palmoplantar pustulosis
- by Eo, Yun-Ho Apr 15, 2024 06:06am
- (From upper side) Tremfya, Skyrizi Interleukin (IL)-23 inhibitors, which are mainly used for psoriasis, are making their way into the field of palmoplantar pustulosis in Korea. Following the approval of Janssen Korea’s ‘Tremfya (guselkumab), AbbVie Korea’s Skyrizi (risankizumab) has also added an indication for palmoplantar pustulosis and has signaled competition in the area. In the case of Tremfya, its reimbursement standard was extended to cover palmoplantar pustulosis as well. Currently, Tremfya is reimbursed for: ▲patients with a PPPASI score of 12 or higher, who have been treated with acitretin or methotrexate or cyclosporine at therapeutic doses for at least 3 months but are unable to continue treatment due to no response or side effects, or ▲ patients who were treated with phototherapy for at least 3 months but is unable to continue treatment due to no response or side effects. The drug was approved as a treatment for adult patients with plague psoriasis in April 2018 and as a treatment for adult patients with active psoriatic arthritis in March 2021, and the indications were applied insurance benefits in September 2018 and May 2022, respectively. Skyrizi was recently approved by the Ministry of Food and Drug Safety for the treatment of moderate to severe palmoplantar pustulosis in adults who have had an inadequate response to, or are intolerant of, standard therapy. Skyrizi was initially approved in Korea in June 2019 for the treatment of moderate-to-severe plaque psoriasis and its indication was later expanded as a treatment for active psoriatic arthritis in adults in January 2022. The approval for palmoplantar pustulosis was based on the results of the JumPPP study, a Phase 3 clinical trial conducted in Japan to evaluate the efficacy and safety of Skyrizi. The study analyzed 119 patients and showed that from baseline to week 16, the PPPASI (Palmoplantar Pustulosis Area and Severity Index) index decreased by an average of 11.96 in the Skyrizi treatment group, which was significantly greater than the 8.48 point decrease in the placebo group. Yong-Beom Choe, President of the Korean Society of Psoriasis (Konkuk University), said “Palmoplantar pustulosis is a cutaneous immune disease characterized by an eruption of sterile pustules on the palms and soles. As it is often accompanied by itching and pain, it severely affects the quality of life of patients. And due to frequent relapses, it needs to be constantly managed with correct diagnosis and effective treatment.”
- InterView
- 'BMS will invest in and improve access to new drugs in KOR'
- by Eo, Yun-Ho Apr 15, 2024 06:06am
- Emma Charles, Senior Vice President of Intercontinental Markets at Bristol-Myers Squibb Multinational pharmaceutical companies are masters of adaptation and transformation. They adjust their pipelines and introduce new drugs through various mergers and acquisitions and technology export agreements to meet the rapidly changing trends in the healthcare industry. This involves a great deal of foresight. The companies need to assess the marketability of a new drug from the earliest stages of development, which is extremely costly and time-consuming. Bristol Myers Squibb is one representative company that has been actively adapting and seeking transformation. The company, which was once considered to have no item after its hepatitis B drug 'Baraclude Tab.' and theimmuno-oncology drug ‘Opdivo’ that it had co-developed with Ono Pharmaceutical, has received approval for 6 new drugs in Korea alone in the past 2 years after making small and large mergers and acquisitions, including the one with Celgene, which owns ‘Revlimid.’ In addition, the company has received reimbursement approval for the myelofibrosis treatment ‘Inrebic’, acute myeloid leukemia treatment ‘Onureg,’ plaque psoriasis treatment ‘Sotyktu,’ and ulcerative colitis treatment ‘Zeposia’ in Korea, and is working to list its obstructive hypertrophic cardiomyopathy drug ‘Camzyos’ for reimbursement as well. Dailypharm met with Emma Charles, Senior Vice President of Intercontinental Markets at Bristol Myers Squibb, who recently visited Korea, to learn more about the company's vision and strategy. The VP is in charge of overseeing the international market, which includes Asia, Oceania, Canada and Latin America. -BMS had once been perceived as a pharmaceutical company that specialized in certain diseases, such as cardiovascular disease, liver disease, and diabetes, but the 6 new drugs you recently launched are all in different therapeutic areas. BMS is in the stage of opening a new chapter for the next decade. We have a number of activities underway to identify the direction we will take in the future, in therapeutic areas such as cardiovascular, immunology, oncology, and hematology. In cardiovascular disease, we are working to develop a pipeline with new indications, including Camzyos, while building on our strengths. In immunology, we will maintain the long-standing leadership we built with our rheumatoid arthritis treatment ‘Orencia’ and continue to develop our new drug ‘Sotyktu’ as well as other drugs for autoimmune diseases such as lupus that are already underway. In addition, the areas of oncology and hematology will continue to serve as important pillars for BMS. -BMS has been actively securing various pipelines and drug candidates through mergers and acquisitions The company has sought aggressive M&A strategies for R&D to bring innovative new medicines to patients and continue growth. The company currently has over 30 pipelines in development. For example, the acquisition of RayzeBio and Mirati Therapeutics has strengthened our oncology area by adding targeted therapy candidates to our pipeline. We recently completed the acquisition of Karuna Therapeutics and acquired KarXT, which is indicated for psychiatric disorders such as schizophrenia and Alzheimer's disease. We plan to launch the drug in the U.S. this year and roll the drug out globally in the future. South Korea is also a very important market for us in driving R&D. We are actively conducting R&D on about 50 drug candidates in Korea. Taken together, we expect BMS to achieve much growth over the next decade and beyond. -I heard that you are conducting clinical studies for the CAR-T drugs ‘Breyanzi’ and 'Abecma’ in Korea. Do you have any specific plans for their launch in Korea? Unlike oral drugs, CAR-T drugs require a complex process of sending the patient's blood to a laboratory to extract T cells and manufacture them into therapeutic drugs. BMS is currently exploring ways to facilitate the introduction of CAR-T therapies in intercontinental markets and which markets to first target. It is clear that South Korea is a ready market, that already has CAR-T therapies available and the capacity to manage the complexities involved in their supply. While it's difficult to say exactly when we'll be able to introduce our drug to Korea, we want you to know that we're committed to bringing this revolutionary new medicine to the world. -Korean companies have been focusing on exporting technology through open innovation rather than full development. I would like to hear the BMS's view on open innovation and Korea’s performance in the area. Innovation is at the core of everything we do at BMS. We invested approximately USD 9.29 billion in R&D last year to provide life-changing treatments for patients, a portion of which was used for open innovation. In fact, products developed through open innovation account for more than 60% of BMS's revenue, making open innovation an important part of BMS's DNA for sustaining R&D and building new pipelines. BMS continues to collaborate with biotechs in various regions with promising candidates, as evidenced by the recent technology transfer agreement we made with the Korean company Orum Therapeutics. The open innovation program in Korea is not the same as in other countries. This shows that Korea values science and innovative drug development. - 6 new drugs have been approved and 4 have entered reimbursement. This is a significant achievement considering Korea’s insurance system, but there are remaining challenges. Reimbursement is a global challenge; it is never easy in any country. We have to prove the drug’s value over the standard of care through clinical trials, and as we negotiate to bring first-in-class treatments to market in areas where there were no treatments, we have to also emphasize how introducing innovative new drugs can save direct and indirect cost compared to existing treatments. Korea’s reimbursement system, which requires the company to prove the value of treatment by designing a clinical study and confirming the efficacy and safety through it, must be challenging for the team. But I trust the Korean team. They are doing their best to build an ecosystem through cross-departmental collaboration to quickly deliver innovative new drugs to patients. -Korea is pushing to make the use of real-world data (RWD) or real-world evidence (RWE) mandatory in the post-marketing evaluation of new drugs. What is your opinion on this? First of all, regardless of the pros and cons, I think it is important to continue collecting RWE after a drug is approved for the benefit of the patients, clinical sites, and the industry. For example, the company is accumulating RWE on Eliquis on its value and safety profile for stroke prevention in patients around the world. We believe that RWE can be actively used during negotiations with regulatory authorities to illustrate its benefits to patients and its complementary economic benefits to hospitals and healthcare systems, but whether it is appropriate to include it as a requirement will depend on market conditions.
- Company
- MSD Korea’s sales 7%↓ due to the transfer of Januvia sales
- by Son, Hyung-Min Apr 15, 2024 06:05am
- The sales of MSD Korea last year declined by 7.3% year-over-year (YoY). The sales of cancer immunotherapy 'Keytruda' have increased significantly, while the sales of COVID-19 treatment 'Lagevrio' have decreased. The company’s external growth appears to have stalled. Moreover, the transfer of local sales rights of a diabetes drug 'Januvia' series to Chon Kung Dang Pharmaceutical might have also contributed to the decline in sales. According to the Financial Supervisory Service on April 13th, MSD Korea recorded KRW 760.9 billion last year, down 7.3% from KRW 820.4 in 2022. Its revenue amounted to KRW 27.4 billion, down 4.2% YoY. The trend in MSD Korea’s sales performance (unit: KRW 100 million ). MSD Korea’s sales were KRW 471.6 billion in 2019 and KRW 484.7 billion in 2020, exceeding KRW 500 billion in 2021. In 2022, the company experienced significant growth, reaching KRW 800 billion, but the sales declined slightly the following year. Keytruda, MSD Korea’s main product, saw sales rise 66.4% from KRW 239.6 billion in 2022 to KRW 398.7 billion last year. However, the industry analysis suggests that the absence of the diabetes drug Januvia lineup and the sales decline of COVID-19 treatment Lagevrio may have led to an overall performance decline. In May of last year, MSD Korea transferred the sales rights of its diabetes drug, including the Januvia series, Steglatro and Stegluzan, to Chon Kung Dang Pharmaceutical. At the same time, the company closed the general medicine (GM) business division. According to UBIST, a market research agency, the outpatient prescriptions for Januvia (sitagliptin), Janumet (sitagliptin·metformin), and Janumet XR (sitagliptin·metformin) amounted to KRW 136.8 billion. The sales of Stegluzan (ertugliflozin·sitagliptin) and Steglatro (ertugliflozin) amounted to KRW 11.2 billion. The analysis suggests that the sales decline was caused by the absence of the cash cow, which generated around KRW 150 billion. The decline in sales of the COVID-19 treatment 'Lagevrio' has been pointed out as contributing to the overall decrease in sales. Global sales of Lagevrio amounted to US$1.4 billion, down 75% from US$5.7 billion in 2022. This sharp decline in sales was due to a decrease in COVID-19 patients as the world transitioned to an endemic. Pharmaceutical industry experts postulate that the South Korean market might have experienced a similar situation. In fact, the Korean government cut down on related funds after announcing an endemic. According to the Korea Disease Control and Prevention Agency (KDCA), the budget allocated to purchase COVID-19 drugs decreased by almost half, from KRW 384.3 billion in 2022 to KRW 179.8 billion last year. Additionally, the sales of the HPV vaccine Gardasil 9 experienced a slight decrease. While Gardasil 9 sales significantly increased from KRW 72.6 billion in 2021 to KRW 117 billion in 2022, it decreased by over KRW 10 billion YoY to KRW 106.4 billion last year. With Keytruda receiving reimbursement expansion and the launch of Vaxneuvance, will MSD Korea bounce back? MSD Korea hopes to bounce back with the reimbursement expansion of its cancer immunotherapy Keytruda and newly launched Vaxneuvance, immunization for the prevention of pneumococcal disease caused by Streptococcus pneumoniae. Last year, Keytruda experienced rapid growth in sales, increasing by more than 60% YoY. As of the end of last year, Keytruda's market share was 54.6% in the anticancer immunotherapy market. Keytruda's revenue expanded from KRW 11 billion in 2016 to over KRW 100 billion in 2020, surpassing KRW 200 billion the following year. Last year, the sales topped KRW 400 billion, recording rapid growth. The main driver for Keytruda's growth lies in its expanded indications. Keytruda has the most indications among anticancer drugs, with 26 approved indications in South Korea. However, the health insurance reimbursement applies to only four cancer types: lung cancer, Hodgkin's lymphoma, urothelial carcinoma, and melanoma. MSD is planning to expand reimbursement to various solid cancer types, including triple-negative breast cancer and head and neck cancer. If reimbursement is expanded, Keytruda's sales growth potential is expected to increase. Cancer immunotherapy Keytruda·pneumococcal vaccine Vaxneuvance. MSD Korea also expects sales growth for its new vaccine, Vaxneuvance, which was released this year. Vaxneuvance is indicated for preventing invasive diseases and pneumonia caused by pneumococcal serotypes (1, 3, 5, 6A, 9V, 14, 18C, 19F, 22F, 23F, 33F). In particular, Vaxneuvance has been included in the National Immunization Program (NIP) starting this month. The NIP vaccination is inteded for infants aged two months to under five years who have not yet received or completed the schedule for the pneumococcal conjugate vaccine. Vaxneuvance is expected to compete with Pfizer's 13-valent pneumococcal vaccine Prevenar13. According to market research firm IQVIA, Prevenar13 recorded sales of KRW 45.8 billion last year.
- Company
- Boryung actively pursues co-promotion deals…
- by Kim, Jin-Gu Apr 12, 2024 05:41am
- Boryung proactively seeks opportunities to partner with pharmaceutical and biotechnology companies in South Korea and overseas. Boryung appears to be in full swing after signing a co-distribution agreement with HK inno.N for 'K-CAB' and the four items of 'Kanarb' series at the end of last year. Pharmaceutical industry experts anticipate that Boryung could achieve synergy, including external growth, portfolio expansion, and strengthening its capacity in a vulnerable market, through a co-promotion expansion strategy. Joint distribution of breast cancer treatment 'Nerlynx'…Boryung strengthens its anticancer therapy portfolio Boryung reported on April 9 that it signed a mutual co-promotion agreement with Bixink Therapeutics for two types of breast cancer treatment. According to the agreements, they will begin jointly selling and marketing Bixink Therapeutics’ 'Nerlynx (neratinib)' and Boryung’s 'Fulvet (fulvestrant).' Nerlynx is an oral HER2-positive breast cancer treatment. It was approved by the U.S. Food and Drug Administration (FDA) in 2017, and Bixink Therapeutics introduced the drug in South Korea in 2021. Nerlynx is the only extended adjuvant therapy available in South Korea, designed to lower the risk of HER2-positive early-stage breast cancer recurrence and prevent brain metastasis. Fulvet is a generic version of Faslodex that was launched by Boryung last year. It is used either alone or as a combination therapy to treat patients with hormone receptor-positive or HER2-negative, post-menopause progressive·metastatic breast cancer. Boryung expands its portfolio. The current agreement is expected to provide a synergy to both companies. Bixink Therapeutics can expect to strengthen its sales and marketing capacity, while Boryung can expect to expand its product portfolio. Boryung has added new anticancer drugs, 'Xeloda'·'Taxol'·'Samfenet,' to its portfolio. According to IQVIA, a pharmaceutical market research agency, Nerlynx generated KRW 8.2 billion in sales last year, an increase of sevenfold compared to KRW 1.2 billion in 2022, when it first launched. With Boryung’s sales capacity, the drug’s annual sales can be expected to surpass KRW 10 billion. This year, the company has signed several co-promotion deals for 'Sonon 500L'·'Suprane Solution'·'Plasma Lyte' On March 21, Boryung has signed a co-promotion agreement with Healcerion for the portable ultrasound device 'Sonon 500L.' Since the beginning of this month, Boryung has been distributing Sonon 500L to nephrology clinics nationwide. The Sonon 500L is a wireless ultrasound device developed by Healcerion for clinical diagnosis. It is convenient and economically affordable compared to bulky conventional wired ultrasound machines. This product assists in locating blood vessel positions during blood dialysis. Dialysis patients need to insert a needle into their blood vessels three times a week for dialysis. However, the lack of nephrology dialysis rooms equipped with ultrasound machines has caused inconvenience in this process. Through the Sonon 500L co-promotion, Boryung expects to strengthen its position in nephrology. Boryung is the only domestic pharmaceutical company operating a specialized dialysis agency that supplies products related to kidney disease treatment. By adding an ultrasound device targeting dialysis rooms, synergy with existing nephrology-related products is anticipated. Boryung’s CEO Duhyeon Chang (left) and Healcerion’s CEO Jeong-won Ryu (right). In January of this year, Boryung signed a domestic sales agreement with Baxter for the inhaled anesthetic 'Suprane Solution' and the IV infusion 'Plasma Lyte.' Suprane Solution is a conventional inhaled anesthetic used for inducing and maintaining anesthesia during surgeries. Plasma Lyte is an IV infusion developed by Baxter. It is used to supply and correct extracellular fluid when the circulating blood volume or interstitial fluid is reduced. Through this agreement, Boryung expanded its portfolio of drugs used for anesthesia. Boryung previously sold the antiemetic 'Naseron (ramosetron)' and the reversal agent of muscle relaxant 'Breathon (sugammadex).' On April 3, Boryung signed a memorandum of understanding (MOU) with Vivozon Pharmaceutical to commercialize the non-narcotic analgesic Unafra (opiranserin) in South Korea. Opiranserin is a non-narcotic analgesic used for postoperative pain, and domestic product approval is expected by the end of the year. Upon receiving product approval, Vivozon Pharmaceutical will supply finished products to Boryung, and both companies will be responsible for distribution and sales, respectively. Boryung started to strengthen its partnership after signing a co-distribution agreement for its 'K-CAB'-'Kanarb' series last year Boryung appears to be in full swing for expanding partnership after signing a co-distribution agreement with HK inno.N for 'K-CAB'-'Kanarb' series at the end of last year. In December of last year, Boryung partnered with HK inno.N to jointly sell 'K-CAB' and four items of the 'Kanarb' series (Kanarb·Dukaro·Dukarb·Dukarb Plus). These two items are both blockbuster drugs with annual sales of over KRW 100 billion. HK inno.N’s CEO Dalwon Kwak (left), Boryung’s CEO Duhyeon Chang (right). Pharmaceutical industry experts anticipate that Boryung’s proactive expansion through partnerships will bring positive effects, including increased external growth, portfolio diversification, and entry into new markets. Boryung has set a sales target of 1 trillion won for this year. Last year, Boryung recorded sales of KRW 859.6 billion. Mathematically, sales need to increase by more than KRW 140 billion compared to the previous year, and it is expected that the contribution of K-CAB will likely play a significant role in this. In addition, it is also likely that the products covered by the co-promotion agreement signed this year will contribute to achieving this goal. By adding Nerlynx to their anticancer portfolio, Boryung can anticipate portfolio expansion, building on past strengths. Additionally, the company can now aim to strengthen its position in areas such as gastroenterology, nephrology, and anesthesiology, where its marketing and sales capabilities have been analyzed as lacking. The K-CAB co-promotion is expected to significantly boost Boryung's marketing and sales capabilities in the gastroenterology field. “We will create momentum for sustained growth through mutual co-promotion with diverse companies. We will also seek opportunities for mutual growth by establishing a 'collaborative business model,' which has been difficult to find in the industry,” the official from Boryung stated.
- Product
- ‘Wholesale inventory of 110 antitumor drugs at its lowest'
- by Kang, Hye-Kyung Apr 12, 2024 05:41am
- The Korean Pharmacists for Democratic Society (President: Kyung-Lim Jeon, KPDS) has pointed out the issue of antineoplastic drugs being out of stock. In the second week of April, the KPDS revealed through the ‘Stock Shortage Drugs of the Week Report’ that an estimated wholesale stock of 110 antineoplastic drugs has run out. The 110 items with less than 5% wholesale stock remaining include ▲ Xeloda Tab 500mg (Boryung), ▲Hydrine Cap 500mg (Korea United Pharm), ▲Agrylin Cap 0.5mg (Takeda Pharmaceuticals Korea), ▲ Tasigna Cap 150mg (Novartis Korea), ▲ Alecensa Cap 150mg (Roche Korea), ▲ Kisqali Tab 200mg (Novartis Korea), ▲ Alkyloxan Tab (JW Pharmaceutical), ▲ Purinetone Tab (Korea United Pharm,) ▲ Tasigna Cap. 200mg (Novartis Korea), ▲ Afinitor Tab 10mg (Novartis Korea), etc. The society reported "The number of items with a wholesale inventory of 5% or less compared to the supply was confirmed to be 110. This is the fourth consecutive week more than 100 items are having difficulties in wholesale supply, following 105 items in the third week of March, 117 items in the fourth week, and 108 items in the first week of April.” There were also 6 drugs with supply interruptions and shortages, which is an increase from the 3 in the previous week. The medicines discontinued or in short supply included 1 oral warfarin drug, 1 diabetic macular edema treatment, 2 eye surgery aids such as cataract surgery, and 2 anti-malignant tumor drugs. Among these, the shortage of the warfarin drug was due to the aftermath of the discontinuation of Jeil Pharmacuetical’s same product in February last year. Although a substitute is available for the warfarin formulation, the substitute is 30 times more expensive than the warfarin drug. The other drugs with supply interruptions and shortages are known to have substitutes available. The KPDS said, “The hospital-reported shortages included antineoplastic drugs, emergency hypertension drugs, enteral nutrition drugs, treatments for sexual precocity and prostate cancer, plasma protein albumin, ulcerative colitis drugs, and osteoporosis injections. The shortages of emergency hypertension drugs, enteral nutrition drugs, and albumin, which were pointed out as an issue in the previous report, do not seem to have been resolved due to the lack of substitutes."
- Company
- ‘Mounjaro may shift the Type 2 diabetes treatment paradigm'
- by Son, Hyung-Min Apr 12, 2024 05:41am
- Dr. Thomas Forst, professor of Internal Medicine and Endocrinology at the Johannes Gutenberg University in Main, Germany (Chief Medical Officer, CRS Clinical Research Services, Germany) Mounjaro has shown the most potent effect among incretin-based therapeutic agents. Based on the dramatic effect it showed in reducing blood sugar levels and weight loss in clinical trials, we expect the drug will bring about many changes field of diabetes treatment.” Thomas Forst, Professor of Internal Medicine and Endocrinology at the Johannes Gutenberg University in Main, Germany (Chief Medical Officer, CRS Clinical Research Services, Germany), met with Dailypharm and said Mounjaro has the potential to become a game-changer in the field of diabetes. Developed by the global pharmaceutical giant Eli Lilly, MUNJARO is a treatment for type 2 diabetes that acts on both the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). People with type 2 diabetes have reduced incretin effect. This decrease in incretin effect is primarily due to decreased secretion of GLP-1 and impaired insulin-stimulating effects of GIP. GLP-1 and GIP are responsible for two-thirds of the postprandial insulin response. By acting on GIP in addition to GLP-1, Mounjaro can further improve glycemic control. Another of its strengths is its weight loss benefit. In 3 clinical studies of patients with type 2 diabetes, more than half of patients lost 5% or more of their body weight. As most patients with diabetes are pre-obese or obese, weight management is a critical issue. This is why the analysis is that Mounjaro’s use could increase on-site. The number of diabetes patients on the rise globally...emphasizing the importance of blood sugar management The number of diabetics is on the rise globally. According to a study published in the medical journal Lancet, approximately 529 million people were living with diabetes worldwide in 2021. By 2050, the number is expected to reach approximately 1.31 billion worldwide. "With the increase in people with type 2 diabetes, complications such as hypertension and dyslipidemia are also on the rise," said Professor Forst. "The increase in the incidence of diabetic complications means that the number of myocardial infarctions, strokes, and deaths from cardiovascular disease is also on the rise. Therefore, there is a great need for the discovery of new therapeutic agents and their effective use.” The number of diabetes patients is also on the rise in Korea. According to the 2021 fact sheet released by the Korean Diabetes Association (KDA), the prevalence of diabetes in adults aged over 30 years was 16.7%. The number has been on the rise for the past 9 years. The problem is in the treatment outcomes. Despite being treated with oral hypoglycemic medications or insulin, 75% of diabetes patients in South Korea do not achieve a glycated hemoglobin (HbA1c) level below 6.5%, which is the treatment goal and pre-diabetes stage. About 20% of people with diabetes have HbA1c levels above 8.0% and are in need of more aggressive treatment. “HbA1c is a measure that gives you a big picture of how well a patient had controlled his or her blood sugar levels over a three-month period,” explained Professor Forst. “Looking at fasting blood glucose level alone can lead to a false sense that your blood sugar is being well controlled.” Due to this importance in achieving an HbA1c level, there has been a need for a treatment that effectively lowers the blood glucose level. Mounjaro demonstrated its blood glucose reduction effect in clinical trials. In the SURPASS 1-5 trials, the drug showed greater HbA1c reduction than semaglutide, insulin, and other existing diabetes treatments. More specifically, in the SURPASS 4-5 and SURPASS J-mono trials that were conducted on patients with type 2 diabetes, Mounjaro reduced HbA1c by a mean of -2.11% to -2.8%. "In clinical trials, many patients achieved their target HbA1c level,” said Professor Forst. “Even patients who did not achieve the HbA1c level goal of 6.5%, which is the diagnostic threshold for diabetes, benefited from the use of Mounjaro." 'Weight loss effect’ is another benefit of the diabetes drug Mounjaro One of the other strengths of Mounjaro is its weight-loss benefit. In clinical trials, most patients who were administered the drug lost weight. Currently, Mounjaro is approved as a treatment for type 2 diabetes and is not indicated for weight loss. However, it is clear that weight loss can be of great benefit to diabetes patients. In Korea, 78% of people with type 2 diabetes are pre-obese or obese. The more obese the people with type 2 diabetes are, the more likely they are to have poor blood sugar control and develop diabetes-related complications Therefore, domestic and international clinical practice guidelines recommend that overweight or obese diabetics lose 5-15% of their body weight. Major international academic societies also concur. The American Diabetes Association (ADA) emphasized the importance and urgency of weight management in the overall care of people with diabetes in its 2024 diabetes treatment guidelines that it released recently. According to the ADA, adult patients with type 2 diabetes can achieve better glycemic blood levels, blood pressure, and lipid control when they lose 3-7% of their body weight, and weight loss of 10% or more can have a positive long-term impact on reducing cardiovascular mortality. In the SURPASS 4-5 and J-mono studies, 48-89% of patients who were administered Mounjaro achieved a weight loss of 5% or more. In the SURPASS-2 study, Mounjaro also demonstrated faster weight loss results compared to the GLP-1 agent semaglutide. "Weight gain and obesity are important risk factors for diabetes, and diabetes is also linked to several inflammatory and cardiovascular diseases, including hypertension and dyslipidemia. Maintaining a healthy weight is as important as controlling the blood glucose level for people with diabetes.” He added, "I would say Mounjaro is a good option for people with diabetes who are struggling with weight control, as the drug has been clinically proven to help them lose weight." ” Mounjaro will rise as a game changer if it also demonstrates cardiovascular benefits" Currently, some diabetes drugs are expanding their area after demonstrating cardiovascular benefits. SGLT-2 inhibitors, for example, are approved for heart failure and chronic kidney disease. The SURPASS-CVOT clinical trial is also underway for Mounjaro to evaluate the drug’s cardiovascular benefits. It has enrolled more than 13,000 adult diabetes patients with comorbid cardiovascular disease. Dr. Forst expects Mounjaro to become a game-changer if it proves to be effective in cardiovascular disease. "We will have to wait for the results of the ongoing studies that have cardiovascular events as an endpoint, but if Mounjaro proves to be more effective than GLP-1 receptor agonists in reducing cardiovascular events, I am confident that Mounjaro will be a game-changer,” said Dr. Forst.
- Opinion
- [Reporter’s View] Additions to the post-management system
- by Eo, Yun-Ho Apr 12, 2024 05:41am
- “The introduction of the post-management system aims to secure additional evidence related to medicines of uncertain safety and efficacy. The system is intended to improve healthcare by reverifying those medicines with medical knowledge.” Although the intention seems reasonable, some are voicing concerns. The concern is that reinforcing the system could eventually result in 'drug price reduction.’ During the 48th Dailypharm Future Forum, which discussed ‘Directions for appropriate system improvement of Post-management System,’ Korean pharmaceutical companies, global companies, and academics all shared a unanimous skepticism toward the system. The prevailing opinion questioned the system’s necessity and whether RWE (Real-world evidence) would be utilized. Their opinion is well-founded. According to the analysis titled ‘A study on the analysis and rationalization of drug expenditures for new drugs in Korea,‘ the expenditures spent on new drugs from Korea’s health insurance funds only represent 8.5% of the Korea’s total drug expenditure. This figure accounts for 2.1% of the total medical service fee covered by Korea’s health insurance. Compared to other OECD countries, the impact of new drugs on Korea's health insurance funds appears to be among the lowest-ranking levels. The expenditures spent on items of Economic Evaluation exemption and RSA drugs, which include new drugs for severe diseases like cancer and rare diseases, are similarly low, accounting for 0.3% and 2.7% of total drug expenditures, respectively. The system’s requirement for RWE (Real-world evidence) appears to be inadequate. Typically, the hierarchy of evidence includes meta-analysis, literature reviews, randomized controlled trials (RCT), clinical and observational studies with control groups, observational studies without control groups, case reports, and expert opinions. The system's RWE requirement falls under 'observational studies without control groups-case reports.' Adjusting insurance drug prices based on data with a high bias probability could be an unreasonable approach. Additionally, if such document submission is reinforced, pharmaceutical companies will bear the burden of allocating a separate budget to conduct research. The industry is concerned that if the system leads to a reduction in drug prices, pharmaceutical companies will essentially be generating data that could contribute to a decline in sales. This aligns with the concerns of Korea-passing. However, the response of the Health Insurance Review and Assessment Service (HIRA) was encouraging. While maintaining the stance that additional evidence is needed for most drugs with uncertain efficacy and safety, as they are essential medicines in clinical practice and are subject to Economic Evaluation exemption, they agreed on RWE's limitations and concerns regarding the requirement of evidence in the data used for analysis. The post-management system will probably be further reinforced. A drug performance evaluation committee within HIRA Research is also postulated. There should be ‘further discussion.’ It’s crucial to determine whether the system will act as another method of reducing drug prices or if it will serve the government’s stated purpose of ‘alleviating uncertainty.’
