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- 2026-04-09 14:41:32
- Company
- Variable for contract renewal for joint sales
- by Kim, Jin-Gu Aug 03, 2023 05:35am
- HK inno.N r, up 17% in about a year after the launch. HK inno.N sold alone, no commission share, profitability improved as more sold Expiration of the joint sales contract with Chong Kun Dang at the end of the year, will it affect renewal negotiations? HK inno.N K-Cab OD tablets accounted for 17.0% of the total prescription performance of this product. HK inno.N's K-Cab joint sales contract with Chong Kun Dang is about to expire at the end of this year. The increase in the proportion of prescriptions for OD tab, sold exclusively by HK inno.N, is expected to act as a variable in determining conditions such as the sales commission rate in the process of contract renewal negotiations between the two companies. According to HK inno.N on the 2nd, the outpatient prescription amount of K-Cab in the second quarter was 38.4 billion won, up 20.0% from 32 billion in the same period last year. Kcab is currently sold in the form of film-coated tablets and OD tabs. Oral disintegrating tablets accounted for 16.3% of total prescription sales in the second quarter. This means that Kc-ab OD tab's prescription sales in 2Q reached 6.3 billion. HK inno. N released the OD tab in May last year. In 2Q09, the prescription portion of OD tabs was 4.2%. Since then, it has rapidly expanded its share to 7.8% in the third quarter, 10.2% in the fourth quarter, 12.9% in the first quarter of this year, and 16.3% in the second quarter. The proportion of prescriptions increased to 17.0% in June. The prescription portion of OD tabs, which stood at 11.8% in January, increased by more than 5.0%p in half a year. If this trend continues, it is expected to expand to more than 20% within the year. OD tab is also contributing greatly to expanding the prescription record of all K-Cabs. Since the second quarter of last year, prescriptions for film-coated tablets have been somewhat stagnant at 0.7 billion, 30.6 billion won, 32.2 billion won, 31.1 billion won, and 32.1 billion won. Compared to the second quarter of last year, it increased only by 1.5 billion won (4.8%) in one year. OD tab's sales increased significantly with 1.3 billion won, 2.6 billion won,3.7 billion won, 4.6 billion, and KRW6.3 billion. Compared to the second quarter of last year, it increased by 4.9 billion won (366%) in one year. It is an analysis that the OD tab is driving the overall growth of K-Cab prescriptions. An increase in the prescription portion of the OD tab is directly linked to improving the OD tab's profitability. In the case of existing film-coated tablets, they were jointly sold with Chong Kun Dang upon release. In the pharmaceutical industry, it is known that HK in no.N pays Chong Kun Dang a sales commission in the upper 20% range. On the other hand, OD tab is sold by OD tab alone. As sales commissions are not paid separately, the profitability of HK inno.N improves as the number of prescriptions increases. HK inno.N signed a joint sales contract with Chong Kun Dang in 2019. The contract expires at the end of this year. It is known that the two companies are currently discussing whether to renew the contract. In the pharmaceutical and investment industries, it is highly likely that the two companies will sign an extension contract at the level of readjusting sales commission rates and incentives. In this situation, the expansion of the prescription portion of the OD tab, sold exclusively by HK inno.N, is expected to have a significant impact on determining specific negotiation conditions. As OD tab prescription performance expands, HK inno.N's bargaining power is expected to increase. Unlike at the time of release, HK inno.N's sales network has been significantly expanded, and K-Cab awareness in front-line hospitals and clinics has also greatly improved. In addition, it is an analysis that HK Innoen is proving its own sales power by producing good results in the single sale of OD tab.
- Company
- Rise of 4-drug combos in hypertension/hyperlipidemia Tx mkt
- by Kim, Jin-Gu Aug 03, 2023 05:35am
- The growth of 3-drug combinations has slowed down in the hypertension/hyperlipidemia combination drug market. After recording double-digit YoY growth every quarter until the first half of last year, the spurt has slowed sharply since the end of last year. On the other hand, the 4-drug combinations that newly entered the market are rapidly expanding their influence. Prescription sales of Hanmi Pharm’s Amosartan XQ, which is leading the growth of 4-drug combinations, are expected to exceed KRW 10 billion in annual prescriptions. Brakes pulled on the growth of 3-drug combos…rate of growth reduced According to the market research institution UBIST, the outpatient prescription market size for 3-drug combo treatments that contain ARB+CCB+statin had reached KRW 15.3 billion in Q2. This is a 5% increase from the KRW 14.5 billion in Q2 last year. Although the market size expanded compared to the same period last year, the growth rate has slowed significantly recently. Sales of the 3-drug combination that contains ARB+CCB+statin for hypertension and hyperlipidemia have been marking double-digit growth until the first half of last year. Especially in 2020, the market has expanded rapidly. Prescriptions more than doubled every quarter, compared to the same period last year. In 2021, the market continued to grow, expanding by more than 30% every quarter. However, the growth slowed significantly since the second half of last year. In Q3 last year, the market size increased by only 8% YoY. From the Q4 of last year to Q2 of this year, the quarterly growth rate of prescriptions fell to 5%. Prescription performance of combo therapies for hypertension and hyperlipidemia It took just one year from Q4 2019 to Q4 2020 for the prescription scale of the 3-drug combination of ARB+CCB+statin for hypertension and hyperlipidemia to expand from KRW 5 billion to over KRW 10 billion. On the other hand, it took two and a half years to increase the size from KRW 10 billion to KRW 15 billion. The prescription size of the market, which had been around KRW 10.8 billion in Q4 2020 expanded to more than KRW 15 billion only in Q2 this year. Sales of most of the major products also showed a slowdown. Boryung Dukaro (fimasartan + amlodipine + rosuvastatin) posted KRW 4 billion in prescriptions in Q2. This is virtually no change from what it had made in Q2 last year. Hanmi Pharmaceutical’s Amosartan Q (losartan + amlodipine + rosuvastatin) and Daewoong Pharmaceutical’s Olomax (olmesartan + amlodipine + rosuvastatin) even showed a decline in prescription performance. For example, prescriptions of Amosartan Q which had been KRW 2.9 billion in Q2 last year, slightly fell to KRW 2.8 billion in one year. Sales of Olomax had also fallen from KRW 2.3 billion to KRW 2.2 billion. Prescription performance of major three-drug combo treatments for hypertension and hyperlipidemia Will sales of the 4-drug combos surge like the 3-drug combos...Sales of Amosartan XQ rise 75% in one-year Unlike the 3-drug combos, the 4-drug combos that were newly introduced to hypertension/hyperlipidemia combination drug market are rapidly expanding prescriptions. In Q2 last year, the 4-drug combination of ARB + CCB + statin + ezetimibe posted a sales performance of KRW 3.2 billion in the outpatient prescription market. Compared to the KRW 1.5 billion it had posted in Q2 last year, this is a more than twofold increase. This is similar to when the 3-drug combination was first introduced to the market. Hanmi Pharmaceutical was the first to release Amosartan XQ (losartan + amlodipine + rosuvastatin + ezetimibe) and form the market. Then, at the end of last year, GC Biopharma and Jeil Pharmaceuticals released Rozetelpine and Telmican-Q, respectively, both of which are combinations of telmisartan, amlodipine, rosuvastatin, and ezetimibe. In January this year, Chong Kun Dang released Nuvorozet. Nuvorozet contains the same combination as Rozetelpine and Telmican-Q with only amlodipine replaced with amlodipine. The market is currently being led by Amosartan XQ. The drug had recorded prescriptions of KRW 2.7 billion in Q2 this year. This is a 75% increase from the KRW 1.5 billion in Q2 last year. Amosartan XQ recorded a combined prescription performance of KRW 5 billion in the first half of the year, and at this rate, the drug is expected to record more than KRW 10 billion in annual sales this year. Meanwhile, the two-drug combinations of ARB + statin are showing a gradual decline in prescriptions. In Q2 last year, the two-drug combination drugs recorded a combined prescription performance of KRW 20.9 billion. This is a 6% YoY decline. The combination sold the most in Q3 2021, accounting for KRW 23.3 billion, but has been downhill ever since with the introduction of the 3-drug combinations.
- Policy
- Countdown to the Prime Minister’s Biohealth Committee
- by Lee, Jeong-Hwan Aug 03, 2023 05:35am
- Expected to be completed before the regular session of the National Assembly this year. The work of establishing a pan-governmental control tower dedicated to fostering Korea’s biopharmaceutical and healthcare industries has entered the countdown. The Ministry of Health and Welfare, along with the Office of the Prime Minister, plans to revise the order for the establishment of the Biohealth Innovation Committee in the near future. Although the specific schedule has not been disclosed to the outside world, the National Assembly and the pharmaceutical industry expect that the order will be completed by the time the regular National Assembly opens this year in September and October. On the 2nd, an official from the Ministry of Health and Welfare explained, "We plan to complete the establishment of the Biohealth Innovation Committee as soon as possible through the revision of the directive rather than legislation." The domestic pharmaceutical industry, led by the Korea Pharmaceutical Bio Association, has repeatedly requested the government to establish a Pharmaceutical Bio Innovation Committee directly under the President's Office. During the presidential election, President Yoon Seok-yeol pledged to become a member of the Pharmaceutical and Bio-Innovation Committee directly under the president, and after the inauguration of the new government, he put forward a plan to establish a new organization under the Prime Minister. Jeong-suk Seo also proposed a bill that the Pharmaceutical Bio Innovation Committee, chaired by the Prime Minister, serves as an industrial control tower. However, the establishment of the Biopharmaceutical Innovation Committee is promoted not by legislation, but by the revision of the Prime Minister's Office order, and the scope was also determined to target the 'bio health' industry, not just the 'pharmaceutical bio' industry. Accordingly, the name of the organization to be established by the revision of the directive is also expected to be the Biohealth Innovation Committee. This is in line with the attitude the Ministry of Health and Welfare showed in the process of reviewing the National Assembly's Health and Welfare Committee's proposal for Seo Jeong-sook. At the time, the Ministry of Health and Welfare expressed the view that an organization was needed to nurture a wider range of areas, such as medical devices and digital healthcare, in addition to the biopharmaceutical industry, regarding the provision of 'upgrading under the Prime Minister's Office of the Pharmaceutical and Bio-Industry Innovation Committee' contained in the bill of Congressman Seo Jung-sook. The external and internal structure of the BioHealth Innovation Committee, which will be newly organized by the Yoon Seok-yeol administration, can be predicted in detail only when the revised order is released. An official from the National Assembly's Welfare Committee said, "The Ministry of Health and Welfare has expressed its position to create a biopharmaceutical innovation committee by revising the Prime Minister's Office directive without legislation, and the outline will be revealed sooner or later." It may not be necessary, but it remains to be seen whether the effectiveness will be equal."
- Company
- Rx of Generics for Xarelto doubled in 1 yr
- by Kim, Jin-Gu Aug 02, 2023 05:25am
- Generics for Xarelto (Rivaroxaban) are rapidly increasing their prescription performance. In the first half of last year, prescription sales of 8 billion won were recorded, more than doubling in one year. On the other hand, the original product's prescription performance decreased by half during the same period. Generics for Xarelto, 3.9 billion → 8 billion won growth in one year, original cut in half According to UBIST, a pharmaceutical market research institute on the 1st, the number of outpatient prescriptions for rivaroxaban in Korea in the first half of last year was 23.8 billion won, down 29% from 33.5 billion won in the same period last year. During this period, Xarelto, the original product, decreased by 46% from 29.6 billion won to 15.9 billion won. Xarelto's quarterly prescriptions peaked at 16.3 billion won in the third quarter of 2021, then steadily declined. In particular, the drop has increased since the third quarter of 2022. Prescription sales, which were 14.8 billion won in the second quarter of last year, plummeted to 11.8 billion won in the third quarter. Analysts say that the drug price cut, which was delayed due to Bayer's administrative lawsuit and application for suspension of execution, took place at this time, leading to a sharp drop in prescriptions. Since then, Xarelto's prescriptions have steadily declined. In the fourth quarter of last year, prescription sales of 8 billion won fell below 10 billion won, and in the first and second quarters of this year, prescription sales were only 8 billion won and 7.8 billion won, respectively. Xarelto generics are expanding. In the first half of last year, Xarelto generics recorded a combined prescription of 8 billion won. Compared to 3.9 billion won in the same period last year, it more than doubled in one year. Generics for Xarelto first appeared in the second quarter of 2021. Then, they exceeded 1 billion won in the first quarter of 2022 and 2 billion won in the second quarter, respectively. In the fourth quarter of that year, it further increased to more than 3 billion won, and in the second quarter of this year, it recorded more than 4 billion won. In the process, the share of generics also steadily increased. In the second quarter of this year, generics accounted for 36% of the rivaroxaban ingredient market. Compared to 13% in the second quarter of last year, it has nearly tripled in one year. Analysts say that generics are succeeding in targeting the original. Among generic products, Chong Kun Dang's Riroxia, Hanmi Pharm's Riroxban, and Samjin Pharm's Riroxaban posted sales of over W1bn in 1H. Prescriptions for each product in 1H were 2.2 billion won for Riroxia, 1.5 billion won for Riroxban, and 1.3 billion won for Riroxaban. Lixiana announces 100 billion won per year, Pradaxa's sluggishness continues Among the NOAC products other than Xarelto, Daiichi Sankyo's Lixiana produced the highest prescription performance. Lixiana's prescription amount in the first half was 51.4 billion won, up 10% from 46.5 billion won in the first half of last year. If this trend continues, Lixiana is expected to generate more than 100 billion won in prescriptions by the end of this year. BMS Eliquis recorded prescription sales of KRW 38.3 billion in the first half. Compared to 35.8 billion won in the first half of last year, it increased by 7% in one year. Boehringer Ingelheim Pradaxa's slump is prolonged. Pradaxa's prescriptions in the first half of this year were 5.9 billion won. It decreased by 11% from 6.6 billion won in the first half of last year. Pradaxa's quarterly prescriptions fell below 4 billion won in the third quarter of 2020 and further decreased to less than 3 billion won in the second quarter of this year.
- Company
- Why HK Inno.N’s sales and operating profit fell
- by Kim, Jin-Gu Aug 02, 2023 05:25am
- HK Inno.N's sales and operating profit declined significantly in Q2 this year. This can be attributed to the sharp decline in MSD vaccine sales amid brisk earnings of its flagship product, K-Cab (tegoprazan),. HK InnoN explained that shipments of Gardasil, its cervical cancer vaccine, were concentrated in the second quarter of last year before the company’s price hike, and the resulting base effect occurred in Q2 this year. According to the Financial Supervisory Service on the 1st, HK Inno.N's sales in Q2 were KRW 204.4 billion, down 18.9% YoY from the KRW 251.9 billion it posted in the second quarter of last year. During the same period, the company’s operating profit decreased by 13.2% from KRW 17.7 billion to KRW 15.3 billion. The company’s ETC sales fell 21.1% from the previous year to record KRW 179.9 billion, down 21.1% from the previous year. The largest decline occured in the sales of its MSD vaccines. HK Inno.N's MSD vaccine sales in Q2 were KRW 36.3 billion, down to less than half (55.3%) of the KRW 82.2 billion it had raised in Q2 last year. HK Inno.N explained, "This is a base effect arising due to the concentration of shipments of Gardasil, a cervical cancer vaccine, in Q2 last year before the company’s drug price hike was expected. However, sales of its flagship product, K-cab continued to grow in Q2. K-Cab’s prescription sales had risen 19.9% YoY to reach KCRW 38.4 billion in Q2. K-Cab began to generate sales in earnest overseas as well. K-Cab's exports in Q2 were KRW 2.4 billion, a significant increase from the KRW 200 million it had made in the previous quarter. HK Inno.N is currently exporting K-Cab to Mongolia, the Philippines, Mexico and Indonesia. The product was released in May in Mexico and in July in Indonesia. In addition, it has currently obtained product approval in Singapore and Peru and is expected to be released in the approved locations in the second half of this year. The product was released in May last year under the name Taixinjian through Luoxin, a pharmaceutical company specializing in digestive medicine. As the drug was listed on China's National Reimbursement Drug List (NRDL) in March this year, sales are expected to increase furtherin the future. Royalty following the NRDL listing is expected to be recognized in the accounts in earnest from Q3 this year. Its solution business, one of the company's new growth engines, is also rolling smoothly. Its sales in the business in Q2 was KRW 27.4 billion, up 7.5% YoY. HK Inno.N explained that their sales are steadily growing due to increased sales activities initiated following the operation of its new plant.
- Company
- GC Biopharma ends its 2-quarter deficit run
- by Kim, Jin-Gu Aug 02, 2023 05:25am
- GC Biopharma, which had recorded an operating loss for 2 consecutive quarters, succeeded in turning a profit this quarter. GC Biopharma explained that the company has succeeded in doing so by increasing sales of highly profitable products and efficient execution of costs. GC Biopharma also announced plans to accelerate its overseas business with a focus on blood derivatives. GC Biopharma explained that the company plans to release its immunoglobulin 10% for intravenous administration product within the second half of next year and speed up exports of its blood product plant in Indonesia. Ends the 2nd quarter streak of operating losses...’Expansion of high-margin product sales + reduced expenditures’ GC Biopharma publicly announced on the 1st that its operating profit in Q2, based on consolidated financial statements, was KRW 23.7 billion, up 80.9% from the KRW 13.1 billion in the same period last year. Also, sales increased by 2.3% YoY to KRW 432.9 billion. The company had consecutively recorded an operating loss in Q4 last year and Q1 this year. The operating loss was KRW 18 billion in Q4 last year and KRW 13.6 billion in Q1 this year. GC Biopharma However, the company had successfully marked a turnaround and turned to a profit in Q2. GC Biopharma explained, "We secured profitability by increasing sales of profitable products and efficient cost execution." The company saw the largest increase in its sales of vaccines. GC biopharma’s vaccine sales had added up to KRW 27.1 billion in Q1 this year, but this had increased 3.6 times to reach KRW 97.4 billion in Q2. This is a 15.4% increase from the KRW 84.4 billion in Q2 last year. The analysis is that the separate reflection of sales of flu vaccines exported to the southern hemisphere largely affected the results. SG&A expenses decreased from KRW 128.8 billion in Q2 of last year to KRW 117.1 billion in Q2 this year. Among SG&A expenses, ordinary development expenses decreased by 8.4% from KRW 50 billion to KRW 45.8 billion. Change in sales of GC Biopharma Spurs sales of its blood derivative products...Plans to release ‘IVIG 10%’ in the U.S. within the second half of next year The company also plans to accelerate its overseas business for blood derivative products in the future. The company’s US project has been attracting the most attention. GC Biopharma plans to release an immunoglobulin 10% (IVIG-SN 10%) product for intravenous administration in the US in the second half of next year. GC Biopharma submitted a BLA to the US Food and Drug Administration (FDA) on the 14th of last month. FDA’s review results will be confirmed on January 13 next year (local time). Spurs sales of its blood derivative products...Plans to release ‘IVIG 10%’ in the U.S. within the second half of next year The company also plans to accelerate its overseas business for blood derivative products in the future. Among those, the company’s plans in the US have been attracting the most attention. GC Biopharma plans to release an immunoglobulin 10% (IVIG-SN 10%) product for intravenous administration in the US in the second half of next year. GC Biopharma submitted a BLA to the US Food and Drug Administration (FDA) on the 14th of last month. FDA’s review results will be confirmed on January 13 next year (local time). In the mid-to-long term, the company set the goal of occupying 3% of the IVIG market share in the US. According to GC Biopharma, the US IVIG market will rise to amount to USD 13.1 billion by 2023 (approximately KRW 16.87 trillion). As only 7 companies are selling 10% IVIG products in the US, the company’s understanding is that there remains a continuous imbalance between supply and demand in the field. GC Biopharma The company also plans to speed up its blood product plant business in Indonesia. GC Biopharma was selected as a preferred contractor for blood product plant construction by the Indonesian government in January this year. The company has also signed business agreements with the Indonesian Red Cross and local pharmaceutical companies. GC Biopharma expects to be able to execute the main contract within this year. In Brazil, the company signed a long-term supply agreement for its IVIG 5% product. Under the agreement it had signed with the Brazilian pharmaceutical company, Blau, GC Biopharma will supply products worth USD 90 million by 2025. It will additionally supply products until 2028, and the specific supply scale for this will be determined after 2025. GC Biopharma predicted that profitability would further improve as the price of IVIG products in Brazil is around twice as high as that in Korea. The company also decided to continue operating its mRNA project. GC Biopharma plans to complete the mRNA pilot production facility at its Hwasun plant within the year. For this, the company invested KRW 15 billion in its Hwasun plant in March this year. GC Biopharma plans to complete the construction of an mRNA pilot production facility this year and begin test operations. GC Biopharma Also, the company decided to develop a mRNA-based treatmnet to treat succinic semialdehyde dehydrogenase deficiency (SSADHD), a rare intractable disease. The company, which first has been devloping the treatment as a protein drug, has changed tracks and decided to develop an mRNA drug. GC Biopharma plans to make the final decision on a candidate substance in the first half of next year. Since there is currently no product on the market released to treat this disease, GC Biopharma predicts that it will become a first-in-class product if clinical trials are successful.
- Company
- Inrebic, tx for myelofibrosis, has become available in Big5
- by Eo, Yun-Ho Aug 02, 2023 05:25am
- Inrebic, a new drug for myelofibrosis, has settled down in Big 5. According to related industries, Korea BMS Pharmaceutical's myelofibrosis treatment Inrebic passed the Drug Committee (DC) of the big five medical institutions, including SMC, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Severance Hospital. Since being registered as an insurance benefit in June, it has been steadily expanding its prescription area. Inrebic was approved in Korea in April of last year for the treatment of splenomegaly or symptoms related to primary myelofibrosis, myelofibrosis after polycythemia vera, and myelofibrosis after essential thrombocythemia in adult patients previously treated with Jakavi. Inrebic is a JAK-2 inhibitor, which is different from Jakavi, a JAK1/2 inhibitor. Inrebic is the first to obtain approval for an oral once-a-day drug that greatly reduces the burden of spleen volume and symptoms in patients with myelofibrosis who have not had a history of treatment. Myelofibrosis is a rare blood cancer that affects the bone marrow and interferes with the body's normal production of blood cells. Patients suffer from symptoms such as an enlarged spleen, fatigue, itching, weight loss, night sweats, fever, and bone pain, which affect their quality of life. experience symptoms. Until now, Jakavi was the only JAK inhibitor approved for the treatment of myelofibrosis, and there was no alternative for patients who failed treatment. Inrebic is a treatment that appeared in the myelofibrosis market 10 years after Jakavi, where there was no second-line treatment option. Meanwhile, Inrebic's reimbursement standard can be covered by insurance if it treats splenomegaly or symptoms related to primary myelofibrosis, polycythemia vera, or essential thrombocythemia in adult patients who have been previously treated with ruxolitinib. Administration can be continued if Clinical Improvement is shown according to the IWG-ELN guidelines for response evaluation criteria.
- Policy
- MOHW ‘Cannnot defer price cuts made under PVA'
- by Lee, Jeong-Hwan Aug 02, 2023 05:25am
- The government has once again put its foot down and opposed to the request made by the pharmaceutical industry and the National Assembly to postpone drug price cuts applied under the Price-Volume Agreement (PVA) system until the exchange rate and prices stabilize. The government also added that it is working on an improvement plan for the drug pricing system that includes a preferential drug pricing policy for homegrown new drugs or preferential drug prices for drugs using domestic APIs. On the 1st, the Ministry of Health and Welfare announced so through the ‘Report on the 2022 National Audit Results Correction and Processing Requirements'. The MOHW again expressed the opinion that a careful review is required to postpone the application of the PVA system. The reason was that for drugs whose use rises temporarily due to treatment of an infectious disease such as COVID-19 or where normal supply was not procured in the previous year due to problems with production facilities or API supply, etc., the authorities are already adjusting the negotiation reference price in comprehensive consideration of each drug’s supply and demand situation and their direct affect on NHI finances. The government added, if a volume-related issue arises due to an exceptional situation, the authorities are already reasonably adjusting the price according to the situation, therefore application of the PVA system does not need to be postponed. Regarding the criticism that the PVA system hinders cooperation between domestic pharmaceutical companies and global pharmaceutical companies for the development of innovative new drugs, the MOHW said it would come up with an improvement plan. The MOHW said, “Since these exceptional circumstances are being reflected in the negotiations, a careful review is required on temporarily suspending the system until the exchange rate or price level stabilizes. We will prepare a policy improvement plan based on the policy research service organized by NHIS and operate a public-private consultative body to come up with measures to improve policies.” Regarding preferential drug pricing for drugs developed by innovative pharmaceutical companies or pharmaceutical companies that produce and develop raw materials in Korea, the MOHW briefly replied, “We are preparing a policy.” The MOHW explained that it is reviewing measures to increase investment in innovative pharmaceutical companies and provide preferential treatment for drugs manufactured with Korean APIs while avoiding WTO disputes as the 3rd Comprehensive Plan to Foster and Support Pharmaceutical Bio-Industry. In particular, the MOHW added that it is preparing a drug pricing system improvement plan to provide preferential treatment for homegrown incrementally modified drugs and new drugs made with native natural products, and has begun to establish a bio-health innovation committee for the Pharma-Bio Innovation Committee that will be directly under the Prime Minister. The MOHW said, “We are preparing a plan for the improvement of the drug pricing system that compensates for innovative values such as preferential drug prices for domestically developed new drugs that have proven clinical superiority. Also, we have been pushing for a revision of order among others for the establishment of a new health innovation committee."
- Company
- Shaperon files Phase II IND for its AD treatment
- by Lee, Seok-Jun Aug 01, 2023 05:33am
- On the 31st, Sharperon announced that it had submitted an investigational new drug (IND) application to the US Food and Drug Administration to conduct a Phase II trial in the U.S. for its atopic dermatitis treatment, ‘NuGel.’ The company plans to evaluate the pharmacokinetics, safety, tolerance, and efficacy of NuGel through the multinational Phase II trial on patients with mild-to-moderate atopic dermatitis. Participants will be double-blinded and receive a placebo or NuGel for 8 weeks. Through this clinical trial, Shaperon seeks to confirm NuGel’s improvement in eczema area and severity index (EASI score)) compared to placebo in patients with atopic dermatitis. NuGel is a new drug candidate that suppresses the expression of cytokines that exacerbate symptoms of atopic dermatitis by suppressing inflammasomes present in immune and vascular cells. By increasing the number of inflammatory regulatory cells in the body, the drug controls a wide range of inflammatory pathological mechanisms in two ways. Currently, 80% of atopic dermatitis patients are treated with moisturizers and steroids. However, this is not a cure and also accompanies various concerns related to side effects such as steroid resistance and telangiectasia. In this sense, NuGel is evaluated to have shown similar effects to steroids while securing safety. According to the market research institution Mordor Intelligence, North America accounts for 48.5% of the global atopy dermatitis market, with a market size of KRW 6 trillion. According to Grand View Research, the global atopy dermatitis treatment market is expected to reach KRW 37 trillion by 2030.
- Company
- US FDA starts review of GC Biopharma’s Alyglo
- by Kim, Jin-Gu Aug 01, 2023 05:33am
- GC Biopharma announced on July 31st that its drug, 'GC5107B (immunoglobulin 10% for intravenous administration) is being reviewed in earnest by the U.S. Food and Drug Administration. GC5107B is one of GC Biopharma’s blood derivative products that goes by the brand name Alyglo. The company had submitted a Biologics License Application (BLA) to the US FDA last month. With FDA starting the review process in earnest, the company expects the results to come out by January next year. The FDA assigned a target action date of January 13th (local time) next year, under the Prescription Drug User Fee Act (PDUFA). Therefore, the decision on 'GC5107B' will be made by then. GC Biopharma received a pre-license inspection for a blood product production facility in Ochang, Chungbuk Province in April of this year, which had been delayed due to the prolonged COVID-19 crisis. Then, the company resubmitted the BLA on the 14th of last month. The company announced that it plans to launch its product in the US market under the brand name Alyglo if it receives final approval from the FDA in January next year. According to GC Biopharma, the U.S. immunoglobulin market was worth USD 10.4 billion (about KRW 13 trillion) as of last year. In particular, blood derivatives, which require large-scale facility investment and advanced manufacturing experience, are known to have frequent supply disruptions due to the limited number of manufacturers.
