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- 2026-05-08 23:15:00
- Policy
- When will the innovative generic price system be improved?
- by Lee, Tak-Sun Jun 12, 2023 05:42am
- As announced, the government-pharmaceutical working group for PVA improvement plans started on the 1st with the first meeting and got on track. The industry is complaining of frustration as there is no news about the plan for preferential drug prices for innovative new drugs whose working group has already ended or the reorganization of the generic drug price system that is being pursued together. According to the industry on the 7th, the PVA improvement plan working group will be held from the first meeting on the 1st to November. Originally, this working group was scheduled to run from May to August, but instead of being delayed by one month, the entire period was extended. The government plans to promote institutional improvement next year through a working group. The external research service, which is the basis for the improvement plan of the usage-drug price linkage system, has already been disclosed. The 'PVA Performance Evaluation and Improvement Study' participated by Bae Seung-jin, professor at Ewha Womans University Pharmacy, was also disclosed to the outside world in April. Looking at the main content, in the case of type Ka, currently, only cases where the billing amount increases by 30% or more are included in the negotiation target, but like Na and Da types, a plan to include items with a 10% increase in billing amount & 5 billion won or more presented. It also proposed a plan increase the efficiency of negotiations and system acceptance by raising the exclusion standard from the current claim amount of 2 billion won to 3 to 5 billion won. The core of the study results is to include more expensive drugs with high claims in the PVA negotiation target and to expand the exclusion of low-priced drugs. In the industry, different opinions are expressed depending on the size of the company. Rumor has it that the one-day meeting ended with sharing the results of the research service and simply listening to the opinions of the industry. The NHIS plans to have its staff members travel abroad to France, Japan, and Taiwan to come up with improvement plans. It has already been brought to Taiwan and is known to be planning to visit France and Japan this month. The industry is calmly participating in the fact that the PVA improvement plan has already been disclosed and the operation of the working group was scheduled. Rather, they are looking forward to a meeting to discuss the government's final plan for improving innovative new drugs, which ended in the first half of this year, and plans to improve the generic drug price system. The public-private consultative body to improve innovative new drugs ended after the 5th meeting in March, and the government is waiting for the final draft. The government never met with the industry in a situation where only the media reported that the government was promoting a plan to improve the generic drug price system. Some predict that there will be a face-to-face meeting with the industry after the government plans to prepare an internal draft for improving the generic drug price system by June. An official from the industry said, "This year, not only PVA but also various consultative bodies such as measures to improve the actual transaction price system are scheduled." He said, "The industry is interested in preferential treatment for innovative new drugs and reform of the generic drug price system, but the government's plan is not clear, so the industry is in a frustrating situation."
- Company
- Crystal Genomics supplies 2.6 billion Acelex to Russia
- by Lee, Seok-Jun Jun 09, 2023 05:36am
- Crystal Genomics will supply $2 million of Acelex, an osteoarthritis drug, to Russia. According to the company on the 7th, this order is based on a supply contract with PharmArtis International, a Russian state-run pharmaceutical company. This is the second order quantity. The contractual obligation to purchase is $43.86 million. Crystal Genomics will receive up to $77.6 million in milestones based on additional sales. PharmArtis is currently developing sales and marketing strategies and more. It will officially release Acelex in Russia next month at the earliest. The Russian COX-2 inhibitor market, to which Acelex belongs, is showing an annual growth rate of more than 30%. It is possible to expand the market to neighboring Eurasian Economic Community regions (Belarus, Kazakhstan, Armenia, Kyrgyzstan, etc.). The Eurasian Economic Community regional regulatory authorities are in the process of obtaining Acelex approval. Acelex is Korea's first bio-venture new drug. It selectively inhibits only COX-2 among cyclooxygenases (COX-1 and COX-2), two enzymes that act on the formation of prostaglandins that cause inflammation and pain. It was developed to overcome stomach cramps and gastrointestinal disorders, which are side effects of non-steroidal anti-inflammatory drugs. An official from Crystal Genomics said, "Following the shipment of the first volume at the end of March, we received an order for the second volume, so local sales are imminent. Sales in Russia are expected to improve performance."
- Policy
- Adtralza is about to be approved in Korea
- by Lee, Hye-Kyung Jun 09, 2023 05:35am
- Domestic product approval for an adult atopic dermatitis treatment developed by LEO Pharma, a Danish pharmaceutical company, is imminent. According to the pharmaceutical industry on the 8th, the Ministry of Food and Drug Safety completed the safety and efficacy review of 'Adtralza 150mg (tralokinumab)', which Leo Pharma applied for. As the safety and efficacy review of the Ministry of Food and Drug Safety has been completed, it is expected to enter the item approval process soon. This drug is a component of tralokinumab and is sold under the trade names of Adbry in the US and Adtralza in Europe. Adtralza is the first biological agent that specifically binds to and inhibits IL-13 cytokine, a key trigger, and symptom of atopic dermatitis, and can be used in combination with topical corticosteroids or as monotherapy. In December 2021, the FDA first approved the IL-13 family of atopic dermatitis treatments and became famous. Adtralza proved effective in three ECZTRA 1-2-3 trials conducted on a total of 2,000 adult patients with moderate to severe atopic dermatitis. In the ECZTRA 1 and 2 clinical trials, the group administered with tralokinumab showed a 50% higher rate of achieving an IGA score of 0 to 1 (completely resolved to almost eliminated dermatitis) than the control group administered with a placebo. In the two clinical trials (ECZTRA 1 and 2) in which only Adtralza effects were judged, the rate of reaching an IGA score of 0 to 1 (completely to almost no dermatitis) was more than 50% higher in the drug-administered group than in the placebo-administered control group. The 75% improvement rate of the Eczema Area and Severity Index (EASI), another primary endpoint, was 33% in the tralokinumab group, much higher than 10% in the control group. The rate of improvement of at least 4 points on the 11-point numerical rating scale for itch was 20% in the tralokinumab group and 10% in the control group. The ECZTRA 3 clinical trial results, in which corticosteroid ointment was added to tralokinumab, were also similar to the ECZTRA 1 and 2 clinical trial results. Side effects included eye and eyelid inflammation, injection site reaction, and eosinophil (a type of white blood cell) increase.
- Company
- Korea’s new drug reimb rate is below OECD average
- by Eo, Yun-Ho Jun 09, 2023 05:35am
- A survey found that Korea’s new drug reimbursement rate does not amount to the OECD average. The Korean Research-based Pharmaceutical Industry Association (KRPIA, Chairman: Dong-Wook Oh) recently announced Korea’s new drug release status based on its ‘Global Access to New Medicines Report’ According to the report, it takes longer than the Organisation for Economic Co-operation and Development (OECD) country average for new drugs to be introduced to Korea after its global launch, and Korea’s release rate and reimbursement rate were also below the OECD country average. The report was based on the ‘Pharmaceutical Research and Manufacturers of America’ report that was published in April. PhRMA’s report subdivided 72 countries including Korea by G20, OECD, and region, and investigated the current status of new drug launches and health insurance coverage in each country. The report was prepared based on an investigation of a total of 460 new drugs that have received marketing authorization in the United States, Europe, and Japan over the past 10 years from 2012 to 2021. When taking a closer look, the report showed that the ratio of new drugs introduced to Korea within 1 year after the initial global launch was found to be less than half of the OECD average. While the average new drug introduction rate (non-reimbursement release rate) in OECD countries is 18%, Korea's level was only 5%, about a quarter of the OECD average. The countries with the highest new drug introduction rates were the United States (78%), Germany (44%), then the United Kingdom (38%). Also, Japan’s new drug introduction rate was nearly twice that of Korea, at 32%. By disease, it took about 27 to 30 months for anticancer drugs and new rare disease drugs to be released in Korea without reimbursement after their global launch. Compared to the average of 12 to 15 months it took in other advanced countries such as the UK and Germany and 18 to 21 months in Japan, it takes twice as long for new drugs to be launched in Korea. Moreover, it took a total of 46 months from the initial global launch of a new drug to reimbursement in Korea. The average time taken in other OECD countries was similar at 45 months, but compared to Japan (17 months) and France (34 months), it took from 10 months to more than twice longer for drugs to be reimbursed in Korea. Meanwhile, the share of new drugs covered by health insurance in Korea was 22%, which was below the OECD average (29%). This is only half that of Japan (48%) and the UK (48%). KRPIA said, “The report holds significance for allowing us to identify the rate and period of new drugs introduced and reimbursed in Korea after their global launch. Improvements should be made to Korea’s system and environment in advance to enable prompt reimbursement of global new drugs for patients in Korea.
- Company
- Non-covalent BTKi pirtobrutinib receives orphan drug desig
- by Eo, Yun-Ho Jun 09, 2023 05:35am
- The BTK inhibitor ‘pirtobrutinib‘ received an orphan drug designation in Korea. The Ministry of Food and Drug Safety recently announced that it had designated Lilly’s Bruton's Tyrosine Kinase (BTK) inhibitor Jaypirca (pirtobrutinib) as an orphan drug. The subject indication is as monotherapy for adult patients with relapsed or refractory mantle cell lymphoma who have been previously treated with a BTK inhibitor. The US FDA granted accelerated approval for Jaypirca in January. The drug received attention as the first non-covalent BTK inhibitor and as an alternative to patients who failed treatment with covalent BTK inhibitors like ‘Imbruvica (ibrutinib),’ ‘Brukinsa (zanubrutinib),’ etc. Jaypirca’s efficacy was evaluated through the BRUIN trial. Results showed that the overall response rate of patients that received 200mg of Jaypirca once a day was 50% (60 patients) among the 120 mantle cell lymphoma patients, with a complete response rate of 13% (15 patients) and a partial response rate of 38% (45 patients). The estimated median duration of response was 8.3 months, and the estimated duration of response rate at 6 months was 65.3%. The pooled safety analysis of the full BRUIN study population evaluated 583 patients with hematologic malignancies administered Jaypirca 200 mg daily as a single agent. In this pooled safety population, the most common adverse reactions (ARs) to Jaypirca therapy, occurring in 20% of patients or more, were decreased neutrophil count, decreased hemoglobin, decreased platelet count, fatigue, musculoskeletal pain, decreased lymphocyte count, bruising, and diarrhea. Meanwhile, the MFDS has been operating the orphan drug designation system to support the development of treatments for rare and intractable diseases. Among the drugs used to diagnose or treat rare diseases, drugs that are irreplaceable or those that significantly improved outcomes compared to their alternatives are designated as orphan drugs. Drugs designated as orphan drugs can receive benefits such as being eligible for accelerated review for marketing authorizations, etc.
- Company
- Humira with sales of 100 billion won
- by Chon, Seung-Hyun Jun 09, 2023 05:35am
- In the autoimmune disease treatment drug ‘Humira’ market, biosimilar products are not showing remarkable activity in the early stages. Although it has been two years since domestic companies penetrated the market, the market share of ‘Humira’ biosimilar has passed two years, but the market share was only 12%. It is analyzed that the price of original drugs and biosimilars did not show an explosive rise because the insurance price was similar. According to IQVIA, a pharmaceutical research institute on the 7th, the market for adalimumab ingredients in the first quarter was 24.5 billion won, up 9.8% from 22.3 billion won in the same period last year. Adalimumab is a TNF-alpha inhibitor that treats autoimmune diseases such as rheumatoid arthritis and psoriasis. AbbVie's Humira is the original drug. Humira posted sales of 104 billion won in 2019, 91.2 billion won in 2021 and 85.8 billion won last year, respectively. Samsung Bioepis and Celltrion released Humira biosimilars in 2021 and last year, respectively. The adalimumab market showed a moderate upward trend after falling 24.9% from 27.5 billion won in the first quarter of 2021 to 20.7 billion won in the second quarter. The sharp decline in sales in the second quarter of 2020 was due to a reduction in drug prices following the entry of biosimilars, which reduced the size of the market. When Samsung Bioepis listed Humira biosimilar Adaloche as a benefit in May 2021, Humira's upper limit also fell a month later. As of June 7, 2021, Humira's insurance cap has been reduced by 30%. The price of three drugs, Humira Pen 40mg/0.4mL, Humira Prefilled Syringe 40mg/0.4mL, and Humira 40mg vial, fell 30% from 411,558 won to 288,091 won, and Humira Prefilled Syringe 20mg/0.2 mL went down from 224,002 won to 156,801 won. Humira has maintained sales at a similar level after drug price cuts following biosimilar registration. Sales of Humira in the first quarter of last year were 21.5 billion won, up 1.5% from the same period last year. It increased by 4.0% from 20.7 billion won in the second quarter of 2021, right after the drug price cut. This means that sales volume has decreased due to drug price cuts, but sales since then have maintained the previous year's level. Analysts say that the pace of market penetration of biosimilar products is slow. In the first quarter of last year, Adalloce of Samsung Bioepis and Yuflyma of Celltrion posted a total of KRW 3 billion in sales. Adalloce and Yuflyma posted sales of 2.6 billion won and 400 million won, respectively. Adalloce posted its first sales of 400 million won in the third quarter of 2021 and exceeded 1 billion won in the first quarter of last year. Adalloce's sales in the first quarter of this year increased by 134.7% compared to the same period last year, but its share in the adalimumab market was only 10.6%. Adalloce's domestic sales will be handled by Yuhan Corporation. Yuflyma posted sales of 200 million won in the third quarter of last year, and sales in the fourth quarter of last year and the first quarter of this year were only around 300 million won. Celltrion Pharmaceuticals is in charge of the domestic sales of Yuflyma. The sales share of Adalloce and Yuflyma in the adalimumab market in the first quarter was 12.2%. It exceeded 10% for the first time in the fourth quarter of last year and recorded 12.5%, but this year it has decreased somewhat. The market share recorded two years after biosimilar penetration is analyzed as a disappointing report card. The upper price of Adalloce PFS 40mg/0.4ml and Yuflyma 40mg/0.4ml is KRW 244,877 each, and the gap between the drug price of Humira PFS 40mg/0.4ml and Humira Pen 40mg/0.4ml of KRW 288,091 is only 15.0%. In principle, under the domestic drug price system, biosimilars can receive up to 70% of the original drug price before the patent expires. From October 2016, up to 80% of products are guaranteed for 'items developed by a company that has entered into a joint contract between an innovative pharmaceutical company, an equivalent company, a domestic pharmaceutical company and a foreign company, or items for which Korea is the first licensed country or items produced in Korea. When biosimilars are released for original drugs whose patents have expired, insurance prices are automatically reduced to 70-80% of the previous level. Even if biosimilars are listed at a price that is 30% cheaper than the price of the original drug before the patent expires, it is not easy to secure price competitiveness as the drug price of the original drug is also reduced. There is also an analysis that medical staff and patients have no choice but to prefer new drugs from multinational pharmaceutical companies that have accumulated reliability for a long time in a situation where drug prices do not differ greatly due to the nature of autoimmune disease drugs used for severe diseases.
- Company
- Daewoong,"promoting to change Fexuprazan's partner"
- by Kim, Jin-Gu Jun 08, 2023 07:47pm
- Daewoong Pharmaceutical is going to change partners in charge of the development and commercialization of Fexuprazan in the North American market. Daewoong Pharmaceutical announced on the 5th that it has terminated the exclusive license agreement with Neurogastrx of the United States for the clinical development and commercialization of Fexuprazan in the US and Canada markets under an agreement between the two companies. The two companies signed a contract in June 2021. Daewoong Pharmaceutical explained that it decided to terminate the contract under the judgment that it needed a strategic partner that can quickly develop Fexuprazan for various indications in the North American market. Neurogastrx is said to have agreed to terminate the contract after determining that the development of Fexuprazan no longer aligns with its strategic business plan through pipeline re-evaluation. Upon termination of the contract, Daewoong Pharmaceutical has withdrawn all rights to clinical development and commercialization of Fexuprazan in the US and Canada. However, the 5% stake in Neurogastrix acquired by Daewoong Pharmaceutical at the time of the contract in 2021 is not returned. Daewoong Pharmaceutical started looking for a new partner. In particular, it has entered into negotiations with multiple multinational pharmaceutical companies that can simultaneously conduct clinical development not only in North America but also in global big markets such as Europe and Japan. Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, “With P-CAB receiving new attention from medical professionals around the world, we are communicating with multiple multinational pharmaceutical companies that can quickly settle Fexuprazan in the global market.” CEO Jeon Seung-ho emphasized, "We will secure additional indications for Fexuprazan in the global big market and accelerate the development of formulations to achieve 1 trillion won in sales by 2030 and develop it into a Best-In-Class within the family." In July of last year, Daewoong Pharmaceutical launched Fexuclue, a gastroesophageal reflux disease treatment in the P-CAB (Potassium Competitive Gastric Acid Blocker) class, as the 34th domestic new drug. Fexuprazan improves the disadvantages of existing PPI drugs and quickly and stably suppresses gastric acid secretion without activation by gastric acid.
- Company
- Competition for interleukin inhibitors heats up in Stelara
- by Kim, Jin-Gu Jun 08, 2023 05:34am
- Stelara, Cosentyx, Skyrizi, and Tremfya (clockwise from top left) The interleukin inhibitor market also grew rapidly in the first quarter. Compared to the first quarter of last year, the market size increased by 26% in one year. While Stelara, the market leader, posted sales of KRW 11.1 billion, up 9.8% YoY, generics are rapidly catching up. Skyrizi saw a 69.7% year-over-year increase in sales and Tremfya's 43.4%. In particular, as generics are scrambling to add new content and expand the scope of reimbursement, competition in this market is expected to intensify in the future. The interleukin inhibitor market increased by 26% in 1 year, and Stelara remains No. 1 in the market for 12 years According to IQVIA, a pharmaceutical market research institute on the 5th, the size of the interleukin inhibitor market in the first quarter was 36.4 billion won. Compared to 28.8 billion won in the first quarter of last year, it increased by 26.4% in one year. Interleukin inhibitors are primarily used to treat psoriasis. It is divided into the IL-17 family and the IL-23 family according to the pathway that inhibits interleukin (IL). Janssen Stellara, which is classified as a first-generation product, is a mechanism that inhibits IL-12/23. Second-generation products, Novartis Cosentyx and Lilly Taltz inhibit IL-17, while Janssen's Tremfya and AbbVie Skyrizi, two successors, inhibit IL-23. This market was formed in 2012 when Stelara was added to the health insurance coverage list. Since 2015, successor products have been added one after another, and it is growing very rapidly. The actual interleukin inhibitor market size was only 10.4 billion won in the first quarter of 2019, but it expanded 3.5 times in 4 years to 36.4 billion won in the first quarter of this year. Analysts say that while Stelara, the market leader, is in good health, generics contributed to the expansion of the market by rapidly increasing sales. Stelara recorded sales of 11.1 billion won in the first quarter of last year. It increased by 9.8% from 10.1 billion won in the first quarter of last year. However, it decreased compared to 12.4 billion won in the fourth quarter of last year, which is interpreted as a result of drug price cuts according to PVA at the end of last year. Since last November, the government has lowered the price of Stelara by 0.2-4.4% by content. 2nd-generation drugs such as Cosentyx, Tremfya, and Skyrizi, heating up competition to expand coverage. The second-generation products released following Stelara are fiercely competing as their sales have increased significantly. Tremfya, which Janssen launched as a successor to Stellara, saw a 43.4% increase in sales within a year. Sales increased from 5.8 billion won in the first quarter of last year to 8.4 billion won. Novartis Cosentyx increased by 13.3% from 7.5 billion won in the first quarter of last year to 8.5 billion won in the first quarter of this year. In particular, with the rapid growth of the competing product Tremfya, the gap between the two products narrowed from 1.7 billion won to 100 million won in one year. AbbVie's Skyrizi, which was the latest to enter the market, is seeing the steepest growth in sales. Skyrizi's sales in the first quarter of last year were 5.9 billion won, up 69.7% from 3.5 billion won in the first quarter of last year. AbbVie launched this product in the second quarter of 2020. Cosentyx, Trempier, and Skyrizi are scrambling to expand their ranges, foreseeing even fiercer competition in the future. For Cosentyx, the high-dose product, which was newly approved in November last year, was additionally applied as a benefit from last month. In addition to the existing 150mg dose, up to 300mg dose is applied as compensation, aiming to expand sales. Tremfya has been covered for palmar and plantar pustulosis since this month. Skyrizi's benefit was expanded in March. Previously, benefits were recognized only for psoriasis, but from March, benefits were applied to active and progressive psoriatic arthritis. Lilly Taltz saw a modest increase in sales from 1.8 billion won in the first quarter of last year to 2.4 billion won in the first quarter of this year.
- Company
- K-Bio appealed for its competitiveness in Bio USA
- by Hwang, Jin-joon Jun 08, 2023 05:33am
- Major domestic pharmaceutical bio companies participated in the '2023 Bio International Convention (Bio USA)', a global partnering event, and introduced their competitiveness. Samsung Biologics disclosed an advanced target operation time for Plant 5 and a plan to build an ADC-only production plant. Lotte Biologics has sought to win biopharmaceutical CMO contracts with major pharmaceutical bio companies at home and abroad. Celltrion's goal to participate in the event was to increase its brand value through strengthening partnering. We discovered partners and held discussions related to new drug development. Bridge Biotherapeutics, Onconic Therapeutics, Inventage Lab, Abion, Vigencell, and Genome & Company announced the competitiveness of their new drug development pipelines. According to the industry on the 7th, major domestic pharmaceutical bio companies participate in Bio USA and introduce their competitiveness. Bio USA was held in Boston, USA on the 5th (local time). It will be open until the 8th. BioUSA is a global event in the biofield held every year by the American Bio Association. About 15,000 biopharmaceutical companies will attend, display new technologies and biotechnology products, and hold business meetings. According to the American Bio Association, 289 major domestic pharmaceutical bio companies participated in Bio USA this year. Of these, 41 opened publicity booths. Samsung Biologics CEO John Rim announced that BioUSA would shorten the target operating period for Plant 5 from September 2025 to April of the same year. It is expected to advance construction by about a year compared to the 180,000-liter third plant of the same size. According to Samsung Biologics, the early operation of Plant 5 is a strategy to preemptively respond to growing CDMO demand. In addition, the fact that new contracts with customers and the volume of existing agreements are increasing also influenced the decision to operate early. Starting with the 5th factory's construction, the 2nd Bio Campus will begin in earnest. Additional production facilities and an open innovation center will be built on the 2nd Bio Campus. The total investment is 7.5 trillion won. CEO John Rim also announced that he would build a production facility exclusively for ADC biopharmaceuticals to participate in the ADC market, which has recently attracted attention. Considering the market growth potential, it plans to start production of ADC commercial products within 2024. Lotte Biologics promoted the Syracuse plant's manufacturing technology, process development service, and quality system. It also revealed plans to build a large-scale factory in Korea by 2030 by spending 3 trillion won. Lotte Biologics prepared a meeting table and a private meeting room inside the booth. We discuss partnering for biopharmaceutical CMOs with about 30 major domestic and foreign pharmaceutical companies and bio companies that have been coordinated in advance. Celltrion participated in Bio USA and set up a promotional booth. (Photo by Celltrion) Celltrion and other bio companies engaged in the development of new drugs have also started to discover partners and introduce pipelines. Celltrion promoted its technological competitiveness and brand to leap forward as a new drug development company. An open meeting space and a private meeting room were set up inside the booth to discuss business. Potential partners were also explored to discover new modalities and new drug candidates. In the future, discussions for joint development are also planned. An official from Bridge Biotherapeutics introduces their new drug pipeline. (Photo by Bridge Bio) Bridge Biotherapeutics presented its corporate competitiveness and pipeline to industry officials. Business Development Director Pavel Princeev introduced major clinical challenges in the field of lung cancer and fibrosis, which the company is strategically focusing on. The fourth-generation lung cancer drug candidate 'BBT-176' phase 1 clinical trial data and self-discovered BBT-207 were shared. Innovative diagnosis technology recently acquired was also disclosed. Onconic Therapeutics sought additional technology transfer for its major pipeline P-CAB-type gastroesophageal reflux disease drug candidate 'Zastaprazan'. In addition, it introduced follow-up pipelines such as 'OCN-201', a dual inhibitor target anti-cancer drug. We plan to discuss building partnerships with domestic and foreign pharmaceutical bio companies. Inventage Lab introduced pipelines 'IVL3001' and 'IVL3002' using the long-acting injectable platform technology 'IVL-Drug Fluidics'. Data on the Alzheimer's treatment candidate 'IVL3003', drug/alcohol addiction candidate 'IVL3004', and prostate cancer treatment candidates 'IVL3008' and 'IVL3016' were also announced. It also presented a blueprint to enter the lipid nanoparticle (LNP) CDMO business based on the gene therapy development platform technology 'IVL-Genefluidic'. Abion promoted the technology transfer of 'ABN401', a c-MET treatment for non-small cell lung cancer, which is undergoing global phase 2 clinical trials, and 'ABN501', a candidate material in the non-clinical stage. Participating in K-Bio Showcase, a side event of Bio USA, introduces the representative pipeline to global investors and industry officials. Genome & Company will unveil its microbiome immuno-oncology treatment pipeline. Through more than 20 meetings, it has started strengthening business partnerships with domestic and foreign pharmaceutical companies. We introduce the development status of GEN-001', a major pipeline, and new target immuno-anticancer drug candidates GENA-104 and GENA-111. In addition to technology transfer, meetings related to joint development will be held.
- Company
- Commercialization of 3rd new P-CAB drug near
- by Kim, Jin-Gu Jun 08, 2023 05:33am
- The launch of the third product is imminent in the P-CAB (potassium competitive acid blocker) class gastroesophageal reflux disease treatment market that has grown to post sales of KRW 140 billion a year. With Onconic Therapeutics, a new drug development subsidiary of Jeil Pharmaceutical, filing an application for the marketing authorization approval of Zastaprazan, competition between this drug and the existing K-Cab (tegoprazan) and Fexclue (fexuprazan) is expected to intensify from next year at the earliest, triggering a 3-way race. The industry predicts that competition for indications between the three drugs will intensify along with the approval of Zastaprazan. P-CAB market nears sales of KRW 150 billion a year... 3rd drug applies for approval According to the pharmaceutical industry on the 7th, Onconic Therapeutics submitted a new drug application (NDA) for Zastaprazan to the Ministry of Food and Drug Safety. The company predicts the product will be approved next year. Therefore, the competition between drugs in this class could develop into a three-way race with HK Inno.n’s K-Cab and Daewoong Pharmaceutical’s Fexclue from next year at the earliest, P-CAB drugs have been showing explosive growth n the gastroesophageal reflux disease treatment market. According to UBIST, a pharmaceutical market research institute, outpatient prescriptions of P-CAB drugs in Korea last year recorded KRW 144.9 billion. This market was formed when HK Inno.N released K-Cab in Q1 2019. K-Cab, which posed KRW 30.4 billion in prescriptions that year, surpassed the KRW 100 billion mark in 2021, just 2 years later. Last year, the market expanded further with the addition of Daewoong Pharmaceutical’s Fexclue. Daewoong Pharmaceutical released the product in Q3 last year and recorded KRW 12.9 billion in prescriptions in the half year. In Q1 this year, K-Cab recorded KRW 35.7 billion and Fexclue recorded KRW 10.8 billion, respectively. If this trend continues, the market will expand to exceed KRW 150 billion by the end of the year. Quarterly sales of K-Cab and Fexclue (Unit: KRW 100 million, Data: UBIST) The industry predicts the P-CAB- market to continue its growth for a while even after Onconic's new product is added to the market. The expectations are that Zastaprazan’s sales will grow not by stealing the market share of K-Cab or Fexclue, but by replacing existing PPI (Proton Pump Inhibitor) drugs. K-Cab showed a 15% increase in prescriptions compared to the previous year, despite the rapid growth of Fexclue in Q1 this year. On the other hand, most of the PPI drugs show slower sales performance. Hanmi Pharmaceutical’s Esomezol (S-omeprazole), a representative PPI-type drug, recorded KRW 15.4 in prescriptions, up 5% from the previous year, and Nexium (esomeprazole) recorded KRW 8.7 billion, up 4% from the previous year. This is in contrast to the double-digit growth the drugs had made every year until the introduction of P-CAB drugs. The analysis is that P-CAB drugs replace existing PPI drugs with advantages such as faster drug expression and intake independent of meals. Competition to expand indications intensify… Zastaprazan plans to add gastric ulcer indication after erosive esophagitis The pharmaceutical industry predicts that the 3 drugs, including Zastaprazan, to compete more fiercely to expand their indications. Onconic plans to first receive approval as a treatment for erosive gastroesophageal reflux disease and then add indications for gastric ulcers. Onconic started a Phase III trial for gastric ulcer patients in May last year. An official from Onconic Therapeutics explained, “Clinical trials are underway to add indications to Zastaprazan.” Major indication extensions plans of P-CAB class drugs Currently, K-Cab has 5 indications: ▲erosive gastroesophageal reflux disease ▲non-erosive gastroesophageal reflux disease ▲gastric ulcer ▲antibiotic combination therapy for eradication of Helicobacter pylori ▲maintenance therapy after treatment of erosive gastroesophageal reflux disease (25mg). In addition, Phase III trials are underway as a preventive treatment for non-steroidal anti-inflammatory drug-induced gastric and duodenal ulcers. After first receiving approval as a ‘treatment for erosive gastroesophageal reflux disease', Fexuclue added an indication for 'improvement of gastric mucosal lesions in acute/chronic gastritis (10mg)'. Daewoong plans to secure 3 more indications for Fexuclu in the future. Phase III trials are already underway for the drug’s use as a 'maintenance treatment after treatment of erosive gastroesophageal reflux disease' and 'prevention of non-steroidal anti-inflammatory drug-induced gastric ulcer.’ In addition, the company plans to enter into clinical trials related to the eradication of Helicobacter pylori.
