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- 2026-04-16 11:27:00
- Policy
- Kcab, compared clinical trial with Nexium
- by Lee, Tak-Sun Aug 07, 2020 06:27am
- HK inno.N's new domestic drug ‘Kcab’ is specifically compared with the reference drug, Nexium. The company said it will explore new indications through the trial. The MFDS approved IND of Phase I clinical trial to explore the pharmacokinetics, Pharmacodynamic properties and safety of Tegoprazan twice a day dosing regimen in healthy subjects' submitted by HK inno.N on the 31st of last month. 64 healthy adults participated in this clinical trial. It is interesting that the reference drug is Nexium injection. In clinical trials, Kcab is administered twice a day to compare the pharmacokinetic and pharmacodynamic properties of Nexium injections. Kcab is currently used in the market once a day. AstraZeneca Korea's Nexium injection is a product administered intravenously once a day, and is mainly used when oral method is not appropriate. .A company official said, "This trial is for exploring new indications." If so, it is presumed to be for the purpose of acquiring the indications possessed by Nexium through comparing the equivalence with Nexium .Accurate indications of Nexium are in the case of adult ▲when oral method is not appropriate, as an alternative to oral therapy, GERD with severe esophagitis or severe symptoms due to gastroesophageal reflux, ▲Prevention of rebleeding after endoscopic treatment of acute hemorrhagic gastric ulcer or duodenal ulcer .In addition, for children aged 1 to 18 years, ▲ when oral method is not appropriate, it is used as an alternative treatment with erosive reflux esophagitis or severe GERD .It is observed that Kcab are attempting clinical trials to obtain indications for 'prevention of rebleeding after endoscopic treatment of acute hemorrhagic gastric ulcer or duodenal ulcer' .K-Cap is currently providing indications including antibiotic therapy for the treatment of H .pylori in patients with peptic ulcer and/or chronic atrophic gastritis, ▲ treatment of erosive GERD, ▲ treatment of non-erosive GERD .Additional clinical trials for maintenance indications of patients with erosive GERD treatment confirmed through an endoscope and clinical trials to investigate the possibility of using NSAIDs in combination are also being conducted .Kcab (Tegoprazan) is a P-CAB (Potassium-Competitive Acid Blocker)-based drug that has a mechanism of reversibly blocking a proton pump that secretes gastric acid from the stomach wall .The industry analyzes that Kcab is leading the evolution of the P-CAB family by conducting clinical trials with PPI-based drugs such as Nexium as a reference drug .So far, PPI drugs have led the market in GERD related diseases .Meanwhile, Kcap has successfully increased sales by recording an outpatient’s prescription amount of ₩30.7 billion only in the first half of this year, based on UBIST .
- Company
- A big deal after various exchanges between companies
- by Lee, Seok-Jun Aug 07, 2020 06:27am
- Big Deal (License Out/LO) of the traditional pharmaceutical companies show that there have been various exchanges in the past. Looking at the recently established Hanmi and Yuhan’s technology transfer partners, it was because there were exchanges such as joint promotion in the past. It was that exchanges in the past led to exchanges between research institutes of both companies, and even technology transfer. Hanmi transferred NASH (non-alcoholic steatohepatitis) treatment, Efinopegdutide (HM12525A) to MSD USA at a scale of ₩1 trillion (down payment of ₩12 billion). It is an analysis that both companies' past ties were involved in the technology export contract. The relationship between Hanmi and MSD goes back to 2009. At the time, the two companies signed a contract to export the hypertensive treatment drug Amosartan to over 50 countries under the brand 'Cozaar XQ'. In 2016, the two companies signed Rosuzet's global export contracts in 23 countries, followed by Mexico this June. An official at a securities company said, “We know that Hanmi has been working with MSD for several years to naturally exchange with the research institutes. There are more and more cases where the reliability accumulated from small exchanges extends to technology transfer”. The 2015 large-scale technology transfer agreement between Hanmi and Sanofi is similar. In 2013, the two companies jointly developed a high blood pressure/hyperlipidemic drug, Rovelito. It covers everything from product development to launch and marketing. Although there has been a change in the relationship between the two companies, including Sanofi's return of rights, there is no disagreement that past exchanges had a positive effect on LO. Small exchanges among Yuhan and Beringer-Gilliard led to big deal Yuhan Corporation is a similar case. Yuhan exported the pre-clinical (animal) NASH therapeutic substances to Beringer Ingelheim in July last year for a total of ₩1 trillion ($870 million). It is a scale that competes for the level among the pre-clinical license agreements in the domestic pharmaceutical industry. The contract amount is $40 million (about ₩45 billion). In 2010, Yuhan entered into a co-promotional agreement with Behringer’s Twynsta, since then, additional treatments for diabetes treatment drugs, Trajenta and Jardiance, are underway. In the early stages, partnerships were expanded as the performance of early joint sale items improved. The relationship between the two companies led to exchanges between research institutes. Based on the confidentiality agreement, they are sharing their research content with each other. In this process, in this process, it is known that exchanges with Yuhan's NASH treatment have also occurred. This is the same as the big deal between Yuhan and Gilead that occurred in January of the same year. Yuhan transferred another NASH therapeutic substance to Gilead Sciences at the time of US$785 million (₩882.3 billion). The down payment is $15 million (about ₩16.8 billion). This case was conducted in the phase of candidate substance discovery. It turns out that it was impossible without the exchange between the two companies. In 2012, Yuhan signed a co-promotional contract with Gilead's hepatitis B treatment drug, 'Viread'. Since 2017, it has been jointly selling various items such as hepatitis C treatment 'Sovaldi' and 'Harvoni', and HIV/AIDS treatment 'Stribild' and 'Genvoya'.
- Boryung eyes KRW 60 bln multiple myeloma drug market
- by Lee, Tak-Sun Aug 07, 2020 06:27am
- Boryung Pharmaceutical HQ in Jongno Boryung Pharmaceutical is taking bold actions to expand its share in the South Korea’s multiple myeloma treatment market valued at 60 billion won. After signing a deal to supply a new drug in the Korean pharmaceutical market, the company is now challenging the original Pomalyst’s patent for the first time in Korea. According to the industry sources on Aug. 5, Boryung Pharmaceutical filed a request for a negative confirmation of scope in Pomalyst capsule on July 31 to evade the original’s pharmaceutical substance patent. Pomalyst, a product by Celgene, is currently dominating the biggest pie in the multiple myeloma treatment market. It was approved for sales in 2014, and received reimbursement from 2017 as a third-line therapy. The drug is indicated to treat patients, who failed with the first-line treatment, Janssen’s Velcade, and show no response to the second-line treatment, Revlimid (lenalidomide). Revlimid is also developed and supplied by Celgene. Boryung Pharmaceutical owns Velkin injection containing bortezomib. The injection was approved for the market in November 2015. In October of the following year, Boryung Pharmaceutical inked an agreement with a Spanish-based pharmaceutical company PharmaMar to supply their multiple myeloma treatment Aplidin (plitidepsin) to Korea. The medication attracted attention recently with its benefit of preventing COVID-19 infection. For the market approval in Korea, Boryung Pharmaceutical has submitted Aplidin’s Phase I trial protocol to Ministry of Food and Drug Safety (MFDS). The Korean company seems to have challenged the Pomalyst patent to prepare development of follow-on drugs. If the court accepts the negative confirmation of the patent scope, Boryung Pharmaceutical would be able to release three products in the multiple myeloma treatment market. Boryung Pharmaceutical is a rare gem in the Korean pharmaceutical industry with strengths in anticancer treatments. It owns originals like Gemzar and Xeloda, and it also supplies the number one follow-on drug Genexol. The industry is paying a close attention to the company on its path to secure a strong income source by strengthening the anticancer business with a variety of multiple myeloma treatments.
- Policy
- SNUH participates in COVID-19 trials using Rebif
- by Lee, Tak-Sun Aug 07, 2020 06:27am
- Seoul National University Hospital participates in a multinational clinical trial using 'Rebif' (Interferon Beta-1A, Merck), which has recently been cited as a candidate for COVID-19 treatment. Rebif is a pre-filled injection that is also approved in Korea. It is used for multiple sclerosis, and has recently been mentioned as a candidate for COVID-19 treatment in Europe. The MFDS approved a multinational sponsor-investigator trials plan for 'multi-center, randomized, double-blind, placebo-controlled study on the safety and effectiveness of new drugs for COVID-19' submitted by Seoul National University Hospital on the 4th. This clinical trial explores the effectiveness of a combination of Remdesivir and Interferon Beta-1A in admitted patients due to COVID-19. There are 1,038 test subjects worldwide, and 100 will participate in Korea. Clinical trials are conducted at Seoul National University Hospital and Bundang Seoul National University Hospital. This is the first clinical approval of COVID-19 using Rebif in Korea.
- Company
- SGLT-2 inhibitors growth surge by 30% in antidiabetic market
- by An, Kyung-Jin Aug 07, 2020 06:26am
- (Clockwise from left) Product image of Forxiga, Jardiance, Steglatro and Suglat In the South Korean oral antidiabetic drug market, the influence of sodium-glucose cotransporter-2 (SGLT2) inhibitors has expanded even further. The outpatient prescription sales in the medicine broke through the 50-million-won point as the single drug prescription is constantly growing and combination therapies have been effective. AstraZeneca and Boehringer Ingelheim, both owning SGLT-2 inhibitor single drug and combination drug, are strongly leading with 95 percent of the market. According to a pharmaceutical market research firm UBIST on July 31, six SGLT-2 inhibitor single drugs and combination drugs have raised 57.4 billion won in the first half of the year from outpatient prescription, surging 30.8 percent from last year same time at 43.9 billion won. Also compared to the first half of 2018 making 32.2 billion won, this year’s prescription sales soared by 78.2 percent. The antidiabetic medicine SGLT-2 inhibitor hinders reabsorption of blood glucose in kidney and induces excretion of the unused glucose through urine, which eventually lowers the glucose level in the blood. Unlike dipeptidyl peptidase 4 (DPP-4) inhibitors, the SGLT-2 inhibitors do not rely on insulin nor get affected by insulin resistance. Also the users have been positive about the medicine’s clinical evidence of weight loss effect and benefit in cardiovascular system. AstraZeneca and Boehringer Ingelheim have launched SGLT-2 inhibitor combination drugs following their single drug line-ups and started expanding the SGLT-2 inhibitor prescription. In the first half of the year, AstraZeneca’s Forxiga (dapagliflozin) generated 17.6 billion won in outpatient prescription and grew by 10.1 percent from last year. After signing a partnership deal with CJ Healthcare in September 2014, AstraZeneca released the first SGLT-2 inhibitor Forxiga in the Korean market. The new drug kept the leadership in SGLT-2 inhibitor market for six consecutive years since then. AstraZeneca is now claiming more of the market influence by becoming the first company to release SGLT-2 inhibitor plus metformin combination drug Xigduo. The combination therapy has raised 13.4 billion won in the first half of the year, which was 42.5 percent higher than last year. Monthly outpatient prescription volume of major SGLT-2 inhibitor drugs (Unit: KRW 1 million) Source: UBIST From 2018, AstraZeneca has started co-marketing Forxiga and Xigduo with a Korean partner Daewoong Pharmaceutical. The two drugs together have generated 31 billion won, taking up 54.0 percent of the market share. The research firm evaluated the global company’s early move and the Korean company’s sales forces have created a synergy effect. Boehringer Ingelheim’s Jardiance (empagliflozin) is the first SGLT-2 inhibitor to prove the benefit in cardiovascular system through EMPA-REG OUTCOME data and it is tailgating its biggest competitor closely. In the first half of the year, Boehringer Ingelheim’s Jardiance has made 16.8 billion won in outpatient prescription. With the growth of 66.7 percent from last year, the gap between the drug and the market leader Forxiga was narrowed down to 800 million won. A metformin combination drug Jardiance Duo have increased this year’s prescription volume by 150.6 percent from last year and generated 6.8 billion won. Boehringer Ingelheim’s Jardiance and Jardiance Duo have jointly made 23.6 billion won in the first half of the year and claimed 41.4 percent of the market. Considering AstraZeneca and Boehringer Ingelheim respectively took 68.0 percent and 27.6 percent of the SGLT-2 inhibitor prescription market, Boehringer Ingelheim’s market influence has surged immensely in a year. Currently, Boehringer Ingelheim’s Jardiance and Jardiance Duo are co-marketed under the joint partnership with Lilly Korea and Yuhan. Outpatient prescription market share of key SGLT-2 inhibitor products in the first half of the year (Source: UBIST) Astellas Pharma and MSD’s SGLT-2 inhibitor single drugs have shown a growth in prescription, but their market shares are still comparatively underwhelming. Astellas Pharma’s Suglat (ipragliflozin) has raised 1.6 billion won in the first half of the year with a growth of 16.7 percent from last year, but its market share is only at 2.8 percent. The company signed a co-marketing deal with Handok in April 2018 for the Korean company to be in charge of distribution, marketing and sales in Korea. MSD jumped into the SGLT-2 inhibitor market in late 2018 with Steglatro (ertugliflozin), but it has not been prominent. The drug made 1.1 billion won in the first half of the year. Compared to last year, the figure doubled but it only has the smallest 2.0-percent pie in the prescription market. Prior to the launch of Steglatro, MSD signed a co-marketing deal with Chong Kun Dang, which they have already formed a partnership over Januvia (sitagliptin). Although MSD and Chong Kun Dang together have made Januvia the number one DPP-4 inhibitor, Steglatro could not break away from the handicap of joining the competition late.
- Policy
- Generics was applied in 7 years after Pelrubi’s PMS ended
- by Lee, Tak-Sun Aug 07, 2020 06:26am
- #The application for generic for Pelubi was received 7 years after the PMS of the original drug was terminated. There have been reasons for not being able to apply because of patents, but it is an analysis that Pelubi's popularity in the market lately has influenced the generic development of pharmaceutical companies. According to the MFDS, on the 29th of last month, Pelubiprofen 30 mg, generic for Pelrubi, applied for permission. However, the generic missed the original indication for antipyretic effect. Pelrubi is also used for the fever of acute upper gastritis along with osteoarthritis, rheumatoid arthritis, and low back pain. However, this generic drug has submitted an application for permission only for osteoarthritis, rheumatoid arthritis, and low back pain (back pain) indications. This is because the PMS of acute upper gastritis indication is ending on September 18, 2021. Before obtaining an antipyretic indication, Pelrubi's PMS expired on April 19, 2013. Therefore, the application for generic permission was made 7 years after the PMS was terminated. Generic drugs are developed at the end of PMS, so it is unusual for Pelrubi’s generic. This is also believed to have influenced that the new drug Pelrubi's prior patent expires in November 2028. Generic companies have been challenging patents since the end of last year. Starting with Yungjin, Mothers Pharm, Hutecs Korea, Huons, Nexpharm, and Chong Kun Dang have filed for a trial to confirm passive scope of rights to avoid patents. At the same time, generic development was also underway. Starting with Mothers Pharm in March, Huons, Yungjin, Nexpharm, and Hutecs Korea have been approved for bioequivalence tests. The key to future success is patent challenge with the recent applications for generic drugs, This is because it is possible to release the product even if the item is approved only by winning the patent evasion judgment. Pelrubi is a large-scale domestic drug with a record of ₩28.9 billion in outpatient prescriptions based on UBIST last year. After the approval in 2008, the indications were expanded through additional clinical trials, and In 8 years, 2017, sales exceeded ₩10 billion. The reason for the delayed development of the generics is that Pelrubi's sales rose late, so the generic companies began to take an interest in it later.
- Company
- Hanmi signed a technology transfer of ₩1 trillion
- by Lee, Seok-Jun Aug 07, 2020 06:26am
- Hanmi signed a technology transfer agreement of ₩1 trillion ($860 million). The down payment is $10 million (₩12 billion), and the other side is MSD, a global US pharmaceutical company. Hanmi announced on the 4th that it has signed a license agreement with MSD to develop, manufacture and commercialize the biomedicine candidate 'LAPSGLP/Glucagon receptor dual agonist' as a therapeutic agent for NASH (non-alcoholic steatohepatitis). The generic name (INN) of 'LAPSGLP/Glucagon Receptor Dual Agonist' is 'Efinopegdutide' and the code name is HM12525A. The LAPSGLP/Glucagon receptor dual agonist is a dual-acting treatment that simultaneously activates GLP-1, which helps insulin secretion and appetite suppression, and Glucagon, which increases energy metabolism. Hanmi's LAPSCOVERY technology, which is based on drug efficacy, is applied. With this agreement, MSD will secure exclusive rights to the development, manufacture and commercialization of the 'LAPSGLP/Glucagon Receptor Dual Agonist' worldwide, excluding Korea. Hanmi will receive a confirmed deposit of $10 million and up to $860 million in milestones for clinical development, licensing, and commercialization by phase from MSD. After the product launch, it will receive a double-digit percent sales royalty.
- Company
- Belgium approved Expanded access of Remimazolam
- by Lee, Seok-Jun Aug 07, 2020 06:26am
- Hana Pharm announced on the 4th that the new drug anesthetic drug 'Remimazolam' was approved by the Federal Agency for Medicines and Health Products of Belgium for sympathetic use for COVID-19 critically ill patients. In recent years, the supply shortage of Propofol and Midazolam for the treatment of critically ill patients with COVID-19 has increased, and Remimazolam is being used to replace it. Expanded access is a system that permits the use of drugs that are under development or have not yet been approved for sale when there is no adequate therapy for a life-threatening and prolonged or severe illness. Remimazolam is currently licensed in Japan, the United States, and China. It was approved as an indication for 'induction and maintenance of general anesthesia' in Japan, and 'sedation under consciousness during surgery and diagnosis' in July. The original developer is Piaon of Germany, and Hana Pharm holds all rights in six countries in Korea and Southeast Asia. Approval is also expected in Korea and Europe.
- Policy
- Pricing settled Prevymis to get listed in Aug. at earliest
- by Kim, Jung-Ju Aug 07, 2020 06:25am
- The MSD Korea’s new drug Prevymis (letermovir) settled on a pricing negotiation with the South Korean health authority and successfully passed the biggest hurdle of the path to healthcare benefit. The novel drug helps to prevent cytomegalovirus (CMV) infection in patients who have received an allogeneic hematopoietic stem cell transplant (HSCT). The prescription drug would be listed for the pharmaceutical reimbursement within this month at earliest after the final reviewer Ministry of Health and Welfare’s (MOHW) Health Insurance Policy Deliberation Committee approves it. Ministry of Food and Drug Safety (MFDS) has indicated the drug ‘to prevent CMV infection and diseases in adult patients who have received HSCT.’ According to National Health Insurance Service (NHIS) on Aug. 3, all four items under the brand—240 mg and 480 mg doses of Prevymis tablets and injections—have concluded the pricing negotiation. In the U.S., the medication has been designated as a breakthrough therapy, priority review drug and fast-track drug and received an approval by the U.S. health authority. After it was green lit for the Korean market by MFDS on Dec. 26, 2018, Prevymis started the pricing negotiation with NHIS immediately following the clearance for reimbursement by Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC). The allogeneic HSCT is essential to completely cure severe blood cancers like acute myeloid leukemia (AML) and acute lymphocytic leukemia. Accordingly, both the patients and healthcare professionals have been constantly demanding for the healthcare reimbursement on the drug. The pharmaceutical company insider said, “The company was actively engaging in the negotiation with the utmost care to meet the high expectation of healthcare providers and patients waiting for the benefits of Prevymis preventing infection and improving overall survival of patients receiving allogeneic HSCT.” The insider added, “We expect to receive the reimbursement soon when HIPDC deliberates and notifies the result. And we would do our best to promptly bring the innovative, CMV infection and disease-preventing Prevymis to the patients who had HSCT.
- Company
- AstraZeneca’s love for Korea expressed through investment
- by Lee, Seok-Jun Aug 05, 2020 06:26am
- A British-based multinational pharmaceutical company AstraZeneca is expanding its investment in the South Korean pharmaceutical industry. Recently, the company inked a deal with SK Bioscience on supplying COVID-19 vaccine as it saw the promising potential of the Korean industry. AstraZeneca’s investment on the Korean pharmaceutical industry has continued for years. The company had various instances recently, where it delivered the promise of investment made years ago and made new partnership with the Korean industry. Among all global pharmaceutical companies operating in Korea, the British company is considered one of the most active investor of the Korean pharmaceutical industry. The Korea Health Industry Development Institute (KHIDI) and AstraZeneca Korea announced yesterday that the seventh Anticancer Research Support Program has selected four new open innovation research plans. The long-term project has selected overall 28 research topics so far, or four cases annually for last seven years since 2014. The anticancer research support program is an event the KHIDI and AstraZeneca Korea jointly organize to provide support on promising basic science research topics related to preclinical test or translational research to expand open innovation in Korean healthcare industry and strengthen Korea’s pharmaceutical industry competitiveness. And on July 21, the global company signed a partnership agreement on the internationally most sought after COVID-19 vaccine. AstraZeneca, SK Bioscience and Ministry of Health and Welfare (MOHW) have agreed to collaborate on globally supplying AstraZeneca’s COVID-19 vaccine in development (ADZ1222). AZD1222 is the first one to enter the Phase III clinical trial among all COVID-19 vaccines in development. According to the agreement, SK Bioscience would be one of global partners to serve a role of a CMO manufacturing drug substance and processing ‘fill and finish’ of the vaccine. The ministry would expedite the both companies complying the agreement and lead the discussion on procuring the vaccine in Korea. Years of investment promises delivered The AZD1222 partnership is actually a follow-up action of the MOU signed in December last year aimed to collaborate in enhancing the Korean biohealth industry development. The company kept its word on the six-month-old promise. Last year, AstraZeneca signed MOU with four partners including Korea Trade-Investment Promotion Agency (KOTRA), KHIDI, Korea Biotechnology Industry Organization (KoreaBio) and Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA). These MOUs were products of five years of investment and collaboration plans made in June 2016. The symposium on accelerating big data and AI-based new drug development convened by AstraZeneca and the British Embassy Seoul in July 2019, and a conference on supporting Korean bio companies entering the Chinese market organized by AstraZeneca and Korea Biomedicine Industry Association (KoBIA) in September 2019 were also part of the 2016 investment plan. Another major collaboration between the global company and Korean industry took place in January 2018. AstraZeneca and SK Biotek signed a partnership deal in pharmaceutical manufacturing and production. And as a result, antidiabetic drugs manufactured by the Korean company were supplied to three million diabetic patients in 98 countries around the world. The industry insider commented, “AstraZeneca has already made multiple investment deals with Korean companies like the COVID-19 vaccine. It’s one of a very few global companies considers Korean pharmaceutical and bio industry as their partner.”
