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- 2025-12-24 13:49:19
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- KPBMA visits Boston...expands exchanges with MIT, etc.
- by Chon, Seung-Hyun Nov 18, 2022 06:04am
- On the 14th (local time) KPBMA Director Hee-Mok Won (8th from the left), Huons Vice Chairman Sung-Tae Yoon (9th from the left), MIT Corporate Relations Executive Director John Roberts is taking a commemorative photograph at the EB that was held at MIT ILP Office at Boston, Cambridge, US On the 17th, Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) announced that its delegation had visited Boston, US to network with local companies and institutions. Hee-Mok Won, Director of KPBMA, Sung-Tae Yoon, Chairman of KPBMA, and other representatives of Korea’s pharmaceutical and bio business attended the executive briefing (EB) prepared through MIT Industrial Liaison Program (ILP) especially for Korean companies for 4 days from the 14th. In June 2020, KPBMA became the first association to join the consortium-type membership in the history of MIT ILP. The EB held this time was the first face-to-face event since the KPBMA became a member, and was held to directly communicate with MIT’s innovation ecosystem. At the event, member companies in the consortium discussed research technologies face-to-face with MIT's top professors in the field of their interest, such as oncology and new drug development. Also at the event, Professor Connor W. Coley from MIT presented on the development of AI-based organic compound synthesis. Also, Professor Arturo Vegas from Boston University and Sean Quinnell presented pm a small molecule inhibitor to the cytokine interleukin-4 related to inflammation and cancer. Then, presentations from MIT spin-off companies followed, including presentations on ▲Small molecule new drug development platform (Deepcure), ▲Innovative treatment methods for resting cancer cells (Felicitex Therapeutics), ▲ Effective drug delivery technology using high molecule dissociation oral administration (Veramorph), ▲Groundbreaking blood clotting diagnostics platform (Coagulo Medical Technologies). Heads and Business Development and R&D executives from Korean pharmaceutical and bio companies including Samjin Pharm, Yuhan Corp, Ildong Pharmaceutical Hanmi Pharmaceutical, and Huons sought partnership opportunities with startups that own advanced biotechnology in addition to MIT’s various academic achievements. After the event, the delegation visited Ginkgo Bioworks, a world-class biofoundry company, to discuss ways to cooperate with domestic companies. Ginko Bioworks, a bioventure that spun off from MIT in 2008, owns its own cell programming platform and provides services that meet the needs of customers in various industries. KPBMA Director Hee-Mok Won said, “In only three years since Korean pharmaceutical companies entered the Cambridge Innovation Center (CIC) and began industry-academia cooperation with MIT in earnest, more than 15 companies have entered the market. We will expand cooperation with Boston’s innovative ecosystem including MIT and new startups to bring practical results.”
- Company
- Generic companies won 9 out of 10 patent disputes
- by Kim, Jin-Gu Nov 17, 2022 05:54am
- In a patent dispute between the original company and the generic company over generic for exclusivity, a study found that the generic company's first trial winning rate reached 88.5%. Lee Myung-hee, a senior researcher at the KIIP, announced the results of the impact assessment of the licensing patent-linked system at the 2022 Pharmaceutical Intellectual Property Policy Forum co-hosted by the Ministry of Food and Drug Safety and the Korea Intellectual Property Protection Agency on the 15th. According to the researcher, a total of 1,087 patent trials have been filed over the nine years since 2013 until the end of last year. Generic companies have a winning rate of 88.5%. Generic companies claim the patent held by the original company in three ways. They include a passive judgment for confirming the scope of rights, a judgment for invalidation, and a judgment for invalidation of the extension of the duration. Among them, the passive judgment on the scope of rights has the highest winning rate for Generic companies. Since 2013, 795 passive rights scope confirmation trials have been filed, of which 767 (96.5%) have been cited. Some citations include 19 cases (2.4%), 8 cases (1.0%), and 1 case of withdrawal. If Generic companies request a passive judgment on the scope of rights, 98.9% of them were cited or partially used. In the case of invalidation trials, the winning rate of General Motors is a little low at 78.9%. A total of 218 invalidation trials were filed over the nine years from 2013 to last year, of which 161 (73.9%) were cited and 13 (6.0%) were partially cited. The winning rate of generic companies, which combines citation and partial citation, is 79.8%. The Korean Intellectual Property Tribunal's rejection (24 cases), partial dismissal (13 cases), and withdrawal (7 cases) were 20.2%. In other words, if General Electric filed for invalidation judgment, the original company succeeded in one out of five cases. Generics have not won the trial that was filed to invalidate some of the extended patent duration. There were a total of 74 trials for invalidation of the extension of the patent duration from 2013 to last year. Among them, only two cases (2.7%) were cited. There were 68 cases of rejection (91.9%), and 4 cases of withdrawal (5.4%). This means that most of the original companies won the dispute over the extended patent duration. Lee Myung-hee, a senior researcher, said, "The Ministry of Food and Drug Safety's approval rate for generic exclusivity sales items is 79.2%, which can be interpreted as meaning that generics are taking on patent challenges with considerable grounds."
- Company
- Announcement of commercialization of oral insulin
- by Eo, Yun-Ho Nov 17, 2022 05:54am
- Expectations are rising for PO use for injectable insulin. Medicox recently signed an exclusive distribution contract with Israeli pharmaceutical company Oramed Pharmaceuticals following the introduction of oral insulin technology. As a result, Medicox will be able to distribute Oramed's oral insulin candidate "ORMD-0801" for 10 years in Korea after approval by the Ministry of Food and Drug Safety. Oramed is said to be innovating the diabetes treatment market through the development of ORMD-0801, which is undergoing phase 3. Topline results of Phase 3 will be released in January 2023, and ORMD-0801 is expected to be the world's first commercial oral insulin capsule for diabetes treatment in the future. SCD Pharmaceutical, a domestic pharmaceutical company, is also developing oral insulin. The company is currently preparing an IND application for oral insulin SCD-0503. This clinical review period takes at least six months, but the clinical review period can be shortened through the submission of data from previous studies. It will be possible to consult with the Ministry of Food and Drug Safety in major countries to simplify the clinical trial period and conditions. In addition, based on the results of previous studies, it is possible to advantageously adjust the contract terms with partners. SCD conducted prior research for the purpose of final verification of global clinical, registration, and commercialization at the request of partners in the United States, Europe, China, and Japan. The company explained that SCD-0503 showed faster drug expression time and higher absorption rate than Israel Oramed at Human Pilot Study. Insulin PO is delivered to the liver through the intestinal absorption process. It is evaluated that insulin can prevent hypoglycemia and help control weight with a principle similar to that of going from the pancreas to the liver.
- Company
- The aftermath of stricter generic regulations?
- by Kim, Jin-Gu Nov 16, 2022 06:11am
- It was found that the number of applications for generic for exclusivity decreased sharply. Experts agree that the implementation of the 1+3 system has affected the decrease in the number of generic for exclusivity applications. Lee Myung-hee, a senior researcher at KIIP, introduced the number of generic for exclusivity applications in 2020 and 2021 at the 2022 Pharmaceutical Intellectual Property Policy Forum held on the 15th. According to him, the number of generic for exclusivity, which reached 272 in 2020, plunged to 26 in 2021. The implementation of the 1+3 system is likely to be the reason for the sharp drop in the number of applications for generic for exclusivity. Lee Myung-hee said, "The 1+3 system has been in effect since July 2021. The number of generic for exclusivity applications has decreased significantly compared to the previous year, he said. "We need to accumulate more data to see if it is the result of the implementation of the system, but we believe that the implementation of the system has affected the decline in a number of generic for exclusion applications." Until now, the pharmaceutical industry has consistently pointed out that the effectiveness of the system is poor due to the acquisition of generic for exclusivity. It was criticized that it did not fit the purpose of introducing the system to induce patent challenges by granting exclusive sales rights. In the case of Jardiance Duo, 99 generics obtained generic for exclusivity. 45 generics for Amosartan, and 33 generics for Janumet won generics. Lawyer Lee & Ko, an example, pointed out, "As many generics acquire generic for exclusivity at the same time, pharmaceutical companies have repeatedly challenged patents due to economic losses due to non-acquisition rather than economic benefits from acquiring generic for exclusivity." A lawyer said, "Since the 1+3 system was implemented in July 2021, BA test data have not been available indefinitely," adding, "As a result, the number of applications for generic for exclusivity seems to have decreased sharply. "In 2022, the acquisition of generic for exclusivity is expected to decrease further," he said. "However, as the effectiveness of the generic for exclusivity increases, it is necessary to examine whether the 1+3 system hinders generic development or hinders generic companies' patent challenges," a lawyer stressed. Attorney Kim Ji-hee said, "A close analysis is needed to see if the implementation of the 1+3 system has actually affected the reduction of generic for exclusivity."
- Company
- Gavreto applies for reimbursement following Retevmo
- by Eo, Yun-Ho Nov 16, 2022 06:10am
- In line with the progress made in Retevmo’s reimbursement review process, its competitor Gavreto was also found to have started its reimbursement process in Korea. According to industry sources, Roche Korea submitted an application for the reimbursement of its RET (Rearranged during transfection) gene fusion targeted therapy Gavreto (pralsetinib). With the reimbursement agenda for Lilly Korea’s Retevmo (selpercatinib) passing the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee (CDDC) meeting earlier this month, the industry’s eyes are on the reimbursement progress of the two drugs. At the meeting, the CDDC set reimbursement standards for Retevmo as a treatment for patients with metastatic RET fusion-positive non-small-cell lung cancer, thyroid cancer who require systemic therapy with prior sorafenib and/or lenvatinib treatment history, etc. Although Gavreto was slightly behind in applying for reimbursement, as both are advanced new drugs that target a very small number of patients, there lies the possibility that the government will discuss the reimbursement listing of the two drugs together. The two RET-targeted anticancer drugs may also benefit from HIRA’s plan to reduce the reimbursement listing period of drugs by 30 days used for life-threatening diseases, depending on the specific timing of its implementation. Meanwhile, Retevmo and Gavreto were both granted marketing authorization by the Ministry of Food and Drug Safety in March this year. As the two drugs not only inhibit primary RET fusions and mutations but also secondary RET mutations that cause resistance to anticancer treatment, the drugs are expected to address the unmet needs that remain in various types of cancers. In terms of the approval period, Retevmo became the first to receive global approval by a few months. Retevmo received marketing authorization from the US FDA in May last year, and Gavreto in September. Retevmo was approved for NSCLC and thyroid cancer indications, whereas Gavreto was first approved as a lung cancer treatment and then approved for thyroid cancer in December of the same year.
- Company
- Impinzi's indication of biliary tract cancer
- by Nov 16, 2022 06:10am
- AstraZeneca Korea announced on the 14th that its immune anticancer drug "Imfinzi" has received additional approval from the Ministry of Food and Drug Safety for biliary tract cancer. Imfinzi can be used as a combination therapy with Gemcitabine and Cisplatin in the primary treatment of patients with locally advanced or metastatic biliary tract cancer. It is the first indication of the first treatment of biliary tract cancer. The approval of this additional indication was based on a phase 3 TOPAZ-1 study that evaluated the effectiveness of lymphoid combination therapy compared to existing chemotherapy (Gemcitabine and Cisplatin) in 685 patients with local progressive or metastatic biliary tract cancer who have no treatment experience and cannot be resected through surgery. The first evaluation variable is the overall survival rate (OS), and the second evaluation variable is the progression-free survival rate (PFS), the objective response rate (ORR), the response duration (DoR), and the patient report results. As a result of the study, Imfinzi group improved the overall survival rate by 20% compared to the placebo group. At the time of two years, the survival rate of the impingement group was 24.9%, and the placebo group was 10.4%. The median PFS value was 7.2 months for Impinzi, which was 25% better than 5.7 months for the placebo group. The ORR of Imfinzi group was 26.7% (91 cases), of which 2.1% (7 cases) was confirmed to be complete, and partial reactions were observed in 24.6% (84 cases). The most common abnormalities were anemia (48.2%), zone (40.22%), constipation (32%), and neutrophil reduction (31.7%), and the Impinzi group (75.7%) and the placebo group (77.8%) were similar. In a recently confirmed additional analysis, Imfinzi group confirmed the overall survival rate, which improved to 24% compared to the placebo group. The total survival rate at the time of two years was also consistently 23.6% and 11.5% in the impingement group and the placebo group, respectively. Based on these findings, the NCCN recommends Imfinzi as the standard treatment (Category 1) in the primary treatment for local progressive or metastatic biliary tract cancer. "Biliary cancer is cancer with a poor prognosis, with no clear symptoms and a recurrence rate of 60-70%, and Korea has a relatively high incidence of biliary tract cancer in the world," said Oh Do-yeon, a general researcher at TOPAZ-1 at Seoul National University Hospital.
- Company
- Tecentriq approved as adjuvant treatment for NSCLC
- by Nov 15, 2022 05:38am
- On the 14th, Roche Korea announced that its anti-PD-L1 immuno-oncology drug Tecentriq (atezolizumab) was approved as adjuvant therapy following resection in patients with early-stage non-small-cell-lung cancer, and became the first immunotherapy to receive approval for the indication. Tecentriq may now be used as an adjuvant treatment following complete resection and platinum-based chemotherapy in adult patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher on tumor cells (TC). With this approval, Tecentriq became the first cancer immunotherapy to be approved as adjuvant therapy in early-stage NSCLC in Korea. The indication extension was approved based on findings from an interim analysis of Phase 3 IMpower010 trial. Tecentriq was found to result in a 57% reduction in the risk of disease recurrence or death compared with best supportive care (BSC) in patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher Also, the disease-free survival (DFS) benefit derived with adjuvant Tecentriq over BSC was consistently observed across most of the subgroups analyzed on the trial, including histology and disease stage. The overall survival (OS) data remain immature for this population, but a trend toward improved survival with atezolizumab over BSC was observed with a stratified HR of 0.43. The median OS and subgroup analysis results at 46 months showed that Tecentriq reduced the risk of disease recurrence or death 57% compared with best supportive care (BSC) in subject patients. The safety profile of Tecentriq was consistent with what has previously been observed with the Tecentriq monotherapy, and no new safety signals were observed. Grade 3-4 adverse effects (AEs) that were most frequently reported in the Tecentriq arm were increased ALT (2%), pneumonia (1%), and increased AST. Based on the data, the U.S. National Comprehensive Cancer Network (NCCN) guideline recommends Tecentriq as adjuvant therapy (Category 2), and the American Society of Clinical Oncology (ASCO) also recommends Tecentriq as adjuvant therapy in its guideline for adjuvant therapy in early-stage lung cancer patients. Sang-We Kim, Professor of Oncology at Asan Medical Center, said, “Around half of NSCLC patients experience recurrence after surgery, some of which at an untreatable state. With immuno-oncology drugs that had been mainly prescribed in metastatic NSCLC now available for use in the early stages of the disease, NSCLC patients in Korea that have a high rate of PD-L1 expression can have the opportunity to reduce their chance of recurrence after surgery and chemotherapy.”
- Company
- CR of AML new drug candidates is identified in Phase 1/2
- by Kim, Jin-Gu Nov 15, 2022 05:38am
- Hanmi Pharmaceutical announced on the 14th that it has confirmed cases of complete response (CR) in various dose groups as a result of phase 1/2 clinical trials of Tuspetinib (HM43239), which is being developed as an AML treatment. Aptose was recently introduced at the KOL webinar, "As a result of the global phase 1/2 for patients with recurrent or refractory acute myeloid leukemia, we confirmed CR cases in all of the various doses (80 mg, 120 mg, 160 mg) of HM43239." Aptose will present details of the study at the 64th ASH in New Orleans, the U.S., from the 10th to the 13th of next month. HM43239 is an oral MKI administered once a day that targets major kinases acting in myelogenous malignant tumors. It was designated as a fast-track development drug by the FDA in May. In 2018, it was also designated as a rare drug. According to the successful results of this clinical trial, Aptose plans to expand clinical trials with single-administration therapy and combination-administration therapy in the future. In the extended clinical trial of single administration therapy, the efficacy of HM43239 120mg will be confirmed in the AML patient group, including patients with FLT3 mutations who do not respond to existing FLT3 inhibitors. In addition, it plans to conduct a combined clinical trial with HM4323980mg and Venetoclax, an existing AML treatment.
- Company
- Merck KGaA has appointed Christoph Hamann
- by Nov 15, 2022 05:38am
- Christoph Hamann, General ManagerMerck Biopharma Korea announced on the 10th that it has appointed Christoph Hamann as the new general representative of its business unit. Harman served as general manager of Merck Biopharma in Malaysia, Singapore, and Brunei, and as Managing Director in Malaysia. Since joining Merck in 2009, he has built various careers through strategic and commercial work in major markets such as Germany, Switzerland, and the United States. In particular, he showed excellent performance as an infertile franchise leader in Europe and vice president of global business development, playing an important role in business development and management at the global and national levels. Including this inauguration in Korea, it will have business experience in a total of seven countries. General Manager Harman majored in economics at the University of Virginia in the United States, and before joining Merck, he spent nine years in investment banking and consulting. "We expect that Korea Merck Biopharma's leadership in the special care sector will be further strengthened by Christian Hamann, a general manager with about 22 years of experience and expertise in various industries, including pharmaceuticals," said the Merck Biopharma division said.
- Company
- Adding AUS as a drug price reference country raise concerns
- by Nho, Byung Chul Nov 14, 2022 06:07am
- The health authorities are known to be considering including Canada and Australia as reference countries for drug pricing reevaluations. Currently, the Ministry of Health and Welfare, Health Insurance Review and Assessment Service, and the National Health Insurance Service refer to drug prices of G7 countries - US, UK, Germany, Switzerland, Italy, France, and Japan – for evaluations and assessments. Adding the two countries, which are considered to be those with the lowest drug price, is expected to raise some issues. From what has been known so far, the government is planning to include Canada and Australia as reference countries and use the drug prices of the counties as standard, but if their use extends to the pricing of new drugs introduced from abroad and new drugs developed in Korea, this may deprive patients of their right to treatment and drive local pharmaceutical companies into a crisis. In Korea, the price of generic drugs is set at 53.55% of the original version. This is slightly higher than that in other countries, ranking 4th among OECD member countries. However, this relatively higher price is only applied to some original and generic drugs and is interpreted to be a strange phenomenon arising from Korea’s odd brand name-based prescription structure rather than ingredient name. According to a booklet issued by Canada’s new drug pricing review committee that was disclosed at the recent NA Audit, the reimbursement listed price of drugs such as Plavitor, Viread, and Simvastatin is 3 to 14 times higher in Korea compared to those in the US. However, rashly concluding that the generic drug price in Korea is higher than those of reference countries without considering how the higher insurance price set for new drugs from multinational pharmaceutical companies during initial listing affected the generic price, may likely cause distortion of the drug price system. As such, applying such an invasive drug price reduction policy of adding Canada and Australia as reference countries following the unilateral drug price reduction that was applied in 2012 and the satisfaction of ‘self-bioequivalence and DMF registration’ requirement, may severely harm and distort the development of the pharmaceutical and bio industry that is regarded as the new growth engine of the future. According to one research institute, some of the generics sold in Australia are sold at a price 1/5th of that in Korea, therefore, the possibility that adding Australia as a reference country may cause a collapse in Korea’s drug pricing system cannot be ruled out. More importantly, Canada and Australia, the countries that the health authorities are considering adding as drug price reference countries are not even new drug developers. Based on US FDA data, 66 new drugs were developed in the US, 25 in Europe, 6 in Japan, and 2 in China over the past 5 years. Just like Korea, Canada and Australia have been unable to overcome the FDA’s high barrier and receive new drug approvals in the US. An industry official emphasized, “As we have learned overcoming the swine flu and COVID-19, establishing and fostering pharmaceutical and bio sovereignty is essential and must be pursued in the long-term. Therefore, applying the short-sighted measure of reducing generic drug price just to save KRW 1.5 trillion in the short term is not the answer.” Currently, the external size of Korea’s pharmaceutical and bio industry is about KRW 27 trillion, and the proportion of original and generic drugs is about 6:4. However, in the case of original prescription drugs, it is not an exaggeration to say that multinational pharmaceutical companies dominate the market as it accounts for over 90% of the original drugs marketed in Korea. Another industry official said, “With the absence of a preferential pricing policy for domestic new drugs, cutting generic drug prices can only be interpreted as a short-sighted policy on the government's part that will only hand over Korea’s pharmaceutical and bio sovereignty to foreign companies." Meanwhile, health authorities and the pharmaceutical industry have not reached a conclusion and is still discussing adding Canada and Australia to the reference countries, but have made a consensus in calculating the average monthly exchange rate using the average exchange rate of 1 to 36 month prior to the pricing negotiations.
