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- 2026-05-05 15:11:21
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- Seize the promising target Claudin market
- by Jun 28, 2023 05:53am
- CLDN18.2 is a protein mainly present on the surface of gastric cancer cells and is known to be expressed at high levels in certain malignant tumors. (Source: Transcenta)Claudin 18.2 (CLDN18.2) is emerging as a new alternative for gastric cancer with a poor prognosis, and a development boom is brewing among global pharmaceutical companies. Various new drugs such as cell therapy drugs and bispecific antibodies have been put to the test in order to preoccupy this market, which is a communist communist country. According to the Ministry of Food and Drug Safety on the 27th, three CLDN18.2 target new drugs have been approved for clinical trials this year alone. Two cases are early-stage (phase 1/2 and phase 1) clinical trials, and one case is a late-stage phase 3 clinical trial. CLDN18.2 is a protein mainly present on the surface of gastric cancer cells. It is also present in normal cells but is expressed at high levels in certain malignant tumors. It is known to be involved in the proliferation, differentiation, and metastasis of cancer cells. BioNTech founder and CEO Ugur Sahin first discovered it in 2008 and started developing the drug at Ganymed Pharmaceuticals, which he was leading at the time. CLDN18.2 is highly anticipated in gastric cancer, where it was difficult to find biomarkers. Currently, gastric cancer is considered cancer with a poor prognosis because there are no suitable targeted therapies except for HER2-targeted anticancer drugs. CLDN18.2 can be a new alternative even in pancreatic cancer, where it is difficult to develop new drugs. Astellas, a Japanese pharmaceutical company, acquired Ganymed and acquired the rights to develop Zolbetuximab, the first CLDN18.2 target substance. The recently announced top-line results of phase 3 clinical trials were positive. Astellas submitted an application for product approval of Zolbetuximab to the Japanese licensing authority on the 9th. If Zolbetuximab is approved, it will be the world's first CLDN18.2 targeted anti-cancer drug. Challenges by competitors to pursue Zolbetuximab are also continuing. On the 16th, Chinese biotech Transenta received approval for a phase 3 clinical trial of TST001, a natural killer (NK) cell therapy targeting CLDN18.2. It is characterized by the fact that it is used in combination with the immuno-oncology drug Opdivo and chemotherapy.
- Company
- SK bioscience collaborates with the Doherty Institute
- by Jun 28, 2023 05:53am
- From left, SK Bioscience CEO Ahn Jae-yong, AustraliaSK bioscience announced on the 27th that it had signed a research cooperation agreement with the Peter Doherty Institute for Infection and Immunity in Australia for global influenza prevention and response. The Peter Doherty Institute for Infection and Immunity is an infectious disease research institute affiliated with the University of Melbourne, Australia. It is the World Health Organization (WHO) Influenza Collaboration Center and one of the world's three major sources of influenza strains. The signing ceremony was held at SK Bioscience Pangyo headquarters with Professor Sharon Lewin, Director of The Peter Doherty Institute for Infection and Immunity and Head of the Department of Infectious Diseases at the University of Melbourne, and Professor Kanta Subbarao, Director of The Peter Doherty Institute for Infection and Immunity and WHO Influenza Research and Surveillance Cooperation Center. , Professor Ian Barr, Deputy Director of The Peter Doherty Institute for Infection and Immunity and WHO Influenza Research and Surveillance Cooperation Center, SK Bioscience President Ahn Jae-yong, and Global R&BD CEO Kim Hoon attended. With the goal of advancing influenza vaccine research and development, the two organizations agreed to cooperate closely with ▲basic research on a new influenza vaccine platform ▲identification of the latest research technologies and industry trends related to global influenza. Through this cooperation, SK Bioscience plans to strengthen its influenza prevention and response system to secure competitiveness in the global influenza market and take the lead in advancing influenza vaccine R&D around the world. According to Fortune Business Insight, a global market research firm, the global influenza vaccine market will grow from $7.54 billion (9.8887 trillion won) in 2022 to $13.58 billion with an average annual growth rate of 8.8% by 2029. size is expected. Sharon Lewin, Director of the Doherty Institute, said, "Participating in this collaborative influenza vaccine development project is a significant achievement in our efforts to fight disease and improve public health." Ahn Jae-Yong, CEO of SK Bioscience, said, "We are looking forward to the synergy created by our know-how in successfully developing the world's first quadrivalent cell-cultured flu vaccine and the infrastructure of the Doherty Institute, a leader in research on global infectious diseases." SK Bioscience continues to cooperate with global institutions and research organizations with the goal of advancing its vaccine portfolio and improving human health. Currently, a number of projects are underway with global organizations and institutions such as the Bill & Melinda Gates Foundation, CEPI, International Vaccine Institute, Wellcome Trust, International AIDS Vaccine Initiative, and Hillemann Institute. It plans to take the lead in establishing an innovative system that can be developed within days and supplied within six months.
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- Reimb progress of 2 NMOSD drugs receive attention in 2H
- by Eo, Yun-Ho Jun 28, 2023 05:52am
- Whether the two optic nerve sclerosis drugs that have remained non-reimbursed for a long time in Korea will be reimbursed this time is receiving attention. According to industry sources, discussions are ongoing to introduce the agenda on reimbursing the neuromyelitis optica spectrum disorder (NMOSD) indication of ’Soliris (eculizumab)’ and ‘Enspryng (satralizumab)’ to the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee in the second half of the year. Both drugs have been receiving reviews for a long time. After expanding its indication in the first half of 2021, Soliris submitted its application to reimburse the indication in the second half of 2022. However, due to their high price, their companies have had difficulty setting reimbursement standards and fiscal sharing plans. However, with recent progress made for the first-in-class drug, Soliris, expectations have been rising on its DREC review. In the case of the latecomer Enspryng, as its company expressed intentions to accept the weighted average price (WAP) as its alternative, Soliris’s reimbursement listing will play an important role in the rise of a treatment option for NMOSD in Korea. Soliris’s efficacy was confirmed through the PREVENT study, in which the drug demonstrated efficacy in preventing the risk of recurrence of NMOSD. The results that were presented at NEJM in 2019 showed that among patients with anti-AQP4 antibody-positive NMOSD, 98% of patients treated with Soliris were relapse-free at 48 weeks compared with the 63% who were treated with placebo. At Week 144, the relapse-free rate in the Soliris group was 96% vs 45% in the placebo group. Enspryng’s efficacy was demonstrated through SAkuraStar and SAkuraSky clinical trials that were conducted on adult patients with anti-AQP4 antibody-positive NMOSD. In the SAkuraStar monotherapy study’s AQP4 antibody-positive subgroup, 76.5% of ENSPRYNG-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with standard immunotherapy, 91.1% of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo.
- Company
- B-cell lymphoma drug Polivy applies for reimb again
- by Eo, Yun-Ho Jun 27, 2023 05:47am
- The B-cell lymphoma drug ‘Polivy’ is reattempting to receive reimbursement in Korea. This time, the company applied for Polivy’s reimbursement with a different indication. According to industry sources, Roche Korea submitted an application for the reimbursement of its Diffuse Large B-Cell Lymphoma (DLBCL) treatment Polivy (polatuzumab vedotin) as a first-line treatment to use in combination with rituximab+ cyclophosphamide, doxorubicin, prednisone, etc. Polivy had applied for reimbursement for its first indication, as a third-line treatment in combination with standard BR therapy (rituximab-cyclophosphamide), in 2021, but failed to pass review by the Cancer Disease Deliberation Committee. Therefore, whether its reattempt for reimbursement in the first-line will be successful this time remains to be seen. Its first-line indication was approved by the US FDA in April and in November in Korea last year. The indication expansion was based on the Phase III POLARIX trial. In the POLARIX trial, all patients were followed for over 24 months, and at a median follow-up of 28.2 months, the risk of disease progression, relapse or death was reduced by 27% with Polivy + R-CHP compared with R-CHOP alone. The most reported adverse events (≥30%) in patients using Polivy+R-CHP were peripheral neuropathy (52.9%), nausea (41.6%), neutropenia (38.4%), and diarrhea (30.8%). Diffuse large B-cell lymphoma is an aggressive type of hematological cancer and the most common form of non-Hodgkin's lymphoma. In Korea, the number of new patients diagnosed with DLBCL is estimated to be near 5,000 each year. As the most common form of non-Hodgkin lymphoma, DLBCL is an aggressive (fast-growing) type of lymphoma that requires immediate treatment. DLBCL is generally responsive to treatment as over half of the patients reach remission, however, 30% to 40% of the patients do not respond to the standard-of-care, R-CHOP or experience relapse after first-line treatment. Despite being a fatal disease where most patients experience relapse within 2 years, and the life expectancy is only 6 months after relapse, the area is known to lack effective treatment options.
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- Boryung Lenvima passed the first hurdle of the patent challe
- by Kim, Jin-Gu Jun 26, 2023 05:53am
- Eisai’s liver cancer drug LenvimaBoryung succeeded in crossing the first hurdle in the patent challenge for Lenvima, a liver cancer treatment. If the remaining two patents are avoided or invalidated, the early generic release is expected to be faster. According to the pharmaceutical industry on the 23rd, the Intellectual Property Trial and Appeals Board sided with Boryeong in a recent trial to confirm the scope of rights for a crystalline form of Lenvima, which Boryeong recently filed against Eisai. Boryeong is single-handedly challenging Lenvima patents. In November of last year, it filed a simultaneous request for a negative right scope confirmation trial and an invalidation trial for three Lenvima patents. At the time, Daewoong Pharmaceutical joined the patent challenge, but soon voluntarily withdrew and left. Lenvima is protected by five patents. Substance patents expiring in April 2025, usage patents expiring in March 2028, crystalline form patents expiring in June 2028, formulation patents expiring in March 2031, and manufacturing method patents expiring in August 2035. Among them, the manufacturing method patent that expires in 2035 has been listed in the Ministry of Food and Drug Safety Patent List since Boryeong started a patent challenge. Boryung plans to release generics in time for substance patent expiration after avoiding or invalidating the rest of the patents except substance patents. Subsequently, registered manufacturing method patents must be overcome by Boryeong. However, in the case of this patent, it is analyzed that Boryeong can be avoided relatively easily by using a composition or salt different from the original. If Boryung succeeds in the remaining patent challenges and releases Lenvima generics early, the anticancer drug portfolio is expected to expand further. Boryeong is concentrating on the anticancer drug business after 2020. Boryung's main strategy is to acquire the domestic copyright for the original product and release the first generic by overcoming patents. Boryung announced plans to add 10 first-generic anticancer drugs by 2026 in its "five-year mid- to long-term plan" announced last year. In July of last year, Fulvet was approved as the first generic of AstraZeneca's breast cancer treatment Faslodex. In addition to Lenvima, ▲Ipsen's liver cancer treatment Cabometyx, ▲BMS' acute lymphocytic leukemia treatment Sprycel ▲Novatis' leukemia treatment Tasigna ▲Pfizer's breast cancer treatment Ibrance challenged patents. However, the patent challenge to Tasigna was voluntarily withdrawn when Boryeong stopped developing generics. In the case of Ibrance, it was defeated in the first trial and has appealed to the Patent Court. The challenge to Sprycel came one step closer to the early release of generics after the usage patent expired in March 2024 as Boryung succeeded in avoiding the crystalline form patent in June of last year. In the case of Cabometyx, although it lost in the first trial, it is analyzed that there is no problem with the early generic release strategy. Ipsen, the original company, voluntarily deleted all claims that were the target of the patent challenge after Boryeong's request for judgment. Boryeong lost in the trial, but in fact, it is in a situation where the patent is not infringed even if the generic is released before February 2032, when the patent expires. Lenvima is Eisai's liver cancer drug. It is used in the first-line treatment of liver cancer together with Nexavar and Tecentriq + Avastin. According to IQVIA, a pharmaceutical market research institute, Lenvima's sales last year were 13.6 billion won. It decreased by 14% compared to 15.8 billion won in 2021. In the first quarter of this year, it posted sales of 2.3 billion won.
- Company
- Entresto’s reimb for HFrEF is extended again
- by Eo, Yun-Ho Jun 26, 2023 05:53am
- The reimbursement standards for the heart failure treatment ‘Entresto’ has been extended once again. According to industry sources, the reimbursement standards for Entresto (sacubitril) will be revised starting next month (July) to cover its use in combination with standard therapy (beta blockers, aldosterone antagonist, etc.) in patients with chronic heart failure with reduced ejection fraction whose left ventricular ejection fraction (LVEF) is below 40%. This is an extension from the previous reimbursement standard that was limited to ‘patients who have been receiving stable dose for over 4 weeks,’ and also an additional extension in becoming a first-line therapy after last year when the drug’s reimbursement was extended to ‘patients who were hemodynamically stabilized after being hospitalized for acute decompensated heart failure and has not received ACE inhibitors or angiotensin II receptor blockers.’ In other words, Entresto can now be used in combination with other standard therapies in patients with an ejection fraction of 40% or less and is positioned at the same status as ACE inhibitors and angiotensin receptor blockers. Entresto’s efficacy in HFrEF was identified in the Phase III PIONEER-HF study. In the PIONEER-HF study, a significant reduction of NT-proBNP was identified from Week 1 of treatment, and the clinical efficacy of Entresto was consistent among various patient groups including patients newly diagnosed with heart failure and RASi-naïve patients. Also, the 12-week open-label extension results that were presented at JAMA Cardiology 2019 showed that Entresto demonstrated consistent treatment effect and safety at Week 12. The difference between the two treatment groups, such as readmission within 8 weeks, was not narrowed for 4 weeks, confirming the clinical necessity of the initial use of Entresto. Entresto is currently recommended as the standard-of-care in heart failure treatment guidelines in Korea and abroad. The European Society of Cardiology (ESC) and the American College of Cardiology (ACC) recommends Entresto as a first-line treatment option, and in January 2021, the 2021 update to the ACC Expert Consensus Decision Pathway amended the guidelines to recommend Entresto ahead of ARB or ACE inhibitors. Also, the ESC’s Heart Failure Guidelines that was updated in August 2021 emphasized a combined treatment strategy that simultaneously initiates the use of 4 essential drugs including ARNI-class drugs (Entresto) that reduce the risk of death from heart failure. Meanwhile, Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that directly works on the heart. It works on two hormonal pathways, to activate the NP nerve hormones that benefit the cardiovascular system while inhibiting RAAS which is harmful for the cardiovascular system.
- Company
- Xospata makes progress for reimb...up for DREC review
- by Eo, Yun-Ho Jun 23, 2023 05:45am
- The reimbursement review for the acute myeloid leukemia treatment Xospata is making way to overcome the existing restriction that limits the reimbursement to 4 cycles. According to industry sources, Xospata (gilteritinib), Astellas Korea’s new drug for patients with relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation will be presented for review at the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting on July 1st. The drug’s reimbursement application is seemingly making relatively quick progress after passing the Cancer Disease Deliberation Committee in May. However, since Xospata was waived the pharmacoeconomic evaluation process, the drug would also have to undergo drug pricing negotiations with the National Health Insurance Service for its reimbursement extensions as well. The drug is indicated as monotherapy for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation (FLT3mut+). However, only patients who received allogeneic hematopoietic stem cell transplantation are eligible for reimbursement, for up to 4 cycles. Other than the financial issues, there are no specific reasons to limit the number of administration cycles for Xospata. In the ADMIRAL trial, Xospata was used without limiting the treatment period, and the NCCN guidelines also issued a ‘Category 1’ recommendation for the drug without restricting its treatment period. The current best option to cure AML patients is hematopoietic stem cell transplantation, but this is accompanied by a high risk of recurrence, and transplantation is not an option for the large number of elderly AML patients that exist. Therefore, there is no suitable treatment alternative other than Xospata available for patients who cannot undergo hematopoietic stem cell transplantations, and these patients are still using the chemotherapy that was developed over 40 years ago due to ineligibility for reimbursement of Xospata. Xospata targets both types of FLT3 mutations, FLT3-ITD and FLT3-TKD, and may be self-administered at home as a single oral tablet once daily without frequent hospital visits. Also, Xostapa has demonstrated improved safety and efficacy compared with existing chemotherapy.
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- IND of LegoChem Bio's ADC was approved by the FDA
- by Hwang, Jin-joon Jun 23, 2023 05:44am
- LegoChem Bioscience announced on the 22nd that it has received approval from the US Food and Drug Administration (FDA) for a phase 1/2 clinical trial plan (IND) for 'LCB84' targeting various solid cancers such as triple-negative breast cancer and colorectal cancer. It submitted a clinical trial protocol to the FDA in May and obtained plan approval within a month. This clinical trial will be conducted in the United States and Canada for about 300 patients with advanced solid cancer. The safety and tolerability of LCB84 monotherapy and immuno-oncology combination therapy will be evaluated. The phase 1 dose-escalation trial is conducted in up to eight institutions. The phase 2 clinical trial (Dose Expansion) is conducted in 20 institutions. LCB84 is ADC new drug candidate that targets the truncated TROP2 antigen specifically expressed in cancer cells. It is a drug that has improved safety and efficacy by applying LegoChem Bio's next-generation ADC platform technology. LegoChem Bio disclosed the efficacy of LCB84 on refractory cancer cells through the American Association for Cancer Research (AACR) last year and World ADC London this year. Refractory cancer cells are cancer cells that do not respond to competing drugs. LegoChem Bio also announced preclinical data showing that LCB84 did not show significant toxicity in TROP2-expressing normal cells. "The clinical entry of LCB84 is meaningful in that LegoChem Bio independently develops clinical trials in the field of ADC," said Kim Yong-joo, CEO of LegoChem Bio. CEO Kim Yong-joo added, "We will enter more than one pipeline into self-directed clinical development every year."
- Company
- Expansion of indications for Forxiga as a treatment for HFrE
- by Jung, Sae-Im Jun 23, 2023 05:43am
- AstraZeneca Korea announced on the 22nd that its SGLT-2 inhibitor Forxiga has additionally obtained indications for HFpEF and HFmrEF from the Ministry of Food and Drug Safety. The indication approved this time is to reduce the risk of death due to cardiovascular disease, hospitalization due to heart failure, and urgent hospital visits due to heart failure in NYHA class II-IV patients. This positions Forxiga as a treatment for patients with chronic heart failure across the entire ejection fraction range. This indication expansion is based on the DELIVER study. DELIVER is the largest clinical study of SGLT-2 inhibitors in heart failure patients with an LVEF of 40% or higher. 6263 patients with chronic heart failure with an LVEF of 40% or more, with or without type 2 diabetes, participated. This included patients with a history of type 2 diabetes, those who were hospitalized or discharged for heart failure, and those whose ejection fraction had improved to 40% or more at the time of study entry. As a result of the study, Forxiga reduced the risk of cardiovascular death or worsening of heart failure (unscheduled hospitalization and hospital visits due to heart failure) by 18% compared to the placebo group. The DAPA-HF study and the DAPA-CKD clinical trial for patients with chronic kidney disease confirmed a reduction in the risk of death as a secondary endpoint compared to a placebo. Forxiga had a 23% lower risk of worsening overall heart failure and cardiovascular death compared to placebo. The KCCQ standard symptom evaluation score improved by an average of 2.4 points more than the placebo group. Shim Il, executive director of AstraZeneca Korea's CVRM division, said, "Forxiga is the only SGLT-2 inhibitor that has all three indications for type 2 diabetes, chronic heart failure, and chronic kidney disease, and we will do our best to provide benefits to more patients." said.
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- GO for patent litigation, NO for suspension of execution
- by Kim, Jin-Gu Jun 22, 2023 04:14pm
- Janssen Korea has decided not to file a lawsuit for canceling a drug price cut and a request for suspension of execution following the appeal in a patent dispute. It is interpreted as an intention to avoid controversy over the abuse of the suspension system related to the so-called 'Drug Price Reduction and Refund Act' that recently passed the National Assembly. Janssen Korea Opsumit Patent Dispute Appeal Decision. "We will not proceed with the lawsuit to cancel the drug price reduction" According to Janssen Korea on the 19th, the company decided to appeal to the Patent Court in a dispute with Samjin Pharmaceutical over the Opsumit composition patent. This dispute was sparked by Samjin's request for a passive trial to confirm the scope of rights to the Opsumit composition patent in May of last year. In April of this year, Samjin Pharmaceutical won the trial by obtaining a 'claim established' from the Intellectual Property Tribunal (1st trial). Samjin, which won the first trial, released Maciten as the first generic of Opsumit earlier this month. This product was also listed on the list at the same time. Opsumit's price is expected to drop by 30% with the generic drug's insurance coverage. Originally, a price cut was expected this month, but it is said that the drug price cut was delayed by one month of the opinion gathering period, and Janssen Korea has made an objection. Janssen Korea decided not to go through legal procedures to delay the drug price cut in addition to raising objections. It was decided not to file a lawsuit against the government to cancel the drug price cut and to suspend execution accordingly. Many original companies have actively utilized the judiciary's suspension system to delay drug price cuts. Among them, the most common form was prolonged patent disputes. As the final decision has yet to be made, the drug price cut is unfair, so it requested that the drug price cut be suspended until the court makes a ruling. The judiciary cited most of these applications for suspension of execution. Even if it lost in the second trial, the original company prolonged the dispute until the third trial with the same logic, and as a result, the original drug price was maintained for three to five years until the final decision of the Supreme Court. Criticism was raised that the suspension of execution was abused by some. It was criticized for abusing the suspension system, which has a very high quotation rate, to delay drug price cuts even though pharmaceutical companies know they will lose in the main lawsuit. In fact, the Ministry of Health and Welfare has won 100% of the main lawsuits that have been going on so far. When this situation was repeated, the Ministry of Health and Welfare promoted legislation of the so-called Drug Price Reduction and Refund Act. It is a law that contains the basis for recovering health insurance finances that were excessively paid during the suspension of execution after the final judgment. Controversy arose in the course of discussions in the National Assembly, but the government pushed ahead with legislation by adding a provision for refunds in case of opposition, and eventually, this law passed the National Assembly in April. In the case of Opsumit, according to the judgment of Janssen Korea, it was possible to file a lawsuit for canceling a drug price cut and apply for suspension of enforcement. This is because the Drug Price Reduction Refund Act will take effect in November. The law, which passed the National Assembly in April, was promulgated in May, and the effective date is November 20, six months after the date of promulgation. From the perspective of Janssen Korea, it was possible to make the same choice as AstraZeneca Korea recently maintained the drug price of Forxiga through administrative litigation and application for suspension of execution. Janssen Korea decided not to do this. Janssen Korea's decision is to accept the drug price cut for Opsumit, which is expected next month. An official from Janssen Korea said, "After much consideration, we decided against pursuing a separate legal action and accept the financial repercussions, in recognition of the Korean government's drug price system and the potential financial burden on our patients." An official from Janssen Korea explained, "That doesn't mean giving up the Opsumit patent." “We have decided to appeal to the Intellectual Property Trial and Appeal Board, which determined that Samjin Pharmaceutical’s generic products do not fall within the scope of the Opsumit patent, and we filled a lawsuit for revocation of the Patent Court’s decision.” he emphasized. "The application for provisional disposition for patent infringement has not yet been decided."
