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- 2026-04-11 09:37:18
- Company
- Celltrion develops anticancer drugs using ADC platform
- by Oct 21, 2022 05:47am
- Celltrion announced on the 17th that it has signed a contract with domestic bio company Pinotbio to introduce options for implementing ADC Linker-Payload platform technology. With this contract, Celltrion paid advance payments and secured the right to utilize Pinotbio's ADC Linker-PINOT-ADC for up to 15 targets. Celltrion plans to develop ADC anticancer drugs targeting solid cancer by applying PINOT-ADC technology to pipeline candidate materials under development. For a total of 15 target options secured this time, Celltrion can use the technology for one target for each option event, and advance payments, milestones, and royalties for each option event are set separately. ADC Linker-PBD technology is a technology that combines payloads with excellent therapeutic effects with antibodies that react only to specific antigens so that drugs can selectively act on cells expressing antigens. The maximum therapeutic effect can be expected with the minimum drug administration, and the drug can be selectively delivered to the target cell. Celltrion has secured anticancer drugs such as blood cancer treatment Truxima, breast and gastric cancer treatment Herzuma, metastatic direct bowel cancer, non-small cell lung cancer, and ovarian cancer treatment Begzelma. The contract is expected to enable the development of more diverse anticancer drugs by securing options for implementing ADC platform technology. Celltrion signed a contract with Pinotbio to introduce platform technology implementation options, as well as a stake investment and joint research contract. The two companies decided to focus their development capabilities as much as possible to achieve the joint goal of developing ADC treatments while establishing a long-term partnership through equity investment and joint research contracts. An official from Celltrion said, "The introduction of Linker-Payload platform technology has added momentum to the development of ADC anticancer drugs as a future growth engine project. We will actively expand new growth engines through continuous cooperation with promising biotech such as Pinotbio."
- Policy
- Xtandi’s use expanded... reimbursement standard changed
- by Lee, Tak-Sun Oct 20, 2022 06:02am
- The scope of use for the prostate cancer treatment Xtandi soft capsule (enzalutamide, Astellas Korea) will be expanded. Although the drug was applied reimbursement only when other drugs that suppress androgen production cannot be used, reimbursement will be applied regardless of such status starting next month. On the 18th, the Health Insurance Review and Assessment service prepared an amendment to the anticancer drug reimbursement standards that contained the changes above and started reviewing industry opinion. Under the proposed amendment, the reimbursement condition, ‘when other drugs that suppress androgen production cannot be used,' will be deleted from the standards for Xtandi’s reimbursed use in patients with metastatic castration-resistant prostate cancer who have failed docetaxel-based or other chemotherapies. On this, HIRA explained, “The condition had been set during RSA reevaluations, and the relevant standards had been revised since then. As the clinical efficacy of the indication remains the same since deliberations, we deemed it medically justifiable to delete the restrictions without changing the drug’s clinical efficacy in the indication.” Once the opinion inquiry is complete, the amended reimbursement standard will be effective from the first of next month. The reimbursement expansion that applied this time has passed HIRA’s Cancer Disease Deliberation Committee in February this year. Xtandi is a blockbuster anticancer drug that recorded sales of KRW 27.4 billion last year and is an androgen receptor inhibitor that targets the androgen signaling pathway that acts on prostate cancer cells.
- Opinion
- [Reporter’s View] LG Chem’s global two-track strategy
- by Oct 20, 2022 06:02am
- LG Chem announced the acquisition of a US biotech firm on the 18th. LG Chem will invest KRW 800 billion to acquire a 100% stake in AVEO Pharmaceuticals. This is the third-largest in the history of M&As made by domestic pharmaceutical companies. It is also the largest single-company investment along with SK's acquisition of Ampac. AVEO Pharmaceuticals is a 20-year-old biotech specializing in anticancer drugs. The company developed a vascular endothelial growth factor (VEGF) inhibitor and received FDA approval. Although its new drug, ‘Fotivda (tivozanib)’ is not a first-in-class drug, therefore not the first drug with that mechanism of action, it has much potential. Rather than directly attacking the tumor cells, VEGF inhibitors starve the tumor cells of the nutrition required for tumor cell growth by blocking the nutrition supply pathway. Due to this mechanism of action, it goes well with other anticancer drugs and also pairs well with the cancer immunotherapies that are expanding influence in the anticancer drug market. LG Chem has long been interested in advancing into the global market through new drug development. For this, the company established a local research center in the US 22 years ago, and also invested USD 5 million in a US bioventure for the development of an anticancer drug. Also, the company has spared no amount in R&D, with its company’s R&D-to-Total-revenue ratio reaching nearly 20%. The company was also the first Korean company to obtain approval for a new drug from the U.S. FDA. However, with new drug development being quite challenging in itself and management problems, LG Chem could not succeed in global expansions. LG Chem’s Life Sciences division was unable to continue the development of new drugs in the process of spin-offs, restructuring, and statutory mergers, and also lost a large number of professional personnel. Then, after absorbing LG Life Sciences in 2016, LG Chem restarted its attempt to advance into the global pharmaceutical market. The company secured cash cows – diabetes treatments, fillers, vaccines – to invest in new drug pipelines for autoimmune diseases, anticancer drugs, nonalcoholic steatohepatitis, etc. LG Chem owns 23 new drug and vaccine pipelines. Also, the company has recently started a global Phase III trial for a new gout drug candidate it has been developing. The trial is set to be conducted in the US, China, and Europe. In the field of oncology, the company opted to acquire a biotech. Of course, LG Chem already owns an in-house oncology drug pipeline that consists of 7 candidate substances. However, their development is not so easy as all are in the early stages of Phase I trials, and the company does not have much experience in developing anticancer drugs. Aside from the huge cost, even big pharmas with extensive commercialization experience, often discontinue the development of anticancer drugs midway. The acquisition of AVEO Pharmaceuticals will be an opportunity for LG Chem to understand all areas of anticancer drug development, approval, and sales. In addition to acquiring expert personnel that develops anticancer drugs, the company will be able to acquire the development know-how of big pharmas that have been conducting joint research with Aveo. Also, by transferring its own cancer pipeline to AVEO in the future, the company will be able to conduct global clinical trials more effectively. With the initiation of a global Phase III trial and the acquisition of AVEO this year, LG Chem made a big leap forward in advancing into the global market. Whether LG Chem's two-track strategy will bear fruit will remain to be seen.
- Company
- LG Chem acquires US pharma company for KRW 800 billion
- by Chon, Seung-Hyun Oct 19, 2022 05:49am
- LG Chem will invest KRW 800 billion to acquire a US bio-company. With the acquisition, the company will also be securing an anticancer drug that is being sold in the US. On the 18th, LG Chem announced that it would acquire AVEO Pharmaceuticals for $566 million (approx. KRW 800 billion). LG Chem will be acquiring a 100% stake in AVEO Pharmaceuticals, a company known for its FDA-approved renal cell carcinoma treatment ‘Fotivda.’ This will be the first time a Korean company acquires a company that owns an FDA-approved new drug. AVEO Pharmaceuticals was established in Boston, MA in 2002. It owns full capabilities ranging from clinical development, approval, sales, and marketing in the oncology market. Listed on the Nasdaq in 2010, the company received FDA approval for its targeted therapy Fotivda for the treatment of renal cell carcinoma in 2021. AVEO Pharmaceuticals is expected to record sales of KRW 150 billion this year, which will abe a threefold year-on-year growth. If the ongoing clinical trial that is evaluating Fotivda in combination with an immuno-oncology drug becomes successful, Fotivda’s indication will expand, raising expectations for its further growth. LG Chem will use its assets to finance the funds for the acquisition to LG Chem Life Science Innovation Center (LG CBL), which is based in Boston, US. LG CBL will then establish a special purpose corporation (SPC) to proceed with the M&A of AVEO Pharmaceuticals. The overall deal is expected to be completed in around 3-6 months, after receiving majority approval from AVEO’s general shareholders' meeting and undergoing deliberation by the Committee on Foreign Investment in the United States. LG Chem said, “With the acquisition, we will be able to secure anticancer commercialization capabilities in the US in a short period of time while establishing a bridgehead to launch various in-house new drugs to the US, the world’s largest pharmaceutical market.” LG Chem made the decision to acquire AVEO Pharmaceuticals, a company that has successfully entered the commercialization stage, as it is possible to operate a business in oncology with a sales organization that focuses around on a small number of medical institutions specializing in cancer. Fotivda received a Category 1 Recommendation in the NCCN Guidelines in August and was evaluated to have settled in the renal cell carcinoma treatment market. In addition to Fotivda, AVEO Pharmaceuticals also owns 3 oncology pipelines including the head-and-neck cancer treatment that is undergoing a Phase III clinical trial, etc. LG Chem has a total of 20 new drug pipelines in the development stage, which includes 9 oncology pipelines including cell therapies in solid cancer, as well as treatments for gout, NASH, and obesity. LG Chem plans to accelerate market entry from the beginning of the launch of its new drugs by securing U.S. commercialization capabilities early on. LG Chem aims to record KRW 2 trillion in sales in Life Sciences by 2027 by internalizing AVEO’s commercialization and clinical capabilities. Ahk Cheol Shin, Vice Chairman & Chief Executive Officer at LG Chem, said, “This acquisition decision is the most important milestone in the 40-year history of LG Chem’s biology business. It will lay the foundation for the business to take the global leap forward. We will continue to strengthen commercialization capabilities in the US and actively expand local sales while further enhancing our clinical and licensing capabilities in the US to accelerate our advance into a global innovative pharmaceutical company.”
- Policy
- All targets for the benefit reassessment will be negotiated
- by Lee, Tak-Sun Oct 19, 2022 05:48am
- All six active ingredients-related companies that re-evaluated their benefit adequacy with the HIRA this year will meet at the negotiating table with the NHIS. In particular, the components for which the benefit maintenance has been decided will also be negotiated with the NHIS. Streptokinase and Streptodornase will negotiate the recovery according to the results of clinical re-evaluation, and 37 companies are subject to negotiation. Some predict that it will not be easy to meet the 30-day deadline for negotiations. According to the NHIS on the 18th, a negotiation order for drugs subject to this year's drug benefit adequacy evaluation will be issued from the Ministry of Health and Welfare on the 14th and will proceed with individual companies until the 18th of next month. Except for Streptokinase and Streptodornase, which are negotiating the return, the rest of the items will be carried out by the generic management department of the drug management office of the industrial complex. The contents of the negotiations are related to supply and quality management obligations, and if there is no problem with supply, there will be no problem in concluding the negotiations. There is a possibility that the companies are not ready because the targets of this negotiation include Almagate, and Tiropramide, which have maintained salaries. In response, the NHIS is also contacting individual companies that have sanctions that have been ordered to negotiate and maintained salaries to guide them that they are subject to negotiations. Celltrion Pharmaceutical's Godex, which was the biggest concern for benefit reassessment, will also negotiate. However, negotiations on separate drug prices are not expected to proceed as Celltrion Pharmaceutical has been recognized for its appropriateness by voluntarily cutting drug prices. The problem is companies with Streptokinase and Streptodornase that have to go through negotiations with the Ministry of Drug Safety and Drug Administration Improvement in the industrial complex. On the 6th, the HIRA decided to suspend the evaluation for one year only for items agreed on in the return negotiation according to the results of the clinical re-evaluation. The companies can maintain their benefits only when they agree with the NHIS in negotiations. It is known that there are 37 target companies alone. Currently, the NHIS-related departments and pharmaceutical companies are working on strategies internally. The NHIS official said, "We plan to reach an agreement, such as the timing and rate of recovery while listening to and coordinating the opinions of the target companies." This year's drugs subject to the re-evaluation of benefit adequacy were six-component drugs, including Streptokinase and Streptodornase, Eperisone HCl, Godex, Sodium Alginate, Almagate, and Tiropramide Hydrochloride. Among them, Streptokinase and Streptodornase were conditional evaluation suspended, Eperisone HCl, and sodium Alginate were not recognized for some indicative benefit eligibility, and all other drugs were recognized for their benefit appropriateness.
- Company
- Novo Nordisk appoints Sasha Semienchuk as new GM
- by Eo, Yun-Ho Oct 19, 2022 05:48am
- Sasha Semienchuk, VP & General Manager, Novo Nordisk Korea On the 18th, Novo Nordisk announced that it has appointed Sasha Semienchuk as the VP and General Manager of its Korean subsidiary effective in October. Sasha Semienchuk owns over 20 years of experience in healthcare across sales, marketing, research, and management at multinational pharmaceutical companies and startups in 7 countries on three continents. After joining Novo Nordisk in 2012, Semienchuk was engaged in various diseases and therapeutic areas. From 2015, Semienchuk served as a Senior Director of Global Marketing in the obesity disease area at Novo Nordisk in Denmark and led communication and commercial activity between global exepert organizations. From 2018, Semienchuk worked as the Senior Marketing Director at Novo Nordisk Japan and led the launch of various new insulin products in its Insulin team. Meanwhile, his predecessor, Rana Azfar Zafar, has been appointed as Vice President of Novo Nordisk's CEM (Commonwealth Independent States Emerging Market) cluster and will be overseeing business in Kazakhstan, Azerbaijan, Georgia, Armenia, Uzbekistan, Turkmenistan, Tajikistan, Kyrgyzstan, and Mongolia.
- Opinion
- [Desktop] Increase accessibility by beating generic prices
- by Kim, Jung-Ju Oct 19, 2022 05:48am
- The direction of the government's guarantee policy has been consistent. It is to reduce finances by preventing inefficient operations and increase patient accessibility with sufficient funds. It's a kind of 'trade-off' way. At one time, there was a massive plan to strengthen the search for hospitals and pharmacies that illegally borrow licenses to prevent unfair claims and raise funds to improve coverage. However, hospitals and pharmacies do not easily lead to collection even if they are searched, so this does not have a significant impact on fiscal appropriation. Then how about the drug price? Generic has already been restricted to cascading hurdles, and the additional system maintenance and re-evaluation of registered drugs have been confirmed to enter the benefit. All drugs must cross the last hurdle of PVA, the concept of follow-up management. Even if you enter a low price in the first place, the price falls easily if selling a lot. Drugs that do not have competitive drugs with the same ingredients are included, and companies eventually decide to stop supply. The imbalance in the supply and demand of cold medicine applies PVA exceptions without worrying about fundamentally solving the problem. When planning such a generic regulation policy, the government explained that it was a strategy to strengthen accessibility by using it to register expensive new drugs by increasing trade-offs, that is, generic drug prices and follow-up hurdles. This price-pressure strategy, which comes out whenever the financial situation is shaken and the need to strengthen guarantees grows, is actually a relatively easy way to secure funds. There is definitely a limit to securing financial resources by cutting drug prices like this without managing prescriptions. We should not delay the diversification of resources to meet the growing need for guarantees, including expanding patients' options, resolving information refraction or asymmetry, activating alternatives and introducing prescriptions for ingredients, and improving consumer awareness.
- Company
- Forxiga & Jardiance are expected to surpass 100 billion won
- by Nho, Byung Chul Oct 19, 2022 05:48am
- The SGLT-2-inhibited original diabetes treatment market recorded 53 billion won in the first half of this year, which is expected to surpass 100 billion won by the end of this year. The SGLT-2 original drug market was divided into Forxiga and Beringer Ingelheim Jardiance, and sales of 22.1 billion won and 30.9 billion won in the first half, respectively. The total sales of both Forxiga and Jardiance products last year were 91.6 billion won, up 94% from 47.1 billion won in 2018. From 2018 to 2021, Jardiance's sales were 19.8 billion won, 26.1 billion won, 29.4 billion won, and 32.3 billion won. During the same period, Jardiance Duo recorded 2.5 billion, 6.5 billion, 13.8 billion, and 21.1 billion won. Compared to the pace of growth between 2018 and 2021, Jardiance Duo increased by 63% (19.8 billion → 32.3 billion) and 744% (2.5 billion → 21.1 billion). Jardiance Duo's overall sales last year were 53.4 billion won, 15.3 billion more than Posh's 38.1 billion won. Jardiance Duo's sales in the first half of this year were 17.5 billion won and 13.3 billion won, respectively, and if such an elastic curve is maintained, it is expected to grow by 8.26% compared to the previous year. Forxiga's growth rate over the past four years is 54%, and its appearance between 2018 and 2021 recorded 24.7 billion won, 27.9 billion won, 32 billion won, and 38.1 billion won. Forxiga 10mg, which was approved in Korea in 2013, maintained 784 won at the beginning of its launch but was cut by 24 won to 760 won in May this year. This drug is used in type 2 diabetes monotherapy and is effective in reducing the risk of chronic heart failure and chronic kidney disease hospitalization and death. In particular, Forxiga is expected to compete fiercely in the market between original and generic due to the expiration of material patents in the first half of next year. When the patent expires, the original drug Forxiga will be recognized for 70% (532 won) of the existing drug price, 68% (516 won) of the generic released by innovative pharmaceutical companies, and 59.5% (452 won) of the generic. Jardiance, which was approved in 2014, is also used as a single and combination therapy for blood sugar control in type 2 diabetic patients, just like Forxiga. Jardiance 10 and Jardiance 25mg prices are 660 won and 852 won, respectively. Jardiance Duo 5/500, 5/850, 5/1000, 12.5/500, 12.5/850, and 12.5/1000 mg receive insurance drug prices of around 330 won to 469 won. New diabetes drugs with SGLT-2 inhibition mechanism have advantages of more advanced efficacy and low side effects, such as less strain on the kidneys while showing excellent blood sugar drop effects compared to existing treatments.
- Policy
- Is it possible to benefit from the K-CAB 4th indication?
- by Lee, Tak-Sun Oct 17, 2022 10:52pm
- Attention is focusing on whether HK inno. N's new drug K-CAB for gastroesophageal reflux disease will succeed in providing additional indications. Currently, K-CAB is being reimbursed to treat erosive and non-erosive gastroesophageal reflux disease and gastric ulcer. In March 2019, K-CAB, which was first applied to the treatment of erosive and non-erosive gastroesophageal reflux disease, expanded its salary to the treatment of gastric ulcers in October last year. According to industries on the 17th, the HIRA has started reviewing the benefit standards for K-CAB. K-CAB has acquired a total of five indications so far. Among them, health insurance benefits are applied to three treatments: erosive and non-erosive gastroesophageal reflux disease treatment and gastric ulcer treatment. In the rest of the patients with peptic ulcers and chronic atrophic gastritis, antibiotic combination therapy for Helicobacter pylori eradication and maintenance indications after treatment with erosive gastroesophageal reflux disease remain non-payment. HK inno.N is trying to being reimbursed for additional indications. If K-CAB succeeds in making additional indications, Daewoong Pharmaceutical, which launched its benefit in July It is expected to gain an edge in competition with Fexuclu. Fexuclu is currently only recognized for the treatment of erosive gastroesophageal reflux disease. Fexuclu 10mg is expected to seek additional benefit as it has an indication of improving gastric mucosal lesions of acute gastritis and chronic gastritis. Fexuclu is a P-CAB-based drug such as K-CAB, and has continued to be so popular that it recorded 2.6 billion won in outpatient prescription performance (based on UBIST) for two months as soon as it was released in July. K-CAB, which has secured exclusive status as the only P-CAB drug since its launch in 2019, has seen a formidable competitive drug. However, it is analyzed that K-CAB is still superior to Fexuclu due to its wide range of use, with medical care benefits applied to the current three indications. On top of that, some predict that the gap will widen if additional indications are secured. K-CAB recorded 60.6 billion won in outpatient prescriptions in the first half of this year, and is likely to surpass 100 billion won annually this year following last year. HK inno.N also plans to lead the market by developing clinical trials to add preventive therapy indications for gastric and duodenal ulcers that induce nonsteroidal anti-inflammatory analgesics.
- Opinion
- [Reporter’s View] The key to the ‘PE Exemption’ issue
- by Eo, Yun-Ho Oct 17, 2022 10:52pm
- The cries that the improvement reduces rather than expand benefits have reached the National Assembly. The government’s improvement plan for the special pharmacoeconomic evaluation (PE) exemption system was brought onto the chopping block at the NA audit. During the NA audit for the Health Insurance Review and Assessment Service that was held on the 13th, Rep. Sun-Woo Kang of the Democratic Party of Korea raised an issue on the PE exemption system improvement plan that had been submitted by the Ministry of Health and Welfare and HIRA. The “Measure to improve patient access and reinforce reimbursement management for high-priced severe disease treatments” that was recently presented by the government includes a measure to improve the PE exemption standards. According to Rep. Kang, unlike the authorities’ explanation, the drugs subject to PE Exemptions will be rather reduced if the improvement plan is applied. The “small number of eligible patients” which had previously been an “OR” clause for PE exemptions became a prerequisite in the proposed amendment, reducing the scope of eligible drugs. This issue has been raised continuously across the industry, including by the Korean Research-based Pharmaceutical Industry Association (KRPIA), since the government announced the amendment. In other words, the concern is that all drugs that wish to take the PE exemption track will have to have a “small number of eligible patients (less than 200 patients)” if the amendment is applied. On this, HIRA President Sun-Min Kim replied that “The 200 people limit is not absolute. All drugs that do not have enough patients to prepare evidence for PE evaluations are applied the PE evaluation exemption track.” In other words, the authorities will show some flexibility in the “small number” standard. However, the impact of this amendment is not only due to the changed premise. If the amendment is applied in the current state, all drugs that wish to take the PE exemption track have to have a small number of patients (as defined as 200 in the current criteria) and receive recognition from the committee for its difficulty in producing evidence to satisfy Article 2.c of the regulation. In other words, the companies will not be able to know if their drugs are eligible for the PE exemption track until HIRA’s Drug Reimbursement Review and Assessment Committee make a decision. This will inevitably have a significant impact on the predictability of reimbursement listings for companies that wish to use the PE exemption system. Considering how the new administration promised rapid listing of anticancer and rare disease drugs immediately upon its inauguration and the non-reimbursed blind spots still remain for drugs that are applied special exemptions, the government needs to seriously consider whether this amendment is achieving its original purpose.
