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- 2026-05-19 18:38:13
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- Stepped pricing to put pressure for patent challenge
- by Kim, Jin-Gu Jan 14, 2021 06:16am
- The stepped drug pricing system, revived since last July, seems to have affected the pharmaceutical industry’s patent strategy. The pricing system would create a structure to naturally diminish the drug pricing competitiveness in other companies, when 20 or more companies simultaneously and successfully challenge the patent. Pharmaceutical companies’ patent strategy originally focused on winning the preferential sales right, but the revised pricing system would unfold even more competitive patent challenge scene as the success would not only bring the preferential sales right but also more favorable generic pricing. Some complain now the companies are inevitably pressured to challenge the patent to defend the generic competitiveness. ◆Patent challenge inevitable to claim better generic pricing According to the pharmaceutical industry source on Jan. 14, the pharmaceutical companies are to face heated competition to nab the generic approval first as the stepped pricing system has been enforced from last July. The core objective of the system is to differentiate the pricing after listing a 20th product with a same substance. 53.55 percent of the original’s pricing would be applied on up to first 20 drugs to be listed. And other drugs listed afterwards would be applied with pricing lower by 15 percent each. In other words, up to 19th generics, except for the one original drug, would be able to receive the pricing level of the upper limit. Considering the reimbursement listing is decided once every month, the stepped pricing system has been technically extended to a first-come-first-served approval competition. Stepped pricing system effective from July 2020 With the shift in regulation, generic makers would be pushed to challenge patent to obtain the maximum pricing. The approval competition would be passed straight on to patent challenge competition. As for pharmaceutical companies, the regulatory change has increased the benefit in patent challenge. Previously, the benefit was limited to earning a preferential sales right, but now it can also grant the top pricing. But in the same sense, a company that did not challenge the patent would have to market their generic later and cheaper than others. ◆49 generic makers challenged Jardiance patent when new pricing system emerged Some say the patent challenge scene has gotten saturated already due to the revised pricing system. Product image of Forxiga For instance, over 60 companies, started from Chong Kun Dang, have challenged the crystalline form patent on Boehringer Ingelheim’s sodium-glucose cotransporter-2 (SGLT2) inhibiting antidiabetic treatment Jardiance (empagliflozin). Eventually, the ruling was in favor of 50 generic companies. The interesting part of the proceeding was the timing of these patent challenge cases. Most of the companies filed the patent litigations after April 2019, when the framework of the stepped pricing system surfaced. Starting from Chong Kun Dang in March 2015, 12 companies requested for the patent nullification, in which all of them lost. Three years later, Chong Kun Dang retried and requested for the negative confirmation of the scope in January 2018. The Korean company was alone during the legal case, but it won in May 2019. From June 2019, other generic makers tried their luck. 49 companies challenged the exact same patent as of August last year. The industry notes the swarm of patent challenge rushed in after the stepped pricing regulation came in sight. The majority of them were shooting for the ‘good pricing.’ A pharmaceutical industry insider explained, “Usually the patent challenge is filed within 14 days from the day of first case registration to win the preferential sales rights. But for Jardiance patent, the tens of companies jumped into the patent challenge a year and a half after Chong Kun Dang began the patent challenge.” He added, “It could be that some tried after Chong Kun Dang’s success, and some joined the legal suit to not fall behind in the pricing competition.” ◆Patent challenge could mean nothing if generic not developed before patent expiration Regardless of increased benefit in challenging a patent, some raise the voice of concern. Small and medium enterprises without the capacity to challenge the original patent argue the regulation is cutting them out of pricing competition. 25 companies have challenged AstraZeneca’s antiplatelets Brilinta (ticagrelor) and received the preferential sales rights before the patent expires late this year. The preferential sales would be protected from November this year to August next year. Assuming the 25 companies would all launch their products, other generics to be released to the market after August next year would receive already reduced pricing. And there is no guarantee of the maximum pricing to all who successfully challenged the original patent overcoming all difficulties. Product image of JardianceCurrently, 19 companies have evaded product patent on AstraZeneca’s SGLT2 inhibitor Forxiga (dapagliflozin) to be expired January 2024. These companies can launch their generics after April 2023. But if one of them fails to finish developing their generic by April 2023, any of other 25 companies that evaded the product patent can launch their generic from January 2024. Regardless of all resources put into the legal case, the company would lose the upper limit pricing when their generic is not ready to be launched when the patent is expires. A pharmaceutical industry insider said, “The patent challenging competition was initially intense to begin with for the sake of preferential sales right. But exclusivity in the market for nine months and receiving lower pricing are quite different story. The generic makers would now have to engage in even more fierce competition centering patent challenge.”
- Policy
- COVID-19 vaccine budget KRW 857.1 Bln received
- by Kim, Jung-Ju Jan 14, 2021 06:15am
- The South Korean health authority is fully readying for COVID-19 vaccination starting off from February as they have first secured the budget for the vaccine purchase and expenditure for inoculation. The Korea Disease Control and Prevention Agency (KDCA) announced on Jan. 12 the vaccine purchasing budget and inoculation expense budget of 857.1 billion won and 38 billion won have been allocated, respectively, through first and second budget request. KDCA first received 857.1 billion won to purchase globally developed vaccine, which would sequentially cover the upfront payment for Moderna vaccine and payments for the other vaccine supply deals. The health authority plans to continue seeking for finance from the financial authority for additional payments to procure vaccines for 56 million people. And approximately 35.6 billion won would be requested for preparing vaccine freezer for storing and inoculation, syringe and other equipments and establishing an integrated management system for vaccine distribution and inoculation. KDCA would also set up vaccine distribution, storage and management system before the first inoculation begins. Currently, KDCA is in process of purchasing mRNA vaccine freezer for Pfizer (-75℃±15℃) and Moderna (-20℃) and required syringe via the Public Procurement Service. Bidding for the freezer is ongoing since from Jan. 7, which would procure 100 units within this month and complete installing 250 units within the first quarter. Moreover, KDCA is to ink contracts with distributors within this month to safely ship vaccine to the inoculation centers. The agency official noted it is setting up a tight cold chain management system, as well as an integrated management system to inform the public of the COVID-19 vaccine and book timeslots for inoculation recipient. The budget of approximately 2.4 billion won is allocated for raising public awareness of inoculation, educating about the inoculation, and operating a call center. The training for human resources would be conducted for streamlined inoculation process, while the government would provide accurate information about the process and call center service for better communication and fact checking. Director Jeong Eun-kyeong stated, “The vaccine doses the government has signed the deal for 56 million people would be introduced in phases, and they would be prepared as soon as feasible. When the COVID-19 vaccine inoculation plan is finalized, the government would pay particular attention to the preparation to immediately and promptly conduct the inoculation.”
- Policy
- There is progress in introducing additional COVID-19 vaccine
- by Lee, Jeong-Hwan Jan 14, 2021 06:15am
- Prime Minister Chung Sye-kyun announced that significant progress has been made in introducing additional vaccines from other platforms, including Pfizer, Moderna, AstraZeneca, Janssen, and others regarding the COVID-19 vaccine. Although the spread of COVID-19 has recently slowed, he has been wary of hasty measures to mitigate quarantine. On the 12th, Prime Minister Chung held the Central Disaster and Safety At the Countermeasure Headquarters meeting, he said, "The government has been making efforts to introduce additional vaccines for another platform, and there has been considerable progress recently. Details will be reported to the public after the contract is finalized." Prime Minister Chung Sye-kyun said, "The government has signed a contract for a vaccine for 56 million people, enough to form collective immunity, and is preparing with all its might to start vaccination next month. Even with the vaccine, it is not yet known how long the immunity will last, and there is a possibility of safety issues. If the vaccination is not done within the expiration date, the vaccine may have to be discarded as it is due to the short expiration date." Regarding the recent COVID-19 situation, Prime Minister Chung said, "The spread has slowed since last weekend, and it can be confirmed as an objective indicator." "Danger comes soonest when it is despised," he stressed. He said, "The number of new outbreaks in the last week has decreased to less than a quarter compared to the previous week, and the infection reproductive index has also fallen to less than 1. The metropolitan area's medical response capacity has also recovered a lot." "It will be decided this week whether it will go to a certain level of stability, or if it will re-proliferate after being distracted," he said. "We have experienced what happens when social awareness is weakened, and we have seen the consequences of premature quarantine mitigation measures in the world case." He said, "A number of European countries have entered social blockade again, and Japan has declared an emergency with more than 100,000 confirmed cases in a month. K-quarantine should never commit the same mistake."
- Policy
- All citizens will be vaccinated free of charge
- by Lee, Jeong-Hwan Jan 14, 2021 06:15am
- President Moon Jae-in promised free vaccination for all citizens according to the priority of the COVID-19 vaccine at the New Year's address on the 11th. It also announced a plan to strengthen vaccine sovereignty with the domestic COVID-19 vaccine, and to transparently disclose the entire process of licensing, including the safety and effectiveness of domestic COVID-19 treatment. In the New Year's address in 2021, President Moon said, "In 2020, a new infectious disease threatened human life, and daily life changed completely. In the midst of crisis, medical staff devotedly cared for patients and the people themselves became the subject of quarantine." President Moon said, "We are finally at the end of the dark COVID-19 tunnel. It is an urgent need to quickly return to a normal routine that does not require a mask. We will do our best to end the COVID-19 epidemic early by passing the last hurdle well." President Moon stated that COVID-19 vaccination will begin next month, and announced a policy that all citizens will receive free vaccinations in order according to priority. President Moon said, "We will allow all citizens to receive COVID-19 vaccine for free according to their priorities. We will transparently disclose the entire process of screening treatments developed by domestic companies. We will contribute to strengthening public safety and international health cooperation by securing sovereignty through the development of our own vaccines." President Moon said, "2021 will be the year of recovery, inclusion, and leap forward for our people. Last year, our people showed the world the most common truth that the safety of our neighbors is my safety, with amazing practices. Korean diagnostic kits, drive-through test methods, and quarantine products such as masks have been distributed around the world to protect humanity. K-Quarantine is built on the dedication and sacrifice of the people."
- Policy
- MFDS OK's removing “redundant” narcotics return approval
- by Lee, Jeong-Hwan Jan 13, 2021 06:12am
- The Ministry of Food and Drug Safety (MFDS) and the National Assembly Expert Committee Office approved of a bill to remove the MFDS narcotics pre-return approval procedure. The bill received the nod prior to the National Assembly Health and Welfare Committee’s review. When it is passed, the pharmacists’ convenience in returning the narcotic products would be improved. On Jan. 12, the National Assembly Expert Committee Office disclosed the review report on Democratic Party Lawmaker Kim Woni’s bill to abolish the narcotics pre-return approval procedure. Lawmaker Kim urged that the pre-return approval is unnecessary, as MFDS operates the Narcotics Information Management System (NIMS), where a narcotics handler or narcotics handling authorizer return narcotics or psychotropic drug they used to own or manage. The lawmaker claimed the advance and post-return reporting via NIMS and the pre-return authorization by the Minister of Food and Drug Safety are redundant regulation. The ministry also agreed with the objective of the bill. As NIMS can verify the transfer record, the pre-transfer approval for the product return would not be problematic. MFDS official said, “Returning narcotics has specified receiver, and the transfer record can be confirmed with the narcotic handling report system. It would be reasonable to omit the MFDS authorization procedure.” The National Assembly Expert Committee Office was also in favor of the bill. The current Narcotics Control Act stipulates a narcotic handler and a narcotic handling authorizer to mandatorily report the import and export, manufacturing, sales and purchase, prescription and administration, and transfer records onto the online database. The office elaborated, when returning the narcotics to the original owner, the purchaser would send back the narcotics already reported to the NIMS, and again, both the purchaser and the seller would have to report the NIMS after the transfer. The Expert Committee Office official stated, “The current regulation stipulates the seller and purchaser specified by the NIMS have to each report to the authority after the transfer. And considering the Minister of Food and Drug Safety passes the narcotics return without a thorough review, regulating the narcotic product transfer could be seen as a redundant regulation. Abolishing it would be more reasonable.”
- Company
- JW Pharma is speeding up the development of Dumirox·Actemra
- by Jan 13, 2021 06:12am
- Dumirox and Actemra, which are monopolized by JW Pharma's domestic development and copyright, are emerging as a possible treatment for COVID-19 On the 8th, the MFDS approved sponsor-investigator trials for patients with COVID-19 of Dumirox 100mg (Fluvoxamine maleate), an antidepressant drug. With the approval of this clinical plan, AMC will conduct a randomized, placebo-controlled method to investigate the treatment effect of Fluvoxamine maleate for 406 mild COVID-19 patients admitted to the Community Treatment Centers. Dumirox is a selective serotonin reuptake inhibitor as an antidepressant primarily prescribed for patients with depression and obsessive-compulsive disorder. It was developed by Abbott in the United States, and JW Pharma secures the exclusive copyright in Korea. It is widely known as Luvox abroad. Dumirox has already proven the effectiveness of COVID-19 treatment in overseas clinical trials. According to the online edition of the Journal of American Medical Association on November 12 last year, research has shown that Dumirox can help prevent the condition from becoming severe by significantly reducing the likelihood of hospitalization for patients with COVID-19. Eric Lenze, Wallace and Lucille K. Renard Professor of Psychiatry at the University of Washington School of Medicine, USA, conducted a clinical trial in Illinois and Missouri in 152 patients with COVID-19, mild to moderate, aged 18 years or older, in self-isolation at home. "Six out of 72 people who took placebo were classified as severely ill, whereas all 80 people taking Dumirox did not get worse," the research team said. "We found that Dumirox may reduce the risk of hospitalization and death in patients with COVID-19." Rheumatoid arthritis treatment Actemra (Tocilizumab) has been shown to lower the mortality rate of critically ill patients with COVID-19 abroad, and the UK government recommended that the treatment be prescribed for the treatment of COVID-19 starting on the 8th (local time). According to the Guardian on the 7th, a study by the Remap-Cap research team showed that the mortality rate of the group receiving general treatment was 35.8%, while the mortality rate of those receiving Actemra treatment was 28%. In addition, patients injected with Actemra left the intensive care unit 7 to 10 days earlier than the control group. In September of last year, global pharmaceutical company Roche unveiled the results of EMPACTA, the second global phase III clinical trial of Actemra, a rheumatoid arthritis treatment to be developed as a treatment for COVID-19. A total of 389 patients were studied, and the risk of dying or wearing a ventilator was 44% lower than that of placebo. The third global phase III clinical trial REMDACTA, which Roche is in cooperation with Gilead Sciences, is also raising expectations. REMDACTA is a trial that evaluates efficacy and safety as a combination therapy of Remdesivir and Actemra, and has been in progress on a total of 450 COVID-19 patients since June of last year. JW Pharma is developing a treatment for COVID-19 through its own new drug strategy. JW Pharma recently secured the right to own and use the results of a study on COVID-19 infection animal model of CWP291 from the Korea Research Institute of Bioscience and Biotechnology (KRIBB), and entered the subsequent development stage. As a result of the efficacy evaluation for the golden hamster of CWP291, a high rate of improvement in lung lesions was shown, and an excellent reduction effect was also confirmed in the amount of virus remaining in the lung tissue (PCR). This can be judged as the result obtained by the GRP78 binding mechanism that CWP291 was identified in the clinical phase I study of the existing target anticancer drug. GRP78 is reported as a host factor for several single-stranded RNA viruses, including COVID-19, MERS, Dengue, Zika, and Japanese encephalitis in many academic data.
- Company
- Sanofi financially supports adolescent Dupixent users
- by Jan 13, 2021 06:11am
- On Jan. 11, Sanofi Aventis Korea (President Kay Bae) presented a patient drug expense support program to partially cover the cost of Dupixent Prefilled injection 200 mg (dupilumab) prescribed to adolescent patient with atopic dermatitis. The program aims to contribute in improving the patients’ quality of life by financially supporting the patients with the drug expense, and to allow them to receive the treatment at the right timing. A topical treatment Dupixent is a first ever biologic drug to be indicated to treat adolescent and adult patients aged 12 years or older with moderate to severe atopic dermatitis. After the 300 mg dose, 200 mg dose was also released to the South Korean market in last October. 200 mg of Dupixent is injected to an adolescent patient aged 12 years or older with atopic dermatitis but weighing less than 60 kg. Other adolescent patients weighing over 60 kg and adult patients are administered with 300 mg. At the moment, the drug’s National Health Insurance reimbursement covers only the adult patient. As a result, Sanofi has decided to operate a program to cover a part of the adolescent patients’ pharmaceutical expense. Patients prescribed with 200 mg of Dupixent, whose median household income level is under 180 percent. Adolescent patient with severe case of atopic dermatitis has high probability of experiencing negative social interactions, such as bullying and isolation struggling with mental issues like anxiety, inferiority and depression. The company anticipates the financial support program to not only grant access to the treatment, but also give benefit of improving the quality of life. Sanofi Aventis Korea’s Specialty Care business unit CEO Park Hee-kyung commented, “To provide treatment access to adolescent patients with moderate to severe atopic dermatitis, who are neglected from the National Health Insurance benefit, the company has decided to contribute a part of Dupixent 200 mg expense.” The company’s call center and website can be reached for any inquiry on the partial refund and expense support on Dupixent.
- Company
- Ferring & Chong Kun Dang signed a contract for Nocdurna
- by Jan 13, 2021 06:11am
- Ferring Korea and Chong Kun Dang announced on the 11th that they have signed a joint sales contract for 'Nocdurna Sublingual Tab (Desmopressin acetate)', a treatment for nocturia. Following the signing of this contract, Ferring Korea will be in charge of marketing for general hospitals from the 18th, and Chong Kun-dang will be in charge of sales and marketing on clinics. Ferring Korea and Chong Kun Dang have been jointly selling Minirin, a treatment for nocturia since 2019. Nocdurna with an additional contract is Minirin's low-dose product. Nocdurna improves the symptoms of nocturia caused by polyuria at night, which accounts for up to 88% of the causes of nocturia. It is a new treatment that improves the safety of patients to reduce the number of nocturia in adults and improve the quality of sleep. Nocdurna 50 μg is administered once a day for men, and Nocdurna 25 μg is administered once a day for women. According to the results of the Nocdurna Phase III study, Nocdurna 25 μg and 50 μg were effective in controlling nocturia-related symptoms in women and men, respectively. Compared to placebo, Nocdurna reduced the average number of nocturia and increased the time to first nighttime urination, prolonging the initial sleep period. Compared to placebo, the quality of life and sleep quality associated with nocturia increased significantly. Yong-beom Choi, CEO of Ferring Korea, said, "We are pleased to sign a joint sales contract for Minirin and Nocdurna with Chong Kun Dang. We hope that Nocdurna will make it easier for elderly patients over 65 who are suffering from sleep disturbances due to nocturia." Chong Kun Dang CEO Kim Young-joo said, "Based on Chong Kun Dang's excellent sales force, we will do our best so that more domestic nocturia patients can Nocdurna’s benefit at clinics visited by many patients."
- Company
- Celltrion's CT-T43 was approved for Phase III clinical trial
- by Kim, Jin-Gu Jan 13, 2021 06:10am
- Celltrion announced on the 8th that it has received approval for the Phase III clinical trial plan of Stelara (Ustekinumab)'s biosimilar. Janssen's autoimmune disease treatment Stelara is a mechanism that inhibits interleukin (IL)-12·23, and has indications for psoriasis, Crohn's disease, and ulcerative colitis. It is known that global sales amount to ₩7 trillion. Celltrion plans to compare the efficacy, pharmacokinetics, and safety of CT-T43 and Stelara at 7 domestic institutions. Clinical trials are conducted simultaneously with global trials. Global clinical trials are conducted in Europe and Korea with 446 patients. Global clinical trials have already begun with European approval on December 21st last year. This phase III clinical trial aims to end in the second half of 2022. Celltrion plans to commercialize the CT-P43 in September 2023 and July 2024, when Stelara's material patents expire in the United States and Europe. Celltrion will secure a diverse portfolio in the autoimmune disease treatment market when CT-P43 is commercialized. Celltrion has two types of Remicade biosimilar Remsima (IV and SC), Herceptin biosimilar Herzuma, and Rituxan biosimilar Truxima. In addition, it is developing Humira biosimilar CT-P17 and Xolair biosimilar CT-P39. CT-P17 is expected to be approved in Europe in the first half of this year, and CT-P39 is aiming to end clinical trials in the first half of 2023.
- Company
- What domestic pharmaceuticals JP Morgan paid attention to?
- by Moon, sung-ho Jan 12, 2021 06:22am
- More than 20 domestic pharmaceutical and bio companies are invited to the world's largest pharmaceutical and bio industry event, annual J.P. Morgan Healthcare Conference. According to the pharmaceutical industry on the 8th, more than 20 domestic pharmaceutical and bio companies, including Samsung Biologics and Hanmi, will participate in the J.P. Morgan Healthcare Conference. which will be held from the 11th to the 14th local time in San Francisco, USA. It is 39th event where about 500 large global pharmaceutical companies as well as domestic companies participate in the event to share new R&D achievements and status, and discuss the future direction of the pharmaceutical and bio industry. It can be an opportunity for domestic pharmaceutical and bio companies to achieve the greatest goals of technology export and partnership signing. A representative example of domestic companies that will attend the conference is Samsung Biologics. It is the only domestic company in charge of the announcement of the Main Track scheduled for the 13th, and the new CEO John Rim will introduce the company's main business details and vision. Celltrion, known as a regular customer of the conference among domestic companies, is expected to be absent from this event. It is the intention to focus on the development of the COVID-19 antibody treatment that is currently being promoted, and the results of the global phase II clinical trial will be announced on the 13th. Companies presenting at the subsidiary session Emerging Market are Hanmi, LG Chem, Hugel, HK inno.N, and Genexine. Hugel, which participated in the conference for the second consecutive year, presented ‘2020 achievements and vision for 2025' based on the success secret of 'Letybo', a botulinum toxin that was recently approved in China, while major overseas institutional investors during the conference. It will also hold 1:1 meetings with institutional investors. Genexine is planning to introduce the business strategy of 'Continuous Interleukin 7 (GX-I7)', which is also being developed as an anticancer drug and COVID-19 treatment at this event. HK inno.N, participating for the first time, plans to introduce autoimmune disease treatment and non-alcoholic steatohepatitis, including K-CAB Tab. LG Chem also decided to disclose its business strategy, including the new drug pipeline. LG Chem is currently conducting phase II gout treatment, phase II treatment for autoimmune diseases, phase I treatment for rare obesity, and phase I treatment for non-alcoholic steatohepatitis. There are various pharmaceutical and bio companies that do not make presentations, but participate in conference meetings. JW-Pharma, Crystal Genomics, Genome & Company, Shaperon, SCM Life Science, AptaBio, MedPacto, ABL bio, Syntekabio, Pharmabcine, Cellivery, KoBioLabs, Oscotec. JW-Pharma decided to introduce research projects through video meetings and conduct one-on-one partnership consultations and consultation meetings for joint research with global investment companies including multinational companies. In particular, JW-Pharma plans to take this opportunity to discuss additional global technology alliance projects for URC102, a gout treatment that has been successfully exported last year and has been recognized in the global market. Pharmabcine will introduce major pipelines, including Olinvacimab, and plan to jointly research materials and transfer technologies. An official from a pharmaceutical company participating in the conference said, “It is difficult to be sure that the progression online will lead to the creation of results such as the export of Lazertinib technology. Nevertheless, global pharmaceutical companies and investors will be informed of differentiated competitiveness to develop even in COVID-19 situation.”
