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- 2026-05-18 11:47:46
- Policy
- Domestic approval for Pfizer's Cibinqo (PO) is imminent
- by Lee, Tak-Sun Oct 22, 2021 05:45am
- It was found that the domestic approval for oral atopic dermatitis treatment developed by Pfizer is imminent. This product is a JAK inhibitor in the same family as Xeljanz, which is used as a treatment for rheumatoid arthritis. As JAK inhibitors have recently obtained permission with atopy treatment indications one after another, it remains to be seen what Dupixent's sales will be like. According to the industry on the 21st, the MFDS recently completed safety and effectiveness screening for Pfizer's Cibinqo 50mg (Abrocitinib), an oral atopic treatment. When the review is completed, The approval is expected to be granted soon. This product was first approved in the UK in August as a moderate to severe atopic dermatitis treatment for adolescents and adults aged 12 or older who are suitable for systemic therapy as a one-time use per day. In September, it was also approved by the Ministry of Health, Labor and Self-care of Japan. Cibinqo is known to regulate (IL)-4, IL-13, IL-31, IL-22 and TSLP, which are known to be involved in atopic dermatitis. In a phase 3 JADE Mono-1 study, 62.7% of patients improved by more than 75% at 12 weeks after administration of Cibinqo, compared with 11.8% of the placebo group. The percentage of patients with more than 90% improvement in symptoms was also 38.6% in the Cibinqo group and 5.3% in the placebo group. JAK inhibitors such as Cibinqo have been approved with atopic dermatitis indications in Korea, and treatment benefits are expected to return to patients. Lilly's Oluminant, which was previously used to treat rheumatoid arthritis, obtained an additional indication for treatment of secondary or severe atopic dermatitis in patients subject to systemic therapy in May. AbbVie's Rinvoq was also approved this month for use in adults suffering from severe atopic dermatitis and patients over the age of 12. Rinvoq has also been used as a treatment for rheumatoid arthritis. Analysts say that if Pfizer JAK inhibitory oral treatments are approved, they may lead the atopic dermatitis treatment market. This is because PO formulations are convenient to use. Sanofi's Dupixent, which was launched in 2018, dominates the atopic dermatitis treatment market. Dupixent is the first targeted biological therapy developed for atopic dermatitis, and is gaining high popularity as soon as it is released in Korea. Last year, it recorded annual sales of 23.6 billion won based on IQVIA.
- Policy
- "Annual unused drug returns record ₩2.7 trillion”
- by Lee, Jeong-Hwan Oct 22, 2021 05:45am
- NA member Jung-sook Suh (Pic provided by NA Press Corp) NA member and pharmacist Jung-sook Suh of the People Power Party urged the Ministry of Health and Welfare and the Ministry of Food and Drug Safety to present a specific solution to resolve the long-standing issue of ‘unused surplus inventory of drugs' in pharmacies. Currently, the burden of the unused surplus drugs is solely borne by the community pharmacists that owns or operates pharmacies, and Suh’s request is that the ministries should operate a consultative group with pharmacists’ associations, pharmaceutical industry, and the distribution industry to come up with a practical and direct solution. On the 21st, Suh criticized that “Medicines are public goods, therefore, the issue of surplus inventory of drugs should be resolved by the government with policies. However, the authorities have been passing on the responsibility to the private sector.” Surplus inventory of unused pharmaceuticals had remained a long-standing issue in the pharmacy community since the separation of prescribing and dispensing drugs. However, no clear solution has been found yet. In particular, a considerable amount of normal drugs are being disposed of without being used, which is increasing the socioeconomic cost and even causing environmental pollution. According to Suh, the total amount of surplus inventory of unused drugs that were returned to wholesalers and manufacturers amounted to ₩13 trillion during the past five years, which roughly translates to an average of ₩2.7 trillion per year. Suh pointed out that returns of opened drugs are a major nuisance in pharmacies, and 100 billion's worth of returns and losses occur every year due to such returns. Suh said that the cause and responsibility for this surplus inventory of unused pharmaceuticals are due to the government’s policy failure. As the government has been transferring the burden and responsibility of surplus inventory of drugs to the private sector, it now needs to establish a system for returning unused drugs and standardize the return process at the government’s level. Suh also pointed out that a private consultative body consisting of members of the MOHW, MFDS, Korean Pharmaceutical Association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, and Korean Pharmaceutical Distribution Association that had been established in August to seek solutions on the issues of unused inventory drugs and out-of-stock drugs should come up with a solution. Suh emphasized, “Various government agencies, KPA, the pharmaceutical industry, and distributors have recognized the issue of unused inventory drugs and established a consultative group. The group should discuss pending issues in depth including the mushrooming generics, generic substitutions, and small packaging unit supply of drugs. She added, “The responsibility should be shared by relevant associations and not be borne solely by the pharmacies. With a strong will to resolve the issues, the relevant bodies should promptly prepare a practical solution.”
- Company
- Supreme court to finally rule on ‘Galvus’ patent dispute
- by Kim, Jin-Gu Oct 22, 2021 05:45am
- The 4-year long patent dispute over the patent of the anti-diabetic DPP-4 inhibitor ‘Galvus (vildagliptin)’ will finally come to an end at the Supreme Court on the 28th. Industry officials believe that the Supreme Court’s decision may affect and modify the overall patent strategies of generic companies in the coming future. If the Supreme Court rules in favor of Ahn-Gook Pharmaceuticals, this will greatly increase the number of challenges filed on substance patents of original drugs, which have been considered impregnable. ◆Will the first ‘invalidation of substant patent extension’ case be born? According to industry sources on the 20th, the Supreme Court issued a notice that it will rule on the Galvus patent dispute between Ahn-Gook Pharmaceutical and Novartis on the 28th. The issue, in this case, is how much of the "extended duration" of the drug substance patent will be considered invalid. The industry anticipates that the Supreme Court’s decision may affect and modify the overall patent strategies of generic companies that will be made. Until now, there has never been a case in which a generic company has overcome the extended term of a drug substance patent.” If the supreme court rules in favor of the generic company and renders even one day of the extended patent term invalid, this will may trigger a series of challenges on substance patents of original drugs, an area that has been considered impregnable. On the other hand, if the Supreme Court accepts Novartis’ claim and recognizes the entire extended period as is, generic companies are expected to maintain their current patent strategy. ◆Mixed rulings at 1st and 2nd trial… what will the Supreme Court’s ruling be? Patent rights are usually protected for 20 years from the filing date. For pharmaceutical products, the time taken for clinical trials and regulatory approval is added to the term. Depending on the recognized period, patent protection for a drug can last 21 years or even 22 years. The same applied to Novartis when applying for Galvus’s patent in Korea. The company requested the patent term for Galvus to be extended to make up for the time spent on clinical trials and for the regulatory review by the Ministry of Food and Drugs Safety. The Korean Intellectual Property Office accepted the request and extended the term by 2 years, 2 months, and 23 days (1068 days). Pic. of GalvusAhn-Gook Pharmaceutical claimed that ‘187 days’ of the extended term for Galvus’s substance patent was invalid. Hanmi Pharmaceutical later joined in the fight. The court ruled in favor of Ahn-Gook Pharmaceutical in the first trial. The Patent Court of Korea accepted Ahn-Gook’s claim and ruled the 187 days invalid. With the ruling, Ahn-Gook Pharmaceutical received the right to release its generic 187 before the expiry of Galvus’s substance patent. Novartis got a partial win in the second trial. The Intellectual Property Trial and Appeal Board had overturned the first instance judgment and ruled that only 55 of the 187 days are invalid. Despite the reduced period, the ruling still rendered a part of the period invalid. As a result, Ahn-Gook did lose the suit but reaped the rewards. Novartis once again appealed, and the case is now being reviewed by the Supreme Court. Novartis is claiming that not a single day should be rendered invalid. The Supreme Court's ruling is expected to be one of the three – recognizing the ‘187 days invalid’ by accepting the ruling of the first trial; recognizing the ’55 days invalid’ by accepting the ruling of the second trial, or accepting Novartis’ claim and not recognizing any part of the term invalid.
- Policy
- There are expectations & concerns about ordering research
- by Lee, Jeong-Hwan Oct 22, 2021 05:44am
- While the government has ordered a study on preferential treatment for domestic new drugs developed by innovative pharmaceutical companies, domestic pharmaceutical companies with new drug technology are expressing both expectations and concerns at the same time. As the government accepts demands from the pharmaceutical industry and criticism from the National Assembly, many pharmaceutical companies think positively about the possibility of enacting a sub-law on innovative new drugs in the Special Act on the Pharmaceutical Industry within next year. International trade friction is not a problem that can be solved by the MOHW alone, but trade pressure-related ministries such as the Ministry of Commerce, Industry and Energy can also make opinions, and if there is a difference in positions between the MOHW. On the 20th, the domestic pharmaceutical industry is paying keen attention to the direction of promoting the "Study on Pharmaceutical Price Support Policy of Innovative Pharmaceutical Companies in Conformity with the International Trade Order" announced by the KHIDI to Korea Online E-Procurement System on the 19th. Pharmaceutical companies said that in order to enact a subordinate law on the preferential treatment of innovative new drugs without problems, the key is to create a "policy and fast policy" by regularizing cooperation between government ministries and government-pharmaceutical companies. First of all, members of the National Assembly's Health and Welfare Committee criticized the absence of Article 17-2 of the Special Act on the Pharmaceutical Industry in this year's parliamentary audit. Pharmaceutical companies are welcoming the Ministry of Health and Welfare's order for research services through the KHIDI. Analysts say that the government has officially promised to enact subordinate laws that have been empty for more than two years after the law was created due to the order of research services. In particular, pharmaceutical companies are positively evaluating the fact that the research service, which was originally scheduled to be ordered next year, has been drastically advanced by nearly half a year due to the announcement of the results in October this year and May next year. Pharmaceutical companies are raising expectations, saying, "More effective domestic drug price preferential measures could be created," when the study included incentives such as suspension and restriction of drug prices after listing for the first time since the development of innovative drugs. Pharmaceutical companies suggested that domestic pharmaceutical companies' willingness to develop new drugs should be specified in the subordinate laws to enjoy the effect of promoting and encouraging domestic pharmaceutical companies' willingness to develop new drugs. Pharmaceutical experts say that the first listed drug price preferential treatment helps domestic new drugs acquire good drug prices in overseas markets when entering the global market, and that the post incentive gives them an advantage over other competitive drugs in the domestic market. An official from A Pharmaceutical, which owns a new domestic drug, explained, "It is positive that the government took the pharmaceutical industry's appeal and the National Assembly's criticism heavily and ordered research sooner than expected. We can expect the government to introduce a specific domestic drug preferential policy in the second half of next year." An official from Company A said, "The fact that we will conduct drug price preferential research, including incentives to lower drug prices, is also in favor of substantially increasing the effectiveness of drug preferential treatment," adding, "However, the upper limit preferential clause should also be prepared at a level without friction." "Only when the government sets the initial registration price for new domestic drugs can it competitively receive drug prices in overseas countries when exporting," he stressed. Pharmaceutical companies expressed serious concern about the fact that even after the ordered study was successfully completed, it could not be introduced or reflected as an actual policy or could be privately cultured. Even if the MOHW and the promotion agency come up with a drug preferential measure without trade friction in the study, pharmaceutical companies are nervous about the possibility that other government ministries, including the Ministry of Commerce, Industry and Energy, will not be reflected as the final policy. If the research agency and the MOHW, which are working-level government ministries enacting subordinate laws, fail to empathize and communicate with the health industry promotion department, the research was completed, but the drug preferential policy could lead to negative results. "In the actual research service process, the Promotion Agency and the MOHW should have a common goal with close consultation," said an official at drug price management at Pharmaceutical B, which owns new domestic drugs. An official from Company B said, "It is difficult to improve the basic evaluation method that only some innovative pharmaceutical companies can preferentially treat new drugs, and it is not easy to avoid controversy." The official said, "In the end, sophisticated sub-laws are needed in the research process to prevent the MOHW from wanting to provide drug preferential treatment," adding, "Efforts should be made to create a drug preferential law that does not differ in opinion between the pharmaceutical field and the government policy."
- Company
- COVID antibody kits are entering the market of clinics
- by Kim, Jin-Gu Oct 22, 2021 05:44am
- Although the sale of COVID-19 antibody diagnostic kits to pharmacies has been banned, diagnostic kit companies are speeding up into the market, especially in hospitals and clinics. It is explained that the industry's impact from the government's measures is not significant because it has focused on the hospital and clinic markets rather than pharmacies in the first place. Although it is said that there is a limit to accurately confirming the effectiveness of the COVID-19 vaccine, related companies are expecting to expand the market in the future due to the increase in vaccination rates. ◆The impact of banning the sale of pharmacies will be limited to some companies According to the diagnostic kit industry on the 20th, the government's ban on selling antibody diagnostic kits at pharmacies is not expected to have a significant impact on the entire antibody diagnostic kit market. This is because most companies have focused on the hospital and hospital markets, not pharmacies. Industry officials say that only a small number of companies have supplied products to pharmacies. According to the MFDS, 14 products from 11 companies were approved as antibody diagnostic kits as of the end of last month. However, about two of them were distributed to pharmacies. ◆The vaccination rate is close to 70%. The demand for antibody diagnostic kits is increasing On the contrary, some companies are expressing expectations in that demand for on-site is expanding as the vaccination rate increases. As of midnight on the 20th, the complete COVID-19 vaccination rate in Korea reached 66.7%. It is expected to exceed 70% within this month. In particular, it is reported that the demand for the vaccine effect has increased further recently as the effect of the COVID-19 vaccine has dropped sharply within two to six months. It is confirmed that front-line hospitals are using antibody diagnosis kits as non-reimbursed items for confirmation of vaccine effects. ◆Pharmaceutical companies are expressing regret over the government's position of "not being able to confirm the vaccine effect" However, the fact that the government reiterated that "there is a lack of medical evidence for the purpose of confirming the vaccine effect" is a common concern among diagnostic kit companies. The diagnostic kit industry has focused on exploring related markets around the time when the domestic complete vaccination rate exceeded 10%. They expected the market for neutralizing antibody diagnostic kits to confirm vaccine effects to grow explosively. However, in July, the government said, there was a lack of medical evidence for the purpose of confirming the effectiveness of the vaccine. The government reaffirmed its position by banning the sale of pharmacies. ◆It is impossible to determine the vaccine effect by simply producing neutralizing antibodies There are three types of domestic approved diagnostic kits. It is a PCR, antigen, and antibody diagnostic kit. PCR and antigen diagnostic kits are used to confirm suspected COVID-19 patients. Antibody diagnostic kits are used to determine if people have been infected with COVID-19. People who have been infected with COVID-19 develop binding antibodies, which is the principle that antibody diagnosis kits check whether or not binding antibodies are produced. The diagnostic kit industry focused on the fact that it can also check whether neutralizing antibodies are produced with antibody diagnostic kits. Neutralizing antibodies are antibodies that occur after vaccination. They have argued that their own clinical results can determine whether neutralizing antibodies are produced with 90% accuracy. The government is in a position that it is difficult to determine the effectiveness of the vaccine simply by producing neutralizing neutralizing antibodies are produced. This is because in order to check the vaccine effect, it is necessary to determine how much neutralizing antibodies are formed in the body.
- Policy
- Janssen, granted permission to import advanced bio medicines
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- Janssen Korea has obtained the second approval for the import business of advanced bio medicines after Novartis Korea. Janssen is also expected to introduce related products in the near future because advanced bio-medicine items designated by the MFDS can only be approved if it is approved for the advanced bio-medicines import business. On the 18th, the MFDS approved Janssen Korea as an advanced bio-medicine importer. Advanced bio-medicine is a new category of medicines created when the Advanced Regenerative Medicine and Advanced Bio-medicine Safety and Support Act was enacted and enforced in August last year. Cell and gene therapy mainly belong to advanced bio medicines. Existing cell and gene therapy drugs have been approved by the Pharmaceutical Affairs Act, but a separate management system has been established in accordance with the new law. All items approved as new items after the enforcement of the law are Novartis products. Previously, Novartis was the only importer to obtain advanced bio-medicine import license. Novartis has been approved for Kymriah, the No. 1 domestic CHIMERIC anti-gen receptor-T cell (CAR-T), as well as Zolgensma and Luxturna. All of these are expensive and "one-shot" treatments that can be treated with one use. Attention is currently being paid to benefit negotiations in that it is a new concept of medicine and is being sold at high prices. Janssen is also expected to rush to introduce related products in Korea as it has acquired a high-tech biopharmaceutical import business this time. Janssen is in the process of overseas listing of products such as "Cilta-cell," a CAR-T treatment that treats multiple myeloma. The MFDS designated the drug as a rare drug in August last year. It is also developing gene therapy for rare retinal diseases. Luxturna, approved by Novartis, is also a gene therapy that treats rare retinal diseases. As Novartis preoccupies advanced bio-medicine in Korea, Janssen is also preparing for approval. With the gradual introduction of advanced biomedics overseas in Korea, serious discussions on drug prices and follow-up management seem to be needed.
- InterView
- Merck will “focus on specialty care capabilities"
- by Eo, Yun-Ho Oct 21, 2021 05:14am
- Javed Alam, General Manager of Merck Biopharma Korea The global chemical and pharmaceutical company Merck is working intently to strengthen its capabilities in the pharmaceutical sector. The company, whose main areas of expertise are liquid crystal and LED, has also been continuing its commitment to introduce new drugs, starting with the anticancer drug ‘Erbitux (cetuximanb),’ the immune-oncology PD-L1 inhibitor ‘Bavencio (avelumab)’ that was co-developed with Pfizer, to the recently approved multiple sclerosis treatment 'Mavenclad (cladribine).’ Dailypharm met with Javed Alam, the General Manager of Merck Biopharma Korea, who has celebrated his 2nd year at the company, to hear about Merck’s vision in the healthcare business. -You have spent most of your time here since your appointment in the COVID-19 pandemic. Could you tell us about your impressions and thoughts about your work here in Korea, and the achievements that were made?. I would have to say my time here was crisis after crisis due to the COVID-19 pandemic. However, despite the COVID-19 pandemic, we were able to protect our employee’s health and safety while continuing communication with our customers and ensuring a smooth supply of products for our patients, based on which we achieved business growth during the past 2 years. In the midst of the COVID-19 crisis, our company had focused on Specialty Care and efficiently reorganized the organization, and carried out our roles smoothly so that there were no disruptions in the supply of our products. In addition, we made various efforts such as actively embracing the use of digital channels to communicate with our customers to frequently update them on the company’s situation. Also, I take special pride in the fact that no Merck Biopharma Korea employee has had COVID-19. -- New changes have occurred in the Pharma business area, such as the launch of new products. Does this mean the company is seeking a change of tone? Merck’s goal in global healthcare is to become a Global Specialty Innovator, under which Merck Biopharma Korea aims to become the most innovative specialty care company in Korea. To achieve this goal, the company had to undergo various changes in its business model, company structure, organization, etc. While making such changes, we also changed our corporate culture to focus on restructuring the business model to focus on specialty care and digitalization. Through these efforts, we expanded our digital channel from 1 to 8, including webinars, websites, and web meetings. Also, the company made various changes structure-wise, and these various efforts have fortunately paid off to benefit the company. -I can see the company’s strong commitment to specialty care. The Specialty Care unit covers rare and incurable diseases that are difficult to diagnose or cure. The number of patients and specialists for such diseases is relatively small, and that is why it is also an area that has the highest unmet need from patients. Among various areas of specialty care, Merck is focusing on 4 areas - Immuno-oncology∙Oncology, Neurology∙Immunology, Infertility, and Endocrinology. Erbitux has been showing good performance in our existing Immuno-oncology unit. In the recent KSMO Annual Meeting, & Conference we have presented the results of OPTIM1SE that demonstrated the drug’s clinical safety and efficacy in Korean patients. In addition, we have also released the immuno-oncology drug ‘Bavencio (avelumab)’ that was co-developed with Pfizer in our efforts to become a specialty care leader. Bavencio is a treatment for Merkel cell carcinoma (MCC) which is a rare and aggressive type of cancer that has a 5-year survival rate of 0-20%. I believe we were able to provide new hope to these patients with Bavencio. In Neurology∙Immunology, we have the multiple sclerosis treatment Mavenclad (cladribine). Multiple sclerosis occurs most commonly in women in their prime - 20s to 30s - causing difficulty in their life and treatment. However, Mavenclad’s innovative dosing and administration allows patients to only take Mavenclad for up to 20 days over 2 years, and then be free from additional dosing requirements for the other 2 years. -What kind of efforts have Merck Biopharma Korea made to advance Korea’s healthcare industry? We have been actively participating in clinical programs and global trials to increase Korea’s level of contribution and influence. Korea is involved in all of the 20 global clinical programs at Merck including its key 7 programs. By actively participating in R&D and the clinical stage, we are increasing our contribution to Merck’s portfolio and ultimately increasing Korea’s influence in the global market. Also, we have been making efforts to increase Korea’s contribution in earlier stage innovation. For example, we help promising startup venture companies in Korea to connect with Merck’s innovation program. The ‘Merck Accelerator program’ has supported a total of 12 companies worldwide until now, and ‘Inhand Plus,’ a Korean startup, was the first in Korea to be selected to receive benefits from the program. -Could you briefly introduce the company’s pipeline products that you plan to introduce in Korea in the future? Merck Biopharma Korea is striving to showcase innovation in all areas of its involvement, therefore, you can continue to expect innovative changes and products from us in the future. In the past, the company had depended heavily on primary care products. However, now, as the Global Specialty Innovator, we hope to become an unrivaled company in specialty areas. Our first goal is to maximize our Korean patients’ accessibility to the company’s excellent pipeline products. Merck Global Is focusing on enriching its entire pipeline, and we will continue our efforts to promptly and broadly introduce all the innovative solutions, products, and technology that is and will be developed by Merck to our patients in Korea.
- Policy
- Vegzelma is the name of Celltrion's Avastin biosimilar
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- Celltrion reported on the 1st that it had submitted an application for approval of the biosimilar "CT-P16" of Avastin (Bevacizumab), Roche's colorectal cancer treatment, to the MFDS and the U.S. FDA. According to the MFDS on the 19th, Celltrion's Avastin biosimilar, which was recently applied for permission, is Vegzelma. This is the first time that the brand name of the development project CT-P16 has been known. Celltrion also registered trademark rights for Vegzelma with the Korean Intellectual Property Office in November last year. Celltrion has conducted a global clinical trial on a total of 689 people in 20 countries in Europe, South America, and Asia since 2018 and applied for permission for Full Label approved for Avastin, including metastatic and non-small cell lung cancer. The company said it plans to launch it on the market sequentially from the second half of next year once it is approved by each national agency. Currently, two Avastin biosimilars have been approved in Korea. In March, Samsung Bioepis' Onbevezy was approved for the first time in Korea, and in May, Pfizer's Jairabeve was approved. In September, Boryung started selling Onbevezy in Korea. Another item was found to have applied for permission in August, which is expected to lead to fierce competition in the Avastin biosimilar market. Since Avastin is a mega-sized item with annual sales of about 120 billion won in Korea alone, Avastin biosimilars are looking for opportunities to increase their performance.
- Policy
- The status of clinical trials is reported annually
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- The subject of conditional approval and Priority review will be more clarified, and follow-up management will be strengthened. Previously, conditional approval regulations were in the notice, but it is expected that management and operation will be strengthened, including related contents in the Pharmaceutical Affairs Act, and procedural justification will be secured. The MFDS announced on the 19th that it had announced some amendments to the rules on drug safety. The revision was prepared to stipulate detailed standards for matters delegated by the revised Pharmaceutical Affairs Act on July 20. The revised bill included ▲simplification of the sample collection procedure for drugs approved for shipment to the state in the event of a public health crisis,▲ regulations on the subject and procedure of conditional permission and priority examination, ▲ regulations on the subject and procedure of disclosure of the results of item permission and report examination, ▲adding the scope of raw materials and drugs subject to registration with overseas manufacturing companies, ▲ exemption from separate designation procedures for performing sample analysis work at a medical institution designated as a clinical trial institution, and ▲ the deletion of some exemption criteria for labeling and description of non-drugs such as sanitary pads and masks. Conditional approval and priority review targets are defined as treatments for severe diseases and rare drugs. ▲Those who have obtained conditional permission report the clinical trial status by the end of March every year, and submit a report on the clinical trial results after the clinical trial is completed. ▲Drugs subject to the Priority Review will be reviewed within 40 days. The subject of disclosure of the results of the product license and report review was defined as finished drugs, and the results of the review were disclosed within 180 days from the date of product license and report with the opinion of the product licensee. The revision included medical institutions designated as clinical trial institutions so that they can perform related tasks even if they are not designated as clinical trial sample analysis institutions. Currently, sanitary pads and masks were exempted from labeling such as efficacy, effectiveness, dosage, and consignment manufacturers, but in the future, they will be listed the same as other pharmaceutical products. National lot release-targeted drugs, such as biological agents, should be collected by MFDS officials and sealed the number of lot release applications, but companies will be able to collect samples needed for testing and submit them to the Minister of Food and Drug Safety. The MFDS said it expects the preparation of detailed regulations on conditional approval and priority review to help expand patient treatment opportunities and quickly supply medicines, and that it will actively review and improve the drug safety management system. Organizations or individuals with opinions on this amendment can submit their opinions to the MFDS or the National Participation Legislative Center by December 20, 2021. For more information on the amendment, visit Korea Ministry of Government Legislation (opnion.lawmaking.go.kr) or It can be found in the MFDS (mfds.go.kr) → statutes and data → legislative/administrative notices.
- Company
- Q3 exports of Biopharmas 'Good’ Diagnostic kits ‘Slow'
- by Kim, Jin-Gu Oct 21, 2021 05:13am
- While pharmaceutical exports in Q3 increased slightly compared to the same period of the previous year, the performance of biopharmaceuticals and chemical drugs have shown mixed results. Export of biopharmaceuticals increased 13% YOY and continued on its strong flow from last year, however, export of chemical drugs fell 13%. Also, diagnostic kits, which rose as an export ‘cash cow’ after the COVID-19 outbreak, saw a decline in export value amount despite the large increase in export volume. The analysis is that this may be due to the continued decline in its export unit price. ◆Earned ₩6.8 trillion in Q3 exports….will the industry exceed last year’s ‘largest ever’ record? According to Korea Customs Service on the 15th, the domestic export value of pharmaceuticals in Q3 was $1.86 billion (approx.. ₩2.2 trillion). This is a 6% YOY increase from the $1.76 billion (approx.. ₩2.07 billion) in Q3 last year. The cumulative amount of exports by Q3 has increased 26% from $4.60 billion (approx. ₩5.44 trillion) last year to $5.77 billion (approx. ₩6.82 trillion) this year. If this trend continues, the industry may break the all-time export record that it made last year. The total pharmaceutical exports last year amounted to $6.89 billion (approx. ₩8.15 trillion). However, exports last year were concentrated around Q4. In Q4 last year, the industry earned $2.30 billion (approx. ₩2.71 trillion), accounting for 33% of the total amount of exports of the whole year. ◆Biopharmaceuticals increase 13% · Chemical drugs decrease 13% … shows clear difference between areas In detail, the export between biopharmaceuticals and chemical drugs have shown mixed results. In Q3, export sales of biopharmaceuticals amounted to $1.4485 billion (approx. ₩1.71 trillion) and increased 13% YOY. The analysis is that the export of biopharmaceuticals is continuing to show good flow. The share of biopharmaceuticals contributing to the total pharmaceutical exports also rose 5%p from 73% in Q3 last year to 78% in Q3 this year. Export of biopharmaceuticals has soared over the past 2 years, mainly around biosimilars from Celltrion and Samsung Biologics. Biopharmaceutical exports doubled from $430.17 million (approx. ₩510 trillion) in Q1 2019 to $868.95 million (approx. ₩1.03 trillion) in Q1 2020 and doubled once more to $1.81 billion (approx. ₩2.14 trillion) in Q1 this year. On the other hand, the export of chemical drugs fell 13% from $467.81 million (approx. ₩550 billion) in Q3 last year to $408.8 million (approx. ₩480 billion) in Q3 this year. ◆Export volume of diagnostic kits the greatest-ever… however value earned falls 5% in one year Also, the export performance of diagnostic kits that soared after the COVID-19 outbreak has been slowing down recently. In Q3 this year, exports of domestic diagnostic kits amounted to $570.37 million (approx. ₩670 billion), which is 5% lower than the $600.41 million (approx. ₩710 billion) in Q3 of last year. By each quarter, sales of diagnostic kits increased steadily until Q4 last year, and then was showing signs of stagnation entering this year. This is due to the worldwide COVID-19 vaccinations that began earlier this year, and the falling unit price of the kits due to intensified competition between global diagnostic kit companies. By export volume, quarterly exports of diagnostic kits set a new record of 2,517 tons in Q3 this year. This is much larger than the export volume in Q3 last year - 1,467 tons. In other words, the export value fell 5% despite a 72% increase in exports export volume in the same period.
