- LOGIN
- MemberShip
- 2026-03-16 21:30:23
- Company
- NPU condemns the unilateral ERP of multinational companies
- by Aug 29, 2022 06:02am
- The NPU condemned global pharmaceutical companies' unilateral ERP moves. The NPU, which gathered 16 domestic and foreign pharmaceutical bio companies, issued a statement on the 24th, signaling a strong response, saying, "Some member companies have recently shown unilateral voluntary retirement, wage negotiations that do not fit common sense, and collective agreement negotiations." NPU claimed that even though global pharmaceutical company A made the largest sales ever with COVID-19 vaccines and treatments, it is trying to conduct forced restructuring under the guise of ERP for many sales department employees in the name of changing business models. Global B Pharmaceutical Company claims that it is conducting ERP without unilaterally breaking the agreement between labor and management on the logic that ERP is not a cut despite the agreement between labor and management regarding employee cuts. The NPU then noted, "Global Company C is shaking employees with rumors that they will inevitably take voluntary retirement as a global policy as if they were riding on this situation." Global companies D and E have a wage problem. Company D presented a very low wage increase rate of 1.5% in the unprecedented high price and high interest rate situation, and the NPU claims that Company E is changing employee performance pay disadvantageously and not providing fuel costs. Finally, Company F mentioned that it is attempting to neutralize the union so that the union cannot be involved in the collective agreement negotiations and that users can proceed unilaterally. The NPU said, "I'm sure that the reason why this happened is because there are forces that lead it, and I think that those forces are representatives of some HR's user interests." The NPU warned, "We will condemn the behavior of ignoring the union without recognizing it as a counterpart, and will carry out a campaign to step down so that the forces leading it will no longer be established in the industry." On the same day, the Korea GSK union also issued a statement condemning the management's unilateral voluntary retirement. GSK Korea announced on the 16th that it will conduct voluntary retirement for employees of the sales department. Applicants will be accepted by the end of this month. In response, the union said, "This voluntary retirement is due to outsourcing of certain departments, and according to Article 21 of the agreement, we agree with the union when the reduction is carried out due to unavoidable management," adding, "But the management notified the union 30 minutes ago." After the surprise announcement, they are pushing ahead with one-on-one interviews with the employees, and putting psychological pressure on early applicants within a week by applying additional payment conditions. The union said, "The union stopped the management's actions and demanded negotiations for discussions in accordance with the principle of good faith that has continued so far, but the ERP, which was able to proceed smoothly with avoidance, faced considerable conflict." The union urged "to immediately stop layoffs disguised as ERP."
- Company
- HK inno.N, Daewoong, & Jeil are competing to secure K-Cab
- by Kim, Jin-Gu Aug 29, 2022 06:02am
- HK Innoen K-Cab and Daewoong Pharmaceutical Fexclue Competition is expected to expand beyond P-CAB to PPI HK inno.N and Daewoong Pharmaceutical are competitively expanding the indication of P-CAB series gastroesophageal reflux disease treatment. On top of that, Jeil Pharmaceutical is planning to join the competition by operating two clinical trials at the same time to launch the third gastroesophageal reflux disease treatment. The pharmaceutical industry predicts that competition in the gastroesophageal reflux disease treatment market, including P-CAB-based drugs as well as PPI-based drugs, will intensify in the future. On the 22nd, Daewoong Pharmaceutical announced that the indication of Fexclue, a new drug for treating gastroesophageal reflux disease, has been added. Fexuclu, which previously received indication for treatment of erosive gastroesophageal reflux disease, added indication of "improvement of gastric mucosal lesions (10mg) of acute and chronic gastritis." In particular, acute and chronic gastritis is an indication that is not present in the competing drug HK Inno. N's K-Cab Daewoong Pharmaceutical plans to focus on highlighting such differences in competition with HK Inno.N. HK Inno. N is also focusing on expanding the indication of K-Cab. Currently, K-Cab has five indications, including erosive gastroesophageal reflux disease, non-irritating gastroesophageal reflux disease, gastric ulcer, combined antibiotic therapy for Helicobacter pylori eradication, and maintenance therapy (25 mg) after treatment of erosive gastroesophageal reflux disease. Phase 3 clinical trials are underway as a "preventive therapy for gastric and duodenal ulcers that induce nonsteroidal anti-inflammatory analgesics." The clinical trial began with the goal of recruiting 390 patients in October 2020. HK Innoen plans to complete clinical trials by the end of this year. Jeil, which aims to approve the third P-CAB-based gastroesophageal reflux disease treatment, also started two clinical phases at the same time. Jeil is developing a P-CAB-based gastroesophageal reflux disease treatment under the name JP-1366 through its subsidiary Oncherapeutics. In December last year, phase 3 clinical trials for patients with erosive esophagitis were launched, and in May this year, phase 3 clinical trials for patients with gastric ulcer were approved.
- Company
- Zerbaxa on the verge of entering insurance benefits in 5 yrs
- by Eo, Yun-Ho Aug 26, 2022 05:35am
- The next-generation antibiotic Zerbaxa is finally registered as insurance benefits. It is the first time in five years that a domestic permit has been granted. According to related industries, MSD recently concluded a drug price negotiation with the NHIS for the antibiotic Zerbaxa. Due to the improvement of the system, it is possible to step on the PE track. The drug was approved in Korea in April 2017, but the prevailing view was that it was difficult to register under the system at the time. This is because it is not easy to prove cost effectiveness compared to the existing Old Drug, and it is difficult to prove clinical superiority due to the nature of the drug. Zerbaxa submitted an application for registration in the second half of 2018 and went through the procedure, but failed to pass the HIRA's committee in 2019. Zerbaxa has seen hope as the government has implemented an improvement plan to include essential drugs such as antibiotics in PE targets as a way to expand coverage. Zerbaxa passed the Drug Evaluation Committee in June this year and concluded the drug price negotiations, leaving only the passage of the Health Insurance Policy Review Committee until its listing. New Cephalosporin antibiotics Ceftolozane and Zerbaxa, a beta-lactamase inhibitor Tazobactam complex, which have an antipseudomonas aeruginosa effect, can be used in adult patients with complexity urinary tract infections and Metronidazole combination therapy. It is meaningful that it is the first alternative option at a time when the three major super bacteria in urgent need of securing treatments are Cabapenem-resistant fungi, Cabapenem-resistant Acinetobacter baumannii bacteria, Cabapenem-resistant and third-generation Cephalosporin-resistant intestinal bacteria.
- Company
- First patient dosed with Yuhan’s degenerative disc drug
- by Aug 26, 2022 05:35am
- Yuhan Corp (President/CEO: Wook-Je Cho) announced on the 25th that the first patient was dosed with its new degenerative disc drug, “YH14618(SB-01, Remedisc).” The clinical trial was led by the US pharmaceutical company Spine BioPharma on 400 degenerative disc patients at 30 clinical sites in the US. The Phase III trial was conducted to evaluate the improvement in persistent pain and other related disorders and the safety of YH14618 for 6 months after initial intradiscal injection. With a 12-month follow-up period, the results of the Phase III trial are expected to be secured by 2024. Yuhan Corp received the license for YH14618 from Ensol Biosciences in 2009 for domestic development. The company had licensed out the development rights and global commercialization rights (in countries other than Korea) for YH14618 to Spine BioPharma in 2018. With the first dosing of a patient complete for the Phase III trial, Yuhan Corp will receive a $2 million milestone payment (₩2.7 billion) as royalty from Spine BioPharma. YH14618 is a peptide drug that is injected into the spine to induce disc regeneration that is receiving expectations to satisfy the unmet need in the degenerative disc market where no cause or cure is yet available. An official from Yuhan Corp said, “This smooth start in the Phase III trial had been made possible through several years of close cooperation between Yuhan and Spine BioPharma. Spine Biopharma was able to receive approval to bypass the Phase II trial and initiate a Phase III trial from the US FDA based on the results of the clinical trial conducted by Yuhan Corp in Korea. We expect the speed of development to commercialization to accelerate after entry of the Phase III trial.”
- Company
- LG Chem Life Science achieves new quarterly sales record
- by Kim, Jin-Gu Aug 25, 2022 05:52am
- LG Chem’s Life Science company, which is in charge of the company’s pharmaceutical business, has broken its quarterly sales record in the second quarter of this year. Its flagship products - the Zemiglo series and growth hormone - had shown strong sales performance in Korea and abroad, rising nearly 20% in one year. According to the Financial Supervisory Service on the 24th, LG Chem’s Life Science sector recorded ₩205.2 billion in sales in Q2 this year. This is a 17.8% increase from the ₩174.2 billion made in Q2 last year. The cumulative sales in 1H this year were ₩408 billion. If the company maintains the current growth rate, it may record sales of nearly ₩1 trillion by the end of the year. The company has continued stable growth despite the prolonged COVID-19 crisis. Compared to Q2 2019 (₩152.3 billion) before the COVID-19 crisis, this is a 34.8% increase made in three years. This strong growth is interpreted to be the result of the strong performance shown by the company’s flagship product, “Zemiglo” series, the growth hormone “Eutrophin,” and hyaluronic acid injection for arthritis, “Synovian inj.” According to LG Chem, combined sales of the DPP-4 inhibitor type diabetes treatment “Zemiglo (gemigliptin),” its metformin combo “Zemimet,” and rosuvastatin combo “Zemiro,” recorded ₩32.6 billion in Q2 this year. The series recorded a 3% external growth compared to the ₩31.5 billion in Q2 last year and maintained its lead among DPP-4 inhibitor class diabetes treatments in Korea. In the same period, its domestic market share increased from 21.1% to 22.5%. In the case of Eutropin, another flagship product, its market share increased by 1%p from 41.0% to 42.0% in the The flagship products performed well in both the domestic and overseas markets. LG Chem Life Science’s exports increased 17.3% from the same period last year from ₩65.3 billion to ₩76.5 billion in Q2 this year. Domestic market sales increased 18.1% from ₩109 billion to ₩128.7 billion during the same period. However, the operating profits of the Life Science company in Q2 decreased 16.6% from ₩29.1 billion to ₩24.2 billion. LG Chem explained that profitability had decreased somewhat due to the rise of R&D expenses in line with progress made in the company’s clinical trials. LG Chem is conducting various clinical trials in Korea and abroad. In Korea, the company received approval for the Phase III clinical trial protocol of its precocious puberty treatment candidate “GPP001” in June. When development is completed, it is expected to create further synergy with the company’s existing growth hormone Eutropin. The company had also completed a Phase 3 clinical trial of the Zemiglo+metformin+dapagliflozin combination. In June, the combination was approved under the name of Zemidapa. Dapagliflozin is an SGLT-2 inhibitor class diabetes treatment, and if development is completed, Zemidapa is expected to become the company’s fourth Zemiglo series drug. The company is also developing new drugs for hereditary obesity and gout abroad. Among them, the company applied for a Phase III clinical trial for its new gout drug candidate “tigulixostat” to the US Food and Drug Administration (FDA) on August 1st. Also, the company is participating in the development of the immuno-oncology drug ‘CUE-102’ with its partner, Cue Biopharma. LG Chem owns the exclusive right to develop and market CUE-102 in 11 Asian countries including Korea, China, and Japan. LG Chem explained, “We plan to further expand R&D investment to develop global new drugs. In particular, we will focus on oncology which has high growth potential, and diabetes and metabolic diseases where we own extensive R&D experience.”
- Company
- Celltrion Applies to Europe for IND to designate Yuflyma
- by Aug 24, 2022 05:55am
- Celltrion announced on the 23rd that it has applied to European regulators for IND to designate Humira biosimilar Yuflyma (CT-17) as an interchangeable similar. If it is designated as an interchangeable similar, it can be prescribed by replacing the original at a pharmacy without intervention by MD. Celltrion recently submitted IND to the U.S. Food and Drug Administration (FDA) to secure a mutual exchange between Yuflyma and Humira. European clinical trials are conducted on 366 Plaque psoriasis patients in many countries, including Estonia and Poland. It plans to compare and verify pharmacokinetics, efficacy, and safety between the multiple cross-medication group between Yuflyma and Humira and the Humira maintenance medication group. Celltrion previously confirmed the efficacy, pharmacokinetics, and safety results similar to Humira through Global Phase 3 clinical trials of Yuflyma in patients with rheumatoid arthritis. Based on the clinical results, Yuflyma obtained permission to sell all indications held by Humira, such as RA, IBD, and PS, from EMA in February 2021 and is in progress. In the U.S., it has completed a patent agreement in the U.S. with its developer AbbVie so that it can start selling on July 1st next year. Celltrion expects FDA approval to sell Yuflyma within this year. When sales of Yuflyma begin in the U.S., it is expected that the advantages of high-concentration formulation, whether to secure interchangeable similarity status, and clinical results on various indications will serve as important competitiveness. Yuflyma is the first high-concentration Humira biosimilar to obtain permission from EMA, characterized by halving drug administration compared to low concentrations and removing citrate that can cause pain. An official from Celltrion said, "We believe that if Yuflyma secures its interchangeable biosimilar status through interchangeable clinical trials, it will greatly help expand its market share by strengthening its competitiveness." "High-quality bio at reasonable prices for global markets, including in Korea, while making every effort to prepare for clinical and licensing, and we will do our best to proceed with the supply of medicines."
- Company
- Omega-3 prescription market doubles in 3 Years
- by Kim, Jin-Gu Aug 23, 2022 06:03am
- KuhnilIt is expected that generic companies will join and fierce competition is expected. The market for Omega-3 is rapidly expanding. The performance of outpatient prescriptions in the first half of the year has more than doubled in three years. The prescription performance of Omega-3 and Statins has increased significantly. It is predicted that competition in this market will become fiercer in the future, centering on the omega-3 and Statin complex. According to UBIST, a pharmaceutical market research firm on the 17th, the size of outpatient prescriptions in the Omega-3 Rx market in the first half of this year is 72 billion won. Compared to the first half of 2019, it has expanded 2.1 times. This market is growing rapidly around 2020. Based on the quarterly prescription amount, it was below 20 billion won until the third quarter of 2019, but it surpassed 20 billion won in the fourth quarter and exceeded 30 billion won in the second quarter of 2021. In the second quarter of this year, it recorded 36.8 billion won, looking at the quarterly prescription amount of 40 billion won. While the Omega-3 single system has steadily expanded its influence, the Omega-3 and statin complex has joined in earnest, driving the market expansion. In fact, the prescription amount of omega-3 and statin composites in the first half of 2019 was only 2.4 billion won, but it increased 5.9 times in three years to 14.3 billion won this year. In July 2017, Kuhnil was approved for Rosumega as the first omega 3+ Rosuvastatin complex. Rosumega paid 600 million won in prescription that year, and increased to 4.1 billion won the following year. After recording 6.7 billion won in 2019, it has become a large item that pays about 10 billion won in prescriptions since 2020. With Rosumega on the market, other generic companies have joined the competition. In December 2020, Jeil, Yuyu, Boryeung, Kyung Dong, Korea Prime, and Futecs were granted generic of the Omega 3·Rosuvastatin complex. These products are manufactured by Kuhnil. Last year, United joined the new competition. Instead of commissioning production to Kuhnil, United challenged Kuhnil head-on through patent raids. United, which won the patent dispute, released Atmeg Combigel Soft Cap in the second quarter of last year as an Omega 3+ Atorvastatin compound. Atmeg Combigel is rapidly expanding its prescription performance with its release. The prescription amount, which was 1.2 billion won in the second quarter of last year, increased seven times to 8.3 billion won in the second quarter of this year. United plans to expand its performance to 20 billion won a year. It is expected to have more intense competition in the future, centering on the Omega-3 and Statin complex. Kuhnil was licensed for combination generics such as Atmeg Combigel, signaling competition. Along with Kuhnil, Daehannupharm, Dongkoo Bio, Hutecs, and Penmix are expected to enter the market. Kuhnil plans to produce their products on consignment. United plan to face Atmeg Combigel with new dosages. In addition to the existing Atorvastatin 10mg + Omega-3 1,000mg product, United has recently received approval for Atorvastatin 5mg + Omega-3 1000mg product. On top of that, it plans to release additional medicines with the same ingredients through its affiliated company Korea Biochem.
- Company
- Abilify 1mg can be prescribed at tertiary hospitals
- by Eo, Yun-Ho Aug 22, 2022 05:53am
- A new 1mg strength formulation of ‘Abilify’ can now be prescribed at general hospitals According to industry sources, Korea Otsuka Pharmaceutical's antipsychotic ‘Abilify (aripiprazole)’ has passed the drug committees (DCs) of major hospitals in Korea, including the Seoul National University Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. The company has been working to make prompt entry into the market after receiving reimbursement approval for its new strength in March this year. The 2mg, 5mg, 10mg, and 15mg strengths of Abilify have already been approved in the past. The introduction of the 1mg strength is the first change made in the product lineup in 6 years since the company received approval for ‘Abilify Maintena inj.’ In 2015. When narrowing the product line to Abilify tablets alone, this is the first change made in 13 years since 2008 when the 2mg tablet formulation was approved. Although a 1mg strength for Abilify did not exist in the past, prescriptions of the 1mg dose have been frequently made by splitting the 2mg strength tablet. The 1mg dose was used for dose-sensitive first-time patients with neuropsychiatric disorders etc. Whether Abilify may be able to secure its sales in the market that is being challenged by generics by introducing the low-strength formulation remains to be seen. According to the market research institution IQVIA, Korea Otsuka Pharmaceutical's Abilify series makes the most sales among all schizophrenia treatments in Korea. Its 3 products - Abilify tab, Abilify OD tab, and Abilify Maintena inj – had raised ₩50.9 billion in sales in 2020. With the same product line, the company made ₩27.4 billion in the first half of the year last year.
- Company
- Strong performance of overseas subsidiaries of companies
- by Kim, Jin-Gu Aug 22, 2022 05:52am
- Starting from the left, "Beijing Hanmi", "YANGZHOU ILYANG PHARM", "GC China"Daewoong Pharmaceutical's Southeast Asian subsidiary doubled in a year. Major overseas subsidiaries of pharmaceutical bio companies showed strong sales in the first half of last year. Most of the local subsidiaries in China and Southeast Asia showed an increase in sales compared to the same period last year. Beijing Hanmi, Celltrion AP (Asia-Pacific), and Celltrion USA set new sales records based on half-year sales. ◆ Beijing Hanmi records half-year sales According to the Financial Supervisory Service on the 20th, the combined sales of 22 Chinese local subsidiaries of 10 Korean pharmaceutical companies in the first half of the year were 314.8 billion won. It increased 14% compared to 275.4 billion won during the same period last year. Net profit increased 28% from 38.5 billion won in the first half of last year to 49.1 billion won in the first half of this year. Beijing Hanmi broke the previous half-year sales record by making 173.3 billion won in sales in the first half of the year. It increased 30% compared to 132.9 billion won in sales in the first half of last year. Half-year sales of Beijing Hanmi recorded around 120 billion won before COVID-19. In the first half of 2020, when COVID-19 was rampant in China, it plunged to 92.8 billion won. However, after recovering to 110.7 billion won in the second half of 2020, 132.9 billion won in the first half of last year, 155.8 billion won in the second half of this year, and 173.3 billion won in the first half of this year. Beijing Hanmi expanded its syrup factory last year. The operation rate of this plant has been maintained at 100% this year. An official from the U.S. in Beijing explained, "As a result of timely expansion of facilities and supplying products in line with the rapid increase in demand for respiratory patients and cold medicines in China, we achieved solid performance until the first and second quarters." Most of the other Chinese subsidiaries have also grown by a large margin. In the case of Chong Kun Dang, sales at Chong Kun Dang Health in Qingdao more than tripled from 1.1 billion won to 6.7 billion won. Guangdong Pharmaceutical's total sales in the first half of the year were 20.1 billion won, up 24% from the same period last year. Daewoong Pharmaceutical has four subsidiaries in China, including Sacheon Daewoong Biotechnology Limited, Liaoning Daewoong Pharmaceutical Limited, and Beijing Daewoong Pharmaceutical and Technology Limited. The combined sales of the four corporations increased 39% from 8.8 billion won to 12.3 billion won in a year. YANGZHOU ILYANG PHARM·TONGHUA ILYANG HEALTH PRODUCTS of Ilyang Pharmaceutical recorded 71.2 billion won in sales in the first half of the year. It increased by 5% compared to 67.7 billion won in the first half of last year. Among major Chinese subsidiaries, sales of GC Pharma's subsidiaries declined. Total sales of GC China and GC China Pharm fell 34% year-on-year to 29.8 billion won. ◆ Celltrion and Takeda products in earnest in the Asia-Pacific region, Diagnostic kits are booming in the U.S Local subsidiaries in Southeast Asia also performed well in the first half of the year. Particularly noticeable is Celltrion's Celltrion Asia Pacific PTE located in Singapore. It recorded 75 billion won in sales in the first half of this year. It nearly tripled from 25.2 billion won in the first half of last year. Net profit also shifted from a deficit of 6.8 billion won to a surplus of 9.7 billion won. Analysts say that the sale of 18 products acquired from Takeda Pharmaceutical has begun in earnest. Celltrion Pharmaceutical is in charge of sales in Korea, and Celltrion Asia Pacific PTE is in charge of sales in the remaining eight countries, including Thailand, Taiwan, Hong Kong, Macau, the Philippines, Singapore, Malaysia, and Australia. In the case of Daewoong Pharmaceutical, the total sales of five local subsidiaries located in Thailand, Indonesia, and the Philippines more than doubled from 8.4 billion won to 17.2 billion won. In the case of Chong Kun Dang, sales of local subsidiaries in Indonesia increased 2.2 times from 2.1 billion won to 4.7 billion won in a year. In addition, in the North American market, Celltrion USA made strides by increasing its sales nearly 16 times in a year. Celltrion USA's sales in the first half of this year increased from 9.4 billion won last year to 150.4 billion won in the first half of this year. Celltrion USA's sales expansion is attributed to strong sales of COVID-19 diagnostic kits. Celltrion is jointly developing and selling antibody diagnostic kits, antigen rapid diagnostic kits, antigen home test diagnostic kits, and neutralization antibody diagnostic kits with Humasis. Among them, antigen rapid diagnostic kits and antigen home test diagnostic kits have been supplied to the U.S. in earnest since late last year through Celltrion USA.
- Company
- Avastin biosimilar Vegzelma has obtained a European license
- by Kim, Jin-Gu Aug 22, 2022 05:52am
- Celltrion announced on the 19th that Vegzelma (CT-P16) developed with Avastin biosimilar has obtained a sales license from EC on the 18th (local time). According to Celltrion, Vegzelma received an EMA approval recommendation in June. Within two months after that, it received permission to sell full labels approved by Avastin, including metastatic direct bowel cancer and non-small cell lung cancer. Celltrion's strategy is to quickly settle Vegzelma in the market with cost competitiveness by mobilizing all of its own drug development and production capabilities. Celltrion has also completed a global patent agreement with the original drug developer before obtaining Vegzelma's permission, and plans to release it in Europe through Celltrion Healthcare within this year. Vegzelma is the third anticancer antibody biosimilar developed by Celltrion after blood cancer treatment Truxima and breast cancer and stomach cancer treatment Herzuma. Celltrion expects Vegzelma's sales license in Europe to further strengthen its anti-cancer drug portfolio. Celltrion is revealing the possibility of Vegzelma's permission in the U.S. and Korean markets following Europe. Celltrion also applied for Vegzelma's sales license to the Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) at the end of last year, and expects approval within the year. According to IQVIA, a global pharmaceutical market research firm, the global Bevacizumab market in 2021 is $6.413 billion, of which the European market accounts for $1.614 billion and the U.S. market accounts for $2.62 billion. A Celltrion official said, "With Vegzelma's permission to sell in Europe, Celltrion has secured its third anticancer antibody biosimilar." He said, "We will do our best to help Vegzelma settle in the European biosimilar market early and proceed with the remaining global licensing process without a hitch."
