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2026-04-08 00:16:29
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Company
High dose Eylea approved in KOR… extends dosing interval
by
Son, Hyung-Min
Apr 05, 2024 05:43am
Bayer Korea announced that its Eylea 8mg, a treatment for macular degeneration, was approved in Korea on the 3rd. Eylea 8mg was developed to maintain the effective drug concentration in the eye longer than the already approved Eylea 2mg product, allowing for longer dosing intervals and fewer injections. Eylea is an intravitreal injection used to treat major retinal diseases, including vision impairment caused by neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). Eylea 8mg is injected once monthly for the first 3 months, after which the dosing interval may be extended to up to 16 weeks based on the physician’s judgment of visual and/or anatomic examination results. Thereafter, the dosing interval may be extended to up to 20 weeks with a treat-and-extend dosing regimen with stable visual and/or anatomic findings. The approval of Eylea 8 mg is based on the results of the PULSAR trial, in patients with neovascular (wet) age-related macular degeneration, and the PHOTON trial, in patients with diabetic macular edema (DME). The PULSAR trial, which was conducted on 1,009 patients with nAMD, showed that Eylea 8mg administered every 12 and 16 weeks was non-inferior to Eylea 2mg administered every 8 weeks in terms of best corrected visual acuity (BCVA) changes. Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 6.7 letters from baseline for its 12-week dosing regimen and 6.2 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 7.6 letters Eylea 2mg achieved at a fixed 8-week treatment interval. In the PHOTON study, which included 658 patients with DME, both dosing regimens of Eylea 8 mg achieved comparable visual improvement to Eylea 2 mg every 8 weeks. Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 8.8 letters from baseline for its 12-week dosing regimen and 7.9 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 9.2 letters Eylea 2mg achieved at a fixed 8-week treatment interval. In terms of dosing intervals, 93% of patients receiving Eylea 8 mg maintained a dosing interval of 12 weeks or longer at Week 48. Sangok Seo, Head of the Specialty Medicine BU at Bayer said, “We are very pleased that this approval establishes Eylea as the only anti-vascular endothelial growth factor (VEGF) on the market that can offer an extended dosing interval of up to 20 weeks. Building on the efficacy and safety that we have established over the past decade and an improved dosing interval, we hope to improve long-term treatment adherence and help patients maintain a better quality of life with Eylea 8mg.”
Company
AbbVie Korea, 52% increase in sales last year…
by
Kim, Jin-Gu
Apr 05, 2024 05:43am
AbbVie Korea’s major performances, including sales and operating profit, have increased by about 50% in a year. The analysis attributes this to the integration with Korea’s Allergan. AbbVie headquarters initiated the integration process between both companies in June 2019. The analysis suggests that the company’s total assets have expanded due to the completion of the integration process between the Korean subsidiaries last year. According to AbbVie Korea’s audit report on April 4, the company generated sales of KRW 234.7 billion last year, up 52% in a year compared to KRW 154.6 billion in 2022. The operating profit of the same period increased from KRW 7.8 billion to KRW 11.5 billion, up 49%. AbbVie Korea reported consistently generating sales within the range of KRW 150 billion for the past five years, with KRW 157.3 billion in 2019, KRW 146.7 billion in 2020, KRW 140.4 billion in 2021, and KRW 154.6 billion in 2022. The operating profits were KRW 7.4 billion in 2020, KRW 7.1 billion in 2021, and KRW 7.8 billion in 2022, without significant changes. Notably, sales and operating profit increased by about 50%. The analysis attributes this to the integration of AbbVie Korea with Korea’s Allergan. Trends in AbbVie Korea’s sales & operating profits (Unit: KRW 100 million, Source: Financial Supervisory Service). On February 1, AbbVie Korea acquired 100% of the shares of Korea’s Allergan. Subsequently, it completed the merger with Allergan. As of the following day, the performance of existing Allergan began to be reflected in AbbVie Korea. AbbVie Korea’s total assets increased by 98% in one year, from KRW 89.9 billion in 2022 to KRW 177.7 billion last year. Similarly, the company’s payroll expenses rose from KRW 20.2 billion to KRW 32.7 billion, up 62%. Additionally, selling and administrative expenses, including payroll, increased from KRW 43.1 billion to KRW 70.4 billion, up 63%. The headquarters completed the acquisition in 2019. On June 25, 2019, AbbVie acquired Allergan for $63 billion (approximately KRW 73 trillion). The major products of AbbVie Kore are Humira, Mavyret, Rinvoq, and Skyrizi. Humira’s sales are seeing a decreasing trend due to patent expiration. Rinvoq and Skyrizi, which are follow-up drugs to Humira, are filling the gap of Humira. Korea’s Allergan had been selling Botox, a botulinum toxin.
Policy
Orphan drug Ilaris receives conditional pass for reimb again
by
Lee, Hye-Kyung
Apr 05, 2024 05:43am
Although the government restarted reimbursement discussions for Novartis Korea's orphan drug Ilaris Inj (canakinumab) after 2 months, the results were the same. According to the "Results of the 4th 2024 Drug Reimbursement Review Committee Deliberations," which was released on the 4th by the Health Insurance Review and Assessment Service, Ilaris was deemed adequate for reimbursement for the following indications: ▲Cryopyrin-Associated Periodic Syndromes (CAPS), Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲Familial Mediterranean Fever (FMF), and ▲ Systemic Juvenile Idiopathic Arthritis (SJIA). However, the approval came with a condition. Further evidence for the three indications - CAPS, TRAPS, and FMF - must be submitted for the reimbursed use of the drug. At the DREC meeting in February, Ilaris was deemed adequate for reimbursement subject to submission of further evidence, but Novartis filed an appeal, putting the decision on hold. Novartis then requested a reevaluation and received another DREC review after 2 months, but the results remained unchanged. Ilaris, which was deemed adequate for reimbursement along with Enhertu Inj, is a treatment for a rare disease called periodic fever syndrome, which affects only 13 patients in Korea. It is a drug that HIRA President Jung-Gu Kang said he would make efforts for prompt reimbursement during the National Assembly audit in October last year. Ilaris is the only IL-1 inhibitor recommended by international guidelines for the treatment of hereditary periodic fever syndrome and is approved by both the U.S. FDA and the European EMA. Based on the efficacy and safety of the drug confirmed through clinical studies, it is being reimbursed in a total of 30 countries. However, it is facing difficulties in receiving reimbursement approval in Korea. Novartis made two previous attempts for Ilaris’s reimbursement in 2017 and 2022 but failed both attempts. This is its third attempt. Ilaris is also an expensive drug, costing KRW 8 million to KRW 100 million per year for once every 8-week dose. If Novartis accepts DREC’s decision this time, the reimbursement process for Ilaris will progress rapidly, but if it doesn't, its reimbursement will again be at a standstill. Meanwhile, ‘Orkedia Tab 1mg, 2mg, (Orkedia Tab),’ Kyowa Kirin Korea’s treatment of secondary hyperparathyroidism in patients on maintenance dialysis was deemed adequate for reimbursement by DREC at the same meeting. In the case of Santen Pharm Korea’s ‘Rhopressa Ophthalmic Soln. 0.02% (Netarsudil Mesylate),’ which is a treatment for open-angle glaucoma and ocular hypertension, the drug was deemed adequate for reimbursement if the company accepted a price lower than the evaluated price. Takeda Pharmaceutical Korea’s ovarian cancer treatment ‘Zejula Cap. 100mg (niraparib tosylate monohydrate)’ was reviewed for RSA coverage expansion, but DREC determined its adequacy to be unclear.
Policy
HIRA in final stages of preparing expense report survey
by
Lee, Tak-Sun
Apr 05, 2024 05:43am
The Health Insurance Review and Assessment Service is busy preparing a survey and public disclosure of the expenditure reports on economic benefits pharmaceutical companies and medical device companies provided to doctors and pharmacists. As the data submitted by pharmaceutical companies through the survey will be subject to public disclosure, HIRA is also planning to build a system for relevant data collection. However, it plans to receive the data through a temporary system this year and open a formal system next year. According to industry sources on the 3rd, HIRA informed pharmaceutical organizations about the survey on expenditure reports. The survey will be conducted for 2 months from June to July like in the past year. In June, drug wholesalers, and in July, drug licensees, importers, and promoters must submit their previous expenditure reports to HIRA's expenditure report management system, Korea Patient Safety Reporting (KOPS). This year, consignment sales organizations (CSOs), which are entrusted with the sales promotion duties, will also be subject to submit data. CSOs are also required to prepare their own expenditure reports. However, HIRA added that it is advisable for the drug suppliers to manage and supervise the expenditure reports prepared by CSOs. The survey will cover general information such as company information and expenditure report operation status, as well as the 1-year expenditure report prepared from January to December 2023. The expenditure report includes the provision of samples, support for conferences, support for clinical trials, product presentations, post-marketing surveys, and discounts based on payment terms. In last year's survey, pharmaceutical companies uploaded the data in an Excel format, but this year's survey will be conducted in two ways: companies can directly enter the information into the temporary system or upload the data in an Excel format. The results of the survey will be posted on the MOHW website in December, just like last year. Separately, the expenditure reports submitted by pharmaceutical companies in December through KOPS will be made public for 5 years. The disclosed data will be replaced with the data the companies submitted for the expenditure report survey. HIRA plans to database the submitted data and post it according to the open principle. Last month, the Ministry of Health and Welfare announced the 'Operational Guidelines for Public Disclosure of Information,' and explained that the names of recipients, including those of the medical practitioners whose personal information may be leaked, and clinical trial information that contains the companies’ business strategies will be de-identified, then disclosed. HIRA has additionally begun hiring personnel to support the disclosure of expenditure reports and surveys. It announced on Jan. 1 that it would hire 12 people for the service through an emergency bid announcement on 'management staff dispatch service'. A HIRA official said, "This year, we plan to temporarily build an expenditure report management system, and open an official system next year. We plan to make the public disclosure in December, and we will disclose the information after discussing the scope of the disclosure and databasing the data submitted by companies."
Policy
Trajenta generics enter reimbursement pricing…
by
Lee, Tak-Sun
Apr 05, 2024 05:43am
DPP-4 diabetes drug Trajenta tab. The generic version of Trajenta (linagliptin), a DPP-4 inhibitor class, has applied for reimbursement pricing ahead of its launch in June. This year, generic market is drawing attention to Trajenta. With the exclusive rights for Trajenta is set to expire, after Forxiga and Januvia last year, the diabetes market is expected to see new competition this year. According to industry reports on the 4th, Trajenta generics applied for reimbursement pricing. Subsequently, the Health Insurance Review and Assessment Service (HIRA) started the pricing process. It is expected that Trajenta generics would be listed on June 9 when the substance patent of the original drug expires. Generic companies have confirmed the release date for June after winning the dispute over Trajenta’s unregistered substance patents. In January, the Intellectual Property Trial and Appeal Board (IPTAB) gave a verdict validating the claims on patent challenges by five generic companies, including Genuonesciences, for invalidating three counts of Boehringer Ingelheim’s use patents for Trajenta. Consequently, when the product patent expires on June 8, the generic companies are expected to enter the market based on the verdict. The DPP4 inhibitor formulation patent, which is set to expire in 2027, remains on the patent list of the Ministry of Food and Drug Safety (MFDS). However, most of the pharmaceutical companies have avoided this patent type. 60 Trajenta monotherapy generics and 204 Trajenta-duo (linagliptin+metformin) combination therapy generics have received approval. Most known domestic pharmaceutical companies are set to enter the market. Notably, generic companies have developed SR tablets unavailable in Trajenta-duo and have completed approval. According to UBIST last year, Trajenta accumulated an outpatient prescription amount of KRW 61.3 billion and Trajenta-duo accumulated an outpatient prescription amount of KRW 62.1 billion. Together, those two generated a KRW 120 billion-worth market. The market size is comparable to Januvia (KRW 34.9 billion), Janumet XR (KRW 41.1 billion), and the Janumet series. Following the expiration of Januvia's patent last year, over 200 products entered the market, and similar interests are observed for Trajenta generics as well. However, Januvia generics occupied the market in advance in September. As many pharmaceutical companies intensify their sales efforts to dominate the market, it is anticipated that they may not be able to put their efforts into Trajenta generics belonging to the same class as Januvia.
Company
Boryung speeds up Lenvima patent challenge
by
Heo sung-kyu
Apr 04, 2024 06:00am
Boryung's challenge against Eisai’s blockbuster anticancer drug Lenvima is gathering pace. As the only domestic pharmaceutical company to continue the patent challenge, Boryung’s journey has passed the 70% mark. With only one patent remaining, expectations of the company’s launch of the Lenvima generic in 2025 are rising. According to industry sources on the 1st, the Intellectual Property Trial and Appeal Board ruled in favor of Boryung that it had filed to invalidate Eisai’s anticancer drug Lenvima (lenvatinib)’s patent for "high purity quinoline derivatives and methods of manufacturing the same.” #The patent that had been in question was registered by Eisai in June 2023 for Lenvima and was set to expire on August 26, 2035. The IPTAB’s ruling is noteworthy because it marks the nearing end of Boryung's ongoing patent hurdle clearings for Lenvima. In fact, in addition to the patent in question, Lenvima also has a patent for ▲"nitrogen-containing aromatic derivatives" (expiring April 4, 2025), ▲"antitumor agent for thyroid cancer" (expiring March 4, 2028), ▲"Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinoli- necarboxamide or the solvate of the salt and a process for preparing the same” (expiring June 7, 2028), and ▲“High-purity quinoline derivative and method for manufacturing same” (expiring on March 19, 2031). Boryung is the only domestic company to challenge all these patents and independently develop a generic version of the original drug. Daewoong Pharmaceutical had challenged 3 patents together with Boryung, except for the last registered patent, but later chose to withdraw all of them. In the end, only Boryung challenged all 4 patents except for the one that expires in 2025, cleared 3 of the patent barriers, and is raising expectations of its generic’s launch in Korea. In fact, Boryung won all of its trials to confirm the passive scope of rights that preceded the patent invalidation trial. First, it received a favorable ruling in June of last year for the patent "Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinoli- necarboxamide or the solvate of the salt and a process for preparing the same” (which expires on June 7, 2028) and in August of last year for the patent ▲“High-purity quinoline derivative and method for manufacturing same” (which expires on March 19, 2031). In particular, in the case of the patent being invalidated this time, Boryung et al. have conquered one more barrier of Lenvima’s that had been built by the Eisai, in less than a year since its patent registration. However, Boryung has filed another invalidation trial for the “Antitumor agent for thyroid cancer” patent, which expires on March 4, 2028, and is awaiting for its results. If the remaining patent is also invalidated, the company will be able to launch its drug after April 4, 2025, when the last “Nitrogen-containing aromatic derivatives” patent expires. Ultimately, Boryung’s decision not to challenge the last patent suggests that it expects to launch its generic version in 2025. Therefore, it remains to be seen whether the company will be able to overcome the last remaining patent barrier and succeed in launching its generic drug in 2025.
Company
Enhertu lands in general hospitals in KOR after reimb
by
Eo, Yun-Ho
Apr 04, 2024 06:00am
Hospitals in Korea are busy preparing a prescription environment for the reimbursed Enhertu. According to industry sources, Daiichi Sankyo and AstraZeneca Korea’s antibody-drug conjugate (ADC) for HER2-positive breast cancer, Enhertu (trastuzumab deruxtecan) has passed the drug committee (DC) review of 46 medical institutions in Korea, including the ‘Big 5’ tertiary hospitals in Korea - Samsung Medical Center, Seoul National University Hospital, Seoul St.Mary’s Hospital, Asan Medical Center, and Sinchon Severance Hospital. After receiving approval for Enhertu in Korea in September 2022, the companies submitted a reimbursement application for the drug in December of the same year, and the agenda passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in February. The same month, the company began negotiating drug prices with the National Health Insurance Service and concluded the negotiations at an unprecedented speed and was listed on the reimbursement list this month (April). With 50,000 people signing the petition and the government being questioned on the reimbursement progress repeatedly by the National Assembly, both the government and the company would have had to carry a significant burden during reimbursement discussions. When considering the limited scope of freedom the company has with regard to the drug price, the fact that Enhertu’s reimbursement passed the DREC review this time implies that the government has set the ICER threshold at least KRW 50 million. With the listing, Enhertu is reimbursed for patients with HER2-positive unresectable or metastatic breast cancer that has failed treatment with both trastuzumab and taxanes (including recurrence while receiving adjuvant therapy after surgery or within 6 months of completion of therapy). Also, patients with locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who failed two or more prior therapies, including trastuzumab +(fluorouracil or capecitabine) +cisplatin; or have HER2 overexpressive (IHC 3+, or 'IHC 2+ and FISH positive or SISH positive') metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; and have an ECOG performance status (PS) of 0 or 1, are eligible to receive reimbursement. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of overall survival (OS), the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1
Policy
Eye drops late to submit test results pass reivew
by
Lee, Hye-Kyung
Apr 04, 2024 05:59am
Amid the ongoing equivalence reevaluations being conducted on eye drops, products that received dispositions for failing to submit equivalence data in time received a final compliant decision. The Ministry of Food and Drug Safety (MFDS) released the results of the ‘2022 drug equivalence reevaluation’ that contained such results on the 3rd. The third list included 4 suspension eye drops, and Daewoo Pharm, which was in charge of the consignment manufacture of the drugs, received a ‘compliant’ judgment, and the other consigned items were also judged compliant and approved. More specifically, the items approved this time are Daewoo Pharm’s ‘Tobeson Eye Drops (exported as Philtobeson Eye Drop, Dextear Eye Drop),’ Hwail Pharm’s ‘Vitodex Eye Drops (exported as Videto Eye Drop, Tosibiam Eye Drop),’ LitePharmTech’s ‘Litetodex Eye Drops),’ and ARI Pharma’s ‘Tobadexa Eye Drops.’ In particular, Daewoo Pharm was suspended from selling Tobeson Eye Drops until April 11 this year for a second violation of failing to submit equivalence reevaluation data in September last year. Results of the 2022 drug equivalence reevaluation results (3rd) Due to delays in completing equivalence reevaluations by their CDMO, Hwail Pharm, LitePharmTech, and ARI Pharma also received sales suspensions last year. On the other hand, the reason why the MFDS’s 2022 equivalence reevaluation results came out 2 years later is because the government granted additional time due to the need to prepare a test method that can accommodate the characteristics of suspension eye drops. The second reevaluation results of the eye drops were released in January, and at the time, only 16 out of 30 products that were reevaluated were deemed suitable. Following the Ministry of Food and Drug Safety’s revision of the 'Rules on the Safety of Pharmaceutical Products, etc,’ and the expansion of the dosage forms subject to submission of equivalence data, the MFDS reevaluated powders and granules in 2021, and eye drops, ear drops, inhalants applied to the lungs, and external preparations in 2022. Items that receive reevaluation notifications will be subject to administrative dispositions such as the first (2-month suspension of sales), second (6-month suspension of sales), and third (revocation of marketing authorization) dispositions if the data is not submitted within the deadline. Also, if the test results do not prove equivalence, the product will be suspended and recalled. This year, 460 tablets (film-coated tablets, etc.) are being reevaluated for equivalence, and next year, oral preparations such as capsules and syrups will be re-evaluated.
Policy
K-CAB is in talks to extend refund-type PVA
by
Lee, Tak-Sun
Apr 04, 2024 05:59am
HK inno.N HK inno.N is in talks with the National Health Insurance Service (NHIS) to extend the refund-type price-volume agreement (PVA) for K-CAB (tegoprazan), a drug developed in Korea for gastroesophageal reflux disease. K-CAB is the only drug under the refund-type price-volume agreement (PVA). Since its release in 2019, K-CAB’s claim amount has been on the rise, so the contract extension is highly probable. According to industry sources on April 3, HK inno.N is discussing with the NHIS to extend the refund-type price-volume agreement (PVA) for K-CAB. In 2021, HK inno.N secured the the refund-type price-volume agreement (PVA) for K-CAB with the NHIS. Under the price-volume agreement (PVA) system, a decrease in drug prices can be avoided with the contract. Instead of decreasing a drug price, the pharmaceutical company refunds the portion of the drug’s price to the NHIS. Drugs should meet the standards set by the Health Insurance Review and Assessment Service (HIRA) for impacting healthcare and being developed by innovative pharmaceutical companies to be eligible for the contract. Currently, K-CAB is the only drug under the contract. With the successful extension of the contract, K-CAB will be under the refund-type contract for the next three years. After the initial refund contract, K-CAB was negotiated two times for a price-volume agreement (PVA). Under the refund contract, K-CAB tab 50 mg is set as the initial upper limit price of KRW 1,300 per tablet since its first listing in 2019. The K-CAB products are now three, with K-Cab ODT 50 mg (KRW 1,300 per tablet) listed in May 2022 and K-CAB tab 25 mg listed last January. The products under the price-volume agreement (PVA) are K-CAB tab 50 mg and K-CAB tab 25 mg. According to the last year’s UBIST report, K-CAB’s outpatient prescription amount totaled KRW 158.2 billion, up 20% from KRW 132.1 billion of the previous year. Although K-CAB generic developments are underway, there is still considerable time before any mandatory reduction in the upper limit price due to the entry of subsequent competitors because its patent expires on August 25, 2031.
Company
AbTis-Progen signs MOU to develop bispecific antibody ADC
by
Son, Hyung-Min
Apr 03, 2024 05:51am
AbTis, Dong-A ST’s affiliate specializing in ADC, announced on April 1 that it has signed a memorandum of understanding (MOU) with Progen to develop a bispecific antibody-drug conjugate (BsADC) to treat autoimmune diseases. The MOU will leverage the two companies’ proprietary platform technologies - AbTis’ AbClick and Progen's NTIG. AbTis’ AbClick linker platform technology is a 3rd-generation linker technology that overcomes the limitations of existing ADCs, allowing selective drug delivery to desired areas, eliminating the need for mutant antibody production, and ensuring uniform production quality by controlling the drug-to-antibody ratio (DAR). Lonza, a Swiss global CDMO (Contract Development and Manufacturing Organization), recognized the superiority of AbClick linker platform technology and signed an ADC platform collaboration agreement in December 2022. AbTis is currently developing various new drugs with its AbClick technology, including an ADC for gastric cancer targeting Claudin18.2. Progen's proprietary NTIG platform technology can extend the blood half-life of proteins, making it scalable for developing two or more multi-target fusion proteins for various diseases. PG-102, which Progen is developing as a treatment for global obesity and diabetes, is a 2-to-4-week injectable that simultaneously targets GLP-1 and GLP-2 using the NTIG® technology. The drug candidate is in Phase Ib clinical trials. Tae Dong Han, CEO of AbTis, said, "Through synergy with Progen's NTIG® technology, we aim to demonstrate the differentiated excellence of our AbClick® platform and make the best efforts to develop new modality drugs that can succeed in the global ADC market.” Jong-Gyun Kim, CEO of Progen, said "We plan to extend the excellence of NTIG® technology to the field of ADC with the MOU. Based on Progen's long experience in immune disease research, we will challenge the development of new immune disease BsADC therapeutics through close collaboration with AbTis, which owns the 3rd-generation linker technology platform AbClick®.”
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