The US Food and Drug Administration allows the resumption of the phase 3 clinical trial.
The US Food and Drug Administration allows the resumption of the phase 3 clinical trial for Invossa in the US.
▷ KOLON TissueGene receives an official notice from the FDA lifting the clinical hold on the phase 3 trial for Invossa, a gene therapy for osteoarthritis, in the US.
▷ The FDA says that all clinical hold issues related to Invossa have been resolved to satisfaction.
▷ The phase 3 clinical trial is set to resume with the transformed kidney-derived cell (second fluid of Invossa).
▷ The FDA recognizes the validity of data of all previous clinical trials for Invossa.
On April 11 (Korean local time), the FDA of the US officially allowed the resumption of the phase 3 clinical trial (patient administration) for Invossa, a cell-and-gene therapy for osteoarthritis currently being developed by KOLON TissueGene, by removing a clinical hold that had been in place.
In its official notice to KOLON TissueGene lifting the clinical hold and dated April 11, the FDA stated, “All clinical hold-related issues of Invossa have been resolved to satisfaction. We lifted the clinical hold, and KOLON TissueGene is now free to perform the clinical trial for Invossa.”
KOLON TissueGene may now resume the Invossa clinical trial after 11 months since the FDA decided to impose the clinical hold in May last year.
This means that the FDA has recognized the validity of the clinical trial data submitted previously by KOLON TissueGene and allowed the resumption of the phase 3 clinical trial, including patient administration, with the transformed kidney-derived cell (second fluid).
On May 3 of last year, the FDA decided to impose a clinical hold on the phase 3 clinical trial for Invossa in the US and requested the submission of the analysis of ingredients and their traits, the background of the change of ingredients, and follow-up measures. On September 20, the FDA additionally requested the submission of complementary data for the materials previously submitted. KOLON TissueGene has been continually exploring the possibility of the resumption of the clinical trial by submitting the required data and discussing the matter with the FDA.
The FDA requested additional data on the improvement measures for the manufacturing process of Invossa specified in the annual report and the stability of the clinical sample in the notice. A KOLON TissueGene staff member said, “This request is unrelated to the removal of the clinical hold and can be easily handled.”
KOLON TissueGene plans to carry out the clinical trial and administer Invossa to patients as soon as updates on the clinical trial plan and the clinical trial patient consent form are made as discussed with the FDA.
A KOLON TissueGene staff member said, “We will thoroughly perform the phase 3 clinical trial in the US to prove the value of Invossa as the world’s first cell-and-gene therapy for osteoarthritis.”
Invossa’s cell-and-gene therapy for osteoarthritis is a combination of cartilage cells extracted from human cartilage (first fluid of HC) and transformed cells with TGF-β1 (second fluid of TC) by the ratio of 3:1. It is injected into the glenoid cavity.
KOLON Industries’ management and labor settle collective bargaining
KOLON Industries’ management and labor settle collective bargaining without negotiations based on their joint commitment to resolving the COVID-19 crisis.
▷ Management and labor join hands to resolve the COVID-19 crisis and rapidly reach an agreement for wage bargaining and collective bargaining in 2020.
▷ The employee gift for the company’s foundation day is Onnuri Gift Certificates aimed at supporting local communities.
The management and labor of KOLON Industries settled this year’s wage bargaining and collective bargaining without negotiations to join hands in the effort to overcome the COVID-19 crisis. KOLON Industries held the signing ceremony for wage and collective bargaining for 2020 on the 18th, which was attended by CEO Jang Hee-goo and labor union head Kim Yeon-sang and transmitted via video conference for social distancing.
On the 12th, the provisional agreement for wage bargaining was drawn up rapidly at the meeting of the representatives of management and labor at the Gumi Production Plant. Voting for labor union members was held for two days from the 16th to the 17th, and the agreement was finalized on the 18th.
Through collective bargaining, the two sides agreed to join hands to provide support for local communities and micro businesses currently experiencing difficulties due to COVID-19. The company foundation day gift provided to the employees each year in the amount of about KRW 1 billion was replaced with Onnuri Gift Certificates for this year. This measure is expected to help revitalize the economy of Daegu and Gyeongsangbuk-do as major locations of KOLON Industries’ businesses are Gumi, Gyeongsan, and Gimcheon. The company also plans to deliver the gift certificates voluntarily donated by employees to local organizations.
CEO Jang said, “KOLON Industries is determined to offer support for the ongoing difficulties as a member of the local communities it serves.” He emphasized the importance of fulfilling corporate social responsibility and thanked the employees including labor union members for their cooperation. Labor union head Kim expressed the union’s will to take part in resolving the crisis, saying, “We tried to rapidly settle bargaining and return to our work to contribute to our local communities.”
KOLON Industries has focused on building sound management-labor relations under the slogan “Coming together towards co-prosperity”, which was adopted in 2007 with an aim of avoiding disputes, and the slogan “Marching forward as one towards co-prosperity”, which was adopted in 2016. The Gumi Production Plant has successfully built its reputation as dispute-free workplace, winning the Silver Tower Order of Industrial Service Merit in 2014, the Prime Minister’s commendation in 2016, and the Grand Prize in the Korea Labor-Management Cooperation Award in 2018. Last year, KOLON Industries declared its new slogan “Uniting as one for co-prosperity”, which encompasses not only management and labor but also partner companies, further expanding the scope of co-prosperity.
KOLON Group will donate a modular negative-pressure ward to Seoul National University Hospital.
▷ KOLON Group plans to construct and donate a modular negative-pressure ward accommodating 24 beds to Seoul National University Hospital.
▷ Seoul National University Hospital will install medical equipment, station healthcare professionals, and operate the ward.
▷ The modular ward is easy to install and dismantle and thus can be reused if a similar crisis occurs in the future.
KOLON Group will construct and donate a modular negative-pressure ward to Seoul National University Hospital to help resolve the COVID-19 crisis.
KOLON Group announced on the 11th that it has decided to construct and donate modular negative-pressure patient rooms to resolve the shortage of treatment facilities and help infected patients receive proper treatment in a timely manner.
The modular negative-pressure ward to be constructed by KOLON Global (CEO Yoon Chang-woon) and installed at the Human Resources Institute of Seoul National University Hospital in Mungyeong, Gyeongsangbuk-do, will accommodate 24 beds, reflecting the needs and requests of frontline healthcare professionals. The entire construction cost, which will total about KRW 2.5 billion, will be assumed by KOLON Group. Seoul National University Hospital will take part in its construction from the design stage onwards and take charge of installing medical equipment, stationing healthcare professionals, and operating the ward.
KOLON Group said, “We decided to donate negative-pressure patient rooms, which are essential for the treatment of infected patients, after contemplating the best ways to contribute to the resolution of this national crisis. We designed the ward in a modular fashion to accelerate its construction as negative-pressure patient rooms are in short supply.” KOLON Group will complete the construction as soon as possible to substantively contribute to the treatment of COVID-19 patients.
Seoul National University Hospital (President and CEO Kim Yon-su) stated, “This will set a good example of corporations and healthcare providers joining hands to rapidly and efficiently install treatment facilities in a national crisis. We agreed to install the ward at the Human Resources Institute in Mungyeong, Gyeongsangbuk-do, to support Daegu and the Gyeongsangbuk-do region that are witnessing the highest number of confirmed cases.” The Human Resources Institute of the hospital in Mungyeong has been used as a living and treatment support center to accommodate mild patients and patients showing no symptoms from Daegu and Gyeongsangbuk-do since the 5th.
KOLON has joined hands with domestic and international specialists in state-of-the-art air-conditioning technology for this project to realize an optimal negative-pressure state that completely blocks the spread of the virus, while also adopting a design that separates the movement path of the patient and that of healthcare staff to prevent infection within the ward.
The modular negative-pressure ward is a medical facility that can be readily put to use in a national crisis and other emergency situations, supporting the isolation and treatment of infected patients. This facility is easy to install and dismantle and thus can be reused in the future.
KOLON Industries supplies free MB filters for masks.
▷ KOLON Industries decides to produce filters for masks and provide them for free to mask manufacturers.
▷ The existing pilot facilities for medical MB filters are being converted to manufacturing facilities for MB filters for masks.
▷ Production will begin on the 9th, with the aim of manufacturing MB filters for about 2 million masks.
KOLON Industries (CEO Jang Hee-goo) decided to produce melt blown (MB)* filters, which are the key subsidiary materials for masks, from the 9th onwards and provide them for free to help resolve the shortage of masks.
KOLON Industries, in consideration of the difficulties that domestic mask manufacturers are experiencing due to the shortage of subsidiary materials, will convert the existing pilot facilities (for research and experiments) for medical MB filters into those for manufacturing MB filters for masks.
KOLON Industries aims to produce filters for about 2 million masks in total and provide them to mask manufacturers in batches for free. To accomplish this, KOLON Industries researchers are working in shifts around the clock to convert and activate the pilot facilities.
The MB filters produced will be provided to mask manufacturers for free after consultation with the government. KOLON Industries emphasized that, as medical MB filters for hemodialysis, etc., are made with technology that is more advanced than that for masks, the filters can be applied to masks without any problems.
CEO Jang of KOLON Industries said, “We decided to produce MB filters for masks to help resolve the shortage of masks and overcome the COVID-19 crisis. The pilot facilities were converted and our research staff is being used as this is an emergency.”
KOLON Industries gains a new foothold by securing more than KRW 300 billion in funds.
▷ KRW 303.5 billion is secured by selling its entire stake in SKC KOLON PI.
▷ KOLON Industries is evaluated to have taken a major step in securing resources for future growth engines and improving cash flow.
▷ KOLON Industries plans to maximize its corporate value by forming partnerships in Korea and beyond and proceeding with new projects.
KOLON Industries (CEO Jang Hee-goo) gained a stronger foothold for investments in new growth engines by securing over KRW 300 billion in cash. The sale of its shares in SKC KOLON PI, which was first initiated last year, concluded on March 6. As a result, its 27.03% stake in SKC KOLON PI was handed over to Korea PI Holdings, according to KOLON Industries on the 9th. The company earned KRW 303.5 billion from the sale.
SKC KOLON PI was jointly established in 2008 by KOLON Industries and SKC. It is the world’s first company in the polyimide film market and was listed on KOSDAQ in 2014. The two companies agreed to sell all their shares in the second half of last year and finalized Glenwood PE as the preferred bidder.
KOLON Industries plans to invest the newly secured funds in elevating existing businesses to new heights and developing new growth engines for the future. Priority is expected to be given to its aramid product (Heracron), which has been contributing to improving the company’s performance through increased sales, and its transparent PI film (CPI®), which was commercialized in May last year and has been delivering stable profits. It is also considering investments in the development of major components of the hydrogen fuel cell and the establishment of a new process for petroleum resin.
In order to maximize its future value, KOLON Industries is seeking to continue to improve its business portfolio. It is currently working to form diverse partnerships in Korea and beyond and proceed with related projects. Although details cannot be fully disclosed under a non-disclosure agreement, part of the funds secured will be used for fortifying existing businesses and investing in new businesses.
CEO Jang of KOLON Industries said, “We will push ahead with full-scale investment in not only organic growth based on the company’s intrinsic competence but also in inorganic growth that draws on external strengths such as M&As and strategic cooperation to enhance KOLON Industries’ competitiveness.”
Kolon Group’s New Employees Join in the Dream Pack Campaign
- Gathering a kit of school supplies for children of low-income households
- Continuing the tradition of starting out as a Kolon Group member by participating in the Dream Pack Campaign launched in 2012
- Funded by donations of employees and matching grants accumulated over the past year
- Delivering Dream Packs to over 1,200 children through 41 local child welfare centers
New employees of Kolon Group kicked off their careers at Kolon Group on the 8th by participating in the Dream Pack Campaign at the Kolon Human Resources Development Center in Yongin, Gyeonggi-do. This volunteer activity is staged jointly by the Kolon Social Volunteers Group (headed by Suh Change-hee) and Korean Food for the Hungry International, an international NGO for hunger relief, to gather and distribute a kit of school supplies for children of low-income households before the start of a new semester.
Kolon Group has continued the tradition of engaging all new employees in producing the Dream Packs for the underserved and delivering them in person as their very first task as a Kolon Group member over the past nine years since 2012.
Each Dream Pack consists of 15 school supplies and winter items and is funded by the donations made by employees and the company’s matching grants accumulated over the previous year. Employees are to pass through the “donation angel’s gate” installed at the entrance of the head office in Gwacheon or Kolon One & Only Tower in Magok-dong on the monthly payday or donate KRW 1,000 by accessing the fund-raising program via the Group’s intranet.
The dream packs made on the day are delivered to over 1,200 children via 41 local child welfare centers across the nation. The participants also visited local child welfare centers in nearby neighborhoods to deliver the dream packs, read cards with warm messages of support, and share memorable moments with the participating children. Kim Seol-ho, who visited a child welfare center located in Gwanyang-dong, Anyang, Gyeonggi-do, said, “It feels very rewarding to be able to make contributions to society through my very first activity as a Kolon Group member. The smiles on those children’s faces filled me with happiness.”
The Kolon Social Volunteers Group was founded in 2012 and has engaged in a variety of community outreach activities to “help children envision their dreams” under the slogan “A Cornerstone for Dreams – Dream Partner”. It operates the Hello Dream program aimed at guiding underprivileged youth to find and nurture their dreams. Last year, the accumulated number of volunteers reached over 8,000.
Kolon Group Declares “Surfing 2020”
- Representing our will to boldly take on new challenges in the business environment with growing uncertainties like an adept surfer
- Outlining plans for the organization and individuals to reinforce the mindset as professionals, improving the flexibility of the horizontal corporate culture, etc.
- Aiming to drive Kolon Group’s growth by discovering items that will serve as future prime movers
Kolon Group held the enterprise-wide kick-off meeting for the year on the 2nd at Kolon One & Only Tower in Magok-dong attended by subsidiary CEOs and employees holding the position of team head or higher.
At the meeting, “Surfing 2020”, the vision for Kolon’s Empathy Management, was declared by the One & Only Committee (chaired by CEO Yoo Seok-jin of Kolon Corporation). The new vision takes its name from the Group’s determination to create Kolon’s own “next big thing” by responding to the fast-changing business conditions and uncertainties of the future like a surfer who skillfully rides the waves, turning each wave into an opportunity for growth.
In particular, this year’s management principle prioritizes “empathy”. This means all the subsidiaries should practice self-led and responsible management and encourage all employees to work together as one to achieve success.
This was the second kick-off meeting organized by the One & Only Committee, the council of Kolon Group’s CEOs formed after the resignation of Chairman Lee Woong-yeol at the end of 2018. The Committee emphasized its will to continue striving for innovation rooted in Chairman Lee’s decision to resign from all positions not to become an obstacle to the Group’s march forward.
The directions for future steps to be taken by the organization and its individual members were also given. The Committee highlighted the importance of seeking new opportunities by taking on new challenges and encouraged all employees to develop top-tier competence as professionals and fulfill their duties with utmost care. The Committee also announced the plan to apply the new position and title system ensuring a horizontal corporate culture and the flexible performance assessment system to all subsidiaries in order to allow the organization to evolve in a manner that facilitates each individual’s success.
The Committee pledged, “We cannot survive unless we find items that can preempt the future market. We must focus on creating the ‘next big thing’ unique to Kolon Group.” It added, “Kolon Group has taken pride in laying the nation’s industrial foundation, improving people’s quality of life, and keeping its integrity over the past 64 years. We will work harder to build a better Kolon powered by our vision and passion for success.”
Kolon Group is projected to record continued growth throughout this year following last year as its new material businesses with high added value, such as aramid fibers and CPI® (colorless polyimide) film, are expanding and its construction sector profits are stabilizing. It also plans to accelerate R&D and investment to preempt the market of materials and components related to hydrogen vehicles in line with the promotion of the hydrogen economy.
Kolon Group continued with its “badge management” practice this year by distributing the badge depicting the management principle of empathy to all employees. The badge shows a Kolon employee riding a colossal wave on a surf board. Kolon Group’s employees have been taking part in wearing the management principle badges for each year over the past eight years since 2013.
Kolon Industries Pioneers the Eco-Friendly Material Market with PET Regeneration Technology
Kolon Industries (CEO Jang Hee-goo) announced on the 19th that it concluded an MOU with Korea Clothing and Textile Recycling Association (Chairperson Koo Seong-ja) at Kolon One & Only Tower to develop and undertake projects related to eco-friendly plastic regeneration technology.
In order to help resolve the global issue of plastic waste, Kolon Industries is focusing on the development of eco-friendly PET regeneration technology. The existing heat treatment-based recycling process has limited applicability and is likely to incur additional environmental problems such as the emission of harmful substances. However, the new PET dismantling method being developed by the Kolon Future Technology Institute is evaluated to be more environmentally responsible as it can reduce energy consumption by 33% and CO2 emissions by over 38% with its chemical regeneration technology compared to the existing recycling process.
PET is found in plastic products, clothing, and textiles. Kolon Industries’ PET regeneration technology is expected to garner acclaim in the eco-friendly material market as it is engineered to dismantle recycled PET to the level of ultrapure materials and regenerate PET useable for all products regardless of the type and contamination level of the recycled materials.
Kolon Industries anticipates that the Association’s waste clothing and waste textile management network will help secure recycled materials on a stable basis and advance the early commercialization of the technology and the creation of a circular economy ecosystem through this MOU.
Kolon Industries plans to aggressively expand its business scope in the PET regeneration market throughout the future. Its goal is to install the pilot PET chemical regeneration facility in 2020 and mass production equipment by 2023 and start expanding its mass production plant in 2025, thereby strengthening its foothold in the recycled PET market.
Kolon Industries’ FnC launched RE;CODE in early 2012, an upcycling brand that instills new value into discarded clothes. In the early days, it focused mainly on dismantling and redesigning the three-year-old inventory of FnC’s brands on the verge of being incinerated. Recently, the range of upcycled materials has continued to grow to encompass military uniforms, parachutes, and airbags. Furthermore, FnC’s eight brands collaborated and released Upcycling Sweetshirts made with textile generated from waste PET last October. RE;CODE is expected to grow into a total upcycling solution brand that enables the production of clothing with materials regenerated using Kolon Industries’ technologies and the regeneration of PET from such clothing.
Director Han Seong-su of the Kolon Future Technology Institute said, “The environmental issues connected to waste plastics are critical tasks facing humanity, and corporations equipped with advanced technologies such as Kolon Industries must take the lead. The Kolon Future Technology Institute remains dedicated to developing related technologies and joining hands with local and international partners through various projects.”
Donate Blood and Celebrate the New Year with Kolon!
Kolon Group will stage the “Donate Blood and Celebrate the New Year with Kolon!” campaign to contribute to ensuring a stable supply of blood for patients in need. Blood donations by employees will take place consecutively for ten days from the 2nd led by the Kolon Social Volunteers Group at eight business places from Kolon One & Only Tower in Magok-dong, Seoul, to Gwacheon, Gangnam, Gumi, and Songdo.
This campaign is Kolon’s leading community outreach program held at major business places nationwide twice a year in summer and winter when the blood supply becomes unstable. The number of blood donors plunges to its lowest level in the winter months due to vacation and holidays. In order to help resolve this issue, Kolon Group has hosted the blood donation campaign since 2013.
Han Gi-baek of Kolon Industires, who donated blood on this day, said, “I feel I have wrapped up this year in the best way possible by donating blood for child patients. I decided to make blood donations whenever possible throughout the future.”
The blood donor certificates of the Kolon employees will be delivered to Korea Childhood Leukemia Foundation to be used for child patients with cancer.