UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2021
Commission File Number: 001-39173
I-MAB
Suite 802, West Tower, OmniVision, 88 Shangke Road, Pudong District
Shanghai, 201210
Peoples Republic of China
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
I-MAB | ||
By: | /s/ Jielun Zhu | |
Name: | Jielun Zhu | |
Title: | Director and Chief Financial Officer |
Date: August 20, 2021
Exhibit Index
Exhibit 99.1Press Release
Exhibit 99.2I-Mab ESG Operation Highlights
Exhibit 99.1
I-Mab Announces Establishment of Environmental, Social and Governance Committee
| I-Mab received highest first-time ESG rating among China-based biotech companies from MSCI |
| New majority independent ESG committee to set overall ESG strategies for the Company |
| Women account for two-thirds of the total workforce and over 30% of I-Mabs Board of Directors |
| Committed to diversity, equity and inclusion, I-Mab has launched Womens Leadership Council in 2020 and has been awarded T+ Excellent Employer for its accomplishments in diversity and innovation |
SHANGHAI, China and GAITHERSBURG, MD. August 19, 2021 I-Mab (the Company) (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that its Board of Directors (the Board) approved establishment of an ESG (Environmental, Social and Governance) Committee.
The committee consists of Dr. Joan Shen, executive director of the Board and CEO of I-Mab, and two independent directors, Mr. Chun Kwok Alan Au and Prof. Rong Shao. Mr. Au will also chair the committee. As the oversight body for the Companys ESG practices, the committee is responsible for supervising the ESG strategies, policies, long-term sustainability objectives and risks of the Company. In addition, the Company will also establish an ESG working group to address daily ESG workflows.
I-Mab is committed to a corporate culture of diversity, inclusion, social responsibility and outstanding governance. In July 2021, I-Mab was granted a BBB rating, the highest newly initiated rating among China-based biotech companies, by the MSCI ESG assessment.
I-Mab has shown it values the principles of ESG since its founding, said ESG Committee Chairman and independent director, Mr. Chun Kwok Alan Au. The Companys vision has been not only to bring innovative therapies to global patients and create value for shareholders, but also to continue its commitment to high corporate governance standards, diversity, green operations, sustainable development and transparent disclosures.
The company has made diversity and inclusivity part of its long-term strategy and has established a strong track record. In 2020, I-Mab launched a Womens Leadership Council (WLC) globally to help future female leaders accelerate their career development. Women account for about two-thirds of its employees, with 57 percent holding a masters degree or above, and over 30 percent of I-Mabs Board of Directors are female. At the peak of COVID-19 outbreak in 2020, I-Mab donated urgently-needed medical supplies worth of RMB 800,000 to hospitals and healthcare workers in Wuhan, China and US$ 50,000 to BayHelix, a non-profit organization focused on global life sciences and healthcare community, to fight against the pandemic globally. In 2021, I-Mab was honored with the T+ Excellent Employer award based on an assessment of best practices in areas such as technological leadership, organization and talent, and commitment to creating a diversified workplace. In July 2021, I-Mab donated RMB 1 million to Henan Charity General Federation for the rescue and reconstruction of flood-hit regions in Henan Province.
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Shanghai (HQ) Suites 802, 505, 702, West Tower 88 Shangke Road, Pudong New District Shanghai, China |
United States Suite 710, 9801 Washingtonian Blvd Gaithersburg Maryland 20878 |
www.i-mabbiopharma.com |
About I-Mab
I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon, commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Companys mission is to bring transformational medicines to patients around the world through innovation. I-Mabs innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Companys Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transition from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facilities, and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong, and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter, and WeChat.
I-Mab Contacts
Jielun Zhu Chief Financial Officer jielun.zhu@i-mabbiopharma.com +86 21 6057 8000 |
Gigi Feng Chief Communications Officer gigi.feng@i-mabbiopharma.com +86 21 6057 8000 |
Investor Inquiries
The Piacente Group, Inc.
Emilie Wu
E-mail: emilie@thepiacentegroup.com
Office line: +86 21 6039 8363
Shanghai (HQ) Suites 802, 505, 702, West Tower 88 Shangke Road, Pudong New District Shanghai, China |
United States Suite 710, 9801 Washingtonian Blvd Gaithersburg Maryland 20878 |
www.i-mabbiopharma.com |
Exhibit 99.2
I-Mab ESG Operation Highlights
Upon establishment of ESG committee, the Company will also continue to improve the management of material ESG issues and communicate periodic progress with investors on the following, including but not limited to:
Code of Conduct
The I-Mabs Code of Conduct, formulated by the Company, covers business ethics, R&D responsible activities, public relations, intellectual property and data protection, workplace, assets, corporate governance, concerns reporting and other behaviours, and serves as a guide for all employees and third parties to take compliance actions in business activities. The Company has arranged compliance training courses for newly hired employee to help them understand the business code of conduct that falls in line with industry and the Companys standards.
Diversity of the Board of Directors
The composition of board of directors is also an example of diversity. The current board has total of 13 directors, among which 4 directors are females, accounting for 30.8% of total, and it also has 5 independent directors, accounting for 38.5% of total. The diversity of board composition is beneficial to corporate operation efficiency and long-term sustainability.
Talent Attraction and Retention
Diversity: diversity in the workplace is essential for I-Mabs success. The Company prohibits any form of discrimination (including but not limited to employment, career development, salary, and benefits) on the basis of an employees gender, race, age, physical condition, sexual orientation, marital status, or disability, so as to ensure a diverse and fair corporate culture.
The Company aims to be a role model in promoting female business leadership in the biotech industry. The Company has undertaken multiple initiatives to encourage female leadership, including launching the I-Mab Womens Leadership Council (WLC) in July 2020. Approximately two-thirds of the Companys employees are female, of which 57% hold a masters degree or above, while over 30% of I-Mabs Board of Directors are female. The Company is carrying out a series of female leadership development programs committed to womens career and personal development. Through increasing the proportion of females among the Companys leadership, I-Mab is determined to become one of the leaders in promoting gender equality.
Compensation and Incentives: The Company offers competitive salaries, benefits, and additional incentive to its employees. Employee compensation and benefits include position-specific salary, bonus and allowance, statutory insurance, and housing employee benefit funds (for those in China), statutory holidays, benefits and vacations, etc. In addition, we purchase additional commercial insurance for employees underaged children, as well as a series of internal morale boosting incentive programs. The Company works to reward employees for exceptional performance. Employee awards in the Company include Project Awards, Quarterly Stars, Management Awards, etc., with the goal of creating a culture of recognition. The Company hired approximately 30% of total employees through internal referrals.
Shanghai (HQ) Suites 802, 505, 702, West Tower 88 Shangke Road, Pudong New District Shanghai, China |
United States Suite 710, 9801 Washingtonian Blvd Gaithersburg Maryland 20878 |
www.i-mabbiopharma.com |
Talent Development: The Company strives to attract and retain talents to sustain its growth. To better foster employee career development, the Company invest in employees career development and provide them opportunities to keep updating their skills and knowledge. The Companys training system includes induction training for new employees, training on general knowledge, professional skills training, and leadership training. Among which, leadership training focuses on improving employees knowledge and ability in compliance management, drug quality control, business audit, financial standard procedures, as well as female leadership development. The Company encourages its employees to develop various training courses, and grades the content setting, applicability, practicability, and lecturer quality of the courses, to continuously improve them through collecting and addressing feedbacks.
Product Quality and Safety
I-Mabs Biopharma Quality Management Review (QMR) is responsible for supervising I-Mabs overall quality management system, including R&D, production and manufacturing, and other functional departments of the Company, to set up a comprehensively risk control system and ensure that I-Mabs operations are in accordance with the requirements of laws and regulations, industry Good X Practices (GXP) and the Companys internal regulations and systems. Under QMR, we have established an R&D Quality Management Committee composed of representatives of various R&D functional departments, which is responsible for supervising the operation of the R&D Quality Management System (QMS) and making final decisions on important quality issues such as patient safety, data integrity and regulatory compliance in the R&D process.
The Companys quality management system covers all business activities such as the selection of outsourcing service vendors, daily management and audit, research, development, and production, and we also have signed quality agreements with CDMO, CMO, CRO, and other vendors. An audit team consists of experts who are responsible for R&D, CMC, and quality assurance within the Company will conduct an annual audit of all sites of its key vendors. Other vendors shall be audited as required at least once every three years.
To support its growing pipeline and planned commercial products, the Company is also building a state-of-the-art GMP manufacturing facility with a pilot plant and commercial scale production lines in Hangzhou, China. The Hangzhou site has been designed in compliance with Good Manufacturing Practice (GMP) standards adopted by the U.S. Food & Drug Administration (FDA), the China National Medical Products Administration (NMPA), and European Medicines Agency (EMA).
Affordability and Accessibility
The Company expects to file its first BLA (Biologics License Application) in Q4 2021. The Company is committed to providing innovative, high-quality, and affordable drugs to global patients. The Company promotes drug affordability and accessibility through:
Target hospital promotion: the Company seeks to gain access for its products in selected hospitals and proactively promote discussions among industry, academia, and clinic about its products. Meanwhile, the Company also plans to build dedicated marketing teams to educate patients and physicians in these hospitals.
Shanghai (HQ) Suites 802, 505, 702, West Tower 88 Shangke Road, Pudong New District Shanghai, China |
United States Suite 710, 9801 Washingtonian Blvd Gaithersburg Maryland 20878 |
www.i-mabbiopharma.com |
Proactively establish collaborations with DTP (Direct to Patient) pharmacies: the Company proactively reach out to DTP pharmacies with high standards and strict requirements for business qualification. To date, the Company has established collaborations with over 100 DTP pharmacies across over 30 provinces in China.
Proactively establish collaborations with specialty pharmacies eligible for National Healthcare Insurance reimbursement: since 2018, the Company has been establishing and strengthening collaborations with specialty pharmacies eligible for dual-channel qualification and identified opportunities for further cooperation with those specialty pharmacies located in more than 150 cities.
Preparation for potential future products inclusion in the National Reimbursement Drug List (NRDL), essential drug list (EDL) and commercial insurance list: even before the planed BLA, the Company conducted pharmacoeconomic research of its products, and initiated active discussions with clinical key opinion leaders, healthcare insurance experts and related government departments. The Company has built up its market access and medical affairs teams to prepare for the product launch and NRDL inclusion, as well as commercial healthcare insurance coverages to reduce the burden of self-paid expenses by patients and improve its products affordability.
Drug pricing: the Company plans to establish a Drug Price Committee consisting of the management team. Its Market Access Department will initiate a drug-pricing proposal, conducting a full benchmarking analysis on the market environment, industry strategy, and insurance coverage to formulate the optimal pricing scenario. The pricing scenario will then be submitted to the Drug Price Committee. During business negotiations, the Company will proactively discuss with healthcare insurance experts about the drug information and market analysis. In global markets, the Company will adopt differentiated pricing strategies based on policymakers, health plans, pharmacy benefit managers (PBMs), and other stakeholders.
Environment, Health and Safety (EHS)
The Company is transitioning from a clinical stage biotech into a fully integrated global biopharma, with the current state of business operations having no significant environmental impact due to no large-scale manufacturing operations. The Company abides by local laws and regulations on environmental protection and only discharges a small amount of waste gas and wastewater after proper treatment. A small amount of hazardous wastewater produced during the research and development process is carefully collected and handed over to qualified third-party professionals for proper treatment before discharged to the sewage treatment plant. A small amount of harmless waste gas is emitted at a high altitude after filtration by activated carbon. Any hazardous waste generated during the research and development process is carefully collected by laboratory technicians daily and placed in a temporary storage facility, and transported to qualified professionals once a month, in accordance with strict local environmental guidelines. The Company also provided employee trainings, set up SOPs and contingency plans for of potential EHS accidents.
Shanghai (HQ) Suites 802, 505, 702, West Tower 88 Shangke Road, Pudong New District Shanghai, China |
United States Suite 710, 9801 Washingtonian Blvd Gaithersburg Maryland 20878 |
www.i-mabbiopharma.com |
At present, energy and resources consumed in the Companys daily operations are mainly municipal electricity and domestic water. The Company assigned a dedicated team to regularly inspect and maintain the equipment, measure total consumption, and train employees on water and energy saving measures.
Safety and health are the foundation of the Companys operational activities. The Company has created a comprehensive internal safety management system to ensure compliance, strengthen risk assessment and management. In addition, the Company provides employees with annual physical check-ups to ensure the health of the employees. The Company offers SOPs to ensure relevant employees are aware of any potential hazards, including providing emergency training, treatment facilities, and Personal Protection Equipment (PPE) to all employees.
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Shanghai (HQ) Suites 802, 505, 702, West Tower 88 Shangke Road, Pudong New District Shanghai, China |
United States Suite 710, 9801 Washingtonian Blvd Gaithersburg Maryland 20878 |
www.i-mabbiopharma.com |