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MediLink Therapeutics announces a multi-target TMALIN® ADC technology platform license agreement with BioNTech, expanding their global strategic partnership

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MediLink Therapeutics has announced a strategic collaboration with BioNTech, granting BioNTech exclusive global rights to MediLink's TMALIN® ADC technology for several targets. BioNTech will pay $25 million upfront, with potential milestone payments up to $1.8 billion and tiered royalties on future sales. MediLink retains negotiation rights for exclusive licensing in Mainland China and adjacent regions. This expands their partnership, initially formed in October 2023, to develop the anti-HER3 ADC BNT326/YL202, reaffirming their collaborative efforts in the ADC arena.

Positive
  • MediLink to receive $25 million upfront payment.
  • Potential milestone payments up to $1.8 billion.
  • Tiered royalties on future global annual net sales.
  • Expansion of strategic partnership with BioNTech.
  • Rights of first negotiation in Mainland China and adjacent regions.
Negative
  • Financial dependence on milestone achievements for up to $1.8 billion.
  • Potential delays or issues in ADC product candidate development.

The new licensing agreement between MediLink Therapeutics and BioNTech is a significant development, primarily due to the financial commitments involved. MediLink will receive an upfront payment of $25 million, which provides immediate financial relief and liquidity. Additionally, the potential milestone payments totaling up to $1.8 billion represent a large future revenue stream which could dramatically impact MediLink's financial health if the ADC platform proves successful.

This deal also includes tiered royalties on global net sales, meaning MediLink could benefit from ongoing revenue based on the success of the products developed using their technology. This revenue model aligns MediLink's incentives with BioNTech's success, ensuring that both companies have a vested interest in the successful development and commercialization of these novel ADC targets.

For investors, this agreement indicates strong confidence from BioNTech in MediLink's TMALIN® ADC technology, enhancing MediLink's credibility and potential market value. However, it's important to note that while the milestone payments are substantial, they are contingent on successful product development and regulatory approvals, which carry inherent risks and uncertainties.

From a market perspective, this partnership between MediLink and BioNTech could be a game-changer. The ADC (antibody-drug conjugate) market is a growing segment in oncology and having a robust platform like TMALIN® could position both companies at the forefront of this technology. The exclusivity of the licensing agreement for BioNTech on a global scale showcases the strategic value of the technology, potentially giving BioNTech a competitive edge in developing new cancer therapies.

The market's reception to this news will likely hinge on the perceived efficacy and market potential of the ADC candidates. If BioNTech can successfully bring these products to market, it could lead to significant commercial success and market share gains. The strategic right of first negotiation for MediLink in the China markets further strengthens their positioning, providing potential for regional market dominance.

For investors, the key takeaway is the expanded strategic collaboration, which not only deepens the partnership but also signals long-term commitment and potential for sustained innovation in the ADC space. However, the risks associated with clinical development and regulatory approval processes should be carefully considered.

From a medical research standpoint, this collaboration is particularly noteworthy. MediLink's TMALIN® ADC platform represents a promising approach in the development of targeted cancer therapies. ADCs work by combining an antibody specific to cancer cells with a cytotoxic drug, effectively delivering the drug directly to cancer cells while minimizing damage to normal tissues. This targeted approach can improve treatment efficacy and reduce side effects, making it a highly desirable area of development in oncology.

The choice of novel targets by BioNTech under this agreement suggests a focused strategy to address unmet medical needs in oncology. The extension of the partnership, following the earlier collaboration on the anti-HER3 ADC, indicates positive initial results and a mutual belief in the potential of the TMALIN® platform. This could pave the way for breakthroughs in cancer treatment, offering new hope for patients and potentially transforming the standard of care.

Investors should be aware that while the scientific potential is high, the journey from clinical research to market approval is fraught with challenges. Success will depend on the outcomes of clinical trials and regulatory reviews and these factors should be monitored closely.

SUZHOU, China, May 26, 2024 /PRNewswire/ -- MediLink Therapeutics (Suzhou) Co., Ltd. ("MediLink"), a clinical-stage biotech company, today announces a new strategic collaboration with BioNTech SE (Nasdaq: BNTX, "BioNTech"), a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, under which BioNTech will receive an exclusive option to an exclusive global license to apply MediLink's TMALIN® antibody-drug conjugate (ADC) platform, for several novel targets chosen by BioNTech.

Under the terms of this new agreement, MediLink will receive an upfront payment of $25 million and is eligible to receive additional development, regulatory and sales milestone payments potentially totaling up to $1.8 billion, as well as tiered royalties on potential future global annual net sales. As part of the agreement, MediLink will hold the right of first negotiation for future collaboration of these ADC product candidates if BioNTech wishes to exclusively license or assign rights in such ADC product candidates solely on the Mainland China market or Mainland China market together with one or more of the markets including of Hong Kong Special Administrative Region (SAR), Macau SAR or Taiwan region.

In October 2023, MediLink and BioNTech entered into a strategic collaboration and global license agreement to develop BNT326/YL202, a next-generation anti-HER3 ADC. Both parties have decided to expand their collaboration and have reached this new platform collaboration license agreement.

The expansion of the collaboration marks a further consolidation of the strategic partnership between MediLink and BioNTech, laying a new foundation for the mutual R&D collaboration in the ADC field.

About MediLink Therapeutics
MediLink Therapeutics, founded in 2020, is a clinical stage biotech company dedicated to developing conjugated drugs with global competitiveness. MediLink has developed its proprietary TMALIN® ADC technology platform, enabling the generation of homogeneous ADC with high drug-antibody ratio and improved therapeutic window for the treatment of solid tumors. MediLink aims to provide improved treatment options for global patients and address unmet medical needs. The company is headquartered in Suzhou, China and has established R&D sites in Shanghai, China and Boston, US.

About TMALIN®
The Tumor Microenvironment Activable LINker-payload (TMALIN®) is an innovative ADC platform technology developed by MediLink Therapeutics with proprietary intellectual property rights. It employs dual cleavage mechanisms, operating both extracellularly in the tumor microenvironment and intracellularly in lysosomes. TMALIN® possesses high hydrophilicity, homogenous DAR value, excellent plasma stability, and specific tumor accumulation characteristics. In preclinical efficacy and toxicology studies, ADCs developed based on TMALIN® exhibited significant therapeutic window. So far, several ADC products based on TMALIN® platform have entered into clinical trial stage.

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SOURCE MediLink Therapeutics

FAQ

What is the recent collaboration between BioNTech and MediLink?

BioNTech and MediLink have entered a new strategic collaboration where BioNTech gains exclusive global rights to MediLink's TMALIN® ADC platform for several targets.

What are the financial terms of the BioNTech and MediLink agreement?

BioNTech will pay MediLink $25 million upfront, with potential milestone payments up to $1.8 billion and tiered royalties on future global sales.

When was the BioNTech and MediLink partnership expansion announced?

The partnership expansion was announced on May 26, 2024.

What rights does MediLink retain in the new agreement with BioNTech?

MediLink retains the right of first negotiation for ADC product candidates exclusively licensed or assigned in Mainland China and adjacent regions.

What was the initial collaboration between BioNTech and MediLink?

The initial collaboration, started in October 2023, focused on developing the anti-HER3 ADC BNT326/YL202.

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