[비즈한국] Recently, global big pharma Pfizer’s decision to halt development of the oral obesity drug candidate 'MET-224o,' which utilized D&D Pharmatech’s technology, has sent ripples through the domestic bio industry. Because global clinical trials were brought to a standstill due to Pfizer’s internal development strategy and pipeline reorganization—regardless of the candidate's technological merit—the structural limitations showing that a partner’s strategic changes can dictate the fate of a new drug have been laid bare once again.
Until now, technology exports have been regarded in the domestic pharmaceutical and bio industry as a symbol proving the global success potential of homegrown new drugs. Whenever trillion-won deals were announced, market attention surged and corporate valuations skyrocketed. However, as cases of conflicts and development setbacks with global partners continue to emerge, managing partnerships after signing contracts has become a new challenge. This is why there is a growing call for strategies to manage risks during development, regulatory approval, and commercialization even after the technology has been handed over.
Loss of Control After Handing Over Rights… Lessons from HanAll and Medytox
The International Chamber of Commerce (ICC) arbitration results for HanAll Biopharma, released on the 22nd of last month, are cited as a prime example of the limitations in control an original developer can face after a technology export.
In 2017, HanAll Biopharma transferred exclusive rights for the autoimmune disease treatment 'Batoclimab (HL161)' in the Greater China region to China's Harbour BioMed. Later, when Harbour BioMed re-transferred the rights to NBP Pharma, a subsidiary of China's CSPC Pharmaceutical Group, in 2022 and development of indications other than generalized myasthenia gravis (gMG) stalled, HanAll Biopharma notified them of contract termination, citing a failure to fulfill development obligations.
However, the ICC arbitration tribunal ruled in favor of Harbour BioMed. It determined that HanAll Biopharma’s notice of contract termination was invalid and that the existing license agreement remained in effect. Consequently, HanAll Biopharma had to abandon its plan to reclaim the business rights to accelerate development and was also burdened with 9.8 billion won in arbitration costs.
Medytox also faced difficulties in regaining development leadership after a technology export. In 2013, Medytox exported its liquid botulinum toxin formulation technology to Allergan (now AbbVie), but the development schedule became protracted, delaying entry into the U.S. market. Although the rights were returned in 2021, it led to a long-term dispute, including international arbitration over responsibility for development delays.
Partner Variables Affecting Regulatory Approval… Commercialization Stages Are No Exception
In the final commercialization stage after a technology export, cases are emerging where a partner's manufacturing capabilities or regulatory response act as variables.
HLB’s liver cancer drug 'Rivoceranib' received a Complete Response Letter (CRL) and saw its approval schedule delayed after issues were raised regarding the manufacturing and quality control (CMC) of 'Camrelizumab,' an immuno-oncology drug produced by its partner, China's Hengrui Medicine, during the U.S. Food and Drug Administration (FDA) inspection process.
This case demonstrated that a partner’s manufacturing, quality control, and regulatory response can directly impact approval timelines during the global licensing process. At the same time, it is being evaluated as revealing the limitations of the technology export structure, where the original developer finds it difficult to exert control.
Even Yuhan Corporation’s lung cancer drug 'Leclaza (Lazertinib),' considered a representative domestic success story in technology exports, has its global clinical, regulatory, and marketing strategies effectively led by Janssen, a subsidiary of Johnson & Johnson (J&J). While Yuhan Corporation secured large-scale milestones and royalty income, the fact that its experience in building global sales networks and brands, as well as leading clinical trials, remains limited is also cited as a drawback of the technology export model.
From 'Contract Signing' to 'Partnership Management'
Experts unanimously agree that the domestic pharmaceutical and bio industry must move beyond the stage of focusing solely on the technology export contract itself and enter an era of managing post-contract risks.
Accordingly, the industry points out that, starting from the technology export contract stage, contractual mechanisms must be meticulously designed to prepare for partner development delays or the transfer of rights. There is a need for clauses that specify deadlines for initiating clinical trials by indication, automatic rights reversion if development milestones are not met at a certain level, and mechanisms that ensure regular sharing of development data and progress.
HLB has also moved quickly to strengthen partner management. Last month, it decided to establish an ongoing cooperation governance system between its top management and the quality (QA) and regulatory (RA) staff at Hengrui Medicine, and has set up a system to proactively manage risks in the global licensing process, such as regularizing existing ad-hoc consultations.
Jung Yoon-taek, CEO of the PharmTech Industry Research Institute, stated, "When pursuing technology exports and joint development, one must clearly design responsibilities, authorities, and dispute resolution procedures at the contract stage, considering risks that may arise in the future, rather than focusing on the deal itself."
He added, "By concretizing the roles and authorities of joint development partnerships in advance, we can prevent the recurrence of similar cases and accumulate the experience and know-how needed for global new drug development."