Meitheal executive Jinsong Liu channels deep regulatory expertise into affordable, high-quality fertility medicines and expanded access to care.
With experience across scientific research and regulatory strategy, Jinsong Liu approaches his work with an emphasis on quality and access., A chemist by training, he has spent 25 years in pharmaceutical drug-product development, after five years in academic biotech and pharmaceutical research.
“I am passionate about contributing to more affordable and high-quality medicines to address unmet needs,” Liu explains. Outside of work, he and his wife “have been serving children’s ministries of different non-profit organizations for many years. We love kids!”
Guiding Meitheal’s Regulatory Strategy
“I am an Executive Vice President of Regulatory and Strategic Alliances at Meitheal Pharmaceuticals. I am heading a team responsible for submitting new drug product applications to the US FDA and obtaining approvals for marketing in the US.” That work spans close coordination with Meitheal’s parent company and cross-functional teams—corporate strategy, business development, marketing, and product development—to “develop business strategies, therapeutic pipelines, regulatory strategies for new products under development, aiming to obtain FDA approvals for marketing in an effective and efficient manner.”
Maintaining a productive relationship with the FDA, Liu says, starts with “Good Understanding: understand and share the similar mission of FDA, that is for public health; Commit to alleviating drug-shortage by providing reliable and sustainable supply.” It continues with “Effective & Efficient Communication: communicate with FDA with solid scientific rationales and strong supporting data; timely respond to FDA’s questions and comments.”
STOP LOSING IVF PATIENTS TO COST & STRESS!
Meitheal Fertility’s Affordable, Generic Medications Keep Patients in Treatment & Boost IVF Conversions
Are your patients dropping out due to high costs and emotional stress? You’re not alone. The biggest hurdle in IVF isn’t just medical—it’s financial and psychological. Now, Meitheal Fertility offers a solution.
✔ Lower costs with high-quality, generic fertility medications
✔ Reduce patient dropout and increase conversions
✔ Boost patient satisfaction with affordable alternatives
✔ Expand revenue streams by unlocking a new market sector
Discover the Solution Now – Learn about our current medications as well as our product pipeline. Help more patients start and complete their IVF journey.
When Collaboration Changes the Timeline
“We have recently obtained approval of a critical complex generics (GLP-1 peptide) which is in drug-shortage list.” Liu’s team worked efficiently with FDA reviewers and kept “timely communication about our manufacturing and supply capacity with the FDA Drug Shortage Office,” leading CDER to grant Pre-Launch Activities Importation Requests (PLAIR) so launch quantities could ship from overseas and be ready “upon approval of this product.”
Complex pathways like Breakthrough Therapy or Accelerated Approval require a broad regulatory view. “We need to understand well all relevant regulatory policies and FDA guidance’s, from drug substances, drug products to delivery devices.” Meitheal “communicate[s] frequently with FDA through different channels, such as citizen petitions, advisory and development meetings, correspondences, and the like, with well-prepared packages, which include sound scientific rationales and solid analysis, supporting documents and data, etc.” Throughout, Liu emphasizes a shared goal: “We share with FDA our passion for delivery of therapeutic medicines to help patients’ life, and our commitment to quality and safety.”
Inclusion as a Regulatory North Star
“To me, a family is the most unique, beautiful unit in the world. Every baby manifests the wonder of life. Everyone deserves a chance to build a family, regardless of income, background, financial or insurance status.” For Liu, that conviction is inseparable from his work at Meitheal: “I feel so fortunate and privileged to work in the pharmaceutical industry, specifically at Meitheal, where we have a passionate commitment to fertility medicines with high quality, and safety through innovation.”
That commitment is visible in Meitheal Fertility’s strategy. “Here at Meitheal Fertility, we are not just making fertility injectables, we are also making hope accessible to more people or families!” Liu points to the launch of generic ganirelix and cetrorelix as “a game-changer, offering a critical fertility medication at a fraction of the cost, without compromising quality or efficacy. This isn’t just innovation, it’s inclusion. In a landscape dominated by exclusivity and high costs, Meitheal Fertility is the disruptor that the public health needs: compassionate, courageous, and committed to the common good!”
As he puts it in a concise endorsement: “I champion Meitheal Fertility because they’re not just making fertility injectables — they’re making hope accessible.”
Innovating the Patient Experience
Meitheal’s fertility pipeline includes “both innovative generic and biosimilar products under development.” One example is “a generic fertility medicine in a multi-dose prefilled pen injector, that we called innovative generics.” Compared with the current single-dose prefilled syringe, Liu believes that the multi-dose pen “may offer convenience, be portable, and may take less time to administer injections, etc.”
Hard Decisions in a Shortage Environment
Liu highlights one particularly difficult call: “To obtain approval of a product in drug shortage list, during the review periods, I have made a decision that needs endorsement from the upper management of both Meitheal and our parental company, alignment with the R&D team.” That decision involved regulatory strategy adjustments and “proactively conducting some high-cost development work to ensure we can address FDA’s potential deficiencies timely, and thus, to obtain the approval for marketing the product to help more patients in the shortest timeframe.”
In every case, his choices trace back to the same throughline: using regulatory expertise not just to clear hurdles, but to make high-quality fertility medicines more affordable, more accessible, and more aligned with the families who need them most.
STOP LOSING IVF PATIENTS TO COST & STRESS!
Meitheal Fertility’s Affordable, Generic Medications Keep Patients in Treatment & Boost IVF Conversions
Are your patients dropping out due to high costs and emotional stress? You’re not alone. The biggest hurdle in IVF isn’t just medical—it’s financial and psychological. Now, Meitheal Fertility offers a solution.
✔ Lower costs with high-quality, generic fertility medications
✔ Reduce patient dropout and increase conversions
✔ Boost patient satisfaction with affordable alternatives
✔ Expand revenue streams by unlocking a new market sector
Discover the Solution Now – Learn about our current medications as well as our product pipeline. Help more patients start and complete their IVF journey.