Bayer sees Korea as a strategic hub for CGT in Asia-Pacific

SAN SEBASTIÁN, Spain -- By Lee Han-soo/Korea Biomedical correspondent -- Bayer is ramping up its efforts in cell and gene therapy (CGT) across the Asia-Pacific region, with Korea emerging as a priority market for clinical development and patient access.

Ashraf Al-Ouf, Bayer’s Head of Commercial Operations APAC and President of Bayer Japan, said Korea’s fast-growing biotech sector and supportive regulators make it a key market for Bayer’s next innovation phase.

“Korea is evolving very fast in the biotech space,” Al-Ouf said during a recent interview with Korea Biomedical Review at the headquarters of Viralgen, a subsidiary of AskBio, which Bayer acquired in 2020. “We were positively surprised by how much the biotech industry is growing, how many companies are emerging, and how much openness there is toward innovation.”

The company is now working with some of these players, and it is looking forward to having a bigger footprint in Korea in the future, he added.

Clinical trial diversity as a global driver

Bayer has made Asia-Pacific one of its most important engines for clinical trials. The company has 34 ongoing studies in the region, spanning oncology, cardiovascular disease, ophthalmology, and women’s health.

Around 26 percent of global participants in Bayer clinical trials come from Asia-Pacific, with oncology studies seeing particularly high participation rates of nearly 50 percent in early-stage settings.

Al-Ouf attributed this to both the reliability of local sites and the diversity of patient populations.

“The quality of data, the predictability of regulatory pathways, and the delivery on commitments are what make the region so attractive,” he said.

Singapore, for example, has established a predictable clinical trial approval system, while larger markets like China, Japan, and Korea contribute to scale and patient recruitment.

Australia has already become the first Asia-Pacific country to host Bayer’s Parkinson’s disease cell therapy program, developed through AskBio and BlueRock -- biotech firms Bayer acquired as part of its push into advanced modalities.

“This is one of our first phase 3 studies,” Al-Ouf said. “But there are many more coming across different indications.”

Korea, he suggested, is well positioned to join the list of trial sites in the near future.

Korea’s regulatory edge

Beyond clinical capacity, Korea’s regulators are recognized for their agility.

Al-Ouf highlighted the Ministry of Food and Drug Safety’s fast-track approval of Eylea 8 mg, Bayer’s high-dose formulation for retinal diseases, which was cleared in just three months compared with the typical six-month timeline.

“That kind of openness to innovation is critical,” Al-Ouf said. “By the time we bring cell and gene therapy to Korea, the ground will be ready to introduce it as soon as possible.”

Al-Ouf noted that Korea’s dual advantages -- a vibrant domestic biotech scene and a regulator willing to accelerate breakthrough approvals -- make it a natural testing ground for novel therapies.

Korean patients have historically gained relatively early access to drugs compared to other Asian peers, a trend Bayer intends to sustain with its CGT portfolio.

Beyond Parkinson’s: Bayer’s expanding CGT scope

While Parkinson’s disease is the most advanced program in Bayer’s CGT pipeline, the company is eyeing broader disease areas where unmet needs are high. Cardiovascular disease, especially heart failure, has become a focal point.

“In Asia-Pacific alone, there will be an estimated 74 million people with heart failure in East and South Asia by 2040,” Al-Ouf noted. “It is already a huge burden, and it cannot be neglected.”

Oncology represents another priority. Bayer continues to expand its conventional oncology portfolio, but Al-Ouf said CGT approaches could ultimately reshape treatment paradigms.

“CGT will not be confined to CNS diseases like Parkinson’s,” he said. “It will expand into cardiovascular, oncology, and many other therapeutic areas over time.”

Bayer’s acquisitions of AskBio, BlueRock Therapeutics, Vividion Therapeutics, and other biotech ventures have laid the foundation for this expansion.

By keeping these companies operationally independent under its “Best Bayer” strategy, the company aims to preserve their entrepreneurial agility while integrating their innovations into Bayer’s global pipeline.

Balancing innovation with affordability

The promise of CGT has always been shadowed by concerns over cost and access. In markets where public insurance dominates, such as Korea, affordability is often the decisive factor determining adoption.

Al-Ouf acknowledged these hurdles but reaffirmed Bayer’s long-standing mission of “health for all.”

“Our heart is in innovation, but that innovation would mean nothing if patients cannot access it,” he said. “We continuously engage in open dialogue with governments, payers, and patient associations to find solutions. Public-private partnerships, access programs, and tailored reimbursement models will all play a role.”

He pointed to Korea as an example of what is possible. In recent years, Bayer has successfully launched finerenone for chronic kidney disease, vericiguat for heart failure, and darolutamide for prostate cancer in Korea, even as global debates over high drug prices intensify.

“It was not easy, but through cooperation with the government and other stakeholders, we managed to bring these innovations to patients,” Al-Ouf said.

A broader regional perspective

Al-Ouf also stressed the diversity of healthcare systems across Asia-Pacific, which requires flexible approaches.

“We have reimbursed markets like Australia, Korea, and Taiwan,” he said. “Then we have out-of-pocket markets such as India and Pakistan, and mixed markets like Thailand and Malaysia, where reimbursement is partial,” he said.

To address these differences, Bayer has formed partnerships with local companies in Southeast Asia and India to expand reach.

“Even in Korea, we work with local partners when it supports our mission of reaching patients,” Al-Ouf said.

For example, Bayer Korea has partnered with Chong Kun Dang Pharmaceutical, which now exclusively distributes its liver cancer drugs Nexavar and Stivarga to hospitals and clinics in Korea.

Looking ahead five years

When asked about his five-year outlook, Al-Ouf expressed optimism that cell and gene therapies would be firmly embedded in the region by then.

“Our ultimate objective is to bring all our innovations everywhere as soon as possible,” he said. “Different modalities come with different challenges, but Korea is extremely advanced and we do not foresee major obstacles.”

Bayer’s continued investment in clinical trials, partnerships, and regulatory engagement in Korea suggests the country will serve as both a development hub and an early-launch market for its CGT pipeline.

With cardiovascular disease, oncology, and neurological disorders representing some of the region’s most pressing health burdens, Bayer sees a clear alignment between its innovation strategy and Asia-Pacific’s medical needs.

“The diversity of APAC is an opportunity, not a challenge,” Al-Ouf concluded. “It allows us to learn more, innovate faster, and deliver better outcomes.”

Korea, with its strengths, will be at the center of that journey, he added.