Can the Pharmaceutical Industry Sustain Its Momentum in Various Drug Formats?

The pharmaceutical industry is witnessing significant developments in different drug formats, creating momentum and attracting the attention of both investors and companies. Let's explore some of these advancements across various areas of drug development.

Nuclear medicine, particularly the success of Pluvicto, has garnered substantial sales and spurred increased interest from pharmaceutical companies. Recent acquisitions, such as Eli Lilly's $1.4 billion purchase of PointPharma and Bristol Myers Squibb's $4.1 billion acquisition of RayzeBio, which raised $729 million in just three years, demonstrate the growing importance of this field.

In the realm of in vivo gene editing, Intellia's NTLA-2001, an ATTR gene-editing therapy, entering Phase III clinical trials represents a significant milestone. Other gene therapies, including lentiviral and AAV-based treatments, are gaining approvals and setting new price records. However, the market outlook for these therapies remains unclear.

The antibody-drug conjugate (ADC) field has witnessed intensive international activity, as Chinese ADC companies expand globally. Globally, ADC transactions continue to make headlines, such as Pfizer's acquisition of Seagen and Merck's $22 billion collaboration with Taiho Pharmaceutical. Additionally, AbbVie's $10.1 billion acquisition of ImmunoGen demonstrates the industry's interest in ADC development.

In the siRNA field, the success of PCSK9 inhibition highlights the tremendous value of siRNA in chronic disease management. Pioneering companies like Alnylam have made rapid progress, advancing multi-organ targeting approaches. Roche's $2.8 billion partnership with Alnylam for AGTsiRNA and Novartis' acquisition of DTx to expand siRNA delivery in CNS further highlight the growing interest in this area. Domestically, Chinese pharmaceutical companies, including Qilu Pharma, Sinobioway, Hengrui Medicine, Fosun Pharma, and Junshi Biosciences, have entered the clinical stage with their siRNA therapeutics.

Cell therapies, such as CAR-NK and CAR-T, have faced challenges. CAR-T therapies for lymphoma have raised concerns from the FDA regarding associated risks, while Iovance's TIL therapy awaits final market approval.

Peptide drugs derived from mRNA display technology have gained approval, with Zilucoplan from UCB's acquired company RAPharma being the first in this category. Merck's oral peptide PCSK9 inhibitor has also entered Phase III clinical trials.

Breakthroughs in oncolytic virus therapy have been observed, with CGOncology's treatment for NMIBC demonstrating significant efficacy and receiving breakthrough therapy designation and fast track qualification from the FDA. Leepharma holds the rights to this therapy in China.

In the field of PROTACs and molecular glues, several companies are venturing into antibody-conjugated degraders, including Seagen/Nurix, Bristol Myers Squibb/Orum, and Merck/C4. Additionally, Roche's collaboration with MonteRosa focuses on developing molecular glue drugs.

In summary, 2023 witnessed substantial mergers, acquisitions, and collaborations in various areas, including ADCs, immunotherapies, metabolism, and CNS. The maturation of technologies, combined with advances in target identification, has provided more possibilities for iterative development in previously explored areas. New drug formats, such as ADCs (HER as an example), nucleic acid therapeutics (PCSK9 as an example), and bispecific antibodies (CD3/CD20 as an example), offer additional tools for target development. Consequently, drug development has entered an era of accelerated progress, where multiple drug formats compete for the same targets from the beginning. This intensified competition increases the likelihood of successful target development and enhances the clinical value of the resulting drugs. While the current capital market may experience a downturn, it represents a rational period of adjustment and reshaping, following several years of homogeneous development in China.

Believing that 2024 will be a pivotal year for the Chinese biopharmaceutical industry, it is more than just a cold winter; it signifies structural adjustments, accumulating strength, and the prelude to a reinvigorated spring.