China's Innovative Pharma Reaches a Historic Inflection Point: World’s First Solid Tumor CAR-T Approved, Billions in Global Deals Surge

Jun 29, 2026 18:02 CST Updated 18:02

Biokin

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GENRIX BIO

Developer of Novel Monoclonal Antibody Drugs

Innovent

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In the summer of 2026, China's biopharmaceutical industry is experiencing an unprecedented surge.

On June 22, an announcement by the National Medical Products Administration sent shockwaves through the global pharmaceutical industry — Shu Rui Ji Ao Lun Sai Injection (brand name: Kailimei), independently developed by CARsgen Therapeutics, has officially been approved for marketing. This is not an ordinary new drug, butThe World’s First CAR-T Cell Therapy Approved for the Treatment of Solid Tumors。

At this moment, a new chapter has been opened in humanity’s war against cancer. And the author of this chapter is a Chinese enterprise.

I. Historic Breakthrough: The "Chinese Solution" for Solid Tumor CAR-T

CAR-T therapy is not a novel concept. Since the approval of the world’s first CAR-T therapy in 2017, more than ten products have been launched successively, all of which are concentrated in the field of hematologic malignancies.

Solid tumors have long been the “Mount Everest” that CAR-T therapy struggles to conquer.

Immunosuppression within the tumor microenvironment, insufficient target specificity, and difficulties in T-cell infiltration... These technical hurdles have led to repeated failures among global pharmaceutical companies. That is, until Carsgen Therapeutics stepped into the spotlight with its CLDN18.2-targeted CAR-T therapy.

Kailimei (Shu Ruiji Aolun Sai Injection), this autologous CAR-T product, developed by Kaixing Life Sciences, a wholly-owned subsidiary of CARsgen Therapeutics, is indicated for patients with advanced gastric or gastroesophageal junction adenocarcinoma who are CLDN18.2-positive, HER2-negative, and have failed at least two prior lines of therapy.

"This not only lights up new hope for cancer patients in dire straits, but also marks China's leap from following to leading in the field of cell and gene therapy," said a relevant official from the Shanghai Municipal Science and Technology Commission.

It is understood that the product is priced atRMB 990,000 per injectionAlthough the price is substantial, given that this is a first-in-class therapy for advanced gastric cancer and targets a large patient population—China sees approximately 480,000 new gastric cancer cases annually, with about 30%-40% expressing CLDN18.2—its clinical value is self-evident.

It is worth noting that on June 22, the “world’s first” approvals were not limited to just this one:

Biokinthe EGFR×HER3 bispecific antibody ADC drug, lenconetugumab, has becomeThe World's First Bispecific Antibody-Drug Conjugate
GENRIX BIOSiltuximab, isThe World’s First Bispecific Antibody for Post-Exposure Prophylaxis Against Rabies

Three world-first drugs approved on the same day, a first in China's pharmaceutical history.

II. Behind the Multi-Billion-Dollar Deal: The "Global Pricing Power" of China's Innovative Drugs

If the approval of three first-in-class drugs represents a "point" breakthrough, then the flurry of cross-border licensing deals outlines the "surface" rise of China's innovative pharmaceuticals.

May 29,Innovent and Pfizera collaboration announcement has taken the pharmaceutical community’s WeChat Moments by storm. The total value of this transaction amounts to$10.5 billion, setting a new record for out-licensing by Chinese pharmaceutical companies.

Under the agreement, Pfizer will pay an upfront fee of $650 million and assume up to $9.85 billion in R&D, regulatory, and commercial milestone payments. The two parties will collaborate on 12 early-stage oncology R&D projects, covering cutting-edge areas such as antibody-drug conjugates (ADCs) and multispecific antibodies.

But the true significance of this deal goes far beyond the monetary figure.

According to an exclusive disclosure by Fierce Pharma, this multi-billion-dollar collaborationAchieved in less than 5 months. What is even more intriguing is the transaction structure: for four of the core assets, Innovent Biologics insisted on adoptingCo-Development and Co-Commercialization (Co-Co) Model, rather than traditional mere licensing.

“Pfizer initially did not accept the Co-Co structure, but Innovent leveraged interest from other companies as bargaining chips to persist in promoting this model,” revealed Dr. Yu Dechao, CEO of Innovent Biologics, in an interview with Fierce Pharma.

This detail is thought-provoking.

There was a time when Chinese pharmaceutical companies were in an extremely disadvantaged position during negotiations with multinational corporations, forced to "bundle sell" overseas rights at low prices. Now, Chinese enterprises like Innovent have the confidence to say "no" and demand a share of the global market.

This is not an isolated case.

Eli LillyandAbace Bio$1.9 Billion Multi-Target R&D Collaboration Achieved
Insilico MedicineandSK BiopharmSigned $2.5 Billion AI Drug Discovery Agreement
Sino BiopharmaceuticalandSanofiGlobal licensing deal for JAK/ROCK dual-target inhibitor reached at $1.53 billion

Data shows that in the first quarter of 2026, the total value of out-licensing deals for Chinese innovative drugs has exceeded$60 billion, a year-on-year increase of 73%, approaching half of the full-year total for 2025.

From "borrowing a boat to go to sea" to "building a boat to go to sea," and from "technology import" to "value export," Chinese innovative drugs are undergoing a profound identity transformation.

III. Transaction Model Upgrade: From License-Out to Risk Sharing

Attentive industry observers will note that this wave of overseas expansion is fundamentally different from previous ones.

In the early stages of Chinese innovative drugs going global, the predominant model was simple License-Out arrangements—Chinese pharmaceutical companies sold overseas rights to specific drugs to multinational pharmaceutical firms, receiving upfront payments and milestone payments, with minimal subsequent sales royalties.

And now, the transaction model is undergoing structural changes:

1. Co-Co Mode Becomes the New Standard

In the collaboration between Innovent and Pfizer, four core assets adopt a co-development and co-commercialization model, which means that Innovent will not only receive milestone payments but also share in global sales revenue after the products are launched.

"This marks the beginning of Chinese pharmaceutical companies truly participating in the distribution of profits in the global market, rather than merely 'selling pipelines,'" an industry analyst pointed out.

2. From Single-Product to Platform-Based Collaboration

Eli Lilly’s $1.9 billion collaboration with Abisko Therapeutics is not focused on a specific drug, but rather leverages Abisko’s drug discovery platform to conduct early-stage research and development on multiple targets selected by Eli Lilly.

This means that multinational pharmaceutical companies are no longer just interested in China's "products," but also in its "R&D capabilities."

3. AI Drug Discovery Emerges

Insilico Medicine and SK Biopharmaceuticals’ $2.5 Billion Collaboration Focuses on Neuroimmune Diseases. Leveraging Insilico Medicine’s AI-driven drug discovery platform in combination with SK’s neuroscience expertise, the partnership aims to jointly discover and develop novel therapeutics.

In the emerging field of AI-driven drug discovery, Chinese enterprises have taken a global lead.

IV. Calm Observation: Challenges Behind the Prosperity

Amidst the accolades, we must also remain clear-headed.

First,Commercialization Capability Remains a Weakness。Carvykti’s price tag of RMB 990,000 remains prohibitively high for most Chinese patients. How to improve accessibility through national reimbursement negotiations, commercial insurance, and patient assistance programs is a pressing challenge facing Carsgen Therapeutics.

Secondly,Global Clinical Validation Is the True Test。Kailimei has currently been approved only in China. To truly become the “world’s first,” it must demonstrate its value in international multicenter clinical trials and gain approval from regulatory agencies such as the FDA and EMA.

Again,Transaction Amount Does Not Equal Actual Value。In these collaborations valued in the tens of billions, the majority of the amount comes from milestone payments, whose actual realization depends on subsequent clinical progress. The upfront payment is the "hard cash" that multinational pharmaceutical companies are willing to pay.

Finally,Shortcomings in basic research persist。Despite China’s rapid progress in translational medicine and clinical development, there remains a gap with international leading standards in fundamental research areas such as source innovation and target discovery.

V. Conclusion: The Dawn of a New Era

The series of events in June may come to be regarded as a landmark milestone for China’s biopharmaceutical industry.

From the global approval of the first CAR-T therapy for solid tumors to the surge of multi-billion-dollar cross-border collaborations, we are witnessing not merely a few new drugs or transactions, but a historic turning point as China’s innovative pharmaceutical industry transitions from “quantitative accumulation” to a “qualitative leap.”

35 years ago, when the concept of CAR-T technology was first proposed, no one anticipated that Chinese companies would be the first to achieve a breakthrough in the field of solid tumors.

Five years ago, Chinese innovative drugs accounted for only 3% of global licensing deals; no one anticipated that multinational pharmaceutical companies would proactively seek collaborations today.

This is the best of times, and also a time full of challenges.

But one thing is certain: on the global map of pharmaceutical innovation, “Chinese power” is no longer an optional supporting player, but is becoming an indispensable major pole.

The future is here; let us wait and see.

Sources: FiercePharma, National Medical Products Administration (NMPA), Shanghai Securities News, The Paper, 21st Century Business Herald, etc.

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