How Candid Therapeutics Leveraged Clinical Trials in China for a $2.2-Billion Acquisition; Marty Makary Allegedly Being Fired; Next-Gen CDK to Watch at ASCO
Asian Biotechies In A Bar; Issue 139; 2026-05-10
Summary
In this week’s issue,
Leon Tang reveals Candid Therapeutics’ highly successful clinical operations campaign in China that enabled its impressive 20-month journey from launch to a $2.2-Billion acquisition.
Angus Liu discusses the reported firing of Dr. Marty Makary as the FDA commissioner after a year of turmoil.
Jiamin Zhuo surveys three next-generation CDK inhibitor strategies converging at ASCO 2026 — selective CDK4 inhibition for improved tolerability, CDK2 inhibition to tackle resistance biology, and China’s triple CDK2/4/6 approach to preemptively suppress resistance.
Last week, Leon Tang gave a presentation about the current M&A and BD&L trends in Biotech at the AtPhilly conference. Paid subscribers can download this informative presentation in the paid subscribers’ session.
Jiamin Zhuo, Angus Liu, and Leon Tang have been the proud writers and editors of this newsletter since 2023.
Email us at contact@iswtc.org to learn how to support or contribute to our newsletter.
How Candid Therapeutics Leveraged China’s Clinical Trial Infrastructure for a $2.2 Billion Exit
Last Sunday, Candid Therapeutics was acquired by UCB for up to $2.2 billion, a move that coincided with the withdrawal of their planned IPO. This transaction underscores the significant appetite among big pharma for T-cell engagers (TCE) in the autoimmunity space, following Ouro Medicines’s $2.2 billion acquisition by Gilead, Antigen’s licensing agreement with UCB, Kali Therapeutics’ deal with Sanofi, Chimagen’s deal with GSK (issue 69, 2024-11-03), and Curon’s asset acquisition by Merck & Co (issue 53, 2024-08-11), as well as many other smaller and undisclosed deals.
While several TCE-based deals for autoimmune diseases have surfaced recently, the Candid-UCB acquisition stands out due to its unique development trajectory.
An Unprecedented 20-Month “Biotech Dash”
The initial TCE clinical data from IGM Biosciences, presented at ACR 2023, sparked industry-wide interest in utilizing T-cell engagers as a scalable alternative to autologous CAR-T therapies for autoimmune indications. Capitalizing on this momentum, our firm secured several advisory mandates in the space.
The seminal Nature Medicine publication by Georg Schett and Ricardo Grieshaber-Bouyer, evaluating a CD19 TCE, followed by their NEJM paper on BCMA-TCE, further validated the modality’s potential.
I published a strategic analysis of BCMA-targeted TCEs just days prior to Candid Therapeutics’ official launch, which featured a substantial $370 million Series A. Since that milestone, I have closely monitored Candid’s progress through my networks in both the US and China.
Candid’s public trajectory has been remarkable: launching in September 2024 with a $370 million series A along with 2 clinical-stage assets, closing multiple R&D partnerships, and establishing cross-border teams. After announcing plans for a $505 million crossover financing in March 2026, the company opted for a $2.2 billion exit this May—completing an extraordinary 20-month cycle from inception to acquisition.
Several investors and collaborators have discussed Candid’s strategic model on BioVerse (BioVerse #13 and #17), and a recent The Long Run podcast interview with Ken Song provides extensive operational details.
By any metric, this journey represents one of the most efficient and impressive value-creation stories in our industry.
Clinical Execution: Leveraging the “China Speed” in Clinical Trials
Biotech insiders recognized early on that Candid’s success was predicated on a sophisticated and impressive clinical operations campaign in China. The first public disclosure of this strategy came in June 2025, when the company announced the “strategic establishment of China operations.”
Caidya served as their primary clinical CRO for the company in China. According to Shen Jinye, Head of Business Development at Caidya and an iSWT Community member, the firm assisted Candid in initiating about 10 trials in China across diverse indications.
This deep engagement with China early-stage clinical trial space even led Ken Song to co-author a Nature Biotechnology commentary on China’s innovative translational medicine ecosystem. Utilizing China’s efficient early-stage trial system, Candid launched multiple investigator-initiated trials (IITs) for their lead BCMA-targeting candidate, cizutamig.
The decision to prioritize China was pragmatic. While Song initially sought to conduct signal-finding trials in the US, the regulatory requirements and preparatory timelines proved prohibitive, according to his The Long Run interview. By pivoting to China and Europe, Candid achieved rapid generation of proof-of-concept clinical data.
Ultimately, the China-based data identified the optimal indications for global Phase 2 development, providing the clinical validation required for the UCB acquisition. While China-originated assets provided the foundation, China’s world-class clinical infrastructure facilitated the $2.2 billion exit.
Insights from the Frontlines of China’s IIT Ecosystem
In my role as fractional BD head of Mianus Accelerator, I have observed the distinct competitive advantages of China’s early-stage development landscape. At the recent AtPhilly conference in Philadelphia, the dedicated China IIT session chaired by Bo Liang highlighted the system’s ability to de-risk innovative therapies through rapid first-in-human studies. Furthermore, the enactment of Decree 818 on May 1st (issue 138) has enhanced R&D efficiency, further solidifying China’s position in global early-stage clinical R&D.
During the panel discussion, perspectives from global pharma executives, biotech leaders, China-based physicians, and CROs suggest that China is building a “first-in-class” clinical trial infrastructure. This system is becoming a core competitive advantage in the global race for biotech innovation.
Operational metrics are impressive: according to one CRO presentation, the timeline from initial discussion to first-patient-in can be as short as four to five months.
Following the success of Legend Biotech, EsoBiotec, and Candid Therapeutics, 173 IITs were initiated by international companies in 2025 in China. We expect this trend to accelerate as global sponsors seek faster paths to clinical data.
Regulatory Reform: A Strategic Imperative for the US
Jake Becraft, who recently testified before Congress regarding biotech competitiveness, recently sat down with our editor Angus Liu for a thought-provoking interview. He emphasized the urgent need for US regulatory and infrastructural reform to maintain leadership in clinical development.
“The defining competitive metric in modern biotechnology is no longer who discovers a promising therapy first. It is who can turn that discovery into first-in-human clinical data the fastest.”, said Jake Becraft.
I can’t agree more.
Leon Tang , Co-Founder of iSWT Community & Founder of ISWT BioAdvisory
Dr. Makary to be fired after months of turmoil: report
President Trump has approved a plan to fire FDA Commissioner Dr. Marty Makary, The Wall Street Journal reported Friday, citing people familiar with the matter.
The decision isn’t yet final and could change, according to WSJ. When asked about Makary’s firing, Trump said: “I know nothing about it.”
Makary was sworn in as FDA commissioner on April 1, 2025. His yearlong tenure has been dogged by turmoil from massive DOGE-led layoffs, endless senior leadership turnover, complaints from the biopharma industry over inconsistent regulatory decisions and protests from antiabortion activists who wanted him to restrict the abortion pill mifepristone.
His pending firing appears to be the result of a combination of factors piling up into a bigger problem that points to him as what WSJ described as “a rogue agent” within the administration. The last straw seems to be Trump’s frustration with him not moving fast enough to approve fruit-flavored vapes. But according to an anonymous White House official cited by Politico, his ouster has been championed by senior leadership at the Department of Health and Human Services rather than the White House.
Dr. Makary’s leadership has indeed been marred by turbulence. But his departure does not restore stability at the agency on the biopharma side.
For one thing, both CDER and CBER are currently under acting leadership following high-profile departures.
Second, what the Trump administration wants in an ideal FDA commissioner and what the industry longs for in a consistent drug regulator are simply mutually exclusive.
What Trump and Robert F. Kennedy, Jr., want is a political servant who will strike on vaccines and endorse unproven peptides at their beck and call. But that kind of political intervention is the very source of uncertainty that the biopharma industry desperately seeks to steer clear of.
This tightrope that Makary was walking was doomed to snap. When Dr. Vinay Prasad held vaccines to an overly high bar as Kennedy wanted, claiming without evidence that at least 10 children had died due to COVID vaccinations, an outcry from the scientific community followed. When he tried to apply the same scrutiny to drug approval, suddenly the right wing called him a socialist. The biopharma industry can handle tight regulatory standards, but they must be predictable and consistent.
After Dr. Prasad was pushed out, the target apparently shifted to Dr. Makary.
Dr. Makary’s pending ouster could confirm a possibility, like the exit of Dr. Prasad before him, that this FDA leadership position has less to do with scientific acumen and more to do with political obedience. Without science-based leadership, all that the biopharma industry is left with is political favoritism and the rest is just uncertainty.
The wry positive side is, I think the industry has already learned to speak the language of the Trump administration. Whenever someone sees an unfavorable policy or decision from the FDA, it warns that China is winning or accuses political disloyalty.
Now, assuming Makary has been fired. What will happen to some of the FDA’s new policies?
First, the controversial Commissioner’s National Priority Review Voucher pilot. That will probably stay because it opens a channel for involvement by political leadership.
Plausible mechanism pathway. This isn’t exactly a new regulatory concept, but it’s being applied to personalized therapies for the first time. Given Kennedy’s public endorsement of CRISPR and an eagerness to chalk up baby KJ as a regulatory win, this will likely stay on as well.
Clinical trial reforms such as real-time review of clinical data and expedited IND, these will likely be kept as well, given broad endorsement and the fact they’re not Dr. Makary’s own pet project.
Potential crackdown on Chinese data and companies? That’s the trend no matter who’s leading the FDA. The question is in what form and to what extent?
Without an official announcement, Dr. Makary is still technically the commissioner. But the White House is already mulling over his potential replacement. Kyle Diamantas, the FDA’s top food regulator who does not have a medical background, is the frontrunner, Politico reported, citing a former HHS official. But Reuters reported that Diamantas is only being considered as acting commissioner, citing three sources.
Former FDA commissioner Dr. Stephen Hahn and former acting FDA commissioner Dr. Brett Giroir are being considered as permanent replacement, according to Reuters. But Politico reported the two as potential interim leaders of the agency.
Hahn’s name was notably missing among the authors of a Dec. 3 NEJM article, in which 12 former FDA leaders—including Dr. Giroir—criticized Dr. Prasad’s vaccine policy and his unverified safety claims against COVID vaccines.
Angus Liu, Deputy Editor of Fierce Pharma and iSWT Community volunteer
The Next Wave of CDK Inhibition: ASCO 2026 Signals a New Competitive Era in HR+/HER2- Breast Cancer
The CDK inhibitor market is entering its second competitive cycle. After nearly a decade in which palbociclib, ribociclib, and abemaciclib reshaped HR+/HER2- breast cancer, the field is fragmenting into distinct next-generation strategies — each targeting a different limitation of the first generation. Upcoming ASCO 2026 may be the meeting where this transition becomes impossible to ignore.
Why the First Generation Is No Longer Enough
CDK4/6 inhibitors remain global first-line standard of care in metastatic HR+/HER2- breast cancer, and their OS and PFS benefits are not in dispute. But two persistent liabilities have opened the door for successors: hematologic toxicity — primarily neutropenia driven by CDK6 inhibition in bone marrow — and resistance that is virtually universal, with roughly 20% of patients showing primary resistance and most others progressing after two to three years.
Three strategic responses are now advancing in parallel:
highly selective CDK4 inhibition to reduce toxicity,
CDK2 inhibition to address resistance biology,
combined CDK2/4/6 inhibition to preemptively suppress resistance emergence.
Selective CDK4 Inhibition: The Front-Running Race
The underlying rationale is straightforward. HR+/HER2- tumors appear more dependent on CDK4 than CDK6, and CDK6 inhibition in hematopoietic cells drives most of the class’s dose-limiting toxicities. A CDK4-selective agent could, in principle, preserve antitumor efficacy while materially improving tolerability.
Pfizer’s atirmociclib is currently the benchmark. In March 2026, Pfizer announced positive topline results from FOURLIGHT-1, a randomized Phase 2 study in second-line HR+/HER2- metastatic breast cancer after prior CDK4/6i therapy. The study met its primary PFS endpoint with a hazard ratio of 0.60 versus fulvestrant or everolimus plus exemestane. OS remains immature. This is among the first meaningful randomized signals that a next-generation CDK4-selective agent can retain efficacy after CDK4/6i progression — a biologically important result given that CDK2-driven resistance is common in this population.
The company is also running FOURLIGHT-3, a head-to-head Phase 3 against investigator’s choice of CDK4/6 inhibitor in first-line disease. That study may become one of the defining competitive trials in the category because it directly tests whether selective CDK4 inhibition can improve efficacy and safety versus established CDK4/6i.
At ASCO 2026, Pfizer will expand the atirmociclib dataset in two directions. FOURLIGHT-2 will report Phase 2 neoadjuvant data pairing atirmociclib with letrozole versus letrozole alone — a setting where no CDK4/6 inhibitor is yet broadly established, making a positive result strategically significant.
Pfizer will also present early combination data for atirmociclib with vepdegestrant (Veppanu), the recently FDA-approved PROTAC ER degrader co-developed with Arvinas, pairing two novel mechanisms in a post-CDK4/6i population.
Atirmociclib + Vepdegestrant ASCO Abstract
BeOne Medicines is the nearest competitor with BGB-43395. At ASCO 2026, BeOne will present first-line metastatic data for BGB-43395 for the first time. According to management commentary, BGB-43395 may demonstrate even greater CDK4 selectivity than atirmociclib, which could translate into a particularly clean hematologic profile, though some GI toxicity appears elevated. BeOne is also preparing a Phase 3 head-to-head trial against CDK4/6i in first-line disease, mirroring Pfizer’s FOURLIGHT-3 approach. The atirmociclib versus BGB-43395 race is now one of the most closely watched competitive dynamics in HR+/HER2- oncology.
ASCO abstract link here:
CDK2 Inhibition: Targeting Resistance Biology
While selective CDK4 inhibition is primarily about improving therapeutic index, CDK2 inhibitors take a different approach: directly attacking the most common resistance escape mechanism. Cyclin E1 (CCNE1) overexpression or amplification activates CDK2 signaling and allows tumor cells to bypass CDK4/6 blockade altogether. CCNE1 dysregulation is also prevalent across ovarian, endometrial, gastric, and other solid tumors, which means CDK2 inhibition has the potential to evolve into a biomarker-driven, pan-solid tumor strategy.
Avenzo Therapeutics is advancing AVZO-021 and will present updated Phase 1 data at ASCO 2026 covering both HR+/HER2- breast cancer and CCNE1-amplified solid tumors. The breadth of the tumor-type inclusion reflects how developers increasingly frame CDK2 inhibition as a platform rather than a breast cancer-only play.
Incyte may be furthest along in CDK2. Its selective CDK2 inhibitor INCB123667 has entered the Maestra-2 Phase 3 trial in CCNE1-overexpressing, platinum-resistant ovarian cancer — the first pivotal CDK2 program to reach this stage. The indication choice is deliberate: it targets a population with high unmet need, clear CCNE1 biology, and limited competitive overlap with breast cancer. Phase 1 data presented at ASCO 2025 showed a 33% ORR at the 100 mg daily dose in platinum-resistant ovarian cancer, with most responders having CCNE1 overexpression.
China’s Contrarian Bet: CDK2/4/6 Triple Inhibition
While Western developers pursue selective inhibition, Sino Biopharmaceutical’s culmerciclib takes the opposite approach — simultaneous CDK2, CDK4, and CDK6 inhibition, with preferential CDK4 activity, designed to preemptively block the resistance escape route rather than address it after the fact.
Culmerciclib has now received two NMPA approvals: the original indication (post-endocrine therapy progression, in combination with fulvestrant, approved December 2025) and a new first-line indication (in combination with fulvestrant, approved May 2026). The first-line approval is based on CULMINATE-2 Phase 3 data, which reportedly showed a median PFS not reached in the culmerciclib arm versus 20.2 months in the control arm, an ORR of 59.3%, Grade ≥3 neutropenia of 20.3%, and a low 3.5% treatment discontinuation rate. At ASCO 2026, Sino will present a small Phase 2 data in Chinese patients who have progressed on prior CDK4/6i therapy
The central unresolved question for culmerciclib is global competitiveness. No direct head-to-head data versus a Western CDK4/6 standard exist, and the broader CDK2/4/6 approach is being tested against an increasingly sophisticated selective-inhibitor field. Whether three-target breadth ultimately proves superior to mechanistically cleaner selective strategies — in terms of resistance control, safety, and combinability — remains to be seen.
The Bigger Picture
The first decade of CDK therapy established CDK4/6 inhibition as one of oncology’s most commercially successful targeted therapy classes. The next decade will be defined by a more fragmented competitive landscape: selective CDK4 inhibitors competing on tolerability and first-line replacement potential; CDK2 inhibitors creating a new biomarker-selected category across tumor types; and CDK2/4/6 agents testing whether upfront resistance suppression can outperform sequential selective approaches.
ASCO 2026 will not resolve these questions — but it could make the shape of the answer start to become more visible.
Jiamin Zhuo , Co-Founder of iSWT Community
