One Year After Launch, Hefluor Pharmaceutical Chongqing Base Delivers Impressive Results-TONACEA

One Year After Launch, Hefluor Pharmaceutical Chongqing Base Delivers Impressive Results

Update time:

2026-04-30 18:13

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In March 2025, Hefluor Pharmaceutical Chongqing ADC CDMO Base (hereinafter referred to as Chongqing Hefluor) was officially put into operation. One year on, as a core base under Hefluor Pharmaceutical’s "Trinity" strategic layout, what kind of performance report has it delivered?

According to insights shared by Hefluor Pharmaceutical, in its first year of operation, Chongqing Hefluor undertook over 14 ADC projects with a 100% delivery rate for core projects. As of the end of March 2026, it had newly signed 7 IND projects, with multiple potential business opportunities under follow-up.

In terms of quality system, Chongqing Hefluor has passed the EU Qualified Person (QP) audit, achieving a 100% passing rate for customer audits. On the production capacity front, its full capacity of 120,000 L antibody drug substance, 1,500 kg ADC drug substance, and 5 million vials of drug formulation has been fully activated, with advanced technologies such as dual-payload and enzymatic conjugation successfully implemented.

Thanks to these solid achievements, Chongqing Hefluor has grown into the largest ADC CDMO platform in Southwest China and been selected as a key biomedical project of Chongqing.

Against the backdrop of rapid expansion of the ADC track and accelerated diversification of XDCs, how does Hefluor Pharmaceutical’s integrated model tackle industry challenges? With this question in mind, Mr. Feng Wei, General Manager of Chongqing Hefluor, granted an exclusive interview to XIEYI Jun.

01、Integrated Closed-loop: Mitigate Risks of Technology Transfer

The manufacturing of ADC drugs covers multiple links including synthesis of small-molecule toxins and linkers, expression of large-molecule antibodies, development of conjugation processes, and formulation filling. It spans three completely distinct industrial sectors: chemical synthesis, microbial fermentation and sterile formulation. Currently, very few domestic CDMO enterprises possess end-to-end integrated manufacturing capabilities.

This complexity has long plagued the industry: most companies have to outsource small-molecule production, large-molecule production and conjugation processes to separate CDMOs. This requires coordinating schedules of multiple vendors simultaneously, exposing projects to potential risks of inconsistent methodologies and divergent standards during technology transfer. Fragmented quality systems further drive up the complexity of regulatory declaration exponentially.

Mr. Feng Wei stated frankly in the interview: "If IND production is divided among different vendors—small molecules at Company A and large molecules at Company B—it will generate enormous communication costs."

Chongqing Hefluor ADC CDMO Base under Hefluor Pharmaceutical offers a fundamentally different solution. By building an in-house same-site commercial manufacturing matrix, it provides global innovative pharmaceutical enterprises with full-lifecycle solutions covering monoclonal antibodies, bispecific antibodies, multispecific antibodies, recombinant proteins and antibody-drug conjugates.

The core logic of this model is to avoid cross-entity technology transfer, with all procedures operated under a unified quality system and project management system. Mr. Feng Wei summarized this closed-loop capability into four dimensions.

First is the physical space closed-loop. Technology transfer is a high-risk stage in ADC production. Even tiny parameter deviations when transferring small-molecule synthesis processes between CDMOs may lead to conjugation failure. Hefluor’s closed-loop model eliminates such transfers at the source, enabling seamless process continuation within one single industrial park.

"From early-stage PCC sample preparation and cell line construction, to IND dossier compilation and subsequent commercial manufacturing, we cover the entire R&D lifecycle of ADC drugs. There is no need to switch between different suppliers; technology transfer risks are eliminated at the source, with full compliance under full lifecycle control," Mr. Feng Wei commented.

Second is the consistent unified quality system throughout all stages. Adopting separate quality systems for small and large molecules would bring huge troubles to the integration of registration dossiers. At Chongqing Hefluor, all workflows follow one set of standards, with GMP compliance consistent from start to finish.

"From small-molecule R&D and GMP production to large-molecule R&D and GMP manufacturing, Hefluor operates under one unified quality system at all times. Clients do not need to adapt to dual standards or liaise with multiple teams. It is precisely this consistency that has enabled our system to pass the EU QP audit smoothly. To date, we maintain a 100% customer audit passing rate, fully supporting global regulatory filings," Mr. Feng Wei pointed out.

Chongqing Hefluor is equipped with 5 OEB5 high-containment production lines and masters diversified conjugation technologies. It can meet differentiated demands for various small molecules and accommodate client choices of reactors in different specifications and materials, including glass reactors, single-use bioreactors and stainless steel reactors. Its production capacity covers the full lifecycle from clinical trials to commercialization. Clients can verify processes rapidly on small-scale production lines for early clinical projects, and the same process route can be scaled up seamlessly for commercial production, realizing flexibility for small batches and cost-efficiency for large batches.

The entire system is connected by unified project management (PM), optimizing the speed and quality of IND and commercial registration filings for clients. Seamless collaboration ensures transparent and controllable execution of complex projects, further shortening delivery cycles.

"For clients, the most direct values are cost reduction, efficiency improvement and risk control — for instance, cutting management costs by over 30%, shortening technology transfer cycles by 3 to 6 months, and achieving full-process traceability of quality," Mr. Feng Wei concluded.

02、The Secret Behind Chongqing Hefluor’s Efficiency Acceleration

In the race for innovative drug R&D, time and cost are two major bottlenecks for pharmaceutical enterprises. Especially in the ADC sector, the traditional pathway from DNA sequence design to IND approval usually takes 18 to 24 months or even longer. In contrast, Chongqing Hefluor has compressed the cycle to 14 months. This achievement stems not from isolated breakthroughs, but from a well-orchestrated systematic operation.

Mr. Feng Wei summarized the operating logic of this system into several interlinked aspects.

First is parallel workflow execution. Traditional CDMO services adopt a serial relay mode: process development starts only after cell line construction is completed, and registration dossiers are prepared only after processes are stabilized. Delays in any link will cascade downstream. In Chongqing Hefluor’s integrated system, key milestones are rearranged. Multiple modules including cell line construction, process development, quality research and stability testing are launched simultaneously. Information and material flow circulate efficiently within the same site, drastically cutting waiting time.

Efficient operation of this parallel mechanism is supported by Chongqing Hefluor’s long-accumulated standard template library. With extensive experience in IND projects, the company has built a clear knowledge map, identifying high-risk links and data points prone to regulatory inquiries. This means every new project is advanced based on mature experience rather than starting from scratch, minimizing repeated trial-and-error costs.

Another critical strategy is proactive registration engagement. Mr. Feng Wei introduced that the registration team of Chongqing Hefluor gets deeply involved in the early stage of process design, preparing core registration dossier documents synchronously, instead of compiling materials after process finalization. This approach enables CMC data and registration texts to be completed almost simultaneously, avoiding the inefficiency of post-process documentation.

In terms of execution, Chongqing Hefluor implements a weekly project tracking mechanism with special coordination for key milestones. Project teams review progress weekly, responding to and resolving any deviations on the same day to ensure zero delays in critical nodes.

03、Seizing the Wave of "Universal Conjugation"

The modular structure of conjugated drugs features inherent scalability. The success of ADCs has spurred the R&D of novel conjugated drugs, making the concept of "universal conjugation" a reality. The conjugated drug landscape is no longer limited to the traditional ADC framework, evolving into a highly modular technology platform:

RDCs conjugate antibodies or ligands with radionuclides;
DACs link antibodies with protein degraders;
PDCs use peptides to replace antibodies.

This trend means that almost any therapeutic or diagnostic payload can be precisely delivered via appropriate linkers and targeting carriers.

The diversification of conjugated drugs poses new challenges to manufacturing platforms: they must rapidly adapt to technical requirements of various conjugation modalities while possessing sufficient flexibility and modular hardware capabilities.

Facing the diversification of RDCs, PDCs and other modalities, Chongqing Hefluor has built a multi-dimensional technology library covering payload-linker-carrier, greatly shortening the construction cycle of novel conjugation platforms. "We can complete the preliminary establishment of a new platform within one to two months," he noted.

On the antibody front, Chongqing Hefluor is building a high-expression tribody platform to form a complete industrial chain covering tribody expression, evaluation and druggability research, accelerating IND declaration.

Breakthroughs in site-specific conjugation technology are more concrete. We have completed technical verification of enzymatic conjugation with a DAR value of 2 and achieved a 100% conjugation efficiency. Preliminary technical verification of glycan-based site-specific conjugation has also been completed, with ongoing optimization of equivalence parameters.

Regarding the dual-payload platform, Mr. Feng Wei revealed: "Preliminary verification has proven technical feasibility, and we are currently advancing a dual-nanobody dual-payload project through the IND process."

In terms of modular production lines, Chongqing Hefluor is equipped with multi-specification reactors and full-range formulation lines, capable of supporting the R&D and production of cold drug components for RDCs. The production platform adopts an independent partition design for high-risk areas, enabling simultaneous manufacturing of multiple products and avoiding cross-contamination risks.

In terms of full-chain collaboration, Mr. Feng Wei stated that the company has successfully undertaken multiple PDC projects in collaboration with its small-molecule division, verifying the extendibility of its integrated model to peptide-drug conjugates.

04、Confidence Behind Chongqing Hefluor’s Capacity Expansion

According to PharmCube statistics, 21 ADC drugs have been approved globally to date. Among the 10 products with disclosed 2025 sales revenue, aggregate sales exceeded 16.8 billion US dollars. Frost & Sullivan predicts that the global ADC market size will reach 66.2 billion US dollars by 2030, leaving enormous room for growth in the next five years with the track far from saturation.

Based on this outlook, Chongqing Hefluor is steadily advancing its capacity expansion plan. The Banan District Government of Chongqing has explicitly included "supporting Hefluor Pharmaceutical’s capacity expansion and volume release" in its 2026 government work report.

Mr. Feng Wei indicated that Chongqing Hefluor’s order backlog has achieved month-on-month growth for consecutive quarters with strong customer demand. The company maintains a rich pipeline of high-potential orders and a high customer repeat order rate. Long-term development will focus on securing long-term commercial production capacity for top-tier clients.

In Mr. Feng Wei’s view, the integrated platform can flexibly undertake diversified conjugated drug projects, improving customer service capabilities while effectively controlling technology transfer risks. With further capacity release, Chongqing Hefluor owns production lines for high-potency and non-high-potency drugs, capable of undertaking XDC projects including antibodies, ADCs, PDCs and cold drug parts of RDCs. It covers the full needs from IND declaration and clinical sample production to commercial manufacturing, delivering comprehensive solutions for clients.

While consolidating manufacturing capacity, Hefluor Pharmaceutical is integrating into the cutting-edge industrial ecosystem with a more open mindset.

In September 2025, Insilico Medicine, Mway Biotech and Hefluor Pharmaceutical announced a strategic partnership to jointly explore the ADC market, pioneering a brand-new ABC cooperation model in the ADC sector: AI + BioTech/BioPharma + CXO. This collaboration further expands the extension and depth of Hefluor’s integrated service model.

From its one-year operational performance report to its resolute pace of capacity expansion against market cycles, Chongqing Hefluor’s integrated model is undergoing real-world validation amid the XDC industry wave. As Mr. Feng Wei remarked: "Going forward, Chongqing Hefluor will continue to consolidate its integrated advantages, adapt to diversified demands of the XDC track, and accelerate the launch of more drugs with more efficient and compliant services."

In the new era of "universal conjugation", whether the integrated model can maintain its leading edge deserves continuous industry attention.

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