He Yuan Bio Ventures into Uncharted Territory: Reshaping the Weight of Life Within Microscopic Cells

(Source: China Business Times)

Source: China Industrial and Commercial Times

Acute B lymphoblastic leukemia (B-ALL) is one of the common hematologic malignancies. For patients with relapsed or refractory conditions, there is a lack of effective clinical treatments, and the survival rate of Chinese patients has not significantly improved in nearly 30 years. With deeper understanding of the pathogenesis and advancements in related clinical research, CAR-T (chimeric antigen receptor T-cell) therapy has gradually emerged among various novel therapies, bringing a ray of hope to patients with relapsed or refractory acute lymphoblastic leukemia.

In a 7,000-square-meter cell drug production base in Tianjin Binhai High-Tech Zone, enclosed bioreactors operate silently as engineers dressed in sterile suits monitor real-time production data. Each 20-milliliter bag of liquid produced here represents a lifeline for Old Zhang (pseudonym), a 39-year-old leukemia patient — in 2021, when traditional chemotherapy proved ineffective, the infusion of Juventas' (Natriol Oncely Injection) brought him recovery.

There are many such cases. Five years ago, it was still extremely difficult for Chinese leukemia patients to access CAR-T drugs produced in China. Today, Yuanruida, manufactured by Juventas (Tianjin) Biotechnology Co., Ltd. ("Juventas"), has already given over 300 patients a new lease on life.

Challenge:

From Uncharted Research Territory to First-in-Class Innovative Drugs

As Juventas' first core product, Yuanruida is the first CAR-T drug in China approved by the National Medical Products Administration (NMPA) for the treatment of leukemia.

"I used to be a hematologist and have witnessed too many leukemia patients exhausting their lives during chemotherapy," said Dr. Lulu Lv, CEO of Juventas, in an interview with the China Industrial and Commercial Times.

In 2018, when Lü Lulu gave up the generous benefits of a multinational pharmaceutical company to establish Juventas, China’s CAR-T cell therapy sector was still at a blank stage of “having research but no industry” — research achievements stayed in the lab while patients eagerly awaited innovative treatments.

"At that time, we hoped to truly transform the advanced CAR-T technology into a drug, allowing patients to achieve long-term survival with just one treatment and live like normal people."

The battlefield of leukemia was once filled with despair. The recurrence rate of adult acute lymphoblastic leukemia is as high as 60%, and the median survival period of patients under traditional treatment is only 2-6 months.

The key to Juventas' breakthrough lies in the design of the "HI19a" sequence (warhead) that precisely identifies tumor cells. "At that time, the mainstream CAR-T 'warhead' internationally was FMC63, but we chose the original HI19a as the recognition element. Its affinity and dissociation force are more moderate, which directly determines the efficacy and safety of the product," explained Lü Lulu. Behind this choice is a firm confidence in independent technology.

The research team collaborated with the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, embedding the unique "warhead" structure of the HI19a sequence into CAR-T cells—a design that has received a national invention patent. This "warhead," acting like a missile guidance system, directs CAR-T cells to precisely identify tumor cells in the body and eliminate leukemia cells within about a month.

When Juventas was advancing the clinical application of its first product, the team encountered a bottleneck — the regulatory authority required the development of a serum-free culture system, but at that time, there were no successful cases in China, and imported products could not be introduced due to technical barriers.

"We had no way out, patients were waiting for the drug." Lü Lulu recalled that the team initiated a "365 days × 24 hours" tough battle mode, screening one by one from more than ten culture media and optimizing parameters through countless experiments. Eventually, Juventas successfully developed a stable serum-free culture system, with 80% of memory T cells in the final product, laying the foundation for patients' long-term survival.

Behind the technological innovation, there is strong support from both "policy-driven initiatives" and "market forces." Juventas has been selected as one of the first batch of gazelle enterprises in Tianjin and recognized as a national intellectual property advantage enterprise. It also received special support from the Ministry of Science and Technology's "Science and Technology Aid Economic 2020" initiative, which has enabled the company to focus on research and development during its critical growth phase.

"There is no reason for China to lag behind in the CAR-T field. We have the scientific research foundation, the talent, the capital, and, more importantly, the expectations of patients." Lu Lulu's words carried weight, and this confidence has allowed Juventas to walk steadily on the path of innovation.

Casting the Soul:

Build a "Life Defense Line" with a Quality System

In June 2021, the first "Drug Production License" for cell therapy in Tianjin was awarded to Juventas. This certificate, numbered "202100," not only recognizes the company's production capabilities but also highlights its quality management system.

"Production quality is the lifeline of pharmaceutical companies; every cell will be infused into patients, leaving no room for error," said Lü Lulu, highlighting the uniqueness of cell therapy — CAR-T is a "living" drug that cannot undergo high-pressure sterilization, yet must ensure sterility and viability. Its quality control difficulty far exceeds that of traditional medicines.

At the cell drug production base, production lines are operating in an orderly manner. The entire process from patient apheresis to drug release takes about 20 days, covering more than 280 process steps, each with strict quality control. "Our quality control is not just endpoint testing, but full-process traceability," said Peng Yuzhong, Vice President of Production at Juventas.

From temperature monitoring during cell collection, to activity analysis during the culture process, to status recording of the final cryopreservation, all real-time data is uploaded to the system to ensure the traceability of each product. This "process control" concept has enabled Juventas to achieve a 100% production success rate in registered clinical research, surpassing the industry average.

Cells are living entities and highly sensitive to environmental changes. To meet internationally leading quality standards, Juventas has independently developed a production process system and established a full-process quality control system. The introduction of a closed magnetic bead sorting system ensures cell sorting purity ≥95%; the use of intelligent bioreactors allows precise control of pH and dissolved oxygen levels, ensuring stable cell expansion. These technologies not only enhance quality but also significantly improve production efficiency—currently, at full capacity, the facility can meet the medication needs of 2,000 patients annually, laying a solid foundation for drug accessibility.

The construction of the quality system ultimately falls on "people".

Of the more than 300 employees at Juventas, one-third hold a master’s or doctoral degree. From researchers to production engineers, everyone undergoes six months of rigorous training before starting their roles, covering process operations, emergency response, and quality awareness. It is this talent pipeline that supports the full-process innovation and quality system from the laboratory to clinical applications.

Autonomous production processes and quality control systems achieve a 100% production success rate, while a full-process quality management system and a closed-loop traceability system minimize the safety risks of CAR-T.

Going Overseas:

Benefit Global Patients with Chinese Innovative Drugs

In December 2024, on the occasion of the 25th anniversary of Macao's return to China, Yuanruida was approved for marketing by the Macao Pharmaceutical Regulatory Authority, becoming the first mainland-developed CAR-T drug to be launched in Macao.

"Macao is an important node of the 'Belt and Road Initiative,' and the approval here has opened the door for us to enter Southeast Asia," said Lü Lulu. Internationalization was one of the "three-step strategy" set when Juventas was established, and it is now proceeding steadily.

Juventas Actively Expands "Belt and Road" Overseas Markets; Delegations from the Ten ASEAN Countries Visited the Company’s Production Base, Showing Strong Interest in Its Technology Platform and Pipeline Layout. "Cell Therapy is a Part of the Global Health Cause; Chinese Innovative Drugs Should Serve Not Only Patients in China but Also Provide Solutions for Countries Along the ‘Belt and Road’ Route," Said Lü Lulu.

In the Middle East, Juventas is making equally rapid progress. In June 2025, Yuan Ruida was granted "Breakthrough Therapy" designation by the Saudi Food and Drug Administration (SFDA).

"The significance of the Breakthrough Therapy Designation lies in its ability to accelerate the drug's market entry in Saudi Arabia, allowing local patients to access innovative therapies more quickly." Lü Lulu explained that, more importantly, China's high-quality clinical data and production quality systems are increasingly gaining recognition from international regulatory authorities, paving a new path for Chinese innovative drugs to enter overseas markets.

In June this year, a batch of Hong Kong immune cell simulants arrived inAir ChinaFlight CA104 entered through Tianjin Binhai International Airport and was efficiently cleared through customs before being transported to Juventas' factory located in the Binhai High-Tech Zone. This was a simulated trial shipment of raw materials for CAR-T cell drugs via the airport.

In order to打通跨境物流的“生命通道”, Juventas closely cooperated with Tianjin Customs, Binhai High-Tech Zone, and other departments. Relying on the pilot permissions in the Free Trade Zone in areas such as investment and trade facilitation and special item supervision for biomedicine, they completed a trial run for the rapid customs clearance of CAR-T raw materials from Hong Kong to Tianjin.

"CAR-T's raw material is 'living cells,' which have extremely high requirements for temperature and time sensitivity, making it impossible for traditional customs clearance models to meet the needs," said Lü Lulu. She introduced that by establishing localized risk assessments and a full-process customs clearance plan, the time from entry to delivery at the factory has been significantly shortened, providing a guarantee for international production. Currently, the company is advancing with market applications in Singapore, Japan, and other regions, and its overseas market layout is proceeding in an orderly manner.

Internationalization is not only about product exports, but also about standard output. Juventas' core technology has been patented in major global markets, and its innovative achievements such as the HI19a "warhead" and serum-free culture system are becoming reference points for international peers.

"Clinical data from China in the CAR-T field is gaining increasing attention. We have published real-world research data on 164 cases at international conferences such as ASCO and EHA, which serves as the best 'business card,'" said Lü Lulu. She noted that Juventas is deepening its cooperation with top international institutions and will integrate Chinese innovative technologies into the global industrial chain through joint research and development, technology licensing, and other means in the future.

With the advancement of internationalization, Juventas' global influence has been gradually increasing. By the end of 2024, the company was selected as one of the emerging enterprises in the Forbes China healthcare industry and the Hurun China medical new forces. Its exploration in the field of cell therapy is seen as a microcosm of China's biopharmaceutical industry "transitioning from catching up to taking the lead."

"We are not looking to replace anyone, but to offer global patients one more choice." Lu Lulu’s words exude confidence, as the path of China's innovative drug industry expands overseas, moving from product export to a new phase of technology and standard export.

Inclusive:

Writing the Era's Answers with a Sense of Mission and Responsibility

"Guarding the Priceless Lives, Making Innovative Drugs Affordable for the Common People." As an entrepreneur transitioning from a clinical doctor, Lü Lulu consistently believes that the value of pharmaceutical companies lies not only in commercial success but also in their responsibility towards life. "Innovative drugs should not benefit just a few; only when they are made accessible to all can the warmth of technology be truly reflected."

Although Yuanruida is priced two-thirds lower than similar products in the U.S., to make it more accessible to patients, Juventas has proactively integrated it into local medical insurance and惠民医保 systems across China. Currently, the product has been included in惠民保 programs in multiple provinces and cities in China, significantly reducing out-of-pocket costs for patients.

"This year, the National Healthcare Security Administration launched the innovative drug list for the first time. We are actively applying, hoping to further improve accessibility through healthcare coverage," said Lü Lulu. Meanwhile, the company continues to reduce costs through process optimization and domestic substitution. "Technological innovation is the fundamental way to reduce costs. We are confident that in the next few years, we can bring down the price of CAR-T drugs by another level."

The integration of industry, academia, and research is an important support for Juventas' innovation. Since its establishment, the company has been in deep cooperation with the Hematology Hospital of the Chinese Academy of Medical Sciences. The earliest warhead technology of Yuanruida originated from the hospital's long-term accumulation of technological innovation and the research and development achievements of Professor Wang Jianxiang's team.

"We develop the laboratory's technology into drugs and then verify their efficacy through clinical research. This collaborative model significantly enhances innovation efficiency," said Lü Lulu. Currently, Juventas has established partnerships with several top-tier institutions, such as Shanghai Ruijin Hospital and Beijing Tiantan Hospital, to explore new indications in areas like lymphoma and rare neurological diseases, accelerating the transformation of scientific research achievements.

As a national postdoctoral research workstation, Juventas always emphasizes talent cultivation. The company collaborates with universities such as Tianjin University and Nankai University to recruit graduates through campus recruitment and then helps them grow rapidly via systematic training.

"Many young people in our R&D team joined right after graduating from university and have now become technical backbone." Lü Lulu stated that enterprises should not only be the main body of innovation but also act as a ‘talent incubator’ to build a reserve force for the cell therapy industry.

"Technological breakthroughs are extremely challenging, and disruptions in the funding chain or hiccups in the supply chain could bring a company to a standstill instantly." Lü Lulu recalled that during the toughest moments of the 2020 pandemic, despite witnessing entire floors of office buildings go dark, they persisted in using ambulances to transport critically ill patients across provinces, ensuring that clinical trials continued without missing a single minute.

As a "Specialized, Precise, Unique and Innovative Small and Medium-sized Enterprise in Tianjin" and a "Leading Enterprise in Strategic Emerging Industries," the development of Juventas serves as a microcosm of the rise of Tianjin's biopharmaceutical industry. In 2024, the output value of Tianjin's biopharmaceutical industry exceeded 90 billion yuan, and it is expected to surpass 100 billion yuan by 2025.

"The industrial ecosystem in Tianjin has provided us with fertile ground for growth, as policy support, research resources, and manufacturing capabilities are all indispensable," said Lü Lulu. The company’s development has always been in sync with regional and national strategies.

From "pioneering" when it was established in 2018, to becoming a benchmark in the cell therapy field today, Juventas' seven-year journey is undoubtedly a microcosm of自主创新 in China's private biopharmaceutical industry.

Each expansion of indications, every approval overseas, and every reduction in cost is gradually reshaping the landscape of cell therapy, while also exemplifying the responsibility and commitment of private enterprises – daring to explore, achieving innovative breakthroughs, focusing on innovation, competing in the market, and demonstrating their capabilities in a vast and promising field.

(Figure 1) Lulu Lv, CEO of Juventas, delivered a speech at the China New Drug Future Conference.

(Figure 2) Inside Juventas' Tianjin production base.

(Figure 3) Juventas collaborates on the signing of the Tianjin Traditional Chinese Medicine Inheritance, Innovation, and Transformation Public Service Platform.

(Figure 4) Engineers at Juventas' Tianjin production base monitor manufacturing data.