1. PURPOSE

This document describes KOUSAI´s position, and reflects our Corporate Policy on how patients in medical need may be able to access our new medicines before they are fully approved for use on prescription. before they are fully approved for use on prescription. 

2. SCOPE

We cover two areas in this document.

1. Where patients participate in one of our clinical studies, we explain how we may provide continued treatment for patients after their study treatment, or after the whole study, has completed. Where patients participate in one of our clinical studies, we explain how we may provide continued treatment for patients after their study treatment, or after the whole study, has completed.

2. Where patients are suffering from a disease that is not possible to be treated with existing medicines, or patients are not able to participate in one of our clinical studies, we explain how we handle requests for compassionate or emergency use of our new medicines. Where patients are suffering from a disease that is not possible to be treated with existing medicines, or patients are not able to participate in one of our clinical studies, we explain how we handle requests for compassionate or emergency use of our new medicines.

3. POLICY

3.1 Criteria

Where there is a possible need for patients to gain early access to a new medicine that is not generally available for prescription, KOUSAI will consider the need for early access using the following criteria. 

- Where it is expected that there is a need for ongoing treatment with one of our new medicines, we recognize that this must be through normal health services once the new medicine is available for prescription. As such we will only conduct clinical studies and provide early access outside of studies, in those countries where we intend to make the medicine available through normal prescription channels after its approval. As such we will only conduct clinical studies and provide early access outside of studies, in those countries where we intend to make the medicine available through normal prescription channels after its approval.

- We recognize that we must have a minimum level of evidence that the new medicine is likely to work before considering early access and must not provide excessive risk to any patient who may receive the new medicine early. not provide excessive risk to any patients who may receive the new medicine early.

- While addressing this patient need, we will ensure that if we agree to provide early access to our new medicines, that there is sufficient While addressing this patient need, we will ensure that if we agree to provide early access to our new medicines, that there is sufficient medicine available to ensure the supply will not run out for those patients receiving it early, or for those patients in our clinical studies. because we want to ensure that when providing early access, it does not prevent us completing clinical studies and regulatory approval that would lead to wider access through normal routes of prescription.

Any early access programs we provide will be in line with the laws and requirements of the country involved. 

3.2 Continued treatment after clinical studies

To be sure that our new medicines will work effectively and be safe enough to be prescribed for the diseases patients are suffering from, we study them rigorously to see whether they provide adequate relief. The results of these clinical studies allow the regulatory authorities to independently assess whether to allow the new medicines to be prescribed. The results of these clinical studies allow the regulatory authorities to independently assess whether to allow the new medicines to be prescribed. As this can take several years, patients who participate in our clinical studies may have to wait for a new medicine to become available on prescription. As this can take several years, patients who participate in our clinical studies may have to wait for a new medicine to become available on prescription. 

Where there may be a benefit for a patient to continue to be treated after the clinical study has ended, but before it is available on prescription, we will This will depend on the severity of the disease we are studying, how much evidence we have that the medicine works as expected and is sufficiently safe, and whether alternative effective medicines are already available. This will depend on the severity of the disease we are studying, how much evidence we have that the medicine works as expected and is sufficiently safe, and whether alternative effective medicines are already available on prescription. If we plan for continued treatment after a clinical study, we will include this information in our study documents so that it is clear to each patient whether this is a possibility before they start in the study. possibility before they start in the study. 

We understand that it can be difficult to decide to participate in a clinical study, so will ensure we make this information as clear as possible. To be sure we can assess whether the new medicine continues to work effectively and is safe enough to continue to be used during early access, we will ask for the patient's consent for their physician to collect some relevant information from them on an ongoing basis while the new medicine is being used. To be sure we can assess whether the new medicine continues to work effectively and is safe enough to continue to be used during early access, we will ask for the patient's consent for their physician to collect some relevant information from them on an ongoing basis while they receive the medicine. 

3.3 Compassionate or emergency use outside of clinical studies

The best way to see if a new medicine is sufficiently safe and effective is to run clinical studies. As such we prefer that, where possible, patients have the opportunity to participate in our clinical studies. We recognize however that not everyone has this opportunity. Where patients who cannot enroll in a clinical study are suffering from serious or immediately life threatening diseases, and there are no patients who are not enrolled in a clinical study. We recognize however that not everyone has this opportunity. Where patients who cannot enroll in a clinical study are suffering from serious or immediately life threatening diseases, and there are no satisfactory alternative treatments available, we will consider early access if there is an opportunity to participate in a clinical study. Where patients who cannot enroll in a clinical study are suffering from serious or immediately life threatening diseases, and there are no satisfactory alternative treatments available, we will consider early access if there is enough evidence available in their condition (as described above) and whether there is a possibility of them being able to access the medicine on prescription in the future. 

In the same way as after a clinical study, we want to be sure we can assess whether the new medicine continues to work and is safe enough to continue to be used. As such we will ask for the patient's consent for their physician to collect some relevant information from them on an ongoing basis while They receive the medicine. 

3.4 Discontinuation of early access

When a new medicine receives approval from the regulatory authorities for the disease we are studying, and is available for prescription in the patient's country, we will phase out the early access to allow the health system to prescribe the new medicine in the normal manner. When a new medicine receives approval from the regulatory authorities for the disease we are studying, and is available for prescription in the patient 's country, we will phase out the early access to allow the health system to prescribe the new medicine in the normal manner. 

If however the medicine is approved but not available for prescription for some reason, and there is no alternative medicine available, we will work with If however the medicine is approved but not available for prescription for some reason, and there is no alternative medicine available, we will work with country authorities to discuss if we can jointly set up a patient-assistance program to allow patients who are benefitting from it, who do not have Patient safety is our primary concern, and we respect patient safety by continually evaluating all the evidence. continually evaluating all the evidence that we have available to ensure that early access use of new medicines remains effective and appropriately safe If however the evidence demonstrates that the new medicine is not going to be as sufficiently effective or safe as we had hoped, we will discontinue all early access and work with patients and their families. If however the evidence demonstrates that the new medicine is not going to be as sufficiently effective or safe as we had hoped, we will discontinue all early access and work with patients and their physicians to help them safely transition patients to other treatments. approve the use of the new medicine for prescription, because it is considered insufficiently safe or effective, and KOUSAI discontinues its work to When regulatory authorities do not approve the use of the new medicine for prescription, because it is considered insufficiently safe or effective, and KOUSAI discontinues its work to achieve regulatory approval, we will work with patients and their physicians to help them safely transition patients to other treatments.

Contacts: Yali Quan

E-mail. clinicaltrial@kousai.vip

Tel: 021-57527655

On December 25, 2025, Kousai Bio, an innovative Chinese biopharmaceutical company, announced a significant piece of good news - its original independently developed dendritic cell vaccine (DC vaccine)KSD-101The injection was officially approved by the U.S. Food and Drug Administration (FDA) granted fast-track status (Fast Track Designation, FTD) for the treatment of relapsed or refractory (R/R)EBV Positive lymphomaKSD-101 has become the first DC vaccine product in China to be recognized by the FTD, signifying that the therapy has been highly recognized by international regulatory agencies for addressing unmet clinical needs and will accelerate its clinical development and marketing review process in the U.S., bringing new therapeutic hope to patients with relapsed or refractory EBV-positive lymphoma disease around the world.

The FTD designation is intended to accelerate the development and review of drugs for serious diseases with unmet medical needs, and to facilitate the early delivery of benefits to patients through a series of facilitation measures, such as more frequent regulatory communication and rolling reviews.KSD-101 was granted the FTD based on its innovation as the world's first broad-spectrum DC vaccine targeting EBV, as well as the significant therapeutic potential it has demonstrated in early-stage clinical studies. KSD-101 was awarded the FTD based on its innovation as the world's first broad-spectrum DC vaccine targeting EBV and its significant therapeutic potential in early clinical studies.

EBV is a common virus with a global prevalence of infection exceeding 95%, and has been clearly recognized by the World Health Organization as the first significant virus associated with human tumors. Its infection can cause a variety of serious diseases such as EBV-associated lymphoproliferative disease (EBV-LPD), nasopharyngeal carcinoma and gastric cancer. Currently, there is still a lack of effective therapeutic options for patients with EBV-associated lymphoproliferative diseases, and there is a significant unmet medical need.KSD-101, as China's first original DC vaccine licensed by the FDA for clinical trials of new drugs (IND), uses patients' own monocytes to induce the differentiation of mature dendritic cells and loads with the EBV-associated tumor complex antigen, which can accurately deliver EBV-associated tumorigen to the patient. It can accurately deliver various viral antigenic epitopes such as EBV latency and lysis proteins LMP2A, EBNA3A/3B, EBNA4, BMLF1, etc., and efficiently activate CD4⁺ helper T-cells and CD8⁺ cytotoxic T-cells, thus building up a comprehensive and powerful antiviral and antitumor immune response.

KSD-101drug aloneIn the phase I clinical study for the treatment of relapsed and refractory EBV-associated hematological tumors, the objective remission rate (ORR) was as high as 91.67%, with a complete remission rate (CR) of 83.33% and a disease control rate (DCR) of 100%, while demonstrating a durable response and a favorable safety profile. This breakthrough data provides solid support for the clinical value of KSD-101.

KSD-101 is the first autologous DC vaccine developed by Kousai Biotechnology on the basis of its self-developed "Eco-DC Vax" technology platform, and it is the first original DC vaccine product in China that has been approved by FDA IND. Its mechanism of action is to prepare an individualized therapeutic vaccine by collecting the patient's own mononuclear cells, inducing them to differentiate into dendritic cells in vitro, and loading them with EBV-related specific complex antigens. After the vaccine is infused back into the patient's body, it can accurately activate and train the patient's own immune system to recognize and kill EBV-antigen-expressing tumor cells, and establish a long-lasting anti-tumor immune memory.

Founded in 2018, Kousai Bio is a scientific and technological innovative enterprise and national high-tech enterprise dedicated to the research, development and industrialization of dendritic cell vaccines (DC vaccines). The company has successfully constructed the Eco-DCVax platform, aiming to break down the technical barriers to industrialization and develop global First-in-Class high-quality DC vaccine products with independent property rights that are safe, efficient and convenient to administer. The developed product, therapeutic dendritic cell vaccine, provides a new approach and strategy for the treatment of relapsed and refractory tumors, chronic viral infections, autoimmune diseases and other diseases that are in urgent need of effective clinical treatments.

Dr. Huining Liu, Founder and CEO of the company, said, "The FDA Fast Track accreditation of KSD-101 is an important affirmation of our R&D strength and product value. Kousai Bio will take this opportunity to fully utilize the regulatory convenience brought by Fast Track to accelerate the global clinical development process of KSD-101 and provide more effective treatment options for domestic and foreign patients with EBV-related diseases at an early date."

As a leader in the field of DC vaccine R&D in China, Kousai Biological has realized the dual reporting of KSD-101 in China and the United States, and its domestic IND application has been formally accepted by China's State Food and Drug Administration (SFDA). The FDA fast-track accreditation will not only accelerate the overseas clinical advancement and listing process of KSD-101, but also further enhance the influence of domestic original biologics in the global tumor immunity field, and inject new momentum into the international development of China's biopharmaceutical industry. KSD-101 is an original DC vaccine product. Its mechanism of action is to prepare an individualized therapeutic vaccine by collecting patients' own mononuclear cells, inducing them to differentiate into dendritic cells in vitro, and loading them with EBV-related specific complex antigens. After the vaccine is infused back into the patient's body, it can accurately activate and train the patient's own immune system to recognize and kill EBV-antigen-expressing tumor cells, and establish a long-lasting anti-tumor immune memory.

- END -

On the morning of August 30, 2025, the Policy Promotion Meeting for New Biomedical Technologies in LeCheng Advanced Zone and the First Batch of Enterprises Concentrated Signing Conference were held in Boao LeCheng Never Ending International Innovative Pharmaceutical and Device Exhibition. Hainan Provincial People's Government, Hainan Provincial Department of Industry and Information Technology, Hainan Provincial Healthcare Commission, Hainan Provincial Medical Insurance Bureau, Hainan Provincial Pharmaceutical Administration, Hainan International Economic and Development Bureau, Lecheng Advanced Zone Management Bureau, Qionghai Municipal People's Government, Lecheng Medical Institutions and Biomedical Enterprises were present to witness the event.

In this conference, LCCA reached signing cooperation with 13 domestic head biomedical enterprises. Mr. Cheng Xiangguo, co-founder and COO of Hengsai Bio, participated in the signing as a representative of the enterprises with approved projects.Marking the official landing of Kousai Bio DC Vaccine Project in Lecheng Pioneering ZoneThe

As the only "special medical zone" in China and an important platform for the construction of Hainan's free trade portIn recent years, LeCheng has fully utilized the "Nine Articles of the State" and other special policies granted by the state, and gradually built up a whole chain service system covering the rapid introduction, clinical application, registration and approval, and production and manufacturing of international innovative medicines and devices. At the same time, actively grasp the medical science and technology revolution and new opportunities for industrial change.Taking the lead in the country in the clinical translation and application of new biomedical technologies such as cell therapy and gene editingThe

Kousai Bio DC vaccine has a good safety profile, is widely used (treatment and prevention of recurrence), does not require pretreatment, can be administered on an outpatient basis, and has a low treatment cost, which is expected to improve clinical accessibility and patient compliance.It is a perfect fit with the policy of biomedical new technology industry in LeCheng Pioneer Zone.As the first batch of domestic enterprises authorized to carry out DC vaccine transformation and application in LeCheng, Kousai Bio will combine its own development needs and LeCheng's policy and platform advantages in the future, and will deeply integrate with LeCheng Pilot Zone for common development.The

The company's pipeline in development are all autologous DC vaccines without any gene editing, with indications covering hematological and solid tumors.Core pipeline KSD-101 is the world's first DC vaccine targeting EBV broad-spectrum, and is also the first original DC vaccine in China to receive FDA IND approval.The

Relying on the independently constructed Eco-DC Vax platform, the company systematically integrates the four modules of antigen prediction, immunological validation, process optimization and quality control, and has the capability of"One drug, multiple targets" and platform extensibilityThe company has a comprehensive R&D and production base with a floor area of 6,300 square meters in Shanghai FTZ Lingang First Area. At present, there is a comprehensive R&D and production base with a floor area of 6,300 square meters and a production capacity of about 5,000 servings/year in Shanghai FTZ Lingang First Area, which is equipped with the industry's top facilities.Hard power from research to industrializationHengsai Bio. Since its establishment, Hengsai Bio has been upholding the principle of"Making painless cures for tumor patients."We aim to break down the technical barriers to industrialization and develop the world's first-in-class, safe, efficient and conveniently administered high-quality DC vaccine products with independent property rights, so as to provide the most effective and efficient vaccine forDiseases in need of effective clinical treatments, such as relapsed and refractory tumors, chronic viral infections, and autoimmune diseasesProvide new avenues and strategies for treatment.

On August 15, 2025, the opening ceremony of the R&D and production base of Hengsai Biologicals in Lingang was held grandly in the 10th phase of Life Blue Bay Intelligence Park in Lingang New Area. With the theme of "Hengchuang Frontier, Sai Leads Health", the ceremony invited the Lingang Administrative Committee, industry experts, shareholders' representatives, partners, leaders of the park and all the staff of Hengsai Biologicals to witness this important moment together.

The snake offered a new chapter, and the elites went to the spring banquet together. At the time when the snake is coiled up and everything is new, all the staff of Hengsai Bio-technology gathered together and held the 2025 Annual Meeting and Annual Summarization Activity in Zhoushan, Zhejiang Province. The team of Hengsai traveled on the waves, refined tacit understanding with collaboration, and coalesced consensus with laughter, and drew the prelude of the New Year together in the blue sea and golden sand.

Breaking through ten thousand hectares of waves, the team went on a journey to the blue sea. Cruising, experiencing the catch, the frequent reports of harvesting the nets, and the picture of the fish jumping in the cabin are just like the epitome of the team's struggle to ride the waves and reap the fruits of success.

Under the setting sun, the tug-of-war field shouting, rope ends of the tug-of-war is the tenacity of all the people; you draw me to guess the fun, between the strokes of the flow is the tacit understanding of the heart; the long rope flying in the leaping figure, like a hundred barges competing for the flow of the enterprising posture. Sweat and laughter intertwined, cohesion into an unstoppable centripetal force.

As the night falls, the fireworks pour down like the Milky Way, and the bright light illuminates every face looking up. Hengsai Bio is willing to be a light chaser in the dark night, with today's fervor as a prelude to become tomorrow's industry stars, so that the team's light is like a prairie fire, reflecting the future journey!

The fruitful results of pectinization and rain, and the continuation of the chapter of China. Dr. Liu Huining, Founder and CEO of Hengsai Biotechnology, delivered a wonderful speech at the year-end summary meeting, reviewing the fruitful results of Hengsai Biotechnology in the past year, affirming the dedication of every team member, and looking forward to the infinite possibilities of dendritic cell vaccines in the future.

The co-founder, Mr. Cheng Xiangguo, takes the company's values as a link to nourish the team's identity and build an evergreen foundation. The concept of gathering the spirit of all rivers, stimulating the potential of cells, empowering doctors, creating a team of grandeur is deeply rooted in people's hearts.

Hengsai Biological R&D Department, Quality Department, Quality Inspection Department, Production Department, Clinical Department, Administration Department, Information Department, Business Department and other persons in charge of the past year's work are summarized in detail, the data is like a pearly gleam on the plate, and the project seems to be like a brocade spread.

Those who take the lead will win the first prize; those who are dedicated to their work will be honored in the end. At the award ceremony, the excellent staff won the high light moment belonging to them with their professional ability and outstanding performance. Hengsai Bio-technology can not be separated from the struggle of every member today, and taking the example as a mirror, we will continue to work hand in hand in the new year to create a brilliant future! We are looking forward to more members standing on the stage of glory and growing together with Hengsai Bio!

With faith as a sail, break the waves of the old age;

Use collaboration as an oar to start a new journey;

Use innovation as an anchor to set the standard of the industry!

May Hengsai Bio be like a star that starts a prairie fire and glows in the sky.

With innovation as the wing to write another chapter;

May the dreamers be like the spring tide that breaks through a thousand pounds.

Climbing to the top by the power of one mind!

END

On March 3, 2025, Hengsai Bio's self-developed KSD-201 DC vaccine for the treatment of advanced renal cell carcinoma was formally launched at Tongji Hospital of Huazhong University of Science and Technology Tongji Medical College ("Wuhan Tongji Hospital").Relying on Hengsai Bio's world-leading Eco-DC Vax technology platform and in collaboration with a team of urology experts from Wuhan Tongji Hospital, the project aims to provide a novel immunotherapy solution for patients with relapsed and refractory kidney cancer. This is another solid tumor pipeline of Hengsai Biotech that has entered clinical research after EBV-related nasopharyngeal carcinoma.

The scene of the launch event

The Department of Urology of Wuhan Tongji Hospital, as one of the "Top 10 Urological Tumors in China", has a leading position in the field of minimally invasive surgery and individualized comprehensive treatment of renal cancer by its multidisciplinary team (MDT). Renal cell carcinoma (RCC) is a malignant tumor originating from the epithelium of renal tubules, accounting for about 85% of renal malignancies. clear cell renal cell carcinoma (ccRCC) is the most common pathological subtype of RCC. ccRCC has the poorest prognosis of all the pathologic types of RCC, with the highest recurrence and metastatic potential, and it is insensitive to both radiotherapy and chemotherapy. Advanced ccRCC is an incurable disease, prone to metastasis, recurrence, and refractory to eradication, with marked individualized differences in efficacy and survival benefit of targeted therapies, severe adverse effects, and easy drug resistance. Therefore, ccRCC has always been a difficult problem for many patients, bringing a heavy burden to patients and their families.

At the launching meeting, a team of urology experts headed by the principal investigator Prof. Wang Shaogang and the clinical team of Hengsai Biologicals discussed the focuses and difficulties of the IIT study of DC vaccine treatment for ccRCC disease, and both sides clarified the project objectives and division of labor between the two sides, showing high expectations and firm confidence in the future development of the project, which laid a solid foundation for the efficient promotion of the subsequent project.

Dr. Huining Liu, Founder and CEO of Hengsai Biologics, said, "The unique advantage of DC Vaccine lies in inducing long-term immune memory and exerting lasting anti-tumor effects through precise and specific immune responses. This collaboration with Wuhan Tongji Hospital will accelerate the translation of the technology from the laboratory to the clinic, and we look forward to DC Vaccine providing more kidney cancer patients with a safe, convenient and long-lasting effective treatment option."

KSD-201It is an autologous dendritic cell vaccine of human mononuclear origin loaded with a broad spectrum of clear cell renal cell carcinoma-associated antigen. It is a tumor therapeutic vaccine prepared by inducing monocytes to transform into dendritic cells through cytokines, loading dendritic cells with broad-spectrum clear cell renal cell carcinoma-associated antigen and inducing them to become mature dendritic cells. It can activate the patient's immune function in the body after subcutaneous injection, so as to achieve the effect of treating advanced clear cell renal cell carcinoma.

Founded in 2018, Kousai Bio is a scientific and technological innovative enterprise and national high-tech enterprise dedicated to the research, development and industrialization of dendritic cell vaccines (DC vaccines). The company has successfully constructed the Eco-DCVax platform, aiming to break down the technical barriers to industrialization and develop global First-in-Class high-quality DC vaccine products with independent property rights that are safe, efficient and convenient to administer. The developed product, therapeutic dendritic cell vaccine, provides a new approach and strategy for the treatment of relapsed and refractory tumors, chronic viral infections, autoimmune diseases and other diseases that are in urgent need of effective clinical treatment.

---

Hengsai Bio's R&D center and pilot plant in Shanghai Lingang Blue Bay were put into use in 2021, and Zhongshan R&D center is under construction. The company's first pipeline KSD-101 has successfully completed the dual reporting in China and the United States, and is about to formally enter the registered clinical stage. The Company has now established stable partnerships with a number of domestic and international research institutions and tertiary hospitals to carry out clinical research and technical cooperation in order to comprehensively verify the clinical safety and efficacy of the DC vaccine. Period completion and efficient operation!"