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Henlius Receives NMPA Approval for Its First Product HLX01 –The Beginning of a New Era for Biosimilar


HLX01 is the first biosimilar approved in China

China National Medical Products Administration (NMPA) approves HLX01, the first product lead developed by Henlius, for the treatment of adult patients in three indications:

Relapsed or refractory, follicular lymphoma;

Previously untreated stages III-IV follicular, non-Hodgkin’s lymphoma; and

CD20-positive, diffuse large B-cell, non-Hodgkin’s lymphoma (DLBCL)

HLX01 provides an alternative treatment option for patients with lymphoma, may improve accessibility to high-quality biological medicine, and has the potential to help many patients with CD20-positive non-Hodgkin’s lymphoma (NHL)

HLX01 has filled the gap in China’s market for biosimilar and represented a notable achievement in the China biopharmaceutical industry

Shanghai, China, February 25, 2019 –Henlius announced today that its first product HLX01 (rituximab injection) has granted approval by the China National Medical Products Administration (NMPA) for the treatment of adult patients in three indications: 1) relapsed or refractory, follicle lymphoma; 2) previously untreated stages III-IV follicular, non-Hodgkin’s lymphoma; and 3) CD20-positive, diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL) which are the approved indications of the originator rituximab (MabThera®) in China1. HLX01 being the first approved biosimilar in China has filled the gap in China’s market for biosimilar, may improve accessibility to high-quality biological medicine and has the potential to help many patients with lymphoma.

Over many years, non-Hodgkin’s lymphoma (NHL) patients and their families have borne extremely high financial burdens, and they are always looking for drugs that have a price advantage while offering guaranteed quality, safety and effectiveness. Rituixmab is the first monoclonal antibody (mAb) for the treatment of cancer, and rituximab in combination with chemotherapy is currently the gold standard of the treatment of NHL. We believe the approval of China’s rituximab will not only provide an alternative treatment option, but may reduce the financial burden on patients and expand their access to treatments2.

“Today is a memorable day for Henlius because HLX01 is our first approved product which is also our first independently researched and developed mAb drug in China,” said Scott Liu, Ph.D., Co-founder, President and Chief Executive Officer at Henlius. “We are proud to receive approval for the first China biosimilar product. We have been working diligently on the HLX01 launch plan to ensure HLX01 will be covered by the public health insurance as soon as possible; therefore, many patients will be able to afford and have access to this high-quality biosimilar drug.”

“Henlius is dedicated to increasing access to high-quality biologics for patients suffering from serious illnesses and helping create a more sustainable healthcare system,” said Weidong Jiang, Ph.D., Co-founder, Chief Scientific Officer at Henlius. “During the early development of HLX01, we immediately decided to modify the amino acid (A.A.) sequence and rebuild the cell line until we got it as similar to the originator rituximab as possible when the A.A. sequence was different from the originator rituximab.”

To encourage the development of biosimilars, the China government has drafted and published a series of policies including the Technical Guideline for the Development and Evaluation of Biosimilars (draft) to regulate the development, registration, efficacy and safety of such drugs in recent years. Biosimilars are biological products with similar therapeutic effects to an already-approved reference drug in terms of quality, safety and efficacy. Unlike generic drugs that can reproduce identical to the originator drug, biological drugs have larger molecule weight with complex structures and physical/chemical properties which are more sensitive to the environment. Therefore, researchers need to explore the production process of biosimilars through reverse engineering to find the right cultivation environment for cells, and prove through head-to-head comparative studies that the biosimilars are highly similar to the originator products in terms of clinical pharmacology, efficacy and safety.

The NMPA approval is based on a comprehensive submission data package of extensive analytical characterization, non-clinical data and three clinical trials (Phase 1a, 1b and 3) evaluating clinical pharmacology, immunogenicity, clinical safety and efficacy data which demonstrated a high degree of similarity for HLX01 and the originator product. The totality of evidence submitted for HLX01 demonstrated that there were no clinically meaningful differences in efficacy and safety between HLX01 and the originator rituximab. The data included results from the multi-center, randomized, double-blind, parallel active-controlled phase 3 HLX01-NHL03 clinical comparative study for the treatment of previously untreated CD20-positive DLBCL, which showed clinical equivalence of best overall response rate (ORR) between intravenous infusion of HLX01 and the originator product in combination with chemotherapy within 6 cycles was 92.5% and 92.1%, respectively.2

The approval of HLX01 has broken the foreign pharmaceuticals’ monopoly in China mAb market, which is a notable achievement on the part of China’s biopharmaceutical industry. Currently, the ongoing Phase 3 clinical trial of HLX01 for the treatment of rheumatoid arthritis is conducted for the patients with auto-immune disease. With the commitment to “affordable innovation”, Henlius is investing in developing and launching a range of high-quality biological products both in China and throughout the globe which can help to reduce healthcare costs and increase patient access to important medicines.

Lymphoma and Treatment

Lymphoma is one of the most common form of hematological malignancy. The incidence rate of lymphoma in China is about 5.94 out of every 100,000 people,3 and about 90% of the cases are non-Hodgkin's lymphoma (NHL), of which the incidence is growing every year. There are complex pathological types for NHL, and there are also various therapies available,4 but rituximab in combination with chemotherapy (immuno-chemotherapy) has become the first-line therapy for the treatment of NHL both in China and abroad. Either CHOP or CVP chemotherapy in combination with rituximab can significantly improve patient's short- and long-term outcomes, including overall survival.5,6

About Henlius

Shanghai Henlius Biotech, Inc., a joint venture company co-founded by Fosun Pharma and a team of overseas scientists in February 2010, with its R&D footprint in Shanghai, Taipei and California, USA, specializes in the discovery, development, manufacturing and commercialization of high-quality biologics including biosimilar, bio-better and novel monoclonal antibody, to treat tumor and auto-immune disease.

Until now, Henlius has completed IND/CTA filings of 13 products and 1 combination therapy with 22 indications and obtained 29 successful IND/CTA approvals (19 approvals from China; 3 from the United States; 3 from Taiwan; each 1 from the European Union, Ukraine, Philippines and Australia).


1. Product Information of approved HLX01

2. Shi Yuankai et al., The Clinical Journey of HLX01: From Phase 1 Clinical Trial to Potentially First MabThera Biosimilar in China. Oral presentation at CSCO 2018.

3. Chen Wanqing, Li He, Sun Kexin, Zheng Rongshou, Zhang Siwei, Zeng Hongmei, Zou Xiaonong, Gu Xiuying, and He Jie. Analysis of the Incidence of Malignancies in China and the Death Caused by Them in 2014. Chinese Journal of Oncology, 2018,40(1): 5-13. DOI: 10.3760/cma.j.issn.0253-3766.2018.01.002

4. The Committee for Guidelines, the Chinese Society of Clinical Oncology: CSCO Guidelines for the Treatment of Lymphoma 2018 (V1), Beijing: People's Medical Publishing House, 2018

5. Marcus R1, Imrie K, Solal-Celigny P, et al. Phases III study of R-CVP compared with cyclophosphamide, vincristine and prednisone alone in patients with previously untreated advanced follicular lymphoma. J Clin Oncol, 2008, 26(28): 4579-4586

6. Hiddemann W1, Kneba M, Dreyling M, et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood, 2005, 106(12): 3725-3732