Shenzhen Pregene Biopharma Co., Ltd.

Shenzhen Pregene Biopharma Co., Ltd. is a Chinese biopharmaceutical company headquartered in Shenzhen, Guangdong, founded in November 2012. It positions itself as a platform-based innovative drug enterprise focused on cell and gene therapy (CGT) medicines, with an international orientation. The company operates a cell drug R&D and industrialization platform, an iPSC reprogramming and multi-gene editing platform, and a nanobody screening platform, supported by pilot and scale-up systems for novel biologics. According to its official website, it has invested several hundred million RMB in R&D, maintains roughly 10,000 square meters of laboratory space, employs more than 80 R&D personnel, and has accumulated over 20 projects. Pregene's product pipeline centers on CAR-T and CAR-NK cell therapies across multiple targets, with indications spanning hematological malignancies, solid tumors, and autoimmune diseases. Its lead program, a BCMA-targeted CAR-T cell drug for multiple myeloma, received an NMPA clinical trial approval in March 2020 — described by the company as the first CAR-T clinical approval in South China. The company also runs a clinical study of BCMA CAR-NK for multiple myeloma in collaboration with Henan Cancer Hospital. Pregene states it is among the first innovative cell drug companies in the industry to achieve multi-regional global licensing of CAR-T cell drugs. Pregene has built a complete cell drug R&D and production quality management system and has passed ISO9001 certification. It is recognized as a National High-Tech Enterprise, a Guangdong Provincial Engineering Technology Research Center for Cell and Gene Therapy Innovative Drugs, and a Shenzhen "Specialized, Refined, Distinctive and Innovative" (专精特新) SME. Its investor shareholders include the National SME Development Fund, CAS Investment (国科嘉和), Haier Capital, Shenzhen Capital Group, and Huabang Health (002004). The company has participated in national drug standard discussions, including contributing to CAR-T quality control and non-clinical research considerations published by the National Institutes for Food and Drug Control (NIFDC) in 2018, and participated in CDE cell drug review standard discussions from 2018 to 2020. In 2022 it took part in legislative discussions for the Shenzhen Special Economic Zone Cell and Gene Industry Promotion Regulations. Pregene pursues a strategy of platformization, productization, commercialization, and internationalization. It has formed licensing partnerships with international players including India's Dr. Reddy's Laboratories for PRG1801 CAR-T and Europe's CellPoint B.V. The company has initiated an IPO process, though it remains privately held as of the available evidence.

Shenzhen Pregene Biopharma Co., Ltd. was founded in November 2012 in Shenzhen, China. In July–October 2015, the company launched its CAR-T project and completed a first angel round of financing of 1.1 million RMB. In April 2016, it completed a 12 million RMB angel financing. In October 2016, it completed the acquisition and delivery of Shenzhen Kadi (深圳咖荻), gaining industry-leading R&D laboratories, and relocated its headquarters to Shenzhen. In May 2017, Pregene completed a 40 million RMB Pre-A round. In November 2017, it reached a strategic cooperation agreement with the National Shanghai Center for New Drug Safety Evaluation and Research, and was approved as an internship teaching base for Guangzhou Medical University and Guangdong Pharmaceutical University. In April 2018, it completed a 50 million RMB Series A round led by CAS Investment (国科嘉和) with participation from Guozhong Venture Capital. In June and December 2018, its CD19-targeted CAR-T cell injection was accepted by CDE, and its BCMA-targeted CAR-T cell injection was submitted to CDE. In 2018, the company participated in drafting the NIFDC-published "CAR-T Cell Therapy Product Quality Control Testing Research and Non-clinical Research Considerations" national drug standard, and from 2018 to 2020 participated in CDE cell drug review standard discussions. In June 2019, it completed another 50 million RMB Series A round led by CAS Investment with Guozhong Venture Capital participating. In November 2019, it acquired Aiteke (艾泰克) to formally enter TCR-T. In December 2019, it received policy-based funding from Shenzhen Capital Group. In February 2020, it licensed the Greater China rights of its CAR-T to a well-known pharmaceutical company. In March 2020, it obtained its first clinical trial implied approval, for the BCMA-targeted CAR-T cell drug for multiple myeloma — described as the first CAR-T clinical approval in South China. In September 2020, it completed a 140 million RMB Series B round led by Haier Medical. In October 2020, it purchased the Greater China rights to a European Phase II clinical stem cell drug, marking its expansion from immune cells to stem cells. In May 2021, Pregene entered a licensing collaboration with India's Dr. Reddy's Laboratories for the PRG1801 CAR-T cell drug. In June 2021, it was selected for the 2021 Shenzhen "Specialized, Refined, Distinctive and Innovative" SME list. In March 2022, it reached a licensing collaboration with Europe's CellPoint B.V. In 2022, it fully participated in discussions and suggestions for the legislation of the Shenzhen Special Economic Zone Cell and Gene Industry Promotion Regulations. The company has initiated an IPO process, with future plans including landing in the capital markets.

• Company founded in Shenzhen.

• Launched CAR-T project; completed first angel round of 1.1 million RMB.

• Completed angel financing of 12 million RMB.

• Completed acquisition of Shenzhen Kadi; relocated headquarters to Shenzhen.

• Completed Pre-A round of 40 million RMB.

• Reached strategic cooperation agreement with National Shanghai Center for New Drug Safety Evaluation and Research; approved as internship teaching base for Guangzhou Medical University and Guangdong Pharmaceutical University.

• Completed Series A round of 50 million RMB led by CAS Investment with Guozhong Venture Capital participating.

• CD19-targeted CAR-T cell injection accepted by CDE.

• BCMA-targeted CAR-T cell injection submitted to CDE.

• Completed another Series A round of 50 million RMB led by CAS Investment with Guozhong Venture Capital participating.

• Acquired Aiteke to formally enter TCR-T.

• Received policy-based funding from Shenzhen Capital Group.

• Licensed Greater China rights of CAR-T to a well-known pharmaceutical company.

• Obtained first clinical trial implied approval for BCMA-targeted CAR-T cell drug for multiple myeloma.

• Completed Series B round of 140 million RMB led by Haier Medical.

• Purchased Greater China rights to a European Phase II clinical stem cell drug, expanding from immune cells to stem cells.

• Reached licensing collaboration with Dr. Reddy's Laboratories for PRG1801 CAR-T cell drug.

• Selected for 2021 Shenzhen "Specialized, Refined, Distinctive and Innovative" SME list.

• Reached licensing collaboration with Europe's CellPoint B.V.

• Fully participated in legislative discussions for Shenzhen Special Economic Zone Cell and Gene Industry Promotion Regulations.

Platform-based innovative biopharma company focused on cell and gene therapy drugs, pursuing platformization, productization, commercialization, and internationalization.

• BCMA-targeted CAR-T cell drug (PRG1801)

  For multiple myeloma; received NMPA clinical trial approval in March 2020, described as the first CAR-T clinical approval in South China.

• BCMA CAR-NK

  Clinical study for multiple myeloma recruiting 13 patients at Henan Cancer Hospital.

• CD19-targeted CAR-T cell injection

  Accepted by CDE in June 2018.

1. 1深圳普瑞金生物药业股份有限公司-普瑞金pregene.com
2. 2关于普瑞金-普瑞金pregene.com
3. 3产品管线-普瑞金pregene.com
4. 4Shenzhen Pregene Biopharma Co., Ltd. (China) - Wikidatawikidata.org