“China’s Multi-Antibody Star” launches IPO

December 6, 2024  Source: drugdu 57

"/Recently, "China's multi-antibody star" Welly Zhibo Biotech submitted a prospectus to the Hong Kong Stock Exchange, intending to go public on the main board of Hong Kong through an IPO.

This biotech, founded in 2012, had just completed a large NewCo-style BD and also completed a C+ round of financing in November. The latest post-investment valuation has exceeded 3 billion yuan. The latest valuation is over 3 billion.

Welly

Zhibo's CEO is Dr. Kang Xiaoqiang, who studied for his master's degree at Tongji Medical College, and completed his doctoral and postdoctoral studies in the United States. Later, he joined a biotech called ImClone Systems, which became famous for the development of the EGFR monoclonal antibody Erbitux. The drug was launched in 2004, with peak sales of more than 2 billion US dollars, and Kangbo participated in the development and launch of the drug. In 2008, ImClone Systems was acquired by Eli Lilly, and Kangbo became Eli Lilly's chief scientist.

The company has two major individual shareholders: Dr. Kang Xiaoqiang and Dr. Lai Shoupeng. They met during their postdoctoral research in tumor immunotherapy at the National Cancer Institute of the United States. In 2012, they founded Weilizhibo together. It was not until 2015 that the company conducted its first round of angel round financing. Nanjing Kaiyuan and Shanghai Zhuangzhong each subscribed RMB 5 million, respectively holding 12.5% of the company's equity.

To date, the company has raised funds to the C+ round, with a post-investment valuation of RMB 3.13 billion and a share capital of around RMB 20. From the current shareholder structure, although it looks complicated, it is dominated by domestic capital background.
From the current shareholder structure, the two major individual shareholders, Dr. Kang and Dr. Lai, account for 9% of the equity, which is not a large proportion for the founders. The top three institutions in terms of equity share are Enran Venture Capital, Zhengxin Valley Capital and Hankang Capital, all of which are domestic capital in China; in addition, there are also state-owned capital such as Shenzhen Capital Group.

Among the top three institutional shareholders, the most famous one should be Zhengxin Valley Capital. It has invested in listed pharmaceutical companies such as Kangfang Bio, Junshi Biosciences, Rongchang Bio, Eli Lilly, and Coherus Pharmaceuticals.

From the overall company's operating situation, although the company was established early and its senior executives are returnees from the United States, it did not follow the popular license-in model of that era. The first round of financing was 3 years away from the establishment of the company, which is very characteristic of a company with research and development as its original intention.

Continuous cooperation

Weilizhibo's first stunning appearance was a large-scale BD with BeiGene at the end of 2021: BeiGene introduced Weilizhibo's LAG-3 monoclonal antibody-LBL-007's rights outside Greater China, with an initial payment of US$30 million and milestone payments of US$742 million; the initial payment of US$30 million is approximately RMB 200 million, reaching one-third of the amount of Series C financing in the same year.

Even today, LAG-3 antibodies are still a very promising immune checkpoint type target. Similar to PD-1 and CTLA-4, this target also has a regulatory effect that inhibits T cells: studies have shown that LAG-3 can interact with MHC-II (type II major histocompatibility complex) and inhibit the binding of MHC-II to CD4 and TCR, thereby inhibiting TCR signal transduction, thereby inhibiting the cellular immune response of T cells. The main function of LAG-3 type monoclonal antibodies is to bind to the target of LAG-3 and block the binding of LAG-3 to MAH-II, so as to block the inhibition of T cells by the LAG-3 pathway. At present, the main imagination of this target is to combine with PD-1 monoclonal antibodies to play a beautiful combination. The

currently listed LAG-3 monoclonal antibody is relatlimab, which is used in combination with PD-1 monoclonal antibodies to treat melanoma. And Wellizbo's LAG-3 monoclonal antibody, LBL-007, has a very extensive layout. On the one hand, it has deployed clinical trials in China in combination with PD-1 and chemotherapy for nasopharyngeal carcinoma; on the other hand, it is led by BeiGene in a wider range of indications such as head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma and other indications, and has launched global clinical trials. The drug has now entered the Phase II clinical stage and is expected to read out Phase II data by the end of this year.

The second cooperation is the recently hot NewCo transaction. In November 2024, Wellizbo's CD19xBCMAxCD3 tri-antibody, LBL-051, was authorized to the newly established company Oblenio with a down payment of US$35 million and a total amount of US$579 million. The new company was established by venture capital Aditum Bio, which can be compared with the capital operation of Conoya's NewCo BD (for details, please refer to the article "Conoya's Second Breakout").

Back to LBL-051 itself, for multiple myeloma, targets such as BCMA, CD19, and CD20 plus a CD3-type bispecific antibody are the current mainstream development direction, but if it is a three-antibody and a CD19 target is added, then it can be said to be a very cutting-edge product. LBL-051 plans to submit an IND to NMPA in the first half of 2026. At that time, the main focus may be whether it can expand in a wider field of autoimmune diseases in addition to blood diseases such as multiple myeloma.

In addition to the above cooperation, Weilizhibo has also cooperated with other pharmaceutical companies in the development of ADC. Weilizhibo has not missed the treatment trend of IO+ADC therapy. In April 2023, Weilizhibo signed a cooperative development agreement with Baikai Pharmaceuticals to jointly develop two ADC drugs, LBL-013 and LBL-052. The two pharmaceutical companies have their own strengths. Weilizhibo is mainly responsible for the antibodies in the ADC part, while Baikai Pharmaceuticals has cutting-edge payload and linker platforms.

LBL-013 is an ADC drug targeting PSMA, and has relatively mature research results on its relationship with prostate cancer. It can be said to be a golden target for prostate cancer. LBL-052 mainly targets the FGFR-2b target. The current monoclonal antibody development direction of this target is breast cancer and gastric cancer. Both drugs will submit IND in the first half of 2026.

Continuous high-quality cooperation proves the profound foundation of the company's technology platform. For Biotech in the IPO stage,

the core pipeline that is about to be harvested

, excellent technology platform, BD transactions that prove themselves, and core pipelines that are about to be commercialized are all major factors affecting their valuation. The core pipeline itself is the part that is more intuitive to value. Weilizhibo's first core pipeline is the PD-L1/4-1BB dual antibody - LBL-024.

One of the targets of LBL-024, PD-L1, is a classic immune checkpoint inhibitor target, while the other target, 4-1BB, is a co-stimulatory factor target. Its main purpose is to enhance the effect of PD-(L)1 monoclonal antibody, which can be seen as another possibility besides TCE dual antibody. LBL-024 is designed to have a higher affinity for PD-L1 and a lower affinity for 4-1BB. The purpose of this is to reduce the binding of monoclonal antibodies to 4-1BB in normal tissue cells and reduce the risk of toxicity. In addition, the first stop for the expansion of TCE bispecific antibodies in solid tumors is SCLC (small cell lung cancer), and the first indication of LBL-024 is extrapulmonary neuroendocrine tumors, which are extremely similar to small cell lung cancer at present, and even the treatment plans are basically the same. At present, LBL-024 has been recognized as a breakthrough therapy for extrapulmonary neuroendocrine tumors by NMPA and has also been certified as an orphan drug by the FDA.

At this year's ASCO Annual Meeting, the drug announced preliminary clinical phase I/II data. Among the 45 patients with extrapulmonary neuroendocrine cancer, 33 patients received the recommended dose treatment in the Phase II clinical trial, and 15 patients achieved PR, with an ORR of 33.3% and a DCR of 51%. More importantly, among the 22 patients with negative PD-L1 (CPS < 1), the ORR was 54.5%, which shows that even patients with low PD-L1 expression can benefit from the treatment of this drug.

The imagination of this drug may not stop there. After all, extrapulmonary neuroendocrine carcinoma is just a small cancer, and its higher ceiling may be on NSCLC. According to the incidence estimates in the prospectus, the incidence of extrapulmonary neuroendocrine carcinoma will be about one-sixth of that of SCLC in 2023, and the incidence of NSCLC is 5.66 times that of SCLC. These are all directions that LBL-024 has great potential to expand in the future.

According to the prospectus forecast, the drug is expected to submit BLA in Q3 2026 and obtain conditional approval in Q2 2027. Perhaps LBL-024 can take another different path for dual antibodies besides Kangfang.

In addition to LBL-024, its other core pipeline is the hematological tumor pipeline - LBL-034, a dual antibody targeting GPRC5D/CD3, and its current main indication is multiple myeloma. GPRC5D is also a classic target for hematological diseases. At present, Johnson & Johnson's Talquetamab, a dual antibody with the same target, has been approved for marketing. Overall, it is a market with strong certainty. The drug has been recognized as an orphan drug by the FDA in November this year for the treatment of multiple myeloma.

Conclusion : It may not be too early for Virizbo to be launched now. A biotech that has been favored by BeiGene in 2021 and a biotech that can BD early preclinical molecules, I believe that with the recovery of the capital market in the future, it will be easier to get funding back and promote more cutting-edge research and development.

https://news.yaozh.com/archive/44628.html

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