On October 17th, Baiyu Pharmaceutical announced an exclusive licensing agreement with Novartis for a small molecule anti-tumor drug. According to the agreement, Baiyu will receive a down payment of 70 million US dollars (approximately 499 million yuan), as well as various milestone payments and corresponding royalties for development, registration, and commercialization up to 1.1 billion US dollars (approximately 7.8 billion yuan). Novartis will obtain exclusive global development and commercialization rights for this small molecule innovative drug.

Founded in 2005, Baiyu Pharmaceutical is headquartered in Chengdu, Sichuan. It is a global pharmaceutical enterprise with innovative drugs as its core, integrating research and development, production, sales, and traditional Chinese medicine cultivation into a full industry chain group.

10 pipelines under research, 5 tumor pipelines
According to the announcement, the asset of this transaction is a small molecule innovative drug for the treatment of malignant tumors invented and discovered by the Baiyu Innovative Drug team. The specific pipeline has not been announced yet.

According to the official website of Baiyu Pharmaceutical, there are currently 10 research pipelines under development, mainly involving two fields: tumor immunity and DNA damage. Among them, there are 5 research pipelines related to tumors.

Among them, the fastest progressing pipeline BY101298 is an oral small molecule inhibitor targeting DNA-PK, which is currently undergoing phase II clinical trials in China for the treatment of malignant solid tumors through both monotherapy and combination therapy pathways. DNA-PK is a serine/threonine kinase associated with DNA damage repair, playing a critical role in DNA double strand damage repair. Targeted inhibition of DNA-PK can enhance the efficacy of radiotherapy, chemotherapy, and other DNA damaging agents (ADC, RDC, etc.).

Another Class 1 new drug that has been approved for clinical trials by NMPA and FDA is BY101921 tablets, a Class 1 new drug declared by Baiyu and Sichuan Hongmingbosi Pharmaceutical earlier this year. It is currently undergoing Phase I single drug clinical trials in China. BY101921 is an oral small molecule inhibitor targeting PARP7. Relevant studies have shown that inhibiting PARP7 can restore the interferon type pathway, activate the innate immune pathway STING pathway, upregulate phosphorylated STAT1, and thus inhibit tumor growth. According to the announcement from Baiyu, BY101921 has demonstrated excellent anti-tumor efficacy and safety in preclinical studies, and has the potential to become a co targeted BIC drug.
The core product of Baiyu Pharmaceutical is a ginkgolide injection - a traditional Chinese medicine injection made from raw materials extracted from ginkgo leaves, with a purity of up to 99%. This product breaks through the bottleneck of unclear traditional Chinese medicine ingredients, unclear mechanisms, and uncertain therapeutic effects, and has international leadership. This product was approved for market at the end of 2011 and has sold nearly 5 billion yuan to date.

In addition, Baiyu Pharmaceutical also has a layout in the field of high-end generic drugs. According to MiNet, Baiyu Pharmaceutical currently has multiple newly classified products under review (including joint applications), including dobutamine hydrochloride injection, magnesium sulfate injection, and memantine hydrochloride tablets, covering fields such as blood and hematopoietic system drugs, respiratory system drugs, cardiovascular and cerebrovascular system drugs, digestive system and metabolic drugs. There is currently no approved injection form of cetirizine hydrochloride in China. The approved formulations of cetirizine hydrochloride mainly include cetirizine hydrochloride tablets, cetirizine hydrochloride capsules, and cetirizine hydrochloride oral solution. Chengdu Baiyu Pharmaceutical's second production of cetirizine hydrochloride injection is currently striving for the first trial.

Three visits to Chinese pharmaceutical companies within one year
In 2024, Chinese innovative pharmaceutical companies will become one of the most important forces on the international stage: multiple innovative pharmaceutical companies will continue to attract funds, and multinational pharmaceutical companies' MNCs will be crazily shopping. From domestically produced innovative drugs, biosimilars to improved new drugs, covering the explosive fields of ADC, small molecules, GLP-1, etc., Chinese biopharmaceutical companies have successfully gone global through various cooperation methods such as Lincense out and co co.
For Novartis, which has been making frequent purchases this year, Chinese pharmaceutical companies have also become a destination for its sales. As of now, Novartis, including Baiyu, has reached cooperation or acquisition agreements with three Chinese pharmaceutical companies this year. In January this year, Novartis announced that it had signed two exclusive license agreements with Bowang Pharmaceutical, involving an overseas right of Phase I/IIa cardiovascular pipeline, a global right of Phase I cardiovascular pipeline, and the option of cardiovascular pipeline with no more than two other targets, with a maximum transaction amount of 4.165 billion US dollars.

At the same time, Novartis announced the acquisition of Chinese pharmaceutical company Sinopharm to strengthen its presence in the field of kidney disease in China. Xinruinuo has been fully integrated into Novartis China, becoming an indirect wholly-owned subsidiary of Novartis.
In Novartis' positioning, it focuses on four core therapeutic areas: cardiovascular renal metabolism, immunology, neuroscience, and oncology. On the technology platform, in addition to traditional chemical and biological drug platforms, Novartis is also vigorously developing RLT (radioligand therapy), CGT, and xRNA therapy.

As of now, Novartis has announced more than a dozen cooperation, licensing, and merger and acquisition transactions this year, with a potential total amount of over 20 billion US dollars, covering fields including AI pharmaceuticals, small nucleic acids, PD-1, CGT (gene and cell therapy), etc., and continues to increase investment in the fields of oncology, immunology, and kidney disease.

In 2022, Vas Narasimhan, the global CEO of Novartis, formally proposed Novartis' goal of "returning to the top five in the US market" at an investment exchange meeting. To achieve this, Novartis established a separate US innovation drug division. According to the 2024 Novartis interim report, Novartis' total net revenue for the first half of 2024 was $5.9 billion, with net sales of $24.3 billion.

Source: https://pharm.jgvogel.cn/c1452217.shtml