Summary: Goto Biopharm and Anglikang Pharma are pushing forward with plans in the fields of plant-derived cholesterol and downstream VD3.

Hubei Goto Biopharm Co., Ltd. (Goto Biopharm) and Zhejiang Anglikang Pharmaceutical Co., Ltd. (Anglikang Pharma) are pushing forward with plans in the fields of plant-derived cholesterol and downstream vitamin D3.

On 18 May, the construction commencement ceremony for "vitamin D3 (and VD3-related substances) biopharmaceutical R&D and production base project", a project undertaken by Hubei Goto Biotechnology Co., Ltd. (Goto Biotech)—Goto Biopharm's wholly-owned subsidiary, was held.

Project overview

• Total investment: USD704.57 million (RMB5.00 billion)
• Construction site location: Baiguoshugou Biopharmaceutical Industrial Park, Danjiangkou City, Shiyan City, Hubei Province
• Site area: 26.67 ha
• Number of production lines: More than 20
• Product scheme (designed production capacity): 20,000 t/a for vitamin D3, 200 t/a for 1,2-dehydrogenase, 200 t/a for 5-Hydroxytryptophan, 200 t/a for progesterone, 100 t/a for testosterone, 50 t/a for estrone and 1,500 t/a for other pharmaceutical intermediates
• Economic benefits: The project is expected to generate yearly output values of USD1.83 billion (RMB13.00 billion) after completion.

According to the chairman of Goto Biotech's board, the project is the first in VD3 manufacturing field to replace animal-derived raw materials with plant-derived raw materials; the technological innovation in this project, as well as the project's development mindset of greenness and sustainability make it the pacesetter in the industry.

This project is also an important move in Goto Biopharm's plan to extend the product chain from bisnoralcohol (BA) to downstream vitamin D3. The production route mainly used in the synthesis of vitamin D3 involves "lanolin - cholesterol - vitamin D3", which has its disadvantages including the limited supply of raw material lanolin and relatively high production costs. The production route "bisnoralcohol (BA) - plant-derived cholesterol - vitamin D3" shows distinct advantages over the conventional route, with fewer discharge volume of pollutants, superior safety, and relatively lower production costs. Over the recent years, there has been a tendency that the BA route could replace the conventional one.

Goto Biopharm's "construction project for production of progesterone (200 t/a) and intermediate BA (800 t/a)" is under construction. The project uses phytosterol to produce BA (plant synthesis route). As of end of 2022, construction progress approached 47.17%. It is expected that the production will commence in 2023, and production capacity will reach 40% of the target capacity once the project is put into operation. Currently, the pre-market preparation for BA in this project was completed in advance, and this product has been sold in small batches; annual sales volume ranges from 40 tonnes to 60 tonnes. Additionally, Goto Biopharm's previous announcement revealed that Shandong Xinhua Pharmaceutical Co., Ltd. was communicating with the company about the potential cooperation opportunities involving plant-derived cholesterol and vitamin D3.

On 20 April, at its explanation meeting of 2022 performance, Zhejiang Anglikang Pharmaceutical Co., Ltd. (Anglikang Pharma) stated that Hunan Kerey Pharmaceutical Co., Ltd. (Kerey Pharma), its controlled subsidiary, had initiated mass production of plant-derived cholesterol (30 t/a) and started to supply this product to the customers; from all the disclosed information in the market, it was found the only Chinese enterprise that could realise commercial production of plant-derived cholesterol was Kerey Pharma, but the possibility of laboratories producing at a small scale still existed; the customers of Kerey Pharma's plant-derived cholesterol mainly included a German-based firm, which had signed Supply Agreement with Kerey Pharma; the company would expedite the pace of renovating Kerey Pharma's production facilities for the conformity of GMP standard, and move forward with development and application of its products in the pharmaceutical field, aiming to achieve upstream-downstream collaboration with Kerey Pharma in intermediates for steroid drugs, cholesterol, cholic acid and VD3 series products.

Thanks to the realisation of mass production of plant-derived cholesterol, Kerey Pharma has formed an upstream-downstream product chain, "plant-derived cholesterol - vitamin D3".

Jiangxi Chundi Biotechnology Co., Ltd., a controlled subsidiary of Kerey Pharma, mainly produces plant-derived vitamin D as well as active vitamin D and its analogues, possessing following capacities: 10 t/a for VD3 crystal, 1,000 t/a for VD3 particle, 10 t/a for VD2 crystal, 10 t/a for 25-Hydroxyvitamin D3 crystal and 1,000 t/a for 25-Hydroxyvitamin D3 particle.