Its all gambling? Tianguangshi, a pharmaceutical company, has neither commercial products nor large-scale income

category:Finance
 Its all gambling? Tianguangshi, a pharmaceutical company, has neither commercial products nor large-scale income


For the fifth set of standards

Founded on February 27, 2003, tianguangshi is an innovative biopharmaceutical company with the ability of antibody drug research and industrialization. It has an efficient antibody glycosylation transformation and bispecific antibody research and development technology platform. At the same time, it has formed a complete R & D system covering antibody drug screening, optimization, clinical research and industrialization. Over the years, the company has developed more than ten antibody products designed to meet the major needs of domestic patients. The clinical indications include lung cancer, lymphoma, leukemia, lupus nephritis, hyperlipidemia, gastric cancer and infectious diseases.

From 2017 to the first quarter of 2020, the operating revenue of tianguangshi was 49.4231 million yuan, 11.6417 million yuan, 88200 yuan and 0 yuan respectively; the net profit attributable to the owners of the parent company was - 20742800 yuan, - 264629900 yuan, - 123.3154 million yuan and - 44.8305 million yuan respectively.

At present, the company has 7 core products (covering 9 clinical studies) and have entered the clinical stage or applied for ind: one of them has submitted an NDA application and received acceptance, one research is in clinical phase 2, and the remaining 7 are in clinical phase 1 or ind stage. In addition, there are still more than 10 products in preclinical R & D stage.

In addition, tianguangshi is building two 1000L stainless steel bioreactors and their supporting purification production and preparation production lines, with an annual capacity of 350000 preparations, which is expected to be put into use in the first half of 2021; it plans to build three 2000L disposable reactors and their supporting purification production lines, with an annual capacity of 500kg antibody.

In a word, tianguangzhen has transferred and increased its capital several times before its debut. The latest one happened at the end of 2019 and the beginning of 2020. Huatai Junshi, Huatai Tianshi and Antai Tianshi transferred their shares. In addition, tianguangshi increased capital and shares from tianguangshi to multiple parties. The transfer price was 47.62 yuan per share, and the capital increase price was 58.03 yuan per share. At present, tianguangshis total share capital is 68.102334 million shares, which is estimated to be close to 4 billion yuan.

Judging from the above conditions, it is obvious that Tianguang is aiming at the fifth set of listing standards. According to item (5) of Article 22 (2) of the rules for the examination and approval of stock issuance and listing on the science and Technology Innovation Board of Shanghai Stock Exchange, the market value is expected to be no less than 4 billion yuan, the main business or products need to be approved by the relevant departments of the state, and the market space is large. At present, phased achievements have been made. Pharmaceutical enterprises should have at least one core product approved to carry out phase II clinical trials, and other enterprises meeting the positioning of the science and technology innovation board should have obvious technical advantages and meet the corresponding conditions.

It is worth mentioning that 1.24% of the total shares of Zhongxin Jinde, a wholly-owned subsidiary of China CITIC Gold Limited, are held by Zhongxin Jinde and Qide Securities Co., Ltd., which are wholly-owned by the underwriters 1.3205% of the companys shares, and Jinshi Yikang indirectly holds 1.3205% of the companys shares through the direct investment fund of the securities company established by its wholly-owned subsidiary Jinshi Investment Co., Ltd.

The products are not commercialized

So what about tianguangshis products?

Source: instruction manual

From the product pipeline point of view, tianguangshis reserves are quite rich. Mil60 (recombinant anti human vascular endothelial growth factor humanized monoclonal antibody injection) is a biological analogue of bevacizumab independently developed by the company. The indication is advanced or recurrent non-small cell lung cancer. Tianguangshi independently completed the preclinical and phase 1 clinical studies, and then cooperated with Beida pharmaceutical to carry out phase 3 clinical trials. At present, the product has been applied for NDA and accepted.

Mil62 (recombinant humanized monoclonal antibody mil62 injection) is an innovative type II anti-CD20 recombinant humanized monoclonal antibody developed by tianguangshi. Mil62 is a product developed on the basis of tianguangshis independent innovation of glycosylation modification antibody technology platform, which has obtained the Chinese patent authorization and the national major new drug creation special support. The clinical trials of this product include: combination of lenalidomide for recurrent / refractory follicular lymphoma and marginal zone lymphoma, currently in clinical stage 2; combined with Btk inhibitor for the treatment of relapsed / refractory CD20 + B-cell lymphoma (jointly developed with Novartis), which is currently in phase 1; combined with standard treatment regimen for lupus nephritis, Ind has been accepted.

Mil86 (recombinant human monoclonal antibody mil86 injection) is an innovative recombinant all human monoclonal antibody against PCSK9 independently developed by tianguangshi, which has been granted the Chinese patent. The indication of this product is hypercholesterolemia, which is in clinical stage 1.

Mbs301 (recombinant humanized bifunctional monoclonal antibody mbs301 for injection) is an innovative bispecific antibody to HER2. The clinical indications of this product are HER2 positive metastatic breast cancer, gastric cancer, pancreatic cancer and other solid tumors, which are currently in clinical stage 1.

Mil77 (recombinant anti Ebola virus monoclonal antibody combined injection) is an anti Ebola triple antibody developed by the Academy of military medicine, Academy of Military Sciences, Chinese peoples Liberation Army, based on tianguangshis independent and innovative glycosylation antibody technology platform, which has won the special support of national major new drug creation. The indication of the product is Ebola hemorrhagic fever, which is currently in clinical stage 1. It is planned to apply for entering the national strategic reserve in the future, and it is not expected to become the main source of future performance.

Mil95 (recombinant humanized monoclonal antibody mil95 injection) is an innovative CD47 monoclonal antibody developed by tianguangshi and kangnoah / Lingyue biology. The indication of this product is lymphoma and advanced malignant solid tumor, which is currently in clinical stage 1.

However, it should be pointed out that among the above products, mil60, the most mature one, has more competitive products. As of the end of August 2020, 14 pharmaceutical enterprises in China have carried out clinical trials of bevacizumab biological analogues, all of which are in clinical phase 3 or application for listing. Although mil62 has shown good safety and effectiveness in phase 1 clinical trials, the results of early clinical studies may not fully predict the results of registered clinical trials. Therefore, there are uncertainties in the research and development and commercialization of mil62.

Therefore, tianguangshi confessed that it is impossible to ensure that the products under research can obtain the approval for drug listing. Even if the companys drugs in research are approved to be listed and recognized by the market in the future, the commercialization prospect of the companys products in research is still uncertain, and the commercialization time and effect may not reach the expected situation. Thus, tianguangshi will not be able to make profits or not in a certain period in the future Distribution of profits .

As mentioned above, mil60 has applied for NDA and has been accepted, which is the product with the fastest development progress. However, for the product to be commercialized, its commercialization rights and interests have been transferred by tianguangshi to Beida Pharmaceutical Co., Ltd. (300558. SZ).

It is reported that tianguangshi first completed the pre clinical and phase 1 clinical studies of mil60 independently, and then signed a cooperation agreement with Beida Pharmaceutical (300558. SZ) on March 1, 2017. The agreement mainly stipulates that: (1) tianguangshi will permanently and exclusively license the product rights and product technology owned by tianguangshi before the effective date of the agreement to Beida Pharmaceutical Co., Ltd. for the latters production in relevant fields in the region Product development. Beida has the right to sublicense the technology of such products; (2) Beida pharmaceutical should bear the costs of the third phase clinical trial, product registration, commercialization, production and sales. Tianguangshi shall bear the research and development expenses before the third phase clinical trial of the product; (3) Beida Pharmaceutical Co., Ltd. shall pay a total of 50 million yuan of milestone fee to tianguangshi in four phases; (4) after the product is put into the market, Beida pharmaceutical will pay a royalty (1 u00d7 8% of the net sales) to tianguangshi every year, and the deadline is tentatively set as 10 years, starting from the end of the year when the product is first marketed (including the current year). On the date of expiration, both parties will re agree on the royalty ratio. The total royalty period shall not exceed 15 years. After 10 years, the royalty ratio will be reduced accordingly based on the current market situation. From this point of view, Tianguang is actually trying to make an abacus of cocky footed shopkeeper. But why should we cooperate? Tian Guangshi said that the development of mil60 is based on the technology of tianguangshi and the industrialization ability, clinical development experience, sales channel and market access ability of Beida Pharmaceutical Co., Ltd., which is conducive to the rapid landing and commercialization of the product after obtaining the production approval. The final effect remains to be proved. Shenzhen real estate market in September: second hand housing transaction fell by 24%, new house continued to warm up, 15 billion euro payment giant was born! Italys two largest payment companies announced merger, fell 7%! SMIC international was subject to us export control measures to deal with potential impact_ NF4425

It is reported that tianguangshi first completed the pre clinical and phase 1 clinical studies of mil60 independently, and then signed a cooperation agreement with Beida Pharmaceutical (300558. SZ) on March 1, 2017. The agreement mainly stipulates that: (1) tianguangshi will permanently and exclusively license the product rights and product technology owned by tianguangshi before the effective date of the agreement to Beida Pharmaceutical Co., Ltd. for the latters production in relevant fields in the region Product development. Beida has the right to sublicense the technology of such products; (2) Beida pharmaceutical should bear the costs of the third phase clinical trial, product registration, commercialization, production and sales. Tianguangshi shall bear the research and development expenses before the third phase clinical trial of the product; (3) Beida Pharmaceutical Co., Ltd. shall pay a total of 50 million yuan of milestone fee to tianguangshi in four phases; (4) after the product is put into the market, Beida pharmaceutical will pay a royalty (1 u00d7 8% of the net sales) to tianguangshi every year, and the deadline is tentatively set as 10 years, starting from the end of the year when the product is first marketed (including the current year). On the date of expiration, both parties will re agree on the royalty ratio. The total royalty period shall not exceed 15 years. After 10 years, the royalty ratio will be reduced accordingly based on the current market situation.