Morning, here's 21 Health News Daily! Welcome to pay attention to the latest events in the pharmaceutical and health industry with the new health team of 21st Century Business Herald!
<h4>First, policy trends</h4>
● The "Eight Provinces and Two Regions" Inter-Provincial Alliance collects and announces the results of the selection
Recently, the Inner Mongolia Autonomous Region Pharmaceutical Procurement Network issued the "Notice on Announcing the Results of the Selection of the "Eight Provinces and Two Regions" Interprovincial Alliance Drug Centralized Procurement"
In this round of interprovincial procurement, a total of 21 products were selected - involving felodipine tablets, todansetron hydrochloride for injection, ceftiam hydrochloride for injection and other drugs, with as many as 19 large varieties of injections. The selected enterprises are also basically large-scale pharmaceutical companies, with a total of 15, including Qilu Pharmaceutical, Hainan Beite Pharmaceutical, Sichuan Kelun and so on.
This round of inter-provincial gathering is led by Heilongjiang. Earlier, the Heilongjiang Provincial Government Procurement Center issued the "Announcement on centralized procurement of drugs in the "Eight Provinces and Two Regions" Interprovincial Alliance" announcing that ten provinces (regions) such as Heilongjiang, Shanxi, Inner Mongolia Autonomous Region, Liaoning, Jilin, Sichuan, Tibet Autonomous Region, Hainan, Qinghai, and Guizhou have formed an interprovincial alliance procurement office to implement centralized drug procurement on behalf of medical institutions in 10 provinces (regions).
<h4>2. Examination and approval of pharmaceutical devices</h4>
●Cinda's first small molecule innovative drug was included in the priority review
On 12 July, the CDE Priority Review column was updated to prioritize two small molecule anticancer drugs, one of which is Cinda's FGFR inhibitor Pemignitinib, for the treatment of advanced, metastatic or non-surgically resectable adult patients with FGFR2 fusion or rearrangement of FGFR2 that have previously received at least one systemic treatment.
●Pfizer III ALK inhibitors were included in the priority review
On July 12, the CDE Priority Review column was updated to prioritize two small molecule anticancer drugs, one of which is Pfizer's third-generation ALK inhibitor, loratinib, for patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received one or more ALK-TKI treatments.
●The Phase 2/3 clinical trial of Haichuang Pharmaceutical for the treatment of COVID-19 AR inhibitors was approved
On July 12, Haichuang Pharmaceutical announced that its application for the "Phase 2/3 Clinical Trial for the Treatment of HC-1119 Covid-19 Hospitalized Patients" was approved by the Brazilian Health Supervision Agency (ANVISA) and will officially launch related clinical trials in Brazil. It is reported that the trial is placebo-controlled, based on standard treatment, to evaluate the efficacy and safety of HC-1119 in the treatment of hospitalized patients with new crown. If the clinical trial is successful, it may provide treatment drugs for COVID-19 patients.
HC-1119, an androgen receptor (AR) inhibitor and one of the core products under research of Haichuang Pharmaceutical, is simultaneously conducting a global multi-center clinical Phase 3 trial for the treatment of prostate cancer and a phase 3 clinical trial in China. The approval of this CLINICAL trial related to the treatment of new crown will help to further develop its indications and expand the therapeutic field of this product.
<h4>3. Capital market</h4>
●Tengsheng Bo Medicine landed on the Hong Kong Stock Exchange today
According to the recent announcement of Brii Biosciences, the company will be officially listed on the Hong Kong Stock Exchange today (July 13). Tengsheng Bo Pharmaceutical is an innovative biotechnology company committed to solving the severe public health disease challenges represented by infectious diseases with breakthrough innovation. According to public information, Tengsheng Bo Pharmaceutical was listed on the Hong Kong Stock Exchange with an issue price of HK$22.25 per share, and the net proceeds from the global offering are expected to be about HK$2.334 billion, and the cornerstone investors are Invesco Advisers, UBS Asset Management of Singapore, RBC King Asset Management, AIHC Master Fund, Springhill Master Fund, etc.
●Biomaterials developer BornRier completed the B+ round of financing
On July 12, it was learned that Jiangxi Born Ruier Biotechnology Co., Ltd., a developer of biomaterials, has completed nearly 100 million yuan of B+ round financing, led by Matrix Partners China, followed by DT Capital, Yuansheng Venture Capital continued to increase, and Kaicheng Capital served as the chief financial adviser of this round. This round of financing will be mainly used for product pipeline development, clinical and other aspects. Previously, the company had also received tens of millions of yuan of Series A financing from Yinying Capital in 2018 and tens of millions of yuan of Series B financing from Yuansheng Venture Capital in 2020.
Founded in 2017, the company focuses on the research and development and production of biomaterials, mainly through clinical medicine to provide rapid hemostasis, wound repair, guide tissue regeneration and other high-end medical consumables, and took the lead in building a number of polymer biomaterials technology platforms, for the continuous development of high-end medical devices to continuously provide the best medical solutions.
●Rongjie Health Co., Ltd. intends to introduce Xunfei Medical as the controlling shareholder
Rongjie Health announced on the evening of July 12 that Anhui Yinglian Yunxiang Medical Technology Co., Ltd., a shareholding company of the company, intends to introduce Anhui iFLYTEK Medical Information Technology Co., Ltd., a subsidiary of iFLYTEK Holdings, as the controlling shareholder through capital increase + equity transfer. After the capital increase, the company holds 13.66% of the equity of Yinglian Cloud, and the company intends to transfer the 6.82% equity of Yinglian Yunxiang held after the capital increase to iFLYTEK Medical for 13.13 million yuan. After the completion of the transaction, it is expected to have an impact on the company's profit in 2021, and the preliminary estimate is about 16.2886 million yuan.
●Heyuan Biotech completed a series C financing of more than 400 million yuan
On July 12, Heyuan Biotech announced the completion of a Series C financing of more than RMB400 million. This round of financing is jointly led by CICC Capital's fund and Haisong Capital, and Delian Capital and existing investors Jiadao Private Capital, Danlu Capital, Tianchuang Capital, Daotong Investment, and Xiangfu Capital. Together with this round of financing, Heyuan Bio has raised nearly 1 billion yuan in the past six months.
Founded in June 2018, Heyuan Biotech is a new generation of biopharmaceutical companies driven by cell and gene innovation technology, focusing on the research and development and commercialization of innovative drugs such as immune cell therapy. Previously, the company has completed a series A financing of RMB 163 million, a series of financing of RMB 100 million, a series of financing of RMB 100 million, and a Series B financing of RMB 450 million.
<h4>Fourth, industry events</h4>
Sinopharm and Cohin Bio began supplying vaccines to COVAX this month
On July 12, local time, the Global Alliance for Vaccines and Immunization (Gavi) announced that Sinopharm and Kexing Biotech signed cooperation agreements with the "Global COVID-19 Vaccine Implementation Plan" (COVAX) to purchase vaccines. Under the agreement, the two companies will immediately provide 110 million doses of vaccine to the COVID-19 Vaccine Implementation Plan from July, and will also provide additional doses as appropriate to help address the current critical supply gap.
According to the agreement, the Beijing Institute of Biological Products will supply 60 million doses of vaccine for the first time from the third quarter of 2021. Gavi will also purchase 60 million doses in the fourth quarter of 2021 and another 50 million doses in the first half of 2022, as needed. These vaccines will be supplied through COVAX to self-financing participating countries as well as participating countries supported by the COVAX Advance Market Commitment Mechanism (AMC).
According to the agreement, SINOVAC Will supply 50 million doses of the COVID-19 inactivated vaccine Kerraf ® by the end of September 2021. In addition, Gavi has the option to purchase a further 150 million doses in Q4 2021 and a further 180 million doses in the first half of 2022. In this way, SINOVAC will provide a total of up to 380 million doses of COVID-19 inactivated vaccine to COVAX self-financing participants and participants eligible for the "Pre-Market Commitment Mechanism" (AMC).
● Nuocheng Jianhua and Bojian reached an agreement: $940 million license out of oboutinib
On July 13, Bo Jian and Sino Cheng Jianhua jointly announced that the two companies have reached a license and cooperation agreement on the oral small molecule Bruton tyrosine kinase inhibitor (BTKi) oboutinib that is expected to treat multiple sclerosis (MS). Obutinib is a covalently bound BTK inhibitor with high selectivity and blood-brain barrier permeability, and is currently undergoing placebo-controlled Phase II clinical studies in patients with relapsing remitting multiple sclerosis in multiple countries.
Obutinib inhibits BTK, a key kinase in the signaling pathway of immune cells, including B cells and myeloid cells. Obutinib can cross the blood-brain barrier (BBB) and has the potential to inhibit the function of B cells and myeloid cells in the central nervous system, and is expected to provide beneficial clinical value for disease progression of all MS subtypes. In response to disease progression, olibutinib is expected to provide new treatment options for MS patients to delay disease progression.
Under the terms of the agreement, Bojian will have exclusive rights to obutinib worldwide in the field of multiple sclerosis, as well as exclusive rights in certain autoimmune diseases in the region other than China (including Hong Kong, Macau and Taiwan), and Noble Jianhua will retain the exclusive global rights of opoutinib in the field of oncology, as well as the exclusive rights of certain autoimmune diseases in China (including Hong Kong, Macau and Taiwan). Nova Healthcare will receive a down payment of $125 million and will be eligible for up to $812.5 million in future payments for potential clinical development milestones and commercial milestones.
●The price of the first domestic ADC drug was exposed
One month after the listing, the price of vidicetizumab (trade name: Edich) for injection of the first domestic antibody-conjugated drug (ADC) was exposed. According to the data of Yaorongyun, at the beginning of this month, Rongchang Bio's vidicetizumab has been officially launched for sale, and the sales price is 13500 yuan / box (dosage form is 60mg / stick).
In June this year, vidicetizumab was approved for the treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who had received at least 2 kinds of systematic chemotherapy, becoming the third ADC drug listed in China and the second product commercialized by Rongchang Biologics.
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