Junshi Biosciences Reports Expected 2021 Net Loss of RMB 736 Million; CanSino Biologics Achieves Profitability with Strong 2021 Earnings

[January 28, 2022 / Pharmaceutical News Overview]Walvax Biotechnology Appoints Dong Shaozhong as Vice President；Biogen Sells Entire Stake in Samsung Bioepis for $2.3 Billion；Junshi Biosciences' 2021 Net Loss Forecast at 736 Million Yuan, Narrowing Year-on-Year……Daily fresh pharmaceutical news and medical updates, Speed Reading Society keeps you informed!

Part 1 Policy Brief

CDE Releases Two Clinical Trial Design Guiding Principles for Liraglutide in Weight Management

On the 28th, CDE released two clinical trial design guidelines, namely, "Guideline for Clinical Trial Design of Liraglutide for Weight Management" and "Guideline for Clinical Trial Design of Once-Daily Basal Insulin Biosimilars," which came into effect on the date of issuance. (CDE)

Procurement of 48 Unapproved Drugs Suspended, Involving Hansoh Pharmaceutical, Haisco, and Hayao…

On the 27th, the Jiangsu Provincial Public Resources Trading Center issued a notice regarding the suspension of procurement of certain generic drugs that did not pass the consistency evaluation. After review, a total of 48 drugs that failed to pass the quality and efficacy consistency evaluation for generic drugs were suspended from procurement, including such key products as Iopamidol Injection, Gliclazide Modified-Release Tablets, Edaravone Injection, Meropenem for Injection, and Cefmetazole Sodium for Injection, involving companies such as Beilu Pharmaceutical, Hansoh Pharmaceutical, Haisco, Hayao Group, and Baiyunshan Tianxin Pharmaceutical. (Jiangsu Provincial Public Resources Trading Center)

Products from ZhenShiMing, Xinhua Pharmaceutical, and Jiudian Pharmaceutical will be delisted.

On the 27th, the Jiangsu Provincial Public Resources Trading Center issued a notice regarding the announcement of proposed delisting of online drugs. After review, a total of 58 products are proposed to be delisted, mainly including Zhen Shi Ming Pharmaceutical's Yanhusuo Eye Drops, Xinhua Pharmaceutical's Calcium Gluconate Tablets, Jiudian Pharmaceutical's Geng Nian An Capsules, Xiangyu Pharmaceutical's Ibuprofen Suspension, and Ruiyang Pharmaceutical's Ticarcillin Sodium Clavulanate Potassium for Injection (freeze-dried), etc. (Jiangsu Provincial Public Resources Trading Center)

"Inter-Provincial Alliance Artificial Lens Medical Consumables Volume-Based Joint Procurement Work Plan" Released

Recently, the Shaanxi Provincial Public Resources Trading Center announced that according to the "Inter-Provincial Alliance Artificial Crystal Medical Consumables Volume-Based Joint Procurement Work Plan," it has decided to carry out volume-based joint procurement of artificial crystals in the regions of Shaanxi, Gansu, Ningxia, Qinghai, Xinjiang, Xinjiang Production and Construction Corps, Hunan, Guangxi, and Hainan. The Shaanxi Provincial Public Resources Trading Center will be responsible for the specific organization and implementation. The scope of this volume-based joint procurement of medical consumables includes artificial crystals that have obtained the Medical Device Registration Certificate of the People's Republic of China. (Shaanxi Provincial Public Resources Trading Center)

Part 2: Industry Economy Observation

Walvax Biotech Appoints Shaozhong Dong as Vice President

On the 28th, Walvax Biotechnology announced that the company's board of directors agreed to appoint Mr. Dong Shaozhong as the vice president of the company, responsible for the company's international business. The term of office is consistent with the fourth board of directors. (Corporate Announcement)

Brii Biosciences Appoints Karen D. Neuendorff as Chief Talent Officer and Head of Human Resources

On the 27th, Brii Biosciences announced the appointment of Karen D. Neuendorff as the company's Chief Talent Officer and Head of Human Resources. Prior to joining Brii Biosciences, she served as Senior Vice President of Human Resources at WeDriveU, a branch of the transportation group National Express LLC. (PR Newswire)

Hengrui Medicine Subsidiary Completes Private Equity Fund Manager Registration

Recently, Hengrui Medicine announced that its subsidiary, Shengdi Private Fund Management, has been registered as a private fund manager with the Asset Management Association of China. (Corporate Announcement)

Biogen Sells Entire Stake in Samsung Bioepis for $2.3 Billion

On the 27th, Biogen announced that it had reached a final agreement with Samsung Biologics to sell its stake in Samsung Bioepis to the latter for $2.3 billion. (PharmaCube)

Huakang Medical Lists on ChiNext with a First-Day Surge of Over 18%

On the 28th, Huakang Medical was listed on the ChiNext Board of the Shenzhen Stock Exchange. The company's stock code is 301235, with an issue price of 39.3 yuan per share and a price-to-earnings ratio of 81.56 times. This public offering comprises 26.4 million shares, including 26.4 million newly issued shares. The new share issuance raised 1.038 billion yuan in funds, with a total post-issue share capital of 105.6 million shares. Huakang Medical is a modern medical purification system solutions provider, mainly serving various hospitals by delivering clean, safe, and intelligent medical environments. As of today’s closing, Huakang Medical’s stock price was 46.62 yuan per share, representing an increase of 18.63%, with a trading volume of 753 million yuan and a total market value of 4.923 billion yuan. (Sina Medicine News)

Walvax Biotech Signs Technical Development and Commercialization Cooperation Agreement for mRNA Vaccine Against SARS-CoV-2 Variants

On the 28th, Walvax Biotechnology announced that it had signed a "Technology Development and Commercialization Cooperation Agreement for mRNA Vaccines Against COVID-19 Variants" with Blue鹊 Biotechnology. The two parties will jointly carry out product development of mRNA vaccines targeting COVID-19 variants and commercial cooperation in mainland China as well as Hong Kong, Macao, and Taiwan regions. The initial payment is RMB 5 million, with RMB 130 million set aside for research and development milestone payments. (Corporate Announcement)

Sinopharm and Everest Medicines Collaborate to Advance the Commercialization of Sacituzumab Govitecan in China

On the 26th, Sinopharm Holdings and Everest Medicines reached a cooperation agreement. Both parties will jointly promote the commercialization process of the innovative oncology ADC drug Trodelvy (Sacituzumab Govitecan) after its approval and market launch in China, facilitating the rapid clinical application of this innovative product. (CPhI China)

Haili Biotech Shanghai Plant Halts Production for Relocation

On the 28th, Haili Bio announced that the company officially shut down its Shanghai plant production line as of the same day. The related production capacity will be mainly transferred to its wholly-owned subsidiary, Shandong Haili. Due to the relocation to another place, according to national regulations, it is necessary to obtain re-approval from relevant competent authorities such as the Ministry of Agriculture and Rural Affairs before production and sales can resume. This process generally takes 6-9 months and is uncertain. (Corporate Announcement)

Junshi Biosciences: Net Loss of 736 Million Yuan Expected in 2021, Narrowing Year-on-Year

On the 28th, Junshi Biosciences announced that the company expects a net profit of -736 million yuan for 2021, a decrease in loss of approximately 933 million yuan compared to the same period last year, representing a year-on-year reduction in loss of about 55.89%. (Corporate Announcement)

CanSino Projects Net Profit of 1.85-2 Billion Yuan for 2021, Set to Turn Loss into Profit

On the 28th, CanSino released its earnings forecast, expecting to achieve a net profit attributable to the parent company's shareholders of 1.85 billion to 2 billion yuan in 2021, representing a turnaround from a loss in the same period last year. (Corporate Announcement)

Zelgen Pharma Expected to Incur Loss of 372 Million to 455 Million Yuan in 2021

On the 28th, Zelgen Pharma announced its preliminary loss forecast for the fiscal year 2021. The company expects a net loss attributable to shareholders of the listed company to be between 372 million yuan and 455 million yuan for 2021. It is also expected that the net loss attributable to shareholders after deducting non-recurring gains and losses will be between 411 million yuan and 509 million yuan for 2021. (Corporate Announcement)

Tasly Predicts 112%-119% Year-on-Year Increase in Net Profit for 2021

On the 28th, Tasly announced its earnings forecast, expecting a net profit of 2.38 billion to 2.47 billion yuan in 2021, representing a year-on-year increase of 112% to 119%. After deducting non-recurring items, the profit decreased by 25% to 35% year-on-year. Tasly Biotech plans to make a provision for asset impairment of 260 million yuan for development expenditure projects. (Corporate Announcement)

Tebio Biotech 2021 Net Profit Increase Forecast: 51.84%-56.99%

On the 28th, Amoytop Biotech announced its 2021 annual earnings forecast. According to preliminary calculations by the company's finance department, the net profit attributable to the parent company's shareholders for the 2021 fiscal year is expected to be between 177 million yuan and 183 million yuan. Compared with the same period last year, it is expected to increase by 60.4304 million yuan to 66.4304 million yuan, representing a year-on-year increase of 51.84% to 56.99%. (Corporate Announcement)

Danaher's Net Income in 2021 Reached $6.3 Billion, Increasing by 74% Year-on-Year

On the 27th, Danaher announced its 2021 earnings report, with a full-year net income of $6.3 billion, or $8.5 per diluted common share, representing a year-on-year increase of 74%. The adjusted non-GAAP diluted net income per common share was $10.05, an increase of 59% compared to last year. Full-year revenue grew by 32% to $29.5 billion, with non-GAAP core revenue growth, including Cytiva, at 25%. Full-year operating cash flow was $8.4 billion, an increase of 34.5% year-on-year, and non-GAAP free cash flow was $7.1 billion, up 30.5% year-on-year. (Corporate Announcement)

Part 3 Pharmaceutical News and Medical Information

Taysha Gene Therapies' Gene Therapy Shows Positive Preliminary Clinical Results

On the 18th, Taysha Gene Therapies announced positive early clinical results for its investigational gene therapy in treating two types of GM2 gangliosidosis—Sandhoff disease and Tay-Sachs disease. Early clinical trial results showed that in a Sandhoff disease patient, Hex A enzyme activity reached 190% of normal levels after one month of treatment and 288% after three months, representing increases of 38-fold and 58-fold compared to the typical 5% level seen in asymptomatic patients. (WuXi AppTec)

Dizhe Medicine's Small Molecule Inhibitor Receives FDA Breakthrough Therapy Designation

Recently, Dizhen Medicine announced that the U.S. FDA has granted Breakthrough Therapy Designation to its investigational treatment DZD9008 for the treatment of non-small cell lung cancer patients with EGFR exon 20 insertion mutations. (WuXi AppTec)

CSPC Group's Bispecific SIRPα Fusion Protein Granted FDA Fast Track Designation

On the 27th, CSPC Pharmaceutical Group announced that its investigational new drug JMT601 has been granted Fast Track designation by the FDA for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. (Corporate Announcement)

CTB001, an autologous CAR-T product of North Heng Bio, obtains FDA orphan drug designation

On the 28th, Beiheng Bio announced that its developed anti-Claudin18.2 autologous CAR-T cell therapy product CTB001 has received orphan drug designation from the U.S. FDA for the treatment of gastric cancer. (MedView)

Enhua Pharmaceutical's Oliceridine Marketing Application Accepted

On the 28th, the CDE official website showed that the new drug marketing application for Oliceridine Fumarate Injection, a novel opioid postoperative analgesic developed by Enhua Pharmaceutical, was accepted by the NMPA. (CDE)

Biogen's Aduhelm Prepares to Launch Phase IV Post-Market Study

Recently, Biogen and its partner Eisai released more details about the Phase IV post-marketing study of the Alzheimer's drug Aduhelm. As part of the Phase IV trial, Biogen and Eisai plan to recruit 18% of U.S. patients from African American and Hispanic populations. Biogen stated that this move is also part of their ongoing efforts to increase the diversity of Aduhelm clinical trials. (Sina Medicine News)

Shanghai Pharmaceuticals' Subsidiary's Hydroxychloroquine Sulfate Tablets Pass Generic Drug Consistency Evaluation

On the 28th, Shanghai Pharmaceuticals announced that its holding subsidiary, Shanghai Pharmaceutical Zhongxi, received the "Drug Supplemental Application Approval Notice" issued by the NMPA for hydroxychloroquine sulfate tablets. This drug has passed the generic drug consistency evaluation. Hydroxychloroquine sulfate tablets are mainly used for rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, as well as skin diseases triggered or exacerbated by sunlight. (Corporate Announcement)

Taysha Plans to Adjust the Clinical Trial Protocol for Gene Therapy TSHA-101

Taysha Gene Therapies Considers Adjusting Immunosuppression Regimen After TSHA-101 Gene Therapy Results in Death of First Recipient (Sina Medicine News)

Novel FXR Agonist Kaissikang Class 1 New Drug Approved for Clinical Trials in China

CDE's official website latest announcement shows that the Class 1 new drug CS0159 oral tablets submitted by Kaisskite have obtained clinical trial tacit permission, intended for development to treat Primary Sclerosing Cholangitis. Public information indicates that CS0159 is a new type of FXR small molecule agonist obtained through crystal structure-assisted design (CDE).