Policy Trends

The National Medical Products Administration has issued a notice regarding 26 batches of cosmetics that do not comply with regulations

On February 11, the WeChat official account of the State Food and Drug Administration issued a document stating that 26 batches of cosmetics with the product label name of Yunman Bathing Lotion did not meet the requirements in the 2024 national cosmetics sampling inspection, which was inspected by Qinghai Institute for Drug Inspection and Testing and other units.

Medical device approval

Two first in class dual antibodies from Johnson&Johnson have been approved for market launch in China

On February 11th, Johnson&Johnson announced that the marketing applications for Ruike (Evantazumab) and Tuolikuo (Taquettuzumab) have both been approved by the National Medical Products Administration. The former is the world's first approved EGFR/c-MET bispecific antibody, while the latter is the first approved bispecific antibody drug targeting GPRC5D.

GSK Mabolizumab's new indication for market application in China

On February 11th, the official website of the China National Medical Products Administration (CDE) announced that GlaxoSmithKline's (GSK) application for the marketing of anti-IL-5 monoclonal antibody Mabolizumab injection, which was declared as a Class 2.2 biological product, has been accepted. According to GSK's official website and public information, it is speculated that the indication for the application for marketing of Mabolizumab in China may be chronic obstructive pulmonary disease (COPD). Mabolizumab has not yet been approved globally for this indication.

Merck antibiotic compound approved for market in China

On February 11th, the official website of NMPA announced that the combination of Merck antibiotics, "Cefuroxime and Tazobactam Sodium for Injection," has been approved for marketing. This compound (R&D code: MK-7625A) was first approved for sale in the United States in December 2014 under the trade name Zerbaxa. It is used in combination with metronidazole to treat complex abdominal and urinary tract infections (including pyelonephritis) caused by designated susceptible microorganisms. Later, its indications were expanded to include hospital acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).

Zhengda Tianqing is the first domestic company to complete the equivalence study of dual branch expansion powder mist agent

On February 11th, Zhengda Tianqing announced that the company's application for the market launch of Umetam Bromide Vilantro Inhalation Powder Mist has been accepted by CDE and is suitable for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Zhengda Tianqing is the first pharmaceutical company in China to complete the equivalence study of dual branch expansion powder mist.

Capital market

Aoxiang Pharmaceutical has obtained a commitment letter for a stock repurchase loan of 90 million yuan

On February 11th, Aoxiang Pharmaceutical announced that the company has recently obtained a "Loan Commitment Letter" issued by Bank of China Taizhou Branch, committing to a maximum loan amount of RMB 90 million, a loan term of 3 years, and a loan purpose limited to repurchasing the company's stocks. The specific loan related matters for this stock repurchase shall be subject to the stock repurchase loan contract officially signed by both parties. The company will implement the repurchase at an appropriate time based on market conditions during the repurchase period, and fulfill its information disclosure obligations in a timely manner according to the progress of the repurchase of shares.

Yixintang plans to repurchase shares for 80 million to 150 million yuan

On February 11th, Yixintang announced that the company plans to repurchase shares for 80 million to 150 million yuan, with funding coming from its own funds and special loans for stock repurchase. The repurchase price shall not exceed 19.02 yuan per share, and the repurchased shares shall be used to maintain the company's value and shareholder equity. The plan is to sell them through centralized bidding trading twelve months after the disclosure of the repurchase results and share change announcement, and complete the sale within three years after the disclosure of the repurchase results and share change announcement. If the sale is not completed within the above-mentioned period, the unsold portion of the shares will be cancelled.

Huahai Pharmaceutical adjusts the amount of private placement funds to no more than 600 million yuan

On February 11th, Huahai Pharmaceutical announced that it has adjusted the fundraising scale for issuing stocks to specific targets, from no more than 1.21 billion yuan (including the principal amount) to no more than 600 million yuan (including the principal amount), and has accordingly adjusted the proposed amount of fundraising for the project.

Industry Events

Novartis acquires Anthos for over $3 billion

On February 11th, Novartis announced that it had reached an agreement to acquire Anthos Therapeutics, a clinical stage biopharmaceutical company based in Boston that is developing the late stage drug FXI/FXIa targeted monoclonal antibody abelacimab for the prevention of stroke and systemic embolism in patients with atrial fibrillation. According to the terms of the agreement, Novartis will make a prepayment of $925 million upon completion of the transaction, subject to certain customary adjustments, and may pay an additional amount of up to $2.15 billion upon reaching designated regulatory and sales milestones. The transaction is expected to be completed in the first half of this year.

Comment 21: Novartis stated that this acquisition is consistent with Novartis' strategic focus, strength, and expertise in the field of cardiovascular therapy. From the perspective of revenue in 2024, cardiovascular kidney metabolism is Novartis' third largest business area, with Entresto (sacubitril valsartan) being the highest revenue single product, with a revenue of $7.8 billion in 2024. However, the drug is facing a severe patent cliff. Meanwhile, from the product pipeline disclosed by Novartis, there are relatively few cardiovascular kidney metabolic reserve pipelines, which may be one of the main reasons why Novartis chose to acquire Anthos and strengthen its cardiovascular field.

Merck intends to acquire a biotech company with a market value of $4 billion

On February 11th, Merck announced that negotiations to acquire SpringWorks Therapeutics (SWTX. US), a US cancer and rare disease pharmaceutical company, are underway. According to industry insiders, the two parties may sign an agreement in the coming weeks.

Lilly and OliX reach a global licensing agreement worth $630 million for a MASH drug

On February 11th, Eli Lilly announced a $630 million global licensing agreement with South Korean biotech company OliX Pharmaceuticals to jointly develop and commercialize OliX's metabolic associated steatohepatitis (MASH) treatment drug OLX75016.

Bairen Medical plans to invest no more than 250 million yuan to build an industrial base project

On February 11th, Bairen Medical announced that the company intends to participate in the auction to obtain the state-owned construction land use right of CP00-1201-36 plot in Block 1201, East District of Changping New City (Nanshao Group) through listing, and invest in the construction of the "Bairen Medical Aiberui Industrial Base Project" after obtaining the above-mentioned state-owned land use right. The land use is M1 Class I industrial land, with a land area of approximately 19300 square meters. The company plans to purchase the land use right for no more than RMB 60 million. The project will be constructed in stages, with this investment being the first phase of the project, with an investment amount not exceeding RMB 250 million (including land transfer fees). The second phase of the project will make a comprehensive judgment based on the construction situation of the first phase, the development of the company's business, and other external factors, and make separate decisions and disclose information in accordance with regulations. The final investment amount will be based on the actual investment in the project construction

Public opinion warning

'Nucleic acid king' Zhang Hepeng restricted from high consumption due to 200000 yuan

According to legal litigation information, on January 23, 2025, the Nanshan District People's Court in Shenzhen filed an application for enforcement of a labor dispute by the applicant Yang. Due to failure to fulfill the payment obligation determined by the effective legal document within the period specified in the enforcement notice, Nuclear Gene and its legal representative Zhang Nuclear were restricted from high consumption. The case process shows that in January of this year, the company was forcibly executed for about 200000 yuan as a result of this case.

Shenzhen Nuclear Gene Technology Co., Ltd. was established in 2012. During the epidemic, the Huaxi Laboratory under Nuclear Gene undertook over 700 million nucleic acid tests. In 2022, Nuclear Gene had densely registered 16 nucleic acid testing institutions, attracting public attention.

*ST Longjin Company's stock may be delisted

On February 11th, ST Longjin announced that the company's stock will be subject to delisting risk warning starting from May 6th, 2024. If the situation specified in Article 9.3.12 of the Shenzhen Stock Exchange Listing Rules occurs after the disclosure of the company's 2024 annual report, there is a risk of the company's stock being delisted. The company has disclosed its performance forecast for the year 2024, and it is expected that the relevant indicators will meet the above-mentioned requirements. If the audited financial data in the final disclosed 2024 annual report is consistent with the scope of the performance forecast data, the company's stock will be delisted from the Shenzhen Stock Exchange.

Ye Xiangzhong, Deputy General Manager of Wantai Biotechnology, plans to reduce his stake in the company by no more than 0.0079%

On February 11th, Wantai Biotechnology announced that Vice General Manager Ye Xiangzhong plans to reduce his holdings by no more than 100000 shares, accounting for 0.0079% of the company's total share capital and no more than 25% of his personal shareholding, through centralized bidding trading within 3 months after the disclosure date of the announcement. Ye Xiangzhong currently holds 462100 shares of the company, accounting for 0.0365% of the total share capital.