Just now (the afternoon of December 6), the National Health Commission held a press conference to introduce the situation regarding "scientific and technological innovation in the pharmaceutical field." Among the topics discussed were key signals released on how to further guide and support pharmaceutical companies in their research and innovation.Liu Dengfeng, Director of the Department of Science and Education of the National Health Commission, stated that over the years, enterprises have played an important role in product-related innovation work during the organization and implementation of major science and technology projects. In order to better leverage the leading and main roles of enterprises in innovation, in planning the new round of scientific and technological innovation work, full play will be given to the important role of market enterprises in the innovation chain. Enterprises, especially innovative drug and innovative vaccine companies, will be guided and supported to carry out technological research around major national needs in the health sector.
First, strengthen the policy guarantee for innovation and development across the entire chain.The National Health Commission and relevant national ministries have jointly studied and introduced policies, including support in scientific research and development, optimized price management, strengthened medical insurance payment, promotion of commercial insurance development, and policies encouraging medical institutions to equip and use innovative drug vaccines, among others. Corresponding policies have also been introduced in investment and financing, drug evaluation and approval, and performance assessment of medical institutions. The main purpose is to provide effective and strong policy guarantees for the entire chain of collaborative innovation and to create a better innovation environment for pharmaceutical enterprises to play a role in the innovation process.Secondly, continue to promote the organization and implementation of major scientific and technological projects in the pharmaceutical field and ensure their continuity.The last round of the major new drug creation project started from the "11th Five-Year Plan" and lasted for three five-year plans, promoting the transformation of China's drug research and development "from imitation to innovation" and the pharmaceutical industry "from large to strong." In this process, pharmaceutical companies have made significant contributions. The new round of major projects still adheres to fully leveraging the role of enterprises as innovation leaders, guiding companies to focus on national major needs, such as the four major chronic diseases, major infectious diseases, as well as pediatric diseases, rare diseases, special medication scenarios, etc., in conducting new drug research and development.Third, strengthen support for enterprise innovation through science and technology program projects.For instance, during the implementation of the project, specific projects undertaken by enterprises were established to support enterprises in leading technological research. Some projects also stipulated that the development of major products must be led by enterprises for application, and required enterprises to invest in innovation, such as providing matching funds. At the same time, projects such as application evaluation and demonstration research, application solution research, and regulatory science research were set up to create a favorable innovation policy environment and supporting scenarios, thereby promoting innovative products from samples to products, from products to the market, and from the market to serving people's health.On the same day, according to foreign media reports,U.S. lawmakers are considering changes to the Biosecure Act, with the compromise version including increased administrative review processes for relevant companies, rather than an automatic ban on biopharmaceutical companies collaborating with Chinese firms.Possibly influenced by this news, the share prices of Wuxi AppTec's A-shares and H-shares both rose.
In addition, to address the current pressure on vaccine companies, Chongqing Zhifei Biological Products Co., Ltd. and GSK have adjusted their strategic cooperation, extending their partnership for the shingles vaccine (Shingrix).The procurement amount between 2024 and 2029 is expected to be approximately 21.6 billion yuan.; At the same time, a 10-year commercial cooperation exploration for the RSV vaccine has been preliminarily reached.
Besides, let's take a look at what other highlights in the pharmaceuticals industry this week are worth paying attention to?
U.S. lawmakers are considering changes to the Biosecurity Act:According to foreign media reports, U.S. lawmakers are considering changes to the Biosecurity Act. The compromise version includes adding administrative review procedures for relevant companies, rather than automatically banning biopharmaceutical companies from cooperating with Chinese companies.The Joint Procurement Office of the National Organization for Medicines issued a document regarding the tenth batch of centralized procurement:On December 5, the National Organization for Medicines Joint Procurement Office released the "Announcement on the Relationships Between Enterprises, Consortium Applications, and 'Violation List' Related to the 10th Batch of National Organization for Medicines Centralized Procurement." The announcement stated that as of 4:00 PM on December 2, 2024, the information submission and review process for the 10th batch of centralized procurement had been fully completed. According to the public list of enterprises involved in the "Violation List" related to the 10th batch of national medicines procurement, the suspected non-compliant products include Dobutamine Injection, Metaraminol Injection, Norepinephrine Injection, Neostigmine Injection, and Doxorubicin Hydrochloride Liposome Injection, among others.Shandong Fourth Batch of Medical Consumables Centralized Procurement Open for Public Comment:On December 5, the Shandong Provincial Medical Insurance Bureau issued a notice soliciting public opinions on the "Draft Document for the Fourth Batch of Centralized Volume-based Procurement of Medical Devices in Shandong Province (Draft for Comments)." The province will carry out the fourth batch of medical device procurements, planning to include 12 types of medical devices. Referring to market price conditions, the procurement will be conducted through volume linkage.The Arrival of Four Vascular Interventional Medical Consumables in Centralized Procurement:On December 3, the official website of Hebei Provincial Medical Insurance Bureau published the "Notice on the Release of the 'Procurement Document' for the Provincial Alliance's Centralized Volume-based Procurement of Vascular Interventional Medical Devices," marking the official start of the Hebei-led vascular interventional medical devices procurement planned in Document No. 8 ("Quality Improvement and Expansion") issued by the National Medical Insurance Bureau on May 20 this year. The notice also announced the procurement documents for four types of vascular interventional medical devices covered in this procurement. Led by Hebei, a procurement alliance consisting of 27 provinces was formed for three product categories, while another alliance comprising 25 provinces was formed for one product category.Tibetan Medicine 7-Provinces Joint Procurement Launch:On December 3, the Qinghai Provincial Drug and Medical Device Centralized Procurement Website published the "Announcement on Launching Joint Procurement of Tibetan Medicine." The announcement revealed that Qinghai will lead an inter-provincial alliance consisting of Inner Mongolia, Sichuan, Yunnan, Gansu, Xinjiang, and the Xinjiang Production and Construction Corps. A total of 85 Tibetan medicines will be included in the joint procurement. The procurement period is two years, which can be extended based on circumstances.Change of Director at Fujian Provincial Medical Insurance Bureau:On December 2, according to the "China Fujian" news, the People's Government of Fujian Province announced a batch of personnel appointment and removal notices: including the appointment of Huang Yu as the Director of the Fujian Provincial Medical Security Bureau, and the removal of her position as the Deputy Director of the Fujian Provincial Health Commission. Public information shows that Huang Yu, female, born in April 1975, holds a master’s degree in medicine. She previously served as a member of the Party Leadership Group and Deputy Director of the Fujian Provincial Health Commission, concurrently serving as the Director of the Office of the Provincial Health Care Committee. During her tenure at the Health Commission, Huang Yu was responsible for medical administration, medical and health system reform, traditional Chinese medicine management, aging health, maternal and child health, and cadre health care.Promotion Regulations for Biomedical New Technologies in Boao Lecheng Pilot Zone Released:On December 5, the Standing Committee of the Hainan Provincial People's Congress announced the "Regulations on Promoting Biomedical New Technologies in the Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port," which will come into effect on February 1, 2025. Article 2 of the Regulations states: This Regulation applies to the clinical research, translational application, and related supervisory activities of biomedical new technologies such as cell therapy, gene therapy, and tissue engineering conducted within the pilot zone.UnitedHealth CEO Shot Dead on the Street:According to foreign media reports, a shooting occurred in New York, the United States, on the morning of December 4 local time. Brian Thompson, CEO of UnitedHealthcare, a subsidiary of UnitedHealth Group, was fatally shot outside the Hilton Hotel in Midtown Manhattan, New York.
Sanofi to Invest 1 Billion Euros in Building New Insulin Production Base in ChinaOn December 2, Sanofi China announced that it had signed a memorandum of cooperation with Beijing Economic and Technological Development Zone to invest approximately 1 billion euros in establishing a new production and manufacturing base.
Lilly to Invest $3 Billion in Expanding U.S. Production Base:According to foreign media reports, Eli Lilly will invest another $3 billion to expand its production base in the United States, in order to increase the output of its blockbuster diabetes and weight loss drugs. According to its statement, the latest investment is the largest investment outside Indiana, where the company's headquarters is located, and will expand the new production plant in Wisconsin, which is expected to start construction next year. This move will help meet the growing demand for injectable drugs such as Mounjaro and Zepbound.
Merck Initiates Phase III Clinical Trial of ROR1 ADC:On December 5, according to the clinical trials website, Merck registered a randomized, open-label, multicenter, Phase 3 study (waveLINE-010) of the ROR1 ADC drug Zilovertamab Vedotin (MK-2140) in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) versus rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for the treatment of previously untreated patients with diffuse large B-cell lymphoma (DLBCL).
AstraZeneca China Management Team Undergoes Major Changes:First, Iskra Reic will replace Leon Wang as AstraZeneca's Global Executive Vice President and Head of International Business; second, Leon Lin has been promoted to General Manager of AstraZeneca China; third, Alex Lai will assume the role of Head of AstraZeneca’s Global Oncology Business Dato-DXd and Lung Cancer Division; fourth, Dongmei Guan will serve as General Manager of AstraZeneca China Oncology Business. Additionally, Dr. Jing He, AstraZeneca's Global Senior Vice President and Head of the Global R&D China Center, will also join the International Business Management Team.
Chongqing Zhifei Biological Products Co., Ltd. and GSK Sign "Supplementary Agreement to the Exclusive Distribution and Co-Promotion Agreement"On December 5, Chongqing Zhifei Biological Products Co., Ltd. announced that the company had signed a "Supplementary Agreement to the Exclusive Distribution and Co-Promotion Agreement" with GSK Biologicals and GSK Hong Kong. The supplementary agreement optimizes and adjusts the relevant terms of the recombinant shingles vaccine procurement plan stipulated in the original "Exclusive Distribution and Co-Promotion Agreement" signed on October 8, 2023. It further extends the duration of the company’s exclusive rights for importing, distributing, and co-promoting the recombinant shingles vaccine in mainland China. In addition, the supplementary agreement further specifies that the company will exclusively explore with GSK and actively facilitate an initial 10-year commercial cooperation for the Respiratory Syncytial Virus (RSV) vaccine in mainland China.
Hankyu Pharmaceuticals signs "Product Supply Agreement" with DS3 RX LLC:On December 5, Hanyu Pharmaceutical announced that the company had signed a "Product Supply Agreement" with DS3. DS3 intends to purchase GLP-1 active pharmaceutical ingredients from the company at a price of approximately 14 million US dollars (equivalent to approximately 102 million RMB). The supply period is from December 2024 to June 2025. Due to the comprehensive factors affecting the current market environment, the remaining part of the "Product Supply Agreement" signed between DS3 and Hanyu Wuhan will no longer be performed. To date, the agreement has been fulfilled for approximately 14.1232 million US dollars.
Glastone's New Drug for Chronic Hepatitis B to Be Included in Breakthrough Therapy:On December 6, the CDE website announced that the GST-HG141 tablet developed by Guangshengtang Pharmaceutical is proposed to be included in the breakthrough therapy category for the treatment of chronic hepatitis B. According to public information, GST-HG141 is a hepatitis B core protein inhibitor or capsid assembly modulator developed by Fujian Guangshengtang for the treatment of chronic hepatitis B, and it belongs to the Type II hepatitis B core protein inhibitors. Unlike the mechanisms of existing nucleos(t)ide drugs and interferons, GST-HG141 has a completely new mechanism of action, which can inhibit the uncoating and assembly of HBV (hepatitis B virus) capsids.
Ruiang Gene's Actual Controller Arrested:On the evening of December 5, Ruian Gene issued an announcement stating that previously, Xiong Hui, the company's actual controller, chairman and general manager, and core technical personnel, and Xiong Jun, the actual controller, director and deputy general manager, were taken into criminal custody by the public security authorities on suspicion of fraud. Recently, the company received notification from the family members of the above individuals that Xiong Hui and Xiong Jun have been arrested on suspicion of fraud and transferred to the procuratorial authorities, and related matters are still under further investigation.Merus's HER2/HER3 Bispecific Antibody Bizengri Receives FDA Approval for Marketing:On December 4, Merus announced that the FDA had granted accelerated approval for the HER2/HER3 bispecific antibody Bizengri for the treatment of adult patients with advanced unresectable or metastatic pancreatic ductal adenocarcinoma or non-small cell lung cancer harboring NRG1 gene fusions, whose disease has progressed after prior systemic therapy. This is the first targeted therapy approved by the U.S. FDA for this patient population.DualityBio's DB-1324 Going Overseas:On December 4, Yingen Bio announced that it had reached an exclusive licensing agreement with GSK for the ADC drug DB-1324. According to the agreement, GSK will obtain the global (excluding mainland China, Hong Kong, and Macao) exclusive rights to DB-1324 to advance the drug's research, development, and commercialization process.Rgenta Collaborates with GSK to Develop Small Molecule Therapies Targeting RNA:On December 4, Rgenta Therapeutics announced a multi-year, multi-target strategic research alliance with GSK. Under the terms of the agreement, Rgenta will receive up to $46 million in upfront cash payments and pre-option exercise milestone payments. Additionally, the company could potentially earn nearly $500 million through option exercise fees, research, development, regulatory and commercial milestones, tiered royalties, and potential equity investments. GSK also has the right to expand the scope of the alliance to include additional targets. Under the framework of the alliance, Rgenta will leverage its proprietary discovery platform to develop novel oral small molecule splicing modulators targeting RNA for GSK-designated targets, and GSK will be responsible for the further development and commercialization of any candidate drugs arising from the alliance.Heartpulse Medical Pays Tens of Millions in Back Taxes:On December 2, Heartpulse Medical announced that the company recently received a "Tax Matters Notice" from the Second Tax Office of the Pudong New Area Tax Bureau. Due to the company's failure to file the enterprise annual development report for two consecutive years, its status as a high-tech enterprise has been revoked. The tax authorities will recover the tax benefits the company has enjoyed since the year it no longer met the qualification requirements, and require the payment of overdue fines. According to the company’s preliminary estimates, the total amount of back taxes and late fees is approximately RMB 60 million to 70 million, which is expected to impact net profit by more than 10% of the audited net profit in the company’s most recent fiscal year.PTC Therapeutics Signs Cooperation Agreement with Novartis:On December 2, PTC Therapeutics announced an exclusive global licensing and collaboration agreement with Novartis regarding the Huntington's disease program PTC518 and its related molecules. Under the agreement, PTC will receive an upfront payment of $1 billion, along with potential development, regulatory, and sales milestone payments of up to $1.9 billion.Lingrui Pharmaceutical Plans to Acquire 100% Equity of Yingu Pharmaceutical:On December 4, Lingrui Pharmaceutical announced that the company plans to use its own funds to acquire 100% of the equity of Yingu Pharmaceutical Co., Ltd. According to a preliminary assessment, the comprehensive valuation of Yingu Pharmaceutical is temporarily set at no more than RMB 782 million.
Yinuo Pharmaceuticals Submits IPO Application to HKEX:On December 3, according to the Hong Kong Stock Exchange website, Yino Pharmaceuticals filed an IPO application. Yino Pharmaceuticals, established in 2014, is committed to developing innovative therapies for diabetes and other metabolic diseases. The company's long-acting GLP-1 receptor agonist, Yisupaglupeptide α, is expected to soon enter the commercialization phase.
Bokang Vision Cloud Submits Third Filing to HKEX:On December 2, according to the Hong Kong Stock Exchange website, Prosperity Biotech Cloud submitted an IPO application. This marks the third time Prosperity Biotech Cloud has filed with the Hong Kong Stock Exchange in half a year.
Xiwēi Microbiology Completes Nearly 100 Million Yuan in Series A Financing:Xiwēi Biology has completed nearly 100 million yuan in Series A financing, led by Daotong Investment. This round of financing will be used to accelerate the research and development, clinical trials, international development, registration, and marketing expansion of innovative ophthalmology and regenerative medicine products such as artificial biomimetic corneas, implantable contact lenses, artificial corneal endothelial patches, and artificial dermis.
Atlas Completes $450 Million New Fundraising:On December 5, Atlas Venture announced that it had raised $450 million for its 14th fund, which will continue to foster and develop new biotechnology companies. This fund will be used for seed rounds and Series A rounds of biotech companies, most of which will be involved in creation.
Cadwell Completes Nearly 200 Million Yuan in Series B Financing:Recently,CadwellAnnounced the completion of a nearly 200 million yuan Series B financing round, led by Fir Capital with an investment of 50 million yuan, and followed by Wuhan GaoKe, Hongtai Industrial Finance, Hubei Science Investment, Jiuzhou Tong Chuchang Investment, and other institutions. The funds from this round will be used for clinical development and market expansion of its various products in the field of gynecological oncology diagnosis and treatment.
First Trial | Huang Jia
Second Trial | Li Fangchen
Third Review | Li Jingzhi
