1. Jimu Biological License: Tian Tian Pharmaceutical ARVN001 600 million yuan
On November 13th, Tian Shan Pharmaceutical and Ji Mu Biotechnology announced that Ji Mu Biotechnology has authorized Tian Shan Pharmaceutical with exclusive commercial rights for its ARVN001 (Triamcinolone Acetonide Choroidal Injection Suspension) under development in mainland China. ARVN001 uses a suprachoroidal microinjection (SCS microinjection) system ®） The patented technology will be used to treat uveitis related macular edema (UME) and other potential ophthalmic indications under development.

Jimu Biotech will receive a total down payment and milestone payments of up to 85 million US dollars (approximately 600 million RMB). Previously, Jimu Biotechnology obtained the rights to develop and commercialize this therapy in the Asia Pacific region from Clearside Biomedical Inc. In July 2024, Jimu Biotechnology announced that ARVN001 achieved positive top line results in the Phase III clinical trial of UME in China. Meanwhile, research on the use of this therapy for other retinal diseases in the eye is also underway.

2. Shibeikang transferred Fosun Pharma SBK010 oral solution (butylphthalein oral solution) for 13.21 million yuan
On September 27, 2024, Fosun Pharma announced that its subsidiary, Jinzhou Aohong Pharmaceutical Co., Ltd., had received approval from the National Medical Products Administration for the registration of its SBK010 oral solution drug. This new drug is a chemical drug for the treatment of mild to moderate acute ischemic stroke, and is licensed and introduced by Chengdu Shibeikang Biomedical Technology Co., Ltd.

As of August 2024, the cumulative R&D investment of the group for this new drug is approximately 13.21 million yuan (unaudited), including licensing fees. According to the latest data from IQVIA CHPA, the sales revenue of similar drugs in China in 2023 is approximately 7.04 billion yuan. Although the acceptance this time will promote the development of new drugs, the company points out that it still needs to pass GMP compliance checks and obtain drug registration approval, which is not expected to have a significant impact on the current performance.

3. Jisheng Aoma licensed Junshi Biological IAMA-001 nasal spray for 1.5 billion yuan
On September 26th, Junshi Biotechnology announced that its controlling subsidiary Juntuo Biotechnology and Jisheng Aoma have signed the "IAMA-001 Nasal Spray Project License and Cooperation Agreement".

According to the license and cooperation agreement, Jisheng Aoma granted Juntuo Biology the exclusive license right to research and develop, improve, manufacture, produce, use, declare, register, commercialize and use IAMA-001 small nucleic acid immunomodulator nasal spray in Greater China based on the licensed intellectual property rights, and cooperate with Juntuo Biology to develop IAMA-001 nasal spray project outside Greater China.

After the signing of the license and cooperation agreement, Juntuo Biotechnology will make a down payment of RMB 40 million to Jisheng Aoma. Juntuo Biotechnology will pay no more than RMB 240 million for research and development milestones in the Greater China region to Jisheng Aoma based on the progress of licensed product research and development, and no more than USD 150 million for research and development milestones outside the Greater China region to Jisheng Aoma after the first indication of the licensed product is approved by the US and EU drug regulatory authorities. Juntuo Biotechnology will pay Jisheng Aoma a sales milestone of no more than RMB 250 million (totaling RMB 1.5 billion) and a sales commission of single digit percentage of annual net sales of licensed products in Greater China based on the sales performance of licensed products in the region. Both parties agree to enjoy all rights and revenue sharing of the licensed products outside of Greater China in a 50%: 50% equity ratio.

4. Pankangshi Cloud licensed Tiansheng Pharmaceutical CBT-001 for 650 million RMB
On August 8th, Cloudbreak Pharma Inc., an international clinical ophthalmic drug company, announced an important product authorization agreement with Japanese ophthalmic company Tiansheng Pharmaceutical Co., Ltd., granting Tiansheng Pharmaceutical the development, production, and commercialization rights of its multi kinase inhibitor CBT-001 for the treatment of pterygium in Southeast Asia, including Japan, South Korea, Vietnam, Thailand, Malaysia, the Philippines, Singapore, and Indonesia, for a down payment of $91 million (approximately over RMB 650 million) and milestone payments. In addition, Kangshi Cloud will receive a double-digit percentage of the future net sales of the product as a royalty fee for the product.

CBT-001 is an innovative and improved product of the marketed pulmonary fibrosis drug Nidanibu - Nidanibu continues to use lotion, which has inhibitory effects on neovascularization and tissue fibrosis, can inhibit the growth of pterygium and control the deterioration of the disease.

As early as 2020, Grand Pharma (0512. HK), which has been deeply involved in ophthalmology for many years in China, has prospectively laid out this blockbuster product. The company has won the exclusive production and commercialization rights of CBT-001 in Chinese Mainland, Hong Kong, Macao and Taiwan, China with a down payment and milestone payment of 74.5 million yuan in total.

5. Aozong Biotech licensed East China Medicine TTYP01 tablets (Edaravone tablets) for 1.285 billion yuan
July 12, 2024- Hangzhou Zhongmei East China Pharmaceutical Co., Ltd. (hereinafter referred to as "East China Pharmaceutical"), a wholly-owned subsidiary of East China Pharmaceutical Co., Ltd. (000963. SZ), and Suzhou Aozong Biotechnology Co., Ltd. (hereinafter referred to as "Aozong Biotechnology"), a China based, global oriented company focusing on the research and development of innovative drugs in the field of nervous system diseases, announced an exclusive strategic cooperation agreement on the development, registration, production and commercialization of the improved new drug Edaravone oral preparation TTYP01 tablet (Edaravone tablet) (hereinafter referred to as the "Licensed Product") in Chinese Mainland, Hong Kong, Macao and Taiwan (hereinafter referred to as the "Licensed Area") for all indications.

According to the terms of the agreement, Aozong Biotechnology will receive a down payment of RMB 100 million, milestone payments for development, registration, and sales not exceeding RMB 1185 million, and a net sales commission fee of up to two digits in tiers.

6. Baicheng Pharmaceutical transfers Beijing Yuanfang Tongda 2022HY052 (levosalbutamol hydrochloride isoproterenol inhalation solution) for 70 million yuan
On June 27, 2024, Baicheng Pharmaceutical (301096) announced that the company has signed a "Technology Development (Cooperation) Contract" with Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd., transferring 70% of the property rights of the Class 2 improved new drug 2022HY052 to the other party for 70 million yuan, and continuing to be responsible for the research and development, clinical and production of the drug. The impact of contract performance on the operating performance of the listed company for the current year: After the signing and smooth implementation of this contract, it is expected to have a positive impact on the company's operating performance for the current and future years.

On January 10, 2024, Baicheng Pharmaceutical announced that it had recently received a clinical trial approval notice from the National Medical Products Administration (NMPA). The company's independently developed drug 2022HY052 will undergo clinical trial research.

Speculation that 2022HY052 is an inhaled solution of levosalbutamol hydrochloride and ipratropium. Is buying 70 million yuan of improved formulations by a company with a registered capital of 10 million yuan the Newco licensing model for improved formulations?

7. East China Medicine introduces MC2 Wynzora cream worth 52 million US dollars
On August 31, 2023, East China Pharmaceutical (000963. SZ) announced that the company signed an exclusive product license agreement with MC2 Therapeutics Ltd. (hereinafter referred to as "MC2"), a wholly-owned subsidiary of Denmark's MC2 Therapeutics A/S, and obtained the exclusive license of the global innovative product Wynzora in Greater China (including the Chinese Mainland, Hong Kong, Macao and Taiwan, hereinafter referred to as the "license area"), including clinical development, registration and commercialization interests. In this transaction, Zhongmei Huadong will pay MC2 a down payment of up to $16 million and clinical development and registration milestones, a sales milestone of up to $36 million, and a tiered double-digit net sales commission fee.

According to the announcement, Wynzora cream is a fixed dose combination for the local treatment of plaque psoriasis. It is currently the only water-based cream in the world that uses a once daily fixed combination of calcipotriol and betamethasone dipropionate, with high patient compliance and treatment convenience.

In July 2020, Wynzora cream was approved by the FDA for the treatment of plaque psoriasis in individuals aged 18 and above, and was approved in Europe in July 2021.

For psoriasis, the company has currently deployed the biologics ustekinumab injection, oral small molecule drug cyclosporine soft capsules, and topical formulation ZORYVE? The cream, ARQ-154 (Roflukast foam) and Wynzora cream, a compound topical preparation, are expected to bring more drug choices for children and adults with psoriasis.

8. East China Medicine introduces Arcutis Rofistat Cream ZORYVE ® And foam agent ARQ-154 $94.25 million
On August 10, 2023, Huadong Pharmaceutical (000963. SZ) announced that its wholly-owned subsidiary, Zhongmei Huadong, has signed an exclusive product license agreement with Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) ("Arcutis"), a Nasdaq listed company in the United States. China, the United States, and East China have obtained Arcuti's globally innovative topical formulation of roflunomide (including roflunomide cream ZORYVE) ® And ROFLAST foam ARQ-154 (the "Licensed Product") in Greater China (including Chinese Mainland, Hong Kong, Macao and Taiwan, China) and Southeast Asia (Indonesia, Singapore, Philippines, Thailand, Myanmar, Brunei, Cambodia, Laos, Malaysia and Vietnam) (the "Licensed Area"), including development, registration, production and commercialization rights and interests. Zhongmei Huadong will make a down payment of 30 million US dollars to Arcutis, with a maximum of 64.25 million US dollars for development, registration, and sales milestone payments, as well as a tiered double-digit net sales commission fee. Introducing ZORYVE this time ® The cream and ARQ-154 will further supplement the company's product pipeline in the field of autoimmune and inflammatory skin diseases. As of now, the company has more than 10 innovative biopharmaceuticals and small molecule products in the field of self curing diseases.

9. Polar Biology introduces Eyenovia's MicroPine and MicroLine micro matrix drug films for myopia and presbyopia, with a total cost of 45.75 million US dollars
On August 11, 2020, Arctic Vision announced a partnership with Eyenovia, a US based company, and obtained exclusive licenses for two major ophthalmic innovative therapies from Eyenovia in Greater China and South Korea. The two products are MicroPine (atropine) for treating progressive myopia and MicroLine (pilocarpine) for treating presbyopia (also known as presbyopia).

Eyenovia's Optejet patented technology can uniformly cover the surface of the eyeball with a very precise drug film within 100ms. We call this technology 'micro matrix drug film' Eddy said. The key to achieving low-dose uniform coverage with MicroPine lies in the patented technology of "micro matrix drug film". The single dose of micro matrix drug film is reduced by 75% compared to conventional eye drops, which greatly reduces the risk of overdose and adverse reactions caused by drug or preservative contact. The solution can penetrate the ocular surface within about 80ms without being affected by the blink reflex. Research has found that the success rate of micro matrix drug film administration has been confirmed to be over 85%, while the success rate of traditional eye drops is only 40% -50%.

According to the terms of the agreement, Eyenovia is expected to receive a total of up to $45.75 million, including a down payment and additional payments based on various clinical development milestones, including the registration initiation and approval of Jimu Biotech in both China and South Korea, as well as related research and development expenses.

10. Shanghai Yizhong successfully went public with a fundraising of 1.05 billion yuan for an unlisted Class 2 good new drug, paclitaxel polymer micelles for injection
Listed on the A-share market on September 9, 2021, with a market value of 5.2 billion yuan.

11. Shenzhen Shankang plans to raise 1.327 billion yuan to go public with a market value of 5.284 billion yuan for an unlisted Class 2 good drug, naltrexone implant.
Shankang Pharmaceutical submitted its prospectus in December 2022 and is preparing to list on the Science and Technology Innovation Board. On September 24, 2024, the IPO review status of Shenzhen Shankang Pharmaceutical Technology Co., Ltd. (referred to as Shankang Pharmaceutical) was changed to terminated.

Source: https://pharm.jgvogel.cn/c1465667.shtml