YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 399 drug applications between 10 January 2025 and 16 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 138, covering 101 drug names.
2025/01/10 – 2025/01/16
- New acceptances this week
- 399
- Drugs with new generic filings (by drug name, de-duplicated)
- 101
- Accepted this week, now under review
- 6
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
399filings, 138 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 184 |
| Generic | 138 |
| New drug | 56 |
| Import | 12 |
| Unspecified | 4 |
| Import re-registration | 4 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 292 |
| TCM | 59 |
| Therapeutic biologic | 43 |
| Biologic | 4 |
| Prophylactic biologic | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
101 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 3 | Diclofenac Diethylamine Emulgel | 2 | 2 | 20 |
| 4 | Pentoxifylline Modified Release Tablets | 2 | 2 | 6 |
| 5 | Bumetanide Injection | 2 | 2 | 13 |
| 6 | Sildenafil Citrate Oral Disintegrating Tablets | 2 | 2 | 8 |
| 7 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 8 | Indocyaninegreen for Injection | 2 | 2 | 7 |
| 9 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 10 | Benzbromarone Tablets | 2 | 2 | 4 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
239 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 10 | 7 | 0 |
| 3 | Anhui Shuang He Pharma Co., Ltd. romanized | 8 | 2 | 0 |
| 4 | Shandong Qidu Pharmaceutical Co., Ltd. | 7 | 7 | 5 |
| 5 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 7 | 6 | 0 |
| 6 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 7 | 5 | 7 |
| 7 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 3 | 0 |
| 8 | Lang Li Biopharmaceuticals (Wuhan) Co., Ltd. romanized | 6 | 6 | 0 |
| 9 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 4 | 0 |
| 10 | Hainan Brilliant Pharmaceutical Co., Ltd. | 5 | 3 | 5 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/16Import · Class 1 | Tozorakimab注射液 · No verified English nameJXSL2500009 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/16Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2500327 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2025/01/16Generic · Class 3 | Benzbromarone TabletsCYHS2500326 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2025/01/16Generic · Class 3 | Benzbromarone TabletsCYHS2500325 | Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/01/16Generic · Class 3 | Zoledronic Acid InjectionCYHS2500323 | Sichuan Tai Ping Yang Pharma Co., Ltd. romanized |
| 2025/01/16Generic · Class 3 | Fluorouracil InjectionCYHS2500317 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/01/16Generic · Class 3 | Fluorouracil InjectionCYHS2500316 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/01/16Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2500313 | Hefei Kang Hui Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Hai Hong Industrial (Group) Chao Hu Jin Chen Pharma Co., Ltd. romanized |
| 2025/01/16New drug · Class 1 | EA5注射液 · No verified English nameCXSL2500051 | Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/16New drug · Class 1 | 注射用DB-2304 · No verified English nameCXSL2500050 | Ying En Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/01/16New drug · Class 1 | 注射用LY4052031 · No verified English nameCXSL2500049 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized |
| 2025/01/16New drug · Class 1 | HSK41959片 · No verified English nameCXHL2500077 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/16New drug · Class 1 | HSK41959片 · No verified English nameCXHL2500076 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/16New drug · Class 2.4 | 谷美替尼片 · No verified English nameCXHL2500075 | Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized; Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/01/16New drug · Class 2.4 | 吡非尼酮胶囊 · No verified English nameCXHL2500074 | Beijing Kang Di Ni Pharma Co., Ltd. romanized |
| 2025/01/15Import · Class 1 | 宗格替尼片 · No verified English nameJXHS2500002 | Boehringer Ingelheim International GmbH; Hovione Farmaciencia S.A.; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2025/01/15Import · Class 1 | Eneboparatide 注射液 · No verified English nameJXHL2500010 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/15Import · Class 1 | Eneboparatide 注射液 · No verified English nameJXHL2500009 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/15Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2500310 | Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; Guangdong An Nuo Pharma Co., Ltd. romanized |
| 2025/01/15Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2500307 | Jiangsu Shen Hua Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2025/01/15Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2500305 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/01/15Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2500304 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/01/15Generic · Class 3 | 盐酸非索非那定干混悬剂 · No verified English nameCYHS2500300 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized |
| 2025/01/15Generic · Class 3 | 盐酸非索非那定干混悬剂 · No verified English nameCYHS2500298 | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized |
| 2025/01/15Generic · Class 3 | Oxycodone And Acetaminophen TabletsCYHS2500297 | Hebei Li Sheng Pharma Group Co., Ltd. romanized |
| 2025/01/15Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2500296 | Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/01/15Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2500295 | Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/01/15Generic · Class 3 | 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2500292 | Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized |
| 2025/01/15Generic · Class 3 | Relugolix TabletsCYHL2500017 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/15New drug · Class 1.1 | 三芪颗粒 · No verified English nameCXZL2500003 | Guangxi Zhong Heng Innovation Pharmaceuticals Research Co., Ltd. romanized |
84 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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