YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 344 drug applications between 6 July 2023 and 12 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 53 drug names.
2023/07/06 – 2023/07/12
- New acceptances this week
- 344
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 0
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
344filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 181 |
| Generic | 73 |
| New drug | 56 |
| Import | 17 |
| Import re-registration | 9 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 269 |
| Therapeutic biologic | 35 |
| TCM | 32 |
| Prophylactic biologic | 8 |
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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Oral Solution | 3 | 2 | 11 |
| 2 | Gadoteric Acid Meglumine Salt Injection | 3 | 1 | 1 |
| 3 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 4 | Dienogest Tablets | 2 | 2 | 2 |
| 5 | Oseltamivir Phosphate For Oral Suspension | 2 | 2 | 2 |
| 6 | Methocarbamol Injection | 2 | 2 | 3 |
| 7 | Tadalafil Tablets | 2 | 1 | 23 |
| 8 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 9 | 复方奥美拉唑干混悬剂 · No verified English name | 2 | 1 | 0 |
| 10 | 头孢羟氨苄片 · No verified English name | 2 | 1 | 0 |
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
200 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan Shuang He Hua Li Pharma Co., Ltd. romanized | 17 | 4 | 0 |
| 2 | Hainan Brilliant Pharmaceutical Co., Ltd. | 15 | 3 | 0 |
| 3 | AstraZeneca AB | 7 | 4 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Upjohn Manufacturing Ireland Unlimited Company | 6 | 1 | 0 |
| 6 | An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized | 4 | 3 | 4 |
| 8 | Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 2 |
| 9 | United States Pharmacopeial Convention | 3 | 3 | 0 |
| 10 | Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized | 3 | 3 | 0 |
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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/12Import · Class 2.4 | 盐酸替纳帕诺片 · No verified English nameJXHS2300064 | Ardelyx Inc.; Patheon Pharmaceuticals Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited |
| 2023/07/12Import · Class 2.4 | 盐酸替纳帕诺片 · No verified English nameJXHS2300063 | Ardelyx Inc.; Patheon Pharmaceuticals Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited |
| 2023/07/12Import · Class 2.4 | 盐酸替纳帕诺片 · No verified English nameJXHS2300062 | Ardelyx Inc.; Patheon Pharmaceuticals Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited |
| 2023/07/12Generic · Class 3 | Bumetanide InjectionCYHS2301876 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/07/12Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2301873 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2023/07/12Generic · Class 3 | 泊马度胺胶囊 · No verified English nameCYHS2301871 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2023/07/12Generic · Class 3 | 泊马度胺胶囊 · No verified English nameCYHS2301870 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2023/07/12Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2301869 | Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized |
| 2023/07/12Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2301868 | Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized |
| 2023/07/12Generic · Class 3 | 艾拉戈利钠片 · No verified English nameCYHL2300084 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized |
| 2023/07/12Generic · Class 3 | 艾拉戈利钠片 · No verified English nameCYHL2300083 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized |
| 2023/07/12New drug · Class 1 | B1344 注射液 · No verified English nameCXSL2300469 | Tian Shi Li Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/12New drug · Class 1 | 注射用SHR-1826 · No verified English nameCXSL2300466 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/12New drug · Class 1.1 | 四价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2300465 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized |
| 2023/07/12New drug · Class 1.1 | 四价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2300464 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized |
| 2023/07/12New drug · Class 1 | ZG005粉针剂 · No verified English nameCXSL2300463 | Name not romanized |
| 2023/07/12New drug · Class 1 | G201-Na胶囊 · No verified English nameCXHL2300771 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2023/07/12New drug · Class 1 | G201-Na胶囊 · No verified English nameCXHL2300770 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2023/07/12New drug · Class 1 | ZG-001胶囊 · No verified English nameCXHL2300769 | Shanghai Zhi Gen Pharmaceuticals Technology Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD; Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized |
| 2023/07/12New drug · Class 1 | ZG-001胶囊 · No verified English nameCXHL2300768 | Shanghai Zhi Gen Pharmaceuticals Technology Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD; Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized |
| 2023/07/12New drug · Class 1 | 锝[99mTc]异腈氨基葡萄糖注射液 · No verified English nameCXHL2300767 | Beijing Shi Hong Pharma Co., Ltd. romanized |
| 2023/07/12New drug · Class 1 | WXFL10203614片 · No verified English nameCXHL2300766 | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized |
| 2023/07/12New drug · Class 1 | WXFL10203614片 · No verified English nameCXHL2300765 | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized |
| 2023/07/12New drug · Class 1 | 注射用YZD-27 · No verified English nameCXHL2300764 | Xian Qin Shen Jia He Drug Research Co., Ltd. romanized |
| 2023/07/11Import · Class 3.1 | 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300056 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2023/07/11Import · Class 3.1 | 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300055 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2023/07/11Import · Class 2.2 | Tezepelumab注射液 · No verified English nameJXSL2300127 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/07/11Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2301865 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/07/11Generic · Class 3 | Potassium Phosphates InjectionCYHS2301864 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/07/11Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2301863 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Lang Ou Pharma Co., Ltd. romanized |
72 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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