YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 301 drug applications between 24 December 2022 and 30 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 51 drug names.
2022/12/24 – 2022/12/30
- New acceptances this week
- 301
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- 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
301filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 146 |
| Generic | 76 |
| New drug | 56 |
| Import | 15 |
| Unspecified | 5 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 229 |
| TCM | 39 |
| Therapeutic biologic | 28 |
| Biologic | 3 |
| In vitro diagnostic reagent | 1 |
| 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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Paliperidone Palmitate Injection | 5 | 1 | 8 |
| 2 | Clindamycin Injection | 3 | 1 | 4 |
| 3 | Remifentanil Hydrochloride for Injection | 3 | 1 | 2 |
| 4 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 12 |
| 5 | Gadobutrol Injection | 3 | 1 | 8 |
| 6 | Gadoteric Acid Meglumine Salt Injection | 3 | 1 | 1 |
| 7 | Esmolol Hydrochloride Injection | 2 | 2 | 3 |
| 8 | Vildagliptin Tablets | 2 | 2 | 0 |
| 9 | Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II) | 2 | 2 | 3 |
| 10 | Voriconazole Tablets | 2 | 1 | 1 |
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
166 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fresenius Kabi Deutschland GmbH | 24 | 2 | 0 |
| 2 | Xian Tang Chen Pharmaceutical Co., Ltd. romanized | 8 | 5 | 0 |
| 3 | Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 3 | 6 |
| 5 | Jilin Te Yan Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 1 |
| 7 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized | 5 | 1 | 5 |
| 8 | Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | 4 | 2 | 4 |
| 10 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 2 | 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 |
|---|---|---|
| 2022/12/30Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2202164 | Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2022/12/30Generic · Class 3 | Pregabalin Oral SolutionCYHS2202161 | Jian Min Pharma Group Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2202157 | Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Timolol Maleate Eye DropsCYHS2202154 | Jiangsu Yuan Heng Pharma Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Timolol Maleate Eye DropsCYHS2202153 | Jiangsu Yuan Heng Pharma Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Olopatadine Hydrochloride GranulesCYHS2202150 | Nanjing Ming Sheng Pharmaceuticals Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2022/12/30Generic · Class 3 | Sulfamethoxazole and Trimethoprim InjectionCYHS2202148 | Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Remifentanil Hydrochloride for InjectionCYHS2202147 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Remifentanil Hydrochloride for InjectionCYHS2202146 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Remifentanil Hydrochloride for InjectionCYHS2202145 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Clindamycin InjectionCYHS2202144 | Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Clindamycin InjectionCYHS2202143 | Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Clindamycin InjectionCYHS2202142 | Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Hydrotalcite SuspensionCYHS2202141 | Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized |
| 2022/12/30New drug · Class 1.1 | 芩翘咽舒颗粒 · No verified English nameCXZL2200056 | Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized; Nanjing Hai Ling Zhong Yao Pharmaceutical Gong Yi Technology Research Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | 西达基奥仑赛注射液 · No verified English nameCXSS2200094 | Nanjing Chuan Qi Bio Technology Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | BA1105注射液 · No verified English nameCXSL2200631 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | STSA-1002注射液 · No verified English nameCXSL2200630 | Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | JS010注射液 · No verified English nameCXSL2200629 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | HH-003注射液 · No verified English nameCXSL2200628 | Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | 注射用LM-302 · No verified English nameCXSL2200627 | Li Xin Pharmaceuticals (Zhejiang) Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | KP104注射液 · No verified English nameCXSL2200626 | Ke Yue Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | BRY805注射液 · No verified English nameCXSL2200625 | Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | CS0159片 · No verified English nameCXHL2200981 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | CS0159片 · No verified English nameCXHL2200980 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/30New drug · Class 2.2 | Meloxicam injectionCXHL2200979 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | LS21031胶囊 · No verified English nameCXHL2200978 | Suzhou Lan Cheng Pharmaceuticals Co., Ltd. romanized |
| 2022/12/30New drug · Class 1 | LS21031胶囊 · No verified English nameCXHL2200977 | Suzhou Lan Cheng Pharmaceuticals Co., Ltd. romanized |
| 2022/12/30New drug · Class 2.2 | 复方盐酸替利定缓释片 · No verified English nameCXHL2200976 | Hebei Ao Xing Group Pharma Co., Ltd. romanized |
| 2022/12/30New drug · Class 2.2 | 卡托普利口服溶液 · No verified English nameCXHL2200975 | Chengdu Bei Te De Nuo 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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