YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 394 drug applications between 6 January 2024 and 12 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 138, covering 106 drug names.
2024/01/06 – 2024/01/12
- New acceptances this week
- 394
- Drugs with new generic filings (by drug name, de-duplicated)
- 106
- Accepted this week, now under review
- 1
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
394filings, 138 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 140 |
| Generic | 138 |
| New drug | 77 |
| Import | 26 |
| Import re-registration | 10 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 304 |
| Therapeutic biologic | 49 |
| TCM | 33 |
| Prophylactic biologic | 6 |
| Biologic | 2 |
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
106 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用头孢唑肟钠 · No verified English name | 4 | 2 | 4 |
| 2 | Acetylcysteine Injection | 3 | 3 | 53 |
| 3 | Levofloxacin Injection | 3 | 2 | 1 |
| 4 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 3 | 2 | 12 |
| 5 | Levofloxacin and Sodium Chloride Injection | 3 | 1 | 14 |
| 6 | Diprophylline Injection | 2 | 2 | 7 |
| 7 | 吸入用丙酸倍氯米松混悬液 · No verified English name | 2 | 2 | 3 |
| 8 | Levodopa and Benserazide Hydrochloride Tablets | 2 | 2 | 2 |
| 9 | Potassium Chloride Oral Solution | 2 | 2 | 11 |
| 10 | Dobutamine Hydrochloride Injection | 2 | 2 | 3 |
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
242 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 8 | 5 | 0 |
| 2 | Novartis Pharma AG | 8 | 3 | 0 |
| 3 | Sanofi-Aventis Recherche & Developpement | 6 | 1 | 0 |
| 4 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 5 | 5 |
| 6 | Sanofi-Aventis Recherche & Développement | 5 | 3 | 0 |
| 7 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 4 | 3 | 3 |
| 9 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Boehringer Ingelheim International GmbH | 4 | 1 | 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
156 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/01/12Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400018 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400017 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400016 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400015 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400014 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400013 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Generic · Class 3 | Potassium Chloride GranulesCYHS2400193 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/01/12Generic · Class 3 | Potassium Chloride GranulesCYHS2400192 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/01/12Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2400188 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
| 2024/01/12Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2400187 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2024/01/12Generic · Class 3 | Epinephrine InjectionCYHS2400186 | Wuhan Jiu An Pharma Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2024/01/12Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2400185 | Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized |
| 2024/01/12Generic · Class 3 | Haloperidol TabletsCYHS2400177 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2024/01/12Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2400176 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized |
| 2024/01/12Generic · Class 3 | Diprophylline InjectionCYHS2400174 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized |
| 2024/01/12New drug · Class 3.1 | 二冬颗粒 · No verified English nameCXZS2400003 | Jiangxi Yao Dou Zhang Shu Pharmaceutical Co., Ltd. romanized |
| 2024/01/12New drug · Class 1 | 注射用RGL-2102 · No verified English nameCXSL2400028 | Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized |
| 2024/01/12New drug · Class 1 | 注射用SHR-A1904 · No verified English nameCXSL2400027 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/01/12New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2400026 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/01/12New drug · Class 1 | TST001注射液 · No verified English nameCXSL2400025 | Suzhou Chuang Sheng Pharmaceuticals Group Co., Ltd. romanized |
| 2024/01/12New drug · Class 1 | TGI-5注射液 · No verified English nameCXSL2400024 | Hefei Tian Gang Mian Yi Drug Co., Ltd. romanized |
| 2024/01/12New drug · Class 2.2; 2.4 | MTS004口崩片 · No verified English nameCXHL2400065 | Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/01/12New drug · Class 2.4; 2.2 | PDX-02 · No verified English nameCXHL2400064 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/01/12New drug · Class 2.4; 2.2 | PDX-02 · No verified English nameCXHL2400063 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/01/12New drug · Class 2.4; 2.2 | PDX-02 · No verified English nameCXHL2400062 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/01/12New drug · Class 1 | HMPL-506片 · No verified English nameCXHL2400061 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2024/01/12New drug · Class 1 | HMPL-506片 · No verified English nameCXHL2400060 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2024/01/11Import · Class 2.4 | LNP023胶囊 · No verified English nameJXHL2400012 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/01/11Import · Class 2.4 | 布地奈德富马酸福莫特罗吸入气雾剂 · No verified English nameJXHL2400011 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2024/01/11Import · Class 1 | PF-07220060 · No verified English nameJXHL2400010 | Pfizer Inc.; Pfizer Investment CO. Ltd |
126 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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