YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 59 drug applications between 28 September 2023 and 4 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 11, covering 11 drug names.
2023/09/28 – 2023/10/04
- New acceptances this week
- 59
- Drugs with new generic filings (by drug name, de-duplicated)
- 11
- 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
59filings, 11 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 35 |
| Generic | 11 |
| New drug | 7 |
| Import | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 34 |
| TCM | 17 |
| Therapeutic 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
11 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Effervescent Tablets | 1 | 1 | 3 |
| 2 | Linagliptin Tablets | 1 | 1 | 2 |
| 3 | Carboplatin Injection | 1 | 1 | 10 |
| 4 | Formoterol Fumarate Inhalation Solution | 1 | 1 | 5 |
| 5 | 布南色林片 · No verified English name | 1 | 1 | 0 |
| 6 | Sacubitril Valsartan Sodium Tablets | 1 | 1 | 70 |
| 7 | Roxatidine Acetate Hydrochloride For Injection | 1 | 1 | 5 |
| 8 | Venlafaxine Hydrochloride Sustained-Release Capsules | 1 | 1 | 0 |
| 9 | Magnesium Sulfate Injection | 1 | 1 | 7 |
| 10 | Sodium Bicarbonate Ringer’s Injection | 1 | 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
42 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Amgen Inc. | 4 | 2 | 0 |
| 2 | Li Shi Zhen Pharmaceuticals Group Co., Ltd. romanized | 3 | 2 | 0 |
| 3 | Jiangxi Jiu Hua Pharma Co., Ltd. romanized | 3 | 2 | 0 |
| 4 | Fresenius Kabi AB | 3 | 1 | 0 |
| 5 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized | 3 | 1 | 0 |
| 6 | Novartis Pharma AG | 2 | 2 | 0 |
| 7 | Chengdu Di Kang Pharma Co., Ltd. romanized | 2 | 2 | 0 |
| 8 | Xizang Peng Lai Hui Bao Pharmaceuticals Co., Ltd. romanized | 2 | 2 | 0 |
| 9 | Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 2 | 1 | 0 |
| 10 | Zhejiang Cheng Yi Pharma Co., Ltd. romanized | 2 | 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
13 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/29Import · Class 2.4 | 马立巴韦片 · No verified English nameJXHL2300245 | Takeda Pharmaceuticals U.S.A. Inc.; Takeda(China) International |
| 2023/09/29New drug · Class 1 | NB002注射液 · No verified English nameCXSL2300663 | Suzhou Luo Cheng Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/29New drug · Class 2.2 | 巯嘌呤微片 · No verified English nameCXHS2300091 | Hua Run Shuang He Pharma Co., Ltd. romanized |
| 2023/09/28Import · Class 1 | XXB750注射液 · No verified English nameJXSL2300170 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/09/28Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2302623 | Guangdong Zhong Sheng Pharma Co., Ltd. romanized |
| 2023/09/28Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2302622 | Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanized |
| 2023/09/28Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2302620 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2023/09/28Generic · Class 3 | Magnesium Sulfate InjectionCYHS2302618 | Hainan Quan Ying Pharma Co., Ltd. romanized; Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized |
| 2023/09/28New drug · Class 2.3 | 尪痹胶囊 · No verified English nameCXZL2300065 | Liaoning Hua Run Ben Xi San Yao Co., Ltd. romanized |
| 2023/09/28New drug · Class 1 | CAB-AXL-ADC注射剂 · No verified English nameCXSL2300662 | Kai Bo Si (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/28New drug · Class 1 | 注射用THDBH120 · No verified English nameCXHL2301040 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/28New drug · Class 1 | 注射用THDBH120 · No verified English nameCXHL2301039 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/28New drug · Class 1 | 注射用THDBH120 · No verified English nameCXHL2301038 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
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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