YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 194 drug applications between 20 June 2023 and 26 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 33 drug names.
2023/06/20 – 2023/06/26
- New acceptances this week
- 194
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
194filings, 39 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 76 |
| New drug | 46 |
| Generic | 39 |
| Import | 16 |
| Import re-registration | 11 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 141 |
| TCM | 26 |
| Therapeutic biologic | 26 |
| 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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 2 | Levofloxacin Eye Drops | 2 | 1 | 16 |
| 3 | Carfilzomib For Injection | 2 | 1 | 0 |
| 4 | Nalbuphine Hydrochloride Injection | 2 | 1 | 11 |
| 5 | Rocuronium Bromide Injection | 2 | 1 | 1 |
| 6 | Trimebutine Maleate Tablets | 2 | 1 | 4 |
| 7 | Acetylcysteine Injection | 1 | 1 | 53 |
| 8 | Lactulose Oral Solution | 1 | 1 | 34 |
| 9 | Potassium Phosphates Injection | 1 | 1 | 2 |
| 10 | Formoterol Fumarate Inhalation Solution | 1 | 1 | 5 |
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
127 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hangzhou An Dao Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 2 | Dr. Reddy's Laboratories Ltd. | 5 | 2 | 0 |
| 3 | Hainan Brilliant Pharmaceutical Co., Ltd. | 5 | 2 | 1 |
| 4 | Hetero Labs Limited | 4 | 2 | 0 |
| 5 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | AbbVie Inc. | 3 | 1 | 0 |
| 8 | AbbVie Limited | 3 | 1 | 0 |
| 9 | Organon Pharma (UK) Limited | 3 | 1 | 0 |
| 10 | Guangxi Jin Kang Pharma Co., Ltd. romanized | 3 | 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
72 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/26Import · Class 1 | RO7565020注射液 · No verified English nameJXSL2300114 | F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd. |
| 2023/06/26Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2301684 | Nanjing Hai Ke Rui Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2023/06/26Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2301683 | Nanjing Hai Ke Rui Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2023/06/26Generic · Class 3 | Vancomycin Hydrochloride CapsulesCYHS2301681 | Shi Sen Hai (Hangzhou) Pharmaceuticals Technology Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized |
| 2023/06/26New drug · Class 1.1 | 小儿佛芍和中颗粒 · No verified English nameCXZL2300044 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2023/06/26New drug · Class 1 | CM310重组人源化单克隆抗体注射液 · No verified English nameCXSL2300430 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2023/06/26New drug · Class 1 | CM310重组人源化单克隆抗体注射液 · No verified English nameCXSL2300429 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2023/06/26New drug · Class 1 | MK-1084片 · No verified English nameCXHL2300693 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2023/06/26New drug · Class 1 | MK-1084片 · No verified English nameCXHL2300692 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2023/06/26New drug · Class 2.2; 2.4 | 醋酸阿比特龙片(Ⅰ) · No verified English nameCXHL2300691 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/06/26New drug · Class 1 | AC-201片 · No verified English nameCXHL2300690 | Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/06/26New drug · Class 1 | AC-201片 · No verified English nameCXHL2300689 | Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/06/26New drug · Class 1 | LIT-00814片 · No verified English nameCXHL2300688 | Shanghai Hui Qi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/26New drug · Class 1 | LIT-00814片 · No verified English nameCXHL2300687 | Shanghai Hui Qi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/22Import · Class 1 | MK-0616 片 · No verified English nameJXHL2300146 | Merck Sharp & Dohme LLC; Name not romanized |
| 2023/06/22Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2301678 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2023/06/22New drug · Class 1 | 注射用D3L-001 · No verified English nameCXSL2300428 | Name not romanized |
| 2023/06/22New drug · Class 1 | 重组抗CD20人源化单克隆抗体皮下注射液 · No verified English nameCXSL2300427 | Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/22New drug · Class 1 | 注射用NCB003 · No verified English nameCXSL2300426 | Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized |
| 2023/06/22New drug · Class 1 | VV119胶囊 · No verified English nameCXHL2300686 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized |
| 2023/06/22New drug · Class 1 | VV119胶囊 · No verified English nameCXHL2300685 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized |
| 2023/06/22New drug · Class 1 | VV119胶囊 · No verified English nameCXHL2300684 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized |
| 2023/06/22New drug · Class 1 | JYP0061片 · No verified English nameCXHL2300683 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/22New drug · Class 1 | JYP0061片 · No verified English nameCXHL2300682 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/22New drug · Class 1 | JYP0061片 · No verified English nameCXHL2300681 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/22New drug · Class 1 | JYP0061片 · No verified English nameCXHL2300680 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/21Import · Class 1 | LEO 138559 注射液 · No verified English nameJXSL2300113 | LEO Pharma A/S; LEO Pharma Consultancy (Shanghai) Company Limited |
| 2023/06/21Import · Class 1 | Sisunatovir 胶囊 · No verified English nameJXHL2300145 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2023/06/21Generic · Class 3 | Pentoxifylline InjectionCYHS2301677 | Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized; Hebei Yi Pin Pharmaceutical Co., Ltd. romanized |
| 2023/06/21Generic · Class 3 | Potassium Phosphates InjectionCYHS2301676 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
42 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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