YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 412 drug applications between 30 January 2024 and 5 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 127, covering 93 drug names.
2024/01/30 – 2024/02/05
- New acceptances this week
- 412
- Drugs with new generic filings (by drug name, de-duplicated)
- 93
- Accepted this week, now under review
- 8
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
412filings, 127 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 185 |
| Generic | 127 |
| New drug | 58 |
| Import | 23 |
| Unspecified | 10 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 278 |
| Therapeutic biologic | 68 |
| TCM | 52 |
| Prophylactic biologic | 9 |
| Biologic | 5 |
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
93 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Minoxidil Liniment | 5 | 1 | 52 |
| 2 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 3 | Lidocaine and Prilocaine Cream | 3 | 3 | 24 |
| 4 | LevomilnacipranHydrochloride Extended-release Capsules | 3 | 1 | 6 |
| 5 | Diprophylline Injection | 2 | 2 | 7 |
| 6 | Tadalafil Tablets | 2 | 2 | 23 |
| 7 | Gatifloxacin Eye Drops | 2 | 2 | 3 |
| 8 | Dronedarone Hydrochloride Tablets | 2 | 2 | 4 |
| 9 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 10 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 2 | 2 | 8 |
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
264 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Inc. | 7 | 3 | 0 |
| 2 | Sichuan Yi Ke Cao Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Sichuan Kelun Pharmaceutical Co., Ltd. | 6 | 4 | 4 |
| 4 | Jiangsu En Hua Pharma Co., Ltd. romanized | 6 | 3 | 4 |
| 5 | Pfizer Europe MA EEIG | 5 | 3 | 0 |
| 6 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 5 | 3 | 5 |
| 7 | Le Fu Si Health Industry Shareholding Company romanized | 5 | 1 | 5 |
| 8 | Shenzhen Han Yu Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Novo Nordisk A/S | 4 | 4 | 0 |
| 10 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/02/05Import · Class 1 | Livmoniplimab 注射液 · No verified English nameJXSL2400035 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/02/05Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSL2400034 | Daiichi Sankyo Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2024/02/05Generic · Class 3 | Pentoxifylline InjectionCYHS2400498 | CISEN PHARMACEUTICAL CO., LTD. |
| 2024/02/05Generic · Class 3 | Potassium Phosphates InjectionCYHS2400497 | Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/02/05Generic · Class 3 | Potassium Phosphates InjectionCYHS2400496 | Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/02/05Generic · Class 3 | Allopurinol TabletsCYHS2400495 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/02/05Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2400494 | Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2024/02/05Generic · Class 3 | Acetylcysteine InjectionCYHS2400493 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2024/02/05Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2400490 | Jiangsu Ming Sheng Kang Yuan Pharma Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2024/02/05Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2400489 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.; CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2024/02/05Generic · Class 3 | Ibuprofen InjectionCYHS2400488 | Shaanxi Tian Yu Pharmaceutical Co., Ltd. romanized |
| 2024/02/05Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2400486 | Hubei Kai Na Pharma Co., Ltd. romanized; Hubei Mei Si Chuang Pharma Co., Ltd. romanized |
| 2024/02/05Generic · Class 3 | Ibuprofen InjectionCYHS2400485 | Shaanxi Tian Yu Pharmaceutical Co., Ltd. romanized |
| 2024/02/05Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2400484 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/02/05Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2400483 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/02/05Generic · Class 3 | Gatifloxacin Eye DropsCYHS2400482 | Hefei Li Min Pharmaceutical Co., Ltd. romanized |
| 2024/02/05Generic · Class 3 | Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2400478 | Name not romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanized |
| 2024/02/05Generic · Class 3 | Diprophylline InjectionCYHS2400476 | Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2024/02/05Generic · Class 3 | Diprophylline InjectionCYHS2400475 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2024/02/05Generic · Class 3 | Revefenacin inhalation solutionCYHL2400035 | Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized |
| 2024/02/05New drug · Class 2.2 | 注射用重组人组织型纤溶酶原激酶衍生物 · No verified English nameCXSS2400016 | Hua Run Ang De Bio Pharma Co., Ltd. romanized |
| 2024/02/05New drug · Class 1.4 | 26价肺炎球菌结合疫苗 · No verified English nameCXSL2400099 | Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized |
| 2024/02/05New drug · Class 1 | KAL-002 · No verified English nameCXSL2400098 | Sichuan Yan Yang Bio Technology Co., Ltd. romanized |
| 2024/02/05New drug · Class 1 | KAL-002 · No verified English nameCXSL2400097 | Sichuan Yan Yang Bio Technology Co., Ltd. romanized |
| 2024/02/05New drug · Class 1 | KAL-002 · No verified English nameCXSL2400096 | Sichuan Yan Yang Bio Technology Co., Ltd. romanized |
| 2024/02/05New drug · Class 1 | KAL-002 · No verified English nameCXSL2400095 | Sichuan Yan Yang Bio Technology Co., Ltd. romanized |
| 2024/02/05New drug · Class 1 | LY01620 · No verified English nameCXSL2400094 | Nanjing Ji Mai Bio Technology Co., Ltd. romanized |
| 2024/02/05New drug · Class 1 | HLX53 · No verified English nameCXSL2400093 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2024/02/05New drug · Class 1 | SK-08片 · No verified English nameCXHL2400142 | Guangzhou Kang Chen Pharma Co., Ltd. romanized |
| 2024/02/05New drug · Class 1 | SK-08片 · No verified English nameCXHL2400141 | Guangzhou Kang Chen Pharma Co., Ltd. romanized |
101 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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