YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 496 drug applications between 1 February 2024 and 7 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 157, covering 121 drug names.
2024/02/01 – 2024/02/07
- New acceptances this week
- 496
- Drugs with new generic filings (by drug name, de-duplicated)
- 121
- 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
496filings, 157 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 197 |
| Generic | 157 |
| New drug | 83 |
| Import | 31 |
| Unspecified | 14 |
| Import re-registration | 14 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 359 |
| Therapeutic biologic | 72 |
| TCM | 54 |
| Prophylactic biologic | 6 |
| 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
121 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 4 | 3 | 23 |
| 2 | Diprophylline Injection | 3 | 3 | 7 |
| 3 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 4 | LevomilnacipranHydrochloride Extended-release Capsules | 3 | 1 | 6 |
| 5 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 6 | Gatifloxacin Eye Drops | 2 | 2 | 3 |
| 7 | Fusidic Acid Cream | 2 | 2 | 15 |
| 8 | Dronedarone Hydrochloride Tablets | 2 | 2 | 4 |
| 9 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 2 | 2 |
| 10 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
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
306 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 7 | 7 | 5 |
| 2 | Sichuan Yi Ke Cao Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 4 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 6 | 5 | 5 |
| 5 | Jiangsu En Hua Pharma Co., Ltd. romanized | 6 | 3 | 4 |
| 6 | AbbVie Inc. | 6 | 2 | 0 |
| 7 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Bayer AG | 5 | 4 | 0 |
| 9 | Pfizer Europe MA EEIG | 5 | 3 | 0 |
| 10 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 3 | 3 |
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
176 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/02/07Import · Class 2.2 | Lebrikizumab注射液 · No verified English nameJXSL2400042 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/02/07Generic · Class 3 | Potassium Chloride InjectionCYHS2400563 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/02/07Generic · Class 3 | Nicorandil for InjectionCYHS2400559 | Shenyang Xin Ma Pharma Co., Ltd. romanized |
| 2024/02/07Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2400557 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2024/02/07Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2400556 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2024/02/07Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2400555 | Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2024/02/07Generic · Class 3 | Magnesium Sulfate InjectionCYHS2400554 | Hebei Yi Pin Pharmaceutical Co., Ltd. romanized |
| 2024/02/07Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2400548 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2024/02/07Generic · Class 3 | Potassium Chloride Extended Release TabletsCYHS2400544 | YaoPharma Co., Ltd. |
| 2024/02/07Generic · Class 3 | 盐酸丙卡特罗片 · No verified English nameCYHS2400542 | Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized |
| 2024/02/07Generic · Class 3 | 水溶性黄体酮注射液 · No verified English nameCYHS2400541 | Shijiazhuang No.4 Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized |
| 2024/02/07New drug · Class 1 | SHR-1905注射液 · No verified English nameCXSL2400109 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/02/07New drug · Class 1 | 注射用QLF31907 · No verified English nameCXSL2400108 | Qilu Pharmaceutical Co., Ltd. |
| 2024/02/07New drug · Class 1 | LNF2008单克隆抗体注射液 · No verified English nameCXSL2400107 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/02/07New drug · Class 1 | AK129注射液 · No verified English nameCXSL2400106 | Kang Fang Hui Ke (Shanghai) Bio Co., Ltd. romanized |
| 2024/02/07New drug · Class 3.3 | 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSL2400105 | Tong Hua Dong Bao Pharma Co., Ltd. romanized |
| 2024/02/07New drug · Class 1 | 玛仕度肽注射液 · No verified English nameCXHS2400010 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/02/07New drug · Class 1 | 玛仕度肽注射液 · No verified English nameCXHS2400009 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/02/07New drug · Class 1 | 玛仕度肽注射液 · No verified English nameCXHS2400008 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/02/07New drug · Class 1 | TQB3117片 · No verified English nameCXHL2400172 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/02/07New drug · Class 1 | TQB3117片 · No verified English nameCXHL2400171 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/02/07New drug · Class 1 | SIM0506胶囊 · No verified English nameCXHL2400170 | Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/02/07New drug · Class 1 | SIM0506胶囊 · No verified English nameCXHL2400169 | Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/02/06Import · Class 3.1 | 美泊利珠单抗注射液 · No verified English nameJXSS2400010 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited |
| 2024/02/06Import · Class 3.1 | 美泊利珠单抗注射液 · No verified English nameJXSS2400009 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited |
| 2024/02/06Import · Class 3.1 | 注射用戈沙妥珠单抗 · No verified English nameJXSS2400008 | Gilead Sciences Inc.; BSP Pharmaceuticals S.p.A.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2024/02/06Import · Class 2.2 | Lebrikizumab注射液 · No verified English nameJXSL2400041 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/02/06Import · Class 2.2 | Risankizumab注射液 · No verified English nameJXSL2400040 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/02/06Import · Class 2.2 | Risankizumab注射液 · No verified English nameJXSL2400039 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/02/06Import · Class 2.2 | Risankizumab注射液 · No verified English nameJXSL2400038 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
146 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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