YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 257 drug applications between 27 March 2023 and 2 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 37 drug names.
2023/03/27 – 2023/04/02
- New acceptances this week
- 257
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- Accepted this week, now under review
- 2
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
257filings, 49 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 134 |
| Generic | 49 |
| New drug | 32 |
| Import | 26 |
| Import re-registration | 9 |
| Unspecified | 5 |
| Drug-device combination product | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 181 |
| TCM | 43 |
| Therapeutic biologic | 25 |
| Prophylactic 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pranoprofen Eye Drops | 3 | 3 | 7 |
| 2 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 3 | Diprophylline Injection | 2 | 2 | 7 |
| 4 | 聚乙二醇钠钾散 · No verified English name | 2 | 2 | 3 |
| 5 | Linaclotide Capsules | 2 | 1 | 13 |
| 6 | Trimetazidine Dihydrochloride Tablets | 2 | 1 | 0 |
| 7 | Ondansetron Hydrochloride Tablets | 2 | 1 | 6 |
| 8 | Citicoline Sodium Injection | 2 | 1 | 3 |
| 9 | 苯磺酸左氨氯地平片 · No verified English name | 2 | 1 | 45 |
| 10 | Dapagliflozin Tablets | 2 | 1 | 84 |
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
156 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Wuhan Xiang Cao Tang Pharma Co., Ltd. romanized | 15 | 14 | 0 |
| 2 | Eli Lilly and Company | 6 | 1 | 0 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 4 | Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | Celgene Corporation | 5 | 1 | 0 |
| 6 | Chengdu Kang Hua Bio Zhi Pin Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 2 | 2 |
| 8 | Chongqing Rui En Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Pfizer Europe MA EEIG | 4 | 1 | 0 |
| 10 | Roche Pharma (Schweiz) AG | 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
64 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300032 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300031 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300030 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300029 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Generic · Class 3 | Pirfenidone TabletsCYHS2300947 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized |
| 2023/04/01Generic · Class 3 | Carbocisteine Oral SolutionCYHS2300946 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2023/04/01Generic · Class 3 | 去氧肾上腺素酮咯酸溶液 · No verified English nameCYHL2300043 | Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/01New drug · Class 1.1 | 安体威颗粒 · No verified English nameCXZL2300025 | Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized |
| 2023/04/01New drug · Class 1 | SYH2051片 · No verified English nameCXHL2300351 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/04/01New drug · Class 1 | SYH2051片 · No verified English nameCXHL2300350 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/04/01New drug · Class 1 | JAB-26766片 · No verified English nameCXHL2300349 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2023/04/01New drug · Class 1 | JAB-26766片 · No verified English nameCXHL2300348 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2023/04/01New drug · Class 1 | ONC201胶囊 · No verified English nameCXHL2300347 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd. |
| 2023/03/31Import · Class 1 | AMG 509 · No verified English nameJXSL2300063 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/03/31Import · Class 1 | ASP1570片 · No verified English nameJXHL2300074 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2023/03/31Import · Class 1 | ASP1570片 · No verified English nameJXHL2300073 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2023/03/31Generic · Class 3 | Diprophylline InjectionCYHS2300943 | Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/03/31Generic · Class 3 | Diprophylline InjectionCYHS2300942 | Anhui Chang Jiang Pharma Co., Ltd. romanized; Anhui Heng Xing Pharmaceutical Co., Ltd. romanized |
| 2023/03/31Generic · Class 3 | Pregabalin Oral SolutionCYHS2300936 | Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Beijing Jiu Long Pharmaceutical Co., Ltd. romanized |
| 2023/03/31Generic · Class 3 | Pimavanserin Tartrate CapsulesCYHL2300042 | Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/31New drug · Class 1.1 | 芎芍止痛颗粒 · No verified English nameCXZL2300024 | Guangdong Kai Zhong Bio Technology Co., Ltd. romanized |
| 2023/03/31New drug · Class 1 | SIM1811-03注射液 · No verified English nameCXSL2300223 | Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized |
| 2023/03/31New drug · Class 1 | SHR8554注射液 · No verified English nameCXHL2300346 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/03/31New drug · Class 1 | SHR8554注射液 · No verified English nameCXHL2300345 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/03/31New drug · Class 2.2; 2.4 | 美洛昔康混悬注射液 · No verified English nameCXHL2300344 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/03/31New drug · Class 1 | 注射用甲磺酸普依司他 · No verified English nameCXHL2300343 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/31New drug · Class 1 | 注射用甲磺酸普依司他 · No verified English nameCXHL2300342 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/31New drug · Class 1 | HS-10516胶囊 · No verified English nameCXHL2300341 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/31New drug · Class 1 | HS-10516胶囊 · No verified English nameCXHL2300340 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/03/30Import · Class 1 | Iberdomide胶囊 · No verified English nameJXHL2300065 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
34 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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