YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 466 drug applications between 5 May 2023 and 11 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 59 drug names.
2023/05/05 – 2023/05/11
- New acceptances this week
- 466
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- 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
466filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 254 |
| New drug | 88 |
| Generic | 77 |
| Import | 25 |
| Import re-registration | 12 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 313 |
| TCM | 86 |
| Therapeutic biologic | 66 |
| Prophylactic 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dasatinib Tablets | 4 | 1 | 4 |
| 2 | Arginine and Ibuprofen Granules | 3 | 1 | 11 |
| 3 | Indobufen Tablets | 2 | 2 | 6 |
| 4 | Levofloxacin Eye Drops | 2 | 2 | 16 |
| 5 | Famotidine Injection | 2 | 2 | 8 |
| 6 | Roxatidine Acetate Hydrochloride For Injection | 2 | 2 | 5 |
| 7 | Minoxidil Liniment | 2 | 2 | 52 |
| 8 | Crisaborole Ointment | 2 | 1 | 26 |
| 9 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 10 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
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
227 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized | 31 | 28 | 0 |
| 2 | Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized | 28 | 23 | 0 |
| 3 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 15 | 14 | 0 |
| 4 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized | 12 | 1 | 0 |
| 5 | Eli Lilly and Company | 9 | 2 | 0 |
| 6 | Novo Nordisk A/S | 8 | 2 | 0 |
| 7 | Bard Pharmaceuticals Limited | 7 | 3 | 0 |
| 8 | Shaanxi Qing Hua Zi Guang Bio Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 9 | Qilu Pharmaceutical (Hainan) Co., Ltd | 6 | 2 | 4 |
| 10 | AbbVie Limited | 6 | 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
142 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/11Import · Class 1 | EYP-1901玻璃体内植入剂 · No verified English nameJXHL2300114 | EyePoint Pharmaceuticals Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2023/05/11Import · Class 1 | EYP-1901玻璃体内植入剂 · No verified English nameJXHL2300113 | EyePoint Pharmaceuticals Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2023/05/11Import · Class 1 | BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2300112 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2023/05/11Generic · Class 3 | Famotidine InjectionCYHS2301278 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/05/11Generic · Class 3 | Famotidine InjectionCYHS2301277 | Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized |
| 2023/05/11Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2301276 | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/05/11Generic · Class 3 | 阿瑞匹坦注射液 · No verified English nameCYHS2301274 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/05/11Generic · Class 3 | Peramivir InjectionCYHS2301271 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Hubei Mei Lin Pharma Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | 注射用A166 · No verified English nameCXSS2300034 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | FL115注射液 · No verified English nameCXSL2300329 | Suzhou Fu Rong Bio Technology Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | ReT01 ACT 注射液 · No verified English nameCXSL2300328 | Beijing An Wei Sen Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | ISM8207胶囊 · No verified English nameCXHL2300508 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | ISM8207胶囊 · No verified English nameCXHL2300507 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | ISM8207胶囊 · No verified English nameCXHL2300506 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | ICP-723口崩片 · No verified English nameCXHL2300505 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/11New drug · Class 1 | 注射用TFX05-01 · No verified English nameCXHL2300504 | Shenzhen Yang Li Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/10Import · Class 1 | Eplontersen注射液 · No verified English nameJXHL2300111 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/05/10Import · Class 1 | 注射用Redasemtide · No verified English nameJXHL2300110 | Shionogi & Co. Ltd.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300109 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300108 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300107 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300106 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300105 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300104 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/10Generic · Class 3 | Dequalinium Chloride Buccal TabletsCYHS2301269 | Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized; Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2023/05/10Generic · Class 3 | Minoxidil Topical SolutionCYHS2301266 | Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized |
| 2023/05/10Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2301262 | Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized |
| 2023/05/10Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2301261 | Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized |
| 2023/05/10Generic · Class 3 | Levofloxacin Oral SolutionCYHS2301258 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2023/05/10Generic · Class 3 | Potassium Chloride GranulesCYHS2301257 | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
112 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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