YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 388 drug applications between 25 December 2022 and 31 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 53 drug names.
2022/12/25 – 2022/12/31
- New acceptances this week
- 388
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- 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
388filings, 80 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 212 |
| Generic | 80 |
| New drug | 77 |
| Unspecified | 8 |
| Import | 8 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 282 |
| TCM | 63 |
| Therapeutic biologic | 37 |
| Biologic | 4 |
| In vitro diagnostic reagent | 1 |
| 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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Paliperidone Palmitate Injection | 5 | 1 | 8 |
| 2 | Esmolol Hydrochloride Injection | 3 | 3 | 3 |
| 3 | Clindamycin Injection | 3 | 1 | 4 |
| 4 | Remifentanil Hydrochloride for Injection | 3 | 1 | 2 |
| 5 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 12 |
| 6 | Gadobutrol Injection | 3 | 1 | 8 |
| 7 | Gadoteric Acid Meglumine Salt Injection | 3 | 1 | 1 |
| 8 | Vildagliptin Tablets | 2 | 2 | 0 |
| 9 | Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II) | 2 | 2 | 3 |
| 10 | Voriconazole Tablets | 2 | 1 | 1 |
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
190 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Lang De Pharma Co., Ltd. romanized | 32 | 16 | 0 |
| 2 | Fresenius Kabi Deutschland GmbH | 24 | 2 | 0 |
| 3 | Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized | 15 | 15 | 0 |
| 4 | Xian Tang Chen Pharmaceutical Co., Ltd. romanized | 8 | 5 | 0 |
| 5 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized | 8 | 1 | 0 |
| 6 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 3 | 6 |
| 7 | Jilin Te Yan Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Jiangxi Xin Zheng Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized | 5 | 1 | 5 |
| 10 | Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
123 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/12/31Import · Class 2.4 | Ganaxolone口服混悬剂 · No verified English nameJXHL2200354 | Marinus Pharmaceuticals Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2022/12/31Generic · Class 3 | Diprophylline InjectionCYHS2202175 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2022/12/31Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2202174 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2022/12/31New drug · Class 2.2; 2.3 | 淫羊藿苷元胶囊 · No verified English nameCXZL2200057 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2022/12/31New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSS2200095 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | CM355 · No verified English nameCXSL2200640 | Beijing Tian Nuo Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | 注射用RS2102 · No verified English nameCXSL2200639 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | 注射用MHB036C · No verified English nameCXSL2200638 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | C5252疱疹病毒注射液 · No verified English nameCXSL2200637 | Shenzhen Shi Yi Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | IO-108注射液 · No verified English nameCXSL2200636 | Yi Ming Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2022/12/31New drug · Class 1.3 | 重组乙型肝炎疫苗(汉逊酵母,CpG和铝佐剂) · No verified English nameCXSL2200635 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | 注射用MHB088C · No verified English nameCXSL2200634 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2022/12/31New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSL2200633 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2022/12/31New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSL2200632 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | BEBT-305片 · No verified English nameCXHL2200991 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | BEBT-305片 · No verified English nameCXHL2200990 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | HX101胶囊 · No verified English nameCXHL2200989 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | RJ4287片 · No verified English nameCXHL2200988 | Nanjing Ao Li Mo Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | RJ4287片 · No verified English nameCXHL2200987 | Nanjing Ao Li Mo Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | QY211凝胶 · No verified English nameCXHL2200986 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | QY211凝胶 · No verified English nameCXHL2200985 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | QY211凝胶 · No verified English nameCXHL2200984 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | QY211凝胶 · No verified English nameCXHL2200983 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2022/12/31New drug · Class 1 | 伊匹乌肽滴眼液 · No verified English nameCXHL2200982 | Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2202164 | Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2022/12/30Generic · Class 3 | Pregabalin Oral SolutionCYHS2202161 | Jian Min Pharma Group Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2202157 | Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Timolol Maleate Eye DropsCYHS2202154 | Jiangsu Yuan Heng Pharma Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Timolol Maleate Eye DropsCYHS2202153 | Jiangsu Yuan Heng Pharma Co., Ltd. romanized |
| 2022/12/30Generic · Class 3 | Olopatadine Hydrochloride GranulesCYHS2202150 | Nanjing Ming Sheng Pharmaceuticals Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd. |
93 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.