YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 406 drug applications between 8 October 2022 and 14 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 65 drug names.
2022/10/08 – 2022/10/14
- New acceptances this week
- 406
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- 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
406filings, 87 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 217 |
| Generic | 87 |
| New drug | 68 |
| Import re-registration | 21 |
| Import | 10 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 305 |
| TCM | 49 |
| Therapeutic biologic | 42 |
| Prophylactic biologic | 8 |
| Biologic | 2 |
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
65 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 复方醋酸钠林格注射液 · No verified English name | 4 | 2 | 2 |
| 2 | Diquafosol Sodium Eye Drops | 3 | 2 | 5 |
| 3 | Compound α-Ketoacid Tablets | 2 | 2 | 0 |
| 4 | Glycopyrronium Bromide and Neostigmine Metilsulfate Injection | 2 | 2 | 3 |
| 5 | 丁酸氯维地平注射用乳剂 · No verified English name | 2 | 1 | 0 |
| 6 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 7 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
| 8 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 9 | Torsemide Injection | 2 | 1 | 1 |
| 10 | Telmisartan Tablets | 2 | 1 | 4 |
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
246 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hainan Pharmaceutical Factory Co., Ltd. Wuhan Branch romanized | 10 | 10 | 0 |
| 2 | Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Guangxi Di Tai Pharmaceutical Co., Ltd. romanized | 9 | 8 | 0 |
| 4 | Haerbin Jun An Tang Pharmaceuticals Co., Ltd. romanized | 8 | 8 | 0 |
| 5 | AstraZeneca UK Limited | 7 | 1 | 0 |
| 6 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 4 | 3 | 3 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Jiangsu En Hua Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Jiangsu Rui Shi Bio Technology Co., Ltd. romanized | 4 | 2 | 4 |
| 10 | Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized | 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
118 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/10/14Import · Class 1 | ChAdOx1-HBV · No verified English nameJXSL2200183 | Vaccitech (UK) Ltd; Novotech Clinical Services (Shanghai) Co. Ltd. |
| 2022/10/14Import · Class 1 | MVA-HBV · No verified English nameJXSL2200182 | Vaccitech (UK) Ltd; Novotech Clinical Services (Shanghai) Co. Ltd. |
| 2022/10/14Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2201741 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2022/10/14Generic · Class 3 | 复方醋酸钠林格注射液 · No verified English nameCYHS2201740 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2022/10/14Generic · Class 3 | 复方醋酸钠林格注射液 · No verified English nameCYHS2201739 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2022/10/14Generic · Class 3 | Peramivir InjectionCYHS2201738 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized |
| 2022/10/14Generic · Class 3 | Cladribine InjectionCYHS2201733 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2022/10/14Generic · Class 3 | 环孢素滴眼液 · No verified English nameCYHL2200091 | Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized |
| 2022/10/14Generic · Class 3 | Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2200090 | Jiangsu Hua Tai Chen Guang Pharma Co., Ltd. romanized |
| 2022/10/14Generic · Class 3 | Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2200089 | Shang Yao Dong Ying (Jiangsu) Pharma Co., Ltd. romanized |
| 2022/10/14New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSS2200083 | Fu Xing Ya Li Feng (Da Lian) Biopharmaceutical Co., Ltd. romanized |
| 2022/10/14New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2200516 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2022/10/14New drug · Class 1 | TB-B002D注射液 · No verified English nameCXHL2200797 | Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized |
| 2022/10/14New drug · Class 1 | TB-B002D注射液 · No verified English nameCXHL2200796 | Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized |
| 2022/10/14New drug · Class 2.2 | 注射用醋酸戈舍瑞林缓释微球 · No verified English nameCXHL2200795 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2022/10/14New drug · Class 1 | [177Lu]Lu-XT033注射液 · No verified English nameCXHL2200794 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/10/13Import · Class 2.2 | Teclistamab 注射液 · No verified English nameJXSL2200181 | Janssen Research & Development, LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/10/13Import · Class 2.2 | Teclistamab 注射液 · No verified English nameJXSL2200180 | Janssen Research & Development, LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/10/13Generic · Class 3 | 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2201730 | Yang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanized |
| 2022/10/13Generic · Class 3 | 厄贝沙坦氨氯地平片(Ⅲ) · No verified English nameCYHS2201729 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2022/10/13Generic · Class 3 | 厄贝沙坦氨氯地平片(Ⅰ) · No verified English nameCYHS2201728 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2022/10/13Generic · Class 3 | Compound α-Ketoacid TabletsCYHS2201722 | Beijing Kang Er Fu Pharma Co., Ltd. romanized |
| 2022/10/13Generic · Class 3 | 丁酸氯维地平注射用乳剂 · No verified English nameCYHL2200088 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2022/10/13Generic · Class 3 | 丁酸氯维地平注射用乳剂 · No verified English nameCYHL2200087 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2022/10/13Generic · Class 3 | ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English nameCYHL2200086 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/10/13New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSL2200515 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2022/10/13New drug · Class 3.4 | 人纤维蛋白原 · No verified English nameCXSL2200514 | Tong Lu Biopharmaceutical Co., Ltd. romanized |
| 2022/10/13New drug · Class 3.4 | 人纤维蛋白原 · No verified English nameCXSL2200513 | Tong Lu Biopharmaceutical Co., Ltd. romanized |
| 2022/10/13New drug · Class 1 | 自体抗CLL-1嵌合抗原受体T细胞注射液 · No verified English nameCXSL2200512 | Guangzhou Bai Ji Ji Yin Technology Co., Ltd. romanized |
| 2022/10/13New drug · Class 2.2 | 麻腮风联合减毒活疫苗 · No verified English nameCXSL2200511 | Beijing Min Hai Bio Technology Co., Ltd. romanized |
88 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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