YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 420 drug applications between 9 October 2022 and 15 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 66 drug names.
2022/10/09 – 2022/10/15
- New acceptances this week
- 420
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- 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
420filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 225 |
| Generic | 92 |
| New drug | 63 |
| Import re-registration | 21 |
| Import | 17 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 318 |
| TCM | 47 |
| Therapeutic biologic | 45 |
| 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
66 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 | Potassium Chloride Granules | 3 | 2 | 4 |
| 3 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 4 | Compound α-Ketoacid Tablets | 2 | 2 | 0 |
| 5 | Glycopyrronium Bromide and Neostigmine Metilsulfate Injection | 2 | 2 | 3 |
| 6 | Methylprednisolone Tablets | 2 | 2 | 3 |
| 7 | 丁酸氯维地平注射用乳剂 · No verified English name | 2 | 1 | 0 |
| 8 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 9 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
| 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
250 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Di Tai Pharmaceutical Co., Ltd. romanized | 12 | 10 | 0 |
| 2 | Hainan Pharmaceutical Factory Co., Ltd. Wuhan Branch romanized | 10 | 10 | 0 |
| 3 | Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Haerbin Jun An Tang Pharmaceuticals Co., Ltd. romanized | 8 | 8 | 0 |
| 5 | AstraZeneca UK Limited | 7 | 1 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 4 | 3 | 3 |
| 8 | AbbVie Inc. | 4 | 2 | 0 |
| 9 | Bayer AG | 4 | 2 | 0 |
| 10 | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 4 | 2 | 4 |
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
120 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/10/15Import · Class 1 | BMS-986278-01片 · No verified English nameJXHL2200305 | Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd |
| 2022/10/15Import · Class 1 | BMS-986278-01片 · No verified English nameJXHL2200304 | Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd |
| 2022/10/15Import · Class 2.4 | Odevixibat 胶囊 · No verified English nameJXHL2200303 | Albireo AB; Syneos Health (Beijing) Inc.Ltd |
| 2022/10/15Import · Class 2.4 | Odevixibat 胶囊 · No verified English nameJXHL2200302 | Albireo AB; Syneos Health (Beijing) Inc.Ltd |
| 2022/10/15Import · Class 2.4 | Odevixibat 胶囊 · No verified English nameJXHL2200301 | Albireo AB; Syneos Health (Beijing) Inc.Ltd |
| 2022/10/15Import · Class 2.4 | Odevixibat 胶囊 · No verified English nameJXHL2200300 | Albireo AB; Syneos Health (Beijing) Inc.Ltd |
| 2022/10/15Generic · Class 3 | Potassium Chloride GranulesCYHS2201746 | Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/10/15Generic · Class 3 | Potassium Chloride GranulesCYHS2201744 | Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/10/15Generic · Class 3 | 美洛昔康纳晶注射液 · No verified English nameCYHL2200092 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 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 |
90 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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