YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 37 drug applications between 16 May 2022 and 22 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 4, covering 3 drug names.
2022/05/16 – 2022/05/22
- New acceptances this week
- 37
- Drugs with new generic filings (by drug name, de-duplicated)
- 3
- 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
37filings, 4 of them generic
By application type
| Application type | Filings |
|---|---|
| New drug | 14 |
| Supplement | 12 |
| Generic | 4 |
| Import re-registration | 4 |
| Import | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 24 |
| Therapeutic biologic | 8 |
| TCM | 4 |
| 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
3 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 2 | Levetiracetam Oral Solution | 1 | 1 | 3 |
| 3 | Urapidil Hydrochloride Injection | 1 | 1 | 6 |
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
21 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 2 | Santen Pharmaceutical Co. Ltd. | 4 | 1 | 0 |
| 3 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 3 | 3 | 0 |
| 4 | Karuna Therapeutics Inc. | 3 | 1 | 0 |
| 5 | Tong Hua Dong Bao Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 6 | Kyowa Kirin Co. Ltd | 2 | 1 | 0 |
| 7 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 2 | 1 | 2 |
| 8 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 2 | 1 | 0 |
| 9 | Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized | 2 | 1 | 0 |
| 10 | Janssen Biologics B.V. | 1 | 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
17 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/05/20Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2200118 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/05/20Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2200117 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/05/20Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2200116 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/05/20New drug · Class 1.1 | 黄酯胶囊 · No verified English nameCXZL2200023 | Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized |
| 2022/05/20New drug · Class 1 | MG-ZG122人源化单抗注射液 · No verified English nameCXSL2200218 | Shanghai Mai Ji Bio Technology Co., Ltd. romanized |
| 2022/05/20New drug · Class 1 | 注射用YL201 · No verified English nameCXSL2200217 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2022/05/20New drug · Class 1 | GR1501注射液 · No verified English nameCXSL2200216 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2022/05/20New drug · Class 1 | TQ-B3139胶囊 · No verified English nameCXHS2200026 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/05/20New drug · Class 1 | TQ-B3139胶囊 · No verified English nameCXHS2200025 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/05/20New drug · Class 1 | TQ-B3139胶囊 · No verified English nameCXHS2200024 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/05/20New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2200313 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/05/20New drug · Class 1 | HRS-5965片 · No verified English nameCXHL2200312 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/05/20New drug · Class 1 | HRS-5965片 · No verified English nameCXHL2200311 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/05/20New drug · Class 1 | SC0245片 · No verified English nameCXHL2200310 | Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized |
| 2022/05/20New drug · Class 1 | SC0245片 · No verified English nameCXHL2200309 | Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized |
| 2022/05/20New drug · Class 1 | 氟[18F]思睿肽注射液 · No verified English nameCXHL2200308 | Shanghai Lan Na Cheng Bio Technology Co., Ltd. romanized |
| 2022/05/18New drug · Class 2.2 | 冻干人用狂犬病疫苗(鸡胚细胞) · No verified English nameCXSL2200214 | Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized |
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.