YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 290 drug applications between 6 September 2022 and 12 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 40 drug names.
2022/09/06 – 2022/09/12
- New acceptances this week
- 290
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
290filings, 56 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 143 |
| Generic | 56 |
| New drug | 38 |
| Import | 30 |
| Unspecified | 15 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 201 |
| Therapeutic biologic | 46 |
| TCM | 39 |
| Prophylactic biologic | 3 |
| 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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Carfilzomib For Injection | 3 | 1 | 0 |
| 2 | Cefotiam Hydrochloride For Injection | 3 | 1 | 0 |
| 3 | Lidocaine Hydrochloride Injection | 3 | 1 | 6 |
| 4 | Rivaroxaban Fine Granules | 2 | 1 | 0 |
| 5 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 6 | Olaparib Tablets | 2 | 1 | 0 |
| 7 | Peramivir Injection | 2 | 1 | 7 |
| 8 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 9 | Parecoxib Sodium for Injection | 2 | 1 | 2 |
| 10 | Vardenafil Hydrochloride 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
154 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 26 | 24 | 0 |
| 2 | Bayer AG | 13 | 11 | 0 |
| 3 | Eli Lilly and Company | 9 | 3 | 0 |
| 4 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 6 | 5 | 0 |
| 5 | Baxalta US Inc. | 6 | 1 | 0 |
| 6 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Janssen-Cilag International NV | 5 | 4 | 0 |
| 8 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 9 | Guo Yao Group Gong Ye Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/10Import · Class 1 | 利特昔替尼胶囊 · No verified English nameJXHS2200081 | Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd. |
| 2022/09/10Import · Class 2.4 | Dapagliflozin TabletsJXHS2200080 | AstraZeneca AB; AstraZeneca Pharmaceuticals LP; AstraZeneca Investment (China)Co. Ltd. |
| 2022/09/10Import · Class 2.4 | Dapagliflozin TabletsJXHS2200079 | AstraZeneca AB; AstraZeneca Pharmaceuticals LP; AstraZeneca Investment (China)Co. Ltd. |
| 2022/09/10Import · Class 1 | KIN-3248片 · No verified English nameJXHL2200284 | Kinnjiu Biopharma Limited; PPC China Corporation Limited |
| 2022/09/10Import · Class 1 | KIN-3248片 · No verified English nameJXHL2200283 | Kinnjiu Biopharma Limited; PPC China Corporation Limited |
| 2022/09/10Import · Class 1 | KIN-3248片 · No verified English nameJXHL2200282 | Kinnjiu Biopharma Limited; PPC China Corporation Limited |
| 2022/09/10Generic · Class 3 | Aripiprazole Oral SolutionCYHS2201507 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2022/09/10Generic · Class 3 | Aripiprazole Oral SolutionCYHS2201506 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2022/09/10Generic · Class 3 | Cefotiam Hydrochloride For InjectionCYHS2201505 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized |
| 2022/09/10Generic · Class 3 | Cefotiam Hydrochloride For InjectionCYHS2201504 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized |
| 2022/09/10Generic · Class 3 | Cefotiam Hydrochloride For InjectionCYHS2201503 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized |
| 2022/09/10Generic · Class 3 | Peramivir InjectionCYHS2201501 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2022/09/10Generic · Class 3 | Peramivir InjectionCYHS2201500 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2022/09/10New drug · Class 1 | Y101D · No verified English nameCXSL2200456 | Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized |
| 2022/09/10New drug · Class 1 | 注射用YL202 · No verified English nameCXSL2200455 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2022/09/10New drug · Class 2.2 | BH009注射液 · No verified English nameCXHL2200668 | Zhuhai Bei Hai Bio Technology Co., Ltd. romanized |
| 2022/09/10New drug · Class 1 | 注射用 GMDTC · No verified English nameCXHL2200667 | Jian Er Sheng (Zhuhai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/10New drug · Class 1 | 卟硒啉片 · No verified English nameCXHL2200666 | Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/10New drug · Class 1 | 卟硒啉片 · No verified English nameCXHL2200665 | Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/10New drug · Class 1 | 卟硒啉片 · No verified English nameCXHL2200664 | Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/09Import · Class 3.1 | 安纳白介素注射液(预充式) · No verified English nameJXSS2200034 | Swedish Orphan Biovitrum AB (publ); Hospira Zagreb d.o.o.; SOBI Pharma (Shanghai) Company Limited |
| 2022/09/09Import · Class 3.1 | 古塞奇尤单抗注射液 · No verified English nameJXSL2200163 | Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd. |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200162 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200161 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200160 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200159 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200158 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200157 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201498 | Hui Yin Bi Group Fu Zhou Pharmaceutical Co., Ltd. romanized; Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized |
| 2022/09/09Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201497 | Hui Yin Bi Group Fu Zhou Pharmaceutical Co., Ltd. romanized; Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized |
55 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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