YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 456 drug applications between 20 September 2024 and 26 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 142, covering 98 drug names.
2024/09/20 – 2024/09/26
- New acceptances this week
- 456
- Drugs with new generic filings (by drug name, de-duplicated)
- 98
- Accepted this week, now under review
- 13
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
456filings, 142 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 167 |
| Generic | 142 |
| New drug | 74 |
| Import | 37 |
| Unspecified | 22 |
| Import re-registration | 13 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 290 |
| Therapeutic biologic | 72 |
| TCM | 66 |
| Biologic | 19 |
| Prophylactic biologic | 9 |
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
98 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Brexpiprazole Tablets | 6 | 2 | 31 |
| 2 | Fentanyl Citrate Buccal Tablets | 6 | 1 | 0 |
| 3 | Cefoperazone Sodium and Sulbactam Sodium for Injection | 6 | 1 | 14 |
| 4 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 5 | Carbamazepine Sustained-Release Tablets(II) | 3 | 1 | 0 |
| 6 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 7 | Amoxicillin Sodium and Sulbactam Sodium for Injection | 3 | 1 | 7 |
| 8 | Procaterol Hydrochloride Granules | 3 | 1 | 2 |
| 9 | Ethyl Iosapentate Capsules | 2 | 2 | 27 |
| 10 | Bumetanide Injection | 2 | 2 | 13 |
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
268 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 11 | 2 | 0 |
| 2 | Amgen Inc. | 9 | 2 | 0 |
| 3 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 9 | 2 | 9 |
| 4 | Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized | 7 | 3 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 6 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized | 7 | 1 | 0 |
| 7 | Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 9 | Janssen-Cilag International NV | 6 | 2 | 0 |
| 10 | Baxalta Manufacturing Sàrl | 6 | 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
167 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/26Import · Class 1 | PF-08046047 · No verified English nameJXSL2400182 | Seagen Inc.; Pfizer Investment CO. Ltd. |
| 2024/09/26Import · Class 1 | JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2400181 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/09/26Import · Class 1 | JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2400180 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/09/26Import · Class 1 | E7386 · No verified English nameJXHL2400237 | Eisai Co. Ltd. |
| 2024/09/26Import · Class 1 | E7386 · No verified English nameJXHL2400236 | Eisai Co. Ltd. |
| 2024/09/26Import · Class 1 | E7386 · No verified English nameJXHL2400235 | Eisai Co. Ltd. |
| 2024/09/26Generic · Class 3 | Aceclofenac TabletsCYHS2403261 | Guangdong Jun Kang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | Minodronic acid TabletsCYHS2403258 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2403257 | Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2403256 | Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | 多索茶碱口服溶液 · No verified English nameCYHS2403255 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/09/26Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2403251 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2403250 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2403249 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | Eltrombopag Lamine For Oral SuspensionCYHS2403244 | Nanjing Si Ling Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2403243 | Anhui Kang Rong Pharma Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | Bumetanide InjectionCYHS2403237 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/09/26Generic · Class 3 | Calcium Polycarbophil Fine GranulesCYHS2403235 | Zhejiang Zuo Li Pharma Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | Verapamil Hydrochloride InjectionCYHS2403234 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400195 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/09/26Generic · Class 3 | 立他司特滴眼液 · No verified English nameCYHL2400194 | Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized |
| 2024/09/26New drug · Class 3.1 | 枇杷清肺颗粒 · No verified English nameCXZS2400032 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2024/09/26New drug · Class 1.1 | 参葛颗粒 · No verified English nameCXZL2400060 | Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized |
| 2024/09/26New drug · Class 2.2 | 纳基奥仑赛注射液 · No verified English nameCXSS2400104 | He Yuan Bio Technology (Tianjin) Co., Ltd. romanized |
| 2024/09/26New drug · Class 1 | 匹康奇拜单抗注射液 · No verified English nameCXSS2400103 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/09/26New drug · Class 1 | 注射用HLX43 · No verified English nameCXSL2400668 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2024/09/26New drug · Class 1 | VUM02注射液 · No verified English nameCXSL2400667 | Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized |
| 2024/09/26New drug · Class 3.3 | SYS6036注射液 · No verified English nameCXSL2400666 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/09/26New drug · Class 1.1 | LVRNA101 · No verified English nameCXSL2400665 | Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized; Changchun Bai Ke Bio Technology Shareholding Company romanized |
| 2024/09/26New drug · Class 1 | MG-K10人源化单抗注射液 · No verified English nameCXSL2400664 | Shanghai Mai Ji Bio Technology Co., Ltd. romanized |
137 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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