YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 328 drug applications between 10 November 2023 and 16 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 47 drug names.
2023/11/10 – 2023/11/16
- New acceptances this week
- 328
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- Accepted this week, now under review
- 1
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
328filings, 65 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 189 |
| Generic | 65 |
| New drug | 40 |
| Import | 21 |
| Unspecified | 9 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 228 |
| TCM | 62 |
| Therapeutic biologic | 34 |
| Biologic | 3 |
| 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
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Granules | 6 | 3 | 4 |
| 2 | Neostigmine Methylsulfate Injection | 5 | 2 | 4 |
| 3 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 4 | Etoricoxib Tablets | 2 | 1 | 8 |
| 5 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 6 | Famotidine Injection | 2 | 1 | 8 |
| 7 | 注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name | 2 | 1 | 2 |
| 8 | Minoxidil Liniment | 2 | 1 | 52 |
| 9 | Vitamin K1 Injection | 2 | 1 | 6 |
| 10 | Dacomitinib Tablets | 2 | 1 | 0 |
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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 41 | 40 | 0 |
| 2 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 11 | 4 | 0 |
| 3 | AstraZeneca AB | 8 | 4 | 0 |
| 4 | Jiu Hua Hua Yuan Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Bao Guang Pharma (Chengdu) Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 1 | 0 |
| 7 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Hangzhou Minsheng Pharmaceutical Co., Ltd | 4 | 2 | 4 |
| 10 | Guangzhou Yin Nuo Pharmaceuticals Group 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
91 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/16Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2303146 | Hebei San He Shi Chuang Bio Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/11/16Generic · Class 3 | Metformin Hydrochloride Extended-release TabletsCYHS2303145 | Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2023/11/16New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2300784 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/11/16New drug · Class 1 | TQB2928注射液 · No verified English nameCXSL2300783 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/11/16New drug · Class 1 | LF0376片 · No verified English nameCXHL2301273 | Wuxi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/15Import · Class 2.2 | Amivantamab注射液 · No verified English nameJXSL2300196 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/11/15Import · Class 1 | AZD5305 · No verified English nameJXHL2300290 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/11/15Import · Class 1 | AZD5305 · No verified English nameJXHL2300289 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/11/15Import · Class 1 | AZD5305 · No verified English nameJXHL2300288 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/11/15Import · Class 1 | AZD5305 · No verified English nameJXHL2300287 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/11/15Import · Class 1 | AZD9833片 · No verified English nameJXHL2300286 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2023/11/15Import · Class 1 | Baxdrostat片 · No verified English nameJXHL2300285 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/11/15Import · Class 2.4 | Lazertinib片 · No verified English nameJXHL2300284 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/11/15Import · Class 1 | Baxdrostat片 · No verified English nameJXHL2300283 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/11/15Import · Class 2.2; 2.4 | Ganaxolone注射剂 · No verified English nameJXHL2300282 | Marinus Pharmaceuticals Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2023/11/15Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2303141 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2023/11/15Generic · Class 3 | Famotidine InjectionCYHS2303140 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized |
| 2023/11/15Generic · Class 3 | Famotidine InjectionCYHS2303139 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized |
| 2023/11/15Generic · Class 3 | Heparin Sodium InjectionCYHS2303138 | Suzhou Erye Pharmaceutical Co., Ltd |
| 2023/11/15Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2303137 | Yunnan Xian Shi Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/11/15Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2303136 | Yunnan Xian Shi Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/11/15Generic · Class 3 | Bumetanide InjectionCYHS2303128 | Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/11/15Generic · Class 3 | 阿瑞匹坦注射液 · No verified English nameCYHL2300138 | Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized |
| 2023/11/15New drug · Class 1 | TQB2916注射液 · No verified English nameCXSL2300782 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/11/15New drug · Class 1 | 舒西利单抗注射液 · No verified English nameCXSL2300781 | Hainan Sai Le Min Bio Technology Co., Ltd. romanized |
| 2023/11/15New drug · Class 1 | SCT650C 注射液 · No verified English nameCXSL2300780 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2023/11/15New drug · Class 1 | TQB2868注射液 · No verified English nameCXSL2300779 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/11/15New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2301272 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/11/15New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2301271 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/11/15New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2301270 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
61 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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