YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 371 drug applications between 9 November 2023 and 15 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 57 drug names.
2023/11/09 – 2023/11/15
- New acceptances this week
- 371
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- 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
371filings, 85 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 203 |
| Generic | 85 |
| New drug | 44 |
| Import | 23 |
| Unspecified | 9 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 260 |
| TCM | 79 |
| Therapeutic biologic | 30 |
| Biologic | 1 |
| 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
57 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 | Ibuprofen Injection | 3 | 2 | 8 |
| 4 | Potassium Chloride Oral Solution | 3 | 2 | 11 |
| 5 | Minoxidil Liniment | 3 | 2 | 52 |
| 6 | Olmesartan Medoxomil and Amlodipine Besylate Tablets | 2 | 2 | 2 |
| 7 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 8 | Etoricoxib Tablets | 2 | 1 | 8 |
| 9 | 复方醋酸钠林格注射液 · No verified English name | 2 | 1 | 2 |
| 10 | 多种微量元素注射液(I) · No verified English name | 2 | 1 | 1 |
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
201 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 | Jiu Hua Hua Yuan Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | AstraZeneca AB | 8 | 4 | 0 |
| 5 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 8 | 2 | 0 |
| 6 | Bao Guang Pharma (Chengdu) Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 3 | 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
113 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/11/15New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2301269 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/11/15New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2301268 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/11/15New drug · Class 1 | LT-002-158片 · No verified English nameCXHL2301267 | Shanghai Ling Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/15New drug · Class 1 | LT-002-158片 · No verified English nameCXHL2301266 | Shanghai Ling Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/14Import · Class 3.1 | 注射用利纳西普(暂定) · No verified English nameJXSS2300084 | Kiniksa Pharmaceuticals (UK),Ltd.; Jubilant HollisterStier LLC; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICALS CO. LTD |
83 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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