YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 398 drug applications between 7 August 2024 and 13 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 77 drug names.
2024/08/07 – 2024/08/13
- New acceptances this week
- 398
- Drugs with new generic filings (by drug name, de-duplicated)
- 77
- Accepted this week, now under review
- 2
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
398filings, 122 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 154 |
| Generic | 122 |
| New drug | 70 |
| Import | 22 |
| Unspecified | 18 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 293 |
| Therapeutic biologic | 46 |
| TCM | 39 |
| Biologic | 10 |
| Prophylactic biologic | 10 |
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
77 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 生理氯化钠溶液 · No verified English name | 5 | 1 | 17 |
| 2 | Dapoxetine Hydrochloride Tablets | 4 | 2 | 20 |
| 3 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 4 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 3 | 3 | 9 |
| 5 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 6 | Cefoperazone Sodium and Sulbactam Sodium for Injection | 3 | 1 | 14 |
| 7 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 8 | Labetalol Hydrochloride Injection | 3 | 1 | 4 |
| 9 | Pioglitazone and Metformin Hydrochloride Tablets | 2 | 2 | 10 |
| 10 | 氯化钙注射液 · No verified English name | 2 | 2 | 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
227 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Boehringer Ingelheim International GmbH | 14 | 1 | 0 |
| 2 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 3 | Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 4 | Novo Nordisk A/S | 7 | 3 | 0 |
| 5 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 6 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 6 | 4 | 0 |
| 7 | Pfizer Inc. | 5 | 4 | 0 |
| 8 | Henan Hua Feng Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Hebei Dao En Pharma Co., Ltd. romanized | 5 | 1 | 5 |
| 10 | Shenyang Hong Yao Group Co., Ltd. romanized | 4 | 4 | 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
152 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/13Import · Class 1 | 马塔西单抗注射液 · No verified English nameJXSS2400065 | Pfizer Inc.; Pfizer Manufacturing Belgium NV; Pfizer Investment Co. Ltd. |
| 2024/08/13Import · Class 1 | CID-103注射液 · No verified English nameJXSL2400148 | CASI Pharmaceuticals Inc.; CASI Pharmaceuticals (China) Co. Ltd. |
| 2024/08/13Import · Class 2.4 | 盐酸奎扎替尼片 · No verified English nameJXHL2400200 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/08/13Import · Class 2.4 | 盐酸奎扎替尼片 · No verified English nameJXHL2400199 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/08/13Generic · Class 3 | Potassium Chloride InjectionCYHS2402622 | Xu Bi Di Pharma (Hebei) Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2402621 | Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2402620 | Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | Diflunisal TabletsCYHS2402617 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2402610 | Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/08/13Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2402609 | Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/08/13Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2402606 | Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2402605 | Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2402604 | Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | 帕立骨化醇软胶囊 · No verified English nameCYHL2400164 | Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/13New drug · Class 1 | 注射用TQB2029 · No verified English nameCXSL2400539 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2024/08/13New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2400538 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/08/13New drug · Class 1 | 注射用DB-1305 · No verified English nameCXSL2400537 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/08/13New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2400536 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2024/08/13New drug · Class 1 | 注射用BGB-B3227 · No verified English nameCXSL2400535 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2024/08/13New drug · Class 1 | KSD-101注射液 · No verified English nameCXSL2400534 | Zhong Shan Heng Sai Bio Technology Co., Ltd. romanized |
| 2024/08/13New drug · Class 1 | 靶向CD19非病毒PD1定点整合CAR-T细胞注射液 · No verified English nameCXSL2400533 | Shanghai Bang Yao Bio Technology Co., Ltd. romanized |
| 2024/08/13New drug · Class 1 | 利厄替尼片 · No verified English nameCXHS2400074 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2024/08/13New drug · Class 1 | ZX-7101A片 · No verified English nameCXHL2400824 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2024/08/13New drug · Class 1 | TQB3616胶囊 · No verified English nameCXHL2400823 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/08/13New drug · Class 1 | TQB3616胶囊 · No verified English nameCXHL2400822 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/08/13New drug · Class 1 | TQB3912片 · No verified English nameCXHL2400821 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/08/13New drug · Class 1 | TQB3912片 · No verified English nameCXHL2400820 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/08/13New drug · Class 1 | YKYY015注射液 · No verified English nameCXHL2400819 | Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2024/08/13New drug · Class 1 | RDSY1801肠溶胶囊 · No verified English nameCXHL2400818 | Shanghai De Jian Cong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/13New drug · Class 1 | RDSY1801肠溶胶囊 · No verified English nameCXHL2400817 | Shanghai De Jian Cong He Biopharmaceuticals Technology Co., Ltd. romanized |
122 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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