YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 275 drug applications between 28 May 2025 and 3 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 56 drug names.
2025/05/28 – 2025/06/03
- New acceptances this week
- 275
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 35
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
275filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 127 |
| Generic | 76 |
| New drug | 46 |
| Import | 10 |
| Unspecified | 8 |
| Import re-registration | 7 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 168 |
| TCM | 61 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 6 |
| Biologic | 4 |
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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 7 | 7 | 53 |
| 2 | Nicardipine Hydrochloride Injection | 3 | 2 | 13 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 5 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 6 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 7 | 复方氨基酸注射液(20AA-Ⅱ) · No verified English name | 2 | 1 | 0 |
| 8 | Levothyroxine Sodium Tablets | 2 | 1 | 12 |
| 9 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 10 | Levobupivacaine Hydrochloride Injection | 2 | 1 | 2 |
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
180 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 13 | 11 | 0 |
| 2 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 9 | 5 | 0 |
| 3 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 5 | 4 | 5 |
| 5 | CISEN PHARMACEUTICAL CO., LTD. | 4 | 2 | 0 |
| 6 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | Jiangsu An Zheng Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | N.V. Organon | 3 | 2 | 0 |
| 10 | Nanjing Hai Jing Pharma Co., Ltd. romanized | 3 | 2 | 3 |
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
79 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/03Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2501973 | Zhejiang Hai Chang Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
| 2025/05/31Generic · Class 3 | 利伐沙班颗粒 · No verified English nameCYHS2501949 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized |
| 2025/05/31Generic · Class 3 | 利伐沙班颗粒 · No verified English nameCYHS2501948 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized |
| 2025/05/31Generic · Class 3 | Salbutamol Sulfate injectionCYHS2501947 | Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2025/05/31Generic · Class 3 | Flurbiprofen PatchesCYHS2501944 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/05/31Generic · Class 3 | Tobramycin Sulfate InjectionCYHS2501943 | Hubei Hua Hong Pharmaceuticals Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2025/05/31Generic · Class 3 | 辅酶Q10片 · No verified English nameCYHS2501942 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2025/05/31Generic · Class 3 | Terbutaline Sulfate InjectionCYHL2500102 | Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized |
| 2025/05/31Generic · Class 3 | Dapsone GelCYHL2500101 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/05/31New drug · Class 3.1 | 桃红四物汤颗粒 · No verified English nameCXZS2500023 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2025/05/31New drug · Class 1 | 注射用STSP-0601 · No verified English nameCXSS2500057 | Jiangsu Bei Jie Tai Bio Technology Co., Ltd. romanized; Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized |
| 2025/05/31New drug · Class 3.2 | ACYW???群脑膜炎球菌多糖结合疫苗 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CXSS2500056 | Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized |
| 2025/05/31New drug · Class 1 | SM2275注射液 · No verified English nameCXSL2500443 | Zhuhai Shuo Xing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/31New drug · Class 3.3 | 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2500442 | Ai Mei Jian Chi Biopharmaceutical Co., Ltd. romanized |
| 2025/05/31New drug · Class 1 | 注射用YL201 · No verified English nameCXSL2500441 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2025/05/31New drug · Class 1 | 注射用BAT8008 · No verified English nameCXSL2500440 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/05/31New drug · Class 2.4 | BAT4706注射液 · No verified English nameCXSL2500439 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/05/31New drug · Class 1 | BAT1308注射液 · No verified English nameCXSL2500438 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/05/31New drug · Class 1 | 伊托法替布软膏 · No verified English nameCXHS2500058 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2025/05/31New drug · Class 2.2 | HEC20002胶囊 · No verified English nameCXHL2500527 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2025/05/30Import · Class 2.2 | 伊奈利珠单抗注射液 · No verified English nameJXSS2500070 | Horizon Therapeutics Ireland DAC; AstraZeneca Nijmegen B.V.; Changzhou Hansoh Pharmaceutical Co. Ltd. |
| 2025/05/30Import · Class 1 | PF-08046047 · No verified English nameJXSL2500085 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2025/05/30Import · Class 2.1 | Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500084 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/05/30Import · Class 2.1 | Mosunetuzumab Injection (Subcutaneous Injection) · No verified English nameJXSL2500083 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/05/30Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2501936 | Shanghai He Feng Pharmaceutical Co., Ltd. romanized |
| 2025/05/30Generic · Class 3 | 复方氨基酸注射液(20AA-Ⅱ) · No verified English nameCYHS2501930 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2025/05/30Generic · Class 3 | 复方氨基酸注射液(20AA-Ⅱ) · No verified English nameCYHS2501929 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2025/05/30Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2501927 | Nanjing Hai Jing Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2025/05/30Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2501926 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/05/30Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2501925 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
49 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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