YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 262 drug applications between 29 May 2025 and 4 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 52 drug names.
2025/05/29 – 2025/06/04
- New acceptances this week
- 262
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 39
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
262filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 124 |
| Generic | 74 |
| New drug | 45 |
| Import | 8 |
| Unspecified | 5 |
| Import re-registration | 5 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 161 |
| TCM | 58 |
| Therapeutic biologic | 37 |
| Prophylactic biologic | 4 |
| Biologic | 2 |
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
52 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 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 5 | Tadalafil Tablets | 2 | 1 | 23 |
| 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 | Hydrocortisone Sodium Succinate for Injection | 2 | 1 | 16 |
| 9 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 10 | Safinamide Methansulfonate Tablets | 2 | 1 | 20 |
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
171 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 9 | 5 | 0 |
| 2 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 8 | 7 | 0 |
| 3 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 5 | 4 | 5 |
| 4 | Jiangsu An Zheng Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Jiangxi Ke Rui Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 6 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized | 4 | 3 | 2 |
| 7 | CISEN PHARMACEUTICAL CO., LTD. | 4 | 2 | 0 |
| 8 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized | 3 | 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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/04Import · Class 2.4 | BMS-986165片 · No verified English nameJXHL2500124 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/06/04Import · Class 2.4 | BMS-986165片 · No verified English nameJXHL2500123 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/06/04Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2501975 | Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2025/06/04Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2501974 | Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2025/06/04Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2501972 | Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized |
| 2025/06/04Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2501966 | Fujian Bo Yue Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2025/06/04Generic · Class 3 | Minoxidil LinimentCYHS2501965 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2025/06/04Generic · Class 3 | Lidocaine and Prilocaine Periodontal GelCYHL2500103 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/06/04New drug · Class 3.1 | 苓桂术甘颗粒 · No verified English nameCXZS2500024 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2025/06/04New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSS2500058 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/06/04New drug · Class 3.3 | SAL023注射液 · No verified English nameCXSL2500445 | Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2025/06/04New drug · Class 1 | 注射用DXC018 · No verified English nameCXSL2500444 | Hangzhou Duo Xi Bio Technology Co., Ltd. romanized |
| 2025/06/04New drug · Class 2.4 | Fruquintinib CapsulesCXHS2500060 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd., He Ji Huang Pu Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/06/04New drug · Class 2.4 | Fruquintinib CapsulesCXHS2500059 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd., He Ji Huang Pu Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/06/04New drug · Class 1 | D-2570片 · No verified English nameCXHL2500529 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/06/04New drug · Class 2.2 | ZK062 · No verified English nameCXHL2500528 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 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 |
46 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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