YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 340 drug applications between 25 May 2026 and 31 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 19 drug names.
2026/05/25 – 2026/05/31
- New acceptances this week
- 340
- Drugs with new generic filings (by drug name, de-duplicated)
- 19
- Accepted this week, now under review
- 50
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
340filings, 27 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 238 |
| New drug | 46 |
| Generic | 27 |
| Import | 17 |
| Unspecified | 8 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 144 |
| Chemical drug | 139 |
| Therapeutic biologic | 47 |
| Biologic | 5 |
| Prophylactic biologic | 5 |
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
19 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sufentanil Citrate Injection | 5 | 1 | 0 |
| 2 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 3 | 口服溶液用盐酸万古霉素 · No verified English name | 2 | 1 | 2 |
| 4 | Milnacipran Hydrochloride Tablets | 2 | 1 | 8 |
| 5 | Ketorolac Tromethamine Injection | 2 | 1 | 4 |
| 6 | 二硫化硒洗剂 · No verified English name | 1 | 1 | 14 |
| 7 | Linaclotide Capsules | 1 | 1 | 13 |
| 8 | 吸入用布地奈德混悬液 · No verified English name | 1 | 1 | 7 |
| 9 | Dexamethasone Sodium Phosphate Injection | 1 | 1 | 5 |
| 10 | Bumetanide Injection | 1 | 1 | 13 |
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
220 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 11 | 9 | 0 |
| 2 | Changsha Dong Feng Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Anhui De Hong Sheng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 5 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 6 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 1 | 5 |
| 8 | Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Guizhou Sheng Ke Hui Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Kyowa Kirin Co. Ltd. | 4 | 2 | 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
80 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/29Import · Class 2.2 | 阿替利珠单抗注射液 · No verified English nameJXSS2600043 | Roche Registration GmbH; Roche Diagnostics GmbH; F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2026/05/29Import · Class 1 | INCA33890注射液 · No verified English nameJXSL2600123 | Incyte Corporation; Incyte Biosciences (Shanghai) Co. Ltd. |
| 2026/05/29Import · Class 1 | Ponsegromab注射液 · No verified English nameJXSL2600122 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2026/05/29Import · Class 1 | Imzokitug注射液 · No verified English nameJXSL2600121 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/05/29Import · Class 2.4 | 瑞米布替尼片 · No verified English nameJXHL2600192 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/05/29Import · Class 1 | ASP3082注射液 · No verified English nameJXHL2600191 | Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2026/05/29Generic · Class 3 | 甲氧氯普胺片 · No verified English nameCYHS2601213 | Yun Peng Pharmaceuticals Group Co., Ltd. romanized |
| 2026/05/29Generic · Class 3 | Bumetanide InjectionCYHS2601212 | Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2026/05/29Generic · Class 3 | 阿托伐他汀钙口服混悬液 · No verified English nameCYHS2601211 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/05/29Generic · Class 3 | Dexamethasone Sodium Phosphate InjectionCYHS2601210 | Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized; Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized |
| 2026/05/29New drug · Class 1.1 | 复方内鲁帕尔颗粒 · No verified English nameCXZL2600049 | He Tian Wei Wu Er Pharma Co., Ltd. romanized |
| 2026/05/29New drug · Class 1 | 莱康奇塔单抗注射液(皮下注射) · No verified English nameCXSS2600087 | Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized |
| 2026/05/29New drug · Class 1 | 脐带间充质干细胞注射液 · No verified English nameCXSL2600585 | Shandong Bai Hong Gan Xi Bao Bio Technology Co., Ltd. romanized; Guangdong Bai Hong Gan Xi Bao Zai Sheng Yi Xue Co., Ltd. romanized |
| 2026/05/29New drug · Class 1 | 注射用BL-M14D1 · No verified English nameCXSL2600584 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized |
| 2026/05/29New drug · Class 1 | 注射用SKB571 · No verified English nameCXSL2600583 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/29New drug · Class 1 | 人源肠道菌群胶囊 · No verified English nameCXSL2600582 | Xiamen Cheng Ge Bio Technology Co., Ltd. romanized |
| 2026/05/29New drug · Class 1 | 注射用GB268 · No verified English nameCXSL2600581 | Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized |
| 2026/05/29New drug · Class 1 | Pumitamig注射液 · No verified English nameCXSL2600580 | Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/05/29New drug · Class 2.2; 2.3 | KL1110L干混悬剂 · No verified English nameCXHL2600638 | Haerbin Shi Kang Long Pharma Co., Ltd. romanized |
| 2026/05/29New drug · Class 2.2; 2.3 | KL1110L干混悬剂 · No verified English nameCXHL2600637 | Haerbin Shi Kang Long Pharma Co., Ltd. romanized |
| 2026/05/29New drug · Class 1 | LT010涂剂 · No verified English nameCXHL2600636 | Chengdu Ling Tai Ke Bio Technology Co., Ltd. romanized |
| 2026/05/29New drug · Class 1 | LT010涂剂 · No verified English nameCXHL2600635 | Chengdu Ling Tai Ke Bio Technology Co., Ltd. romanized |
| 2026/05/29New drug · Class 2.4 | BCM758 · No verified English nameCXHL2600634 | Hangzhou He Li Xin Jian Biopharmaceuticals (Group) Co., Ltd. romanized |
| 2026/05/29New drug · Class 1 | HRS-4508片 · No verified English nameCXHL2600633 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/29New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2600632 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/28Import · Class 2.4 | 甲磺酸亮丙瑞林注射液(6M) · No verified English nameJXHS2600057 | Accord BioPharma Inc.; Fareva Pau; Changchun GeneScience Pharmaceuticals Co. Ltd. |
| 2026/05/28Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2601208 | Hubei Ke Tian Pharma Co., Ltd. romanized |
| 2026/05/28Generic · Class 3 | 口服溶液用盐酸万古霉素 · No verified English nameCYHS2601207 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/05/28Generic · Class 3 | 口服溶液用盐酸万古霉素 · No verified English nameCYHS2601206 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/05/28Generic · Class 3 | Sufentanil Citrate InjectionCYHL2600068 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
50 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.