YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 414 drug applications between 22 September 2025 and 28 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 62 drug names.
2025/09/22 – 2025/09/28
- New acceptances this week
- 414
- Drugs with new generic filings (by drug name, de-duplicated)
- 62
- Accepted this week, now under review
- 97
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
414filings, 79 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 214 |
| Generic | 79 |
| New drug | 73 |
| Import | 26 |
| Import re-registration | 12 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 239 |
| TCM | 98 |
| Therapeutic biologic | 70 |
| Prophylactic biologic | 4 |
| Biologic | 2 |
| Unspecified | 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
62 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Mometasone Furoate Cream | 4 | 2 | 16 |
| 2 | Ezetimibe and Atorvastatin Calcium Tablets(II) | 2 | 2 | 9 |
| 3 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 4 | 蒙脱石混悬液 · No verified English name | 2 | 2 | 31 |
| 5 | Acetylcysteine Granules | 2 | 1 | 4 |
| 6 | Tacrolimus Ointment | 2 | 1 | 6 |
| 7 | Carboplatin Injection | 2 | 1 | 10 |
| 8 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 9 | Levocarnitine Oral Solution | 2 | 1 | 9 |
| 10 | 昂丹司琼口溶膜 · No verified English name | 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
257 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Ke Lun Pharma Co., Ltd. romanized | 15 | 2 | 0 |
| 2 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 11 | 8 | 0 |
| 3 | AstraZeneca AB | 9 | 5 | 0 |
| 4 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Otsuka Pharmaceutical Co.,Ltd. | 6 | 1 | 0 |
| 6 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Pfizer Inc. | 4 | 2 | 0 |
| 10 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized | 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/28Import · Class 3.1 | 注射用维布妥昔单抗 · No verified English nameJXSS2500129 | Takeda Pharma A/S; BSP Pharmaceuticals S.p.A.; Takeda (China) International Trading Co. Ltd |
| 2025/09/28Import · Class 1 | Ponsegromab注射液 · No verified English nameJXSL2500189 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/28Import · Class 1 | AZD5335 · No verified English nameJXSL2500188 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/09/28Import · Class 1 | AZD0516 · No verified English nameJXSL2500187 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/09/28Import · Class 1 | EVO756片 · No verified English nameJXHL2500302 | Maruho Co. Ltd.; Linical (Shanghai) Pharmaceutical Technology Co. Ltd. |
| 2025/09/28Import · Class 1 | EVO756片 · No verified English nameJXHL2500301 | Maruho Co. Ltd.; Linical (Shanghai) Pharmaceutical Technology Co. Ltd. |
| 2025/09/28Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2503558 | Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/09/28Generic · Class 3 | 盐酸沙丙蝶呤散剂 · No verified English nameCYHS2503557 | Sichuan De Feng Pharma Co., Ltd. romanized |
| 2025/09/28Generic · Class 3 | Gabexate Mesilate For InjectionCYHS2503554 | Xizang Zhu Feng Shou Gao Bio Pharma Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized |
| 2025/09/28Generic · Class 3 | 昂丹司琼口溶膜 · No verified English nameCYHS2503553 | Fujian Pin Teng Pharma Co., Ltd. romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2025/09/28Generic · Class 3 | 昂丹司琼口溶膜 · No verified English nameCYHS2503552 | Fujian Pin Teng Pharma Co., Ltd. romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2025/09/28Generic · Class 3 | Minoxidil LinimentCYHS2503551 | Tang Shan Hong Xing Pharma Co., Ltd. romanized |
| 2025/09/28Generic · Class 3 | Minoxidil LinimentCYHS2503550 | Tang Shan Hong Xing Pharma Co., Ltd. romanized |
| 2025/09/28Generic · Class 3 | Potassium Aspartate And Magnesium Aspartate InjectionCYHS2503549 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/09/28Generic · Class 3 | Cycloserine CapsulesCYHS2503535 | Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/09/28Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2503533 | Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized |
| 2025/09/28Generic · Class 3 | 聚乙二醇3350散 · No verified English nameCYHS2503532 | Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2025/09/28New drug · Class 1.1 | 金草止咳口服液 · No verified English nameCXZS2500042 | Beijing Lang Zhen Pharmaceuticals Technology Co., Ltd. romanized; Beijing Hua Run Gao Ke Tian Ran Drug Co., Ltd. romanized |
| 2025/09/28New drug · Class 3.1 | 异功散颗粒 · No verified English nameCXZS2500041 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2025/09/28New drug · Class 1.1 | 甲炎康泰颗粒 · No verified English nameCXZL2500089 | Beijing Ying Ke Rui Innovation Pharmaceuticals Co., Ltd. romanized |
| 2025/09/28New drug · Class 1.1 | 知柏清凉颗粒 · No verified English nameCXZL2500088 | Shanghai Shi Biopharmaceuticals Technology Research Institute romanized; Hua Dong Hospital romanized |
| 2025/09/28New drug · Class 1.1 | 平纳蜜膏 · No verified English nameCXZL2500087 | Xin Qi Kang Pharma Co., Ltd. romanized; Xinjiang Qi Mu Pharmaceuticals Research Institute (Co., Ltd.) romanized |
| 2025/09/28New drug · Class 1 | DB006溶瘤腺病毒注射液 · No verified English nameCXSL2500840 | Hainan Ji Min Bo Ao International Hospital Co., Ltd. romanized; Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized |
| 2025/09/28New drug · Class 1 | 注射用XNW28012 · No verified English nameCXSL2500839 | Shanghai Xin Nuo Wei Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/28New drug · Class 1.3 | 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2500838 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
| 2025/09/28New drug · Class 1 | 注射用ZL-1310 · No verified English nameCXSL2500837 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/09/28New drug · Class 1 | JSKN016注射液 · No verified English nameCXSL2500836 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2025/09/28New drug · Class 1 | SSGJ-627注射液(静脉输注) · No verified English nameCXSL2500835 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2025/09/28New drug · Class 1 | HRS-6257片 · No verified English nameCXHL2501047 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/28New drug · Class 1 | HRS-6257片 · No verified English nameCXHL2501046 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
84 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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