YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 431 drug applications between 9 July 2025 and 15 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 112, covering 76 drug names.
2025/07/09 – 2025/07/15
- New acceptances this week
- 431
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- Accepted this week, now under review
- 79
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
431filings, 112 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 190 |
| Generic | 112 |
| New drug | 91 |
| Import | 27 |
| Import re-registration | 9 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 287 |
| TCM | 79 |
| Therapeutic biologic | 62 |
| Biologic | 2 |
| Prophylactic biologic | 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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 4 | 2 | 22 |
| 2 | Empagliflozin Tablets | 4 | 2 | 18 |
| 3 | Minoxidil Liniment | 4 | 2 | 52 |
| 4 | Quetiapine Fumarate Extended-release Tablets | 4 | 1 | 0 |
| 5 | Guanfacine Hydrochloride Extended Release Tablets | 4 | 1 | 4 |
| 6 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 7 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 8 | Ilaprazole Enteric-coated Tablets | 2 | 2 | 26 |
| 9 | 醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English name | 2 | 2 | 2 |
| 10 | 低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name | 2 | 1 | 3 |
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
247 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 17 | 13 | 0 |
| 2 | Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized | 13 | 7 | 13 |
| 3 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 8 | 6 | 0 |
| 4 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 8 | 3 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 2 | 0 |
| 6 | Eli Lilly and Company | 7 | 2 | 0 |
| 7 | AstraZeneca AB | 6 | 3 | 0 |
| 8 | Celgene Corporation | 6 | 1 | 0 |
| 9 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 5 | 4 | 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
163 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/15Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2502531 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized |
| 2025/07/15Generic · Class 3 | Dexamethasone Sodium Phosphate InjectionCYHS2502529 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2025/07/15Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2502527 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
| 2025/07/15Generic · Class 3 | 辅酶Q10片 · No verified English nameCYHS2502526 | Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Hao Ge Pharma Co., Ltd. romanized |
| 2025/07/15New drug · Class 1 | 注射用AK138D1 · No verified English nameCXSL2500593 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/15New drug · Class 1 | OVV-01注射液 · No verified English nameCXSL2500592 | Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/15New drug · Class 1 | OVV-01注射液 · No verified English nameCXSL2500591 | Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/15New drug · Class 1 | 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2500590 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/07/15New drug · Class 1 | 注射用MR001双特异性抗体 · No verified English nameCXSL2500589 | Shenzhen Shi Mai Jia Rui Bio Technology Co., Ltd. romanized |
| 2025/07/14Import · Class 1 | IcoSema 注射液 · No verified English nameJXSL2500122 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2025/07/14Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2502518 | TC Pharmaceuticals (Jiangsu) Co., Ltd |
| 2025/07/14New drug · Class 2.2 | 恩朗苏拜单抗注射液 · No verified English nameCXSL2500588 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/07/14New drug · Class 2.2 | QL2107注射液 · No verified English nameCXSL2500587 | Qilu Pharmaceutical Co., Ltd. |
| 2025/07/14New drug · Class 1 | KDTV001注射液 · No verified English nameCXSL2500586 | Wuhan Kai De Ji Nuo Bio Technology Co., Ltd. romanized |
| 2025/07/14New drug · Class 1 | 注射用QLC5508 · No verified English nameCXSL2500585 | Qilu Pharmaceutical Co., Ltd. |
| 2025/07/14New drug · Class 1 | EVM14注射液 · No verified English nameCXSL2500584 | Yun Ding Xin Yao (Beijing) Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/14New drug · Class 2.3 | BTP4507 · No verified English nameCXHL2500698 | Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2025/07/12Import · Class 1 | AZD5335 · No verified English nameJXSL2500121 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/12Import · Class 2.4 | Sulfur Hexafluoride Microbubbles for InjectionJXHL2500183 | Bracco International B.V.; Bracco Imaging Medical Technologies (Shanghai) Co. Ltd |
| 2025/07/12Import · Class 1 | AZD9574 · No verified English nameJXHL2500182 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/12Import · Class 1 | AZD9574 · No verified English nameJXHL2500181 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/12Import · Class 1 | AZD9574 · No verified English nameJXHL2500180 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/12Import · Class 1 | AZD9574 · No verified English nameJXHL2500179 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/12Generic · Class 3 | 盐酸西替利嗪干糖浆 · No verified English nameCYHS2502516 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized |
| 2025/07/12Generic · Class 3 | Cimetidine InjectionCYHS2502505 | Sen Miao (Shandong) Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2025/07/12Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2502504 | Shanghai Zhao Hui Pharma Co., Ltd. romanized |
| 2025/07/12Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502503 | Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/07/12Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502502 | Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/07/12Generic · Class 3 | Minoxidil LinimentCYHS2502500 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized |
| 2025/07/12Generic · Class 3 | Minoxidil LinimentCYHS2502499 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized |
133 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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