YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 379 drug applications between 7 March 2025 and 13 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 77 drug names.
2025/03/07 – 2025/03/13
- New acceptances this week
- 379
- Drugs with new generic filings (by drug name, de-duplicated)
- 77
- Accepted this week, now under review
- 14
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
379filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 168 |
| Generic | 109 |
| New drug | 47 |
| Import re-registration | 25 |
| Unspecified | 15 |
| Import | 15 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 307 |
| Therapeutic biologic | 34 |
| TCM | 31 |
| Prophylactic biologic | 7 |
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
77 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 7 | 3 | 70 |
| 2 | Brexpiprazole Tablets | 5 | 2 | 31 |
| 3 | 地氯雷他定口服溶液 · No verified English name | 4 | 2 | 26 |
| 4 | Mivacurium Chloride Injection | 4 | 2 | 3 |
| 5 | Levofloxacin and Sodium Chloride Injection | 3 | 1 | 14 |
| 6 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 7 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 8 | Acipimox Capsules | 2 | 2 | 2 |
| 9 | Multiple Vitamins Injection | 2 | 1 | 4 |
| 10 | 甲氧氯普胺片 · 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
214 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized | 18 | 17 | 1 |
| 2 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 17 | 17 | 0 |
| 3 | Bracco Imaging S.P.A. | 13 | 1 | 0 |
| 4 | Fresenius Kabi Deutschland GmbH | 12 | 2 | 0 |
| 5 | Bayer AG | 6 | 3 | 0 |
| 6 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Hubei Wu Shi Pharma Co., Ltd. romanized | 4 | 3 | 4 |
| 8 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 0 |
| 9 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Bayer Vital GmbH | 4 | 1 | 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
91 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/13Import · Class 3.1 | 注射用维替索妥尤单抗 · No verified English nameJXSS2500023 | Seagen Inc.; Baxter Oncology GmbH; Zai Lab(Shanghai) Co. Ltd |
| 2025/03/13Import · Class 1 | MK-7240注射液 · No verified English nameJXSL2500037 | Merck Sharp & Dohme LLC; Name not romanized |
| 2025/03/13Import · Class 1 | SAR441566 · No verified English nameJXHL2500042 | Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd. |
| 2025/03/13Import · Class 1 | LY3549492片 · No verified English nameJXHL2500041 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/13Import · Class 1 | LY3549492片 · No verified English nameJXHL2500040 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/13Import · Class 1 | LY3549492片 · No verified English nameJXHL2500039 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/13Import · Class 1 | LY3549492片 · No verified English nameJXHL2500038 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/13Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2501047 | Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2025/03/13Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2501043 | Chengdu Yao Yi Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized |
| 2025/03/13Generic · Class 3 | Furosemide TabletsCYHS2501040 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/03/13Generic · Class 3 | 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2501039 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2025/03/13Generic · Class 3 | 碘解磷定注射液 · No verified English nameCYHS2501036 | Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized |
| 2025/03/13Generic · Class 3 | Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2501035 | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized |
| 2025/03/13Generic · Class 3 | 盐酸甲氧氯普胺口服溶液 · No verified English nameCYHS2501032 | Shanghai Hai Hong Industrial (Group) Chao Hu Jin Chen Pharma Co., Ltd. romanized |
| 2025/03/13Generic · Class 3 | 注射用醋酸亮丙瑞林混悬液 · No verified English nameCYHL2500060 | Suzhou Shan Wan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/13New drug · Class 3.3 | 戈利木单抗注射液 · No verified English nameCXSS2500036 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/03/13New drug · Class 3.3 | 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSS2500035 | Shanghai Rong Sheng Bio Pharma Co., Ltd. romanized |
| 2025/03/13New drug · Class 1 | EMB-01注射液 · No verified English nameCXSL2500222 | Shanghai An Mai Bio Technology Co., Ltd. romanized |
| 2025/03/13New drug · Class 1 | FWD1802片 · No verified English nameCXHL2500277 | Shenzhen Fu Wo Pharma Co., Ltd. romanized |
| 2025/03/13New drug · Class 1 | FWD1802片 · No verified English nameCXHL2500276 | Shenzhen Fu Wo Pharma Co., Ltd. romanized |
| 2025/03/13New drug · Class 1 | FWD1802片 · No verified English nameCXHL2500275 | Shenzhen Fu Wo Pharma Co., Ltd. romanized |
| 2025/03/13New drug · Class 1 | 注射用KH617 · No verified English nameCXHL2500274 | Sichuan Hong He Bio Technology Co., Ltd. romanized |
| 2025/03/12Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2501026 | Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2025/03/12Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2501025 | Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2025/03/12Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2501019 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2025/03/12Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2501018 | Tianjin He Zhi Pharma Group Co., Ltd. romanized |
| 2025/03/12Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2501017 | Tianjin He Zhi Pharma Group Co., Ltd. romanized |
| 2025/03/12Generic · Class 3 | 羧甲司坦糖浆 · No verified English nameCYHS2501016 | Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2025/03/12Generic · Class 3 | 羧甲司坦糖浆 · No verified English nameCYHS2501015 | Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2025/03/12Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2501014 | Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized |
61 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.